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NICE Endorses Oral Alternative to Chemo in Prostate Cancer
A faster, oral alternative to docetaxel is set to reach NHS clinics after the National Institute for Health and Care Excellence (NICE) recommended darolutamide (Nubeqa, Bayer) in combination with androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer who are unable to receive or tolerate chemotherapy.
Detailed in NICE’s final draft guidance, the decision will make darolutamide available through the NHS in England and Wales to approximately 6000 patients, offering a new oral therapy for those who with limited alternatives to docetaxel or other androgen-receptor inhibitors.
New Option for Chemo-Ineligible Patients
Darolutamide functions by blocking hormones that fuel cancer growth, specifically depriving prostate cancer cells of testosterone required for multiplication and spread. Patients take two tablets twice daily alongside standard ADT.
Peter Johnson, national clinical director for cancer at NHS England, welcomed the decision and expects this approval to give clinicians and their patients “more flexibility to choose the approach best suited to individual circumstances and clinical needs.”
The guidance was finalised 5 weeks ahead of the standard review timeline, underscoring NICE’s commitment to accelerating access to effective prostate cancer treatments.
Clinical Trial Evidence
The NICE’s decision was supported by evidence from the phase 3 ARASENS trial (N = 1306).
The results showed that adding darolutamide to ADT and docetaxel significantly improved overall survival in metastatic hormone-sensitive prostate cancer, reducing the risk for death by 32% compared with ADT and docetaxel alone. Progression-free outcomes, measured by time to castration-resistant disease or death, also favoured darolutamide.
A NICE network meta-analysis of the TITAN, ARCHES, LATITUDE, and STAMPEDE trials suggested that combining ADT with androgen-receptor pathway inhibitors such as apalutamide, enzalutamide, and abiraterone provides comparable survival benefits in this disease setting.
Cost and Implementation
NICE determined that darolutamide plus ADT delivers similar or lower overall costs to the NHS compared with apalutamide plus ADT. The list price is £4040.00 for a 28-day supply (112 × 300-mg tablets), though Bayer has agreed to a confidential commercial discount.
The guidance requires healthcare providers to use the least expensive suitable treatment option, considering administration costs, dosages, price per dose, and commercial arrangements when choosing between darolutamide plus ADT and apalutamide plus ADT.
NHS England and integrated care boards must provide funding within 30 days of final publication, with routine commissioning beginning after this interim period.
A version of this article first appeared on Medscape.com.
A faster, oral alternative to docetaxel is set to reach NHS clinics after the National Institute for Health and Care Excellence (NICE) recommended darolutamide (Nubeqa, Bayer) in combination with androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer who are unable to receive or tolerate chemotherapy.
Detailed in NICE’s final draft guidance, the decision will make darolutamide available through the NHS in England and Wales to approximately 6000 patients, offering a new oral therapy for those who with limited alternatives to docetaxel or other androgen-receptor inhibitors.
New Option for Chemo-Ineligible Patients
Darolutamide functions by blocking hormones that fuel cancer growth, specifically depriving prostate cancer cells of testosterone required for multiplication and spread. Patients take two tablets twice daily alongside standard ADT.
Peter Johnson, national clinical director for cancer at NHS England, welcomed the decision and expects this approval to give clinicians and their patients “more flexibility to choose the approach best suited to individual circumstances and clinical needs.”
The guidance was finalised 5 weeks ahead of the standard review timeline, underscoring NICE’s commitment to accelerating access to effective prostate cancer treatments.
Clinical Trial Evidence
The NICE’s decision was supported by evidence from the phase 3 ARASENS trial (N = 1306).
The results showed that adding darolutamide to ADT and docetaxel significantly improved overall survival in metastatic hormone-sensitive prostate cancer, reducing the risk for death by 32% compared with ADT and docetaxel alone. Progression-free outcomes, measured by time to castration-resistant disease or death, also favoured darolutamide.
A NICE network meta-analysis of the TITAN, ARCHES, LATITUDE, and STAMPEDE trials suggested that combining ADT with androgen-receptor pathway inhibitors such as apalutamide, enzalutamide, and abiraterone provides comparable survival benefits in this disease setting.
Cost and Implementation
NICE determined that darolutamide plus ADT delivers similar or lower overall costs to the NHS compared with apalutamide plus ADT. The list price is £4040.00 for a 28-day supply (112 × 300-mg tablets), though Bayer has agreed to a confidential commercial discount.
The guidance requires healthcare providers to use the least expensive suitable treatment option, considering administration costs, dosages, price per dose, and commercial arrangements when choosing between darolutamide plus ADT and apalutamide plus ADT.
NHS England and integrated care boards must provide funding within 30 days of final publication, with routine commissioning beginning after this interim period.
A version of this article first appeared on Medscape.com.
A faster, oral alternative to docetaxel is set to reach NHS clinics after the National Institute for Health and Care Excellence (NICE) recommended darolutamide (Nubeqa, Bayer) in combination with androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer who are unable to receive or tolerate chemotherapy.
Detailed in NICE’s final draft guidance, the decision will make darolutamide available through the NHS in England and Wales to approximately 6000 patients, offering a new oral therapy for those who with limited alternatives to docetaxel or other androgen-receptor inhibitors.
New Option for Chemo-Ineligible Patients
Darolutamide functions by blocking hormones that fuel cancer growth, specifically depriving prostate cancer cells of testosterone required for multiplication and spread. Patients take two tablets twice daily alongside standard ADT.
Peter Johnson, national clinical director for cancer at NHS England, welcomed the decision and expects this approval to give clinicians and their patients “more flexibility to choose the approach best suited to individual circumstances and clinical needs.”
The guidance was finalised 5 weeks ahead of the standard review timeline, underscoring NICE’s commitment to accelerating access to effective prostate cancer treatments.
Clinical Trial Evidence
The NICE’s decision was supported by evidence from the phase 3 ARASENS trial (N = 1306).
The results showed that adding darolutamide to ADT and docetaxel significantly improved overall survival in metastatic hormone-sensitive prostate cancer, reducing the risk for death by 32% compared with ADT and docetaxel alone. Progression-free outcomes, measured by time to castration-resistant disease or death, also favoured darolutamide.
A NICE network meta-analysis of the TITAN, ARCHES, LATITUDE, and STAMPEDE trials suggested that combining ADT with androgen-receptor pathway inhibitors such as apalutamide, enzalutamide, and abiraterone provides comparable survival benefits in this disease setting.
Cost and Implementation
NICE determined that darolutamide plus ADT delivers similar or lower overall costs to the NHS compared with apalutamide plus ADT. The list price is £4040.00 for a 28-day supply (112 × 300-mg tablets), though Bayer has agreed to a confidential commercial discount.
The guidance requires healthcare providers to use the least expensive suitable treatment option, considering administration costs, dosages, price per dose, and commercial arrangements when choosing between darolutamide plus ADT and apalutamide plus ADT.
NHS England and integrated care boards must provide funding within 30 days of final publication, with routine commissioning beginning after this interim period.
A version of this article first appeared on Medscape.com.
Two ADCs Offer More Hope for Patients With Advanced TNBC
BERLIN — Patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) who are not candidates for immunotherapy may experience improved survival outcomes with TROP2-directed antibody-drug conjugates (ADCs), suggested two trials presented at European Society for Medical Oncology (ESMO) Annual Meeting 2025 on October 19.
ASCENT-03 compared sacituzumab govitecan with standard of care chemotherapy, finding that the drug was associated with a 38% improvement in progression-free survival (PFS) in this patient population that has, traditionally, a poor prognosis. Overall survival data remain immature.
TROPION-Breast02 studied datopotamab deruxtecan (Dato-DXd) against investigator’s choice of chemotherapy. The PFS improvement with the ADC was 43%, while patients also experienced a 21% improvement in overall survival. In both cases, the safety profile of the experimental drugs was deemed to be manageable.
Discussant Ana C. Garrido-Castro, MD, director, Triple-Negative Breast Cancer Research, Dana-Farber Cancer Institute, Boston, who was not involved in either study, said that both sacituzumab govitecan and Dato-DXd showed a PFS benefit. The choice between them, leaving aside overall survival until the data are mature, will be largely based on factors such as the safety profile and the patient preference, she continued.
Sacituzumab govitecan is associated with an increase in neutropenia, nausea, and diarrhea, she pointed out, while Dato-DXd has increased rates of ocular surface toxicity, oral mucositis/stomatitis, and requires monitoring for interstitial lung disease.
Dato-DXd has a higher objective response rate than chemotherapy, unlike sacituzumab govitecan, but, crucially, requires one infusion vs 2 for sacituzumab govitecan per 21-day cycle, and has a shorter total infusion time.
There are nevertheless a number of unanswered questions about the drugs, including how the ADCs affect quality of life, and how common patient adherence to the recommended prophylaxis is. Patients with early relapse of < 12 months remain an “urgent unmet need,” Garrido-Castro said, and the role of immunotherapy rechallenge remains to be explored.
ADCs are also being tested in the neo-adjuvant TNBC setting, and the potential impact of that on the use of the drugs in the metastatic setting is currently unclear. In addition, there are questions around access to therapy.
“Ultimately, it will be very important to have a better understanding of the biomarkers of response and resistance and toxicity to these agents, and whether we should be sequencing antibody drug conjugates,” Garrido-Castro said. “All of this will help shape the next wave of treatment strategies for this patient population.”
She concluded: “Today, marks a paradigm shift of metastatic TNBC, in my opinion. ASCENT-03 and TROPION-Breast02 support TROP2 ADC therapy as the new preferred first-line regimen for this patient population.”
Method and Results of ASCENT-03
ASCENT-03 study presenter Javier C. Cortés, MD, PhD, International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain, said there is currently an unmet clinical need in the approximately 60% of patients with previously untreated metastatic TNBC who are not candidates for immune checkpoint inhibitors.
Median PFS in previous first-line studies was < 6 months with chemotherapy — the current standard of care — and Cortés said that around half of the patients who receive that in the first-line do not receive second-line therapy because of clinical deterioration or death.
“The sobering truth is that across studies in the US and Europe, approximately 25% to 30% of patients diagnosed with metastatic TNBC are no longer alive at 6 months from their metastatic diagnosis,” said Garrido-Castro. “So if there is a new drug that is able to significantly improve PFS with an acceptable toxicity profile, this should be sufficient to change the current standard of care in the first-line setting.”
As sacituzumab govitecan is already approved for second-line metastatic TNBC and for pretreated hormone receptor positive/HER2- metastatic breast cancer, the ASCENT-03 researchers studied the drug in patients with previously untreated locally advanced inoperable, or metastatic TNBC.
The patients were deemed not to be candidates for PD-L1 inhibitors through having PD-L1-negative tumors, by having PD-L1-positive tumors that had previously been treated with PD-L1 inhibitors in the curative setting, or by having a comorbidity that precluded PD-L1 inhibitor use.
The patients were required to have finished any prior treatment in the curative setting at least 6 months previously. Previously treated, stable central nervous system metastases were allowed.
They were randomized to sacituzumab govitecan or chemotherapy, comprising paclitaxel or nab-paclitaxel, or gemcitabine plus carboplatin, until progression, as verified by blinded independent central review (BICR), or unacceptable toxicity. Patients who progressed on chemotherapy were offered crossover to second-line sacituzumab govitecan.
In all, 558 patients were randomized. The median age was 56 years in the sacituzumab govitecan group vs 54 years in the chemotherapy group. The majority (64% in both groups) of patients were White individuals. The most common metastatic site was the lung (59% vs 61%), and 58% of patients in both groups had previously received a taxane.
Cortés reported that sacituzumab govitecan was associated with a “statistically significant and clinically meaningful” improvement in PFS by BICR, at a median of 9.7 months vs 6.9 months, or a hazard ratio (HR) of 0.62 (P < .0001). This benefit was seen across prespecified subgroups.
The objective response rate was almost identical between the two treatment groups, at 48% with sacituzumab govitecan vs 46% with chemotherapy, although the median duration of response was longer with the ADC, at 12.2 months vs 7.2 months.
Cortés showed the latest results on overall survival. This showed no significant difference between the two treatments, although he underlined that the data are not yet mature.
He also reported that the rates of grade ≥ 3 treatment-emergent adverse events (TEAEs) were similar in the two groups, at 66% with sacituzumab govitecan vs 62% with chemotherapy. However, the rates of TEAEs leading to treatment discontinuation (4% vs 12%) or dose reduction (37% vs 45%) were lower with the ADC.
Cortés concluded that the results suggest that sacituzumab govitecan “is a good option for patients with triple negative breast cancer when they develop metastasis and are unable to receive immune checkpoint inhibitors.”
TROPION-Breast02 Methods and Results
Presenting TROPION-Breast02, Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, explained that the trial looked at a patient population similar to that of ASCENT-03, here focusing instead on Dato-DXd.
Patients were included if they had histologically or cytologically documented locally recurrent inoperable or metastatic TNBC, no prior chemotherapy or targeted systemic therapy in this setting, and in whom immunotherapy was not an option.
They were randomized to Dato-DXd or the investigator’s choice of chemotherapy, with treatment continued until investigator-assessed progressive disease on RECIST v1.1, unacceptable toxicity, or another criterion for discontinuation was met.
In total, 642 patients were enrolled. The median age was 56 years for those in the Dato-DXd group and 57 years for those in chemotherapy group, and less than half (41% in the Dato-DXd group and 48% in the chemotherapy group) were White individuals. The number of metastatic sites was less than three in 64% and 67% of patients, respectively.
Dent showed that Dato-DXd was associated with a statistically significant and clinically meaningful improvement in BICR-assessed PFS, at a median of 10.8 months vs 5.6 months with chemotherapy, at a HR of 0.57 (P < .0001). The findings were replicated across the prespecified subgroups.
There was a marked overall survival benefit with Dato-DXd, at a median of 23.7 months vs 18.7 months, at a HR of 0.79 (P = .0291). Dent reported that, at 18 months, 61.2% of patients in the Dato-DXd group were still alive vs 51.3% in the chemotherapy group. Again, the benefit was seen across subgroups.
The confirmed objective response rate with Dato-DXd was far higher than that with chemotherapy, at 62.5% vs 29.3%, or an odds ratio of 4.24. The duration of response was also longer, at 12.3 months vs 7.1 months.
Rates of grade ≥ 3 adverse events were comparable, at 33% with Dato-DXd vs 29% with chemotherapy, although there were more events associated with dose reduction (27% vs 18%) and dose interruption (24% vs 19%) with the ADC.
“These results support Dato-DXd as the first new first-line standard of care for patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy is not an option,” Dent said.
“What’s important is the patients enrolled into this trial are clearly representative of real world patients that we are treating in our clinics every day. These patients are often excluded from our current clinical trials,” she said.
ASCENT-03 was funded by Gilead Sciences.
TROPION-Breast02 was funded by AstraZeneca.Cortés declared relationships with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Lilly, Merck Sharpe & Dohme, Leuko, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, Scorpion Therapeutics, Bridgebio, Biocon, Biontech, Circle Pharma, Delcath Systems, Hexagon Bio, Novartis, Eisai, Pfizer, Stemline Therapeutics, MAJ3 Capital, Leuko, Ariad Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer healthcare, Guardant Health, and PIQUR Therapeutics.
Dent declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, and Gilead Sciences.
Garrido-Castro declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, Gilead Sciences, Pfizer, TD Cowen, and Roche/Genentech.
A version of this article first appeared on Medscape.com.
BERLIN — Patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) who are not candidates for immunotherapy may experience improved survival outcomes with TROP2-directed antibody-drug conjugates (ADCs), suggested two trials presented at European Society for Medical Oncology (ESMO) Annual Meeting 2025 on October 19.
ASCENT-03 compared sacituzumab govitecan with standard of care chemotherapy, finding that the drug was associated with a 38% improvement in progression-free survival (PFS) in this patient population that has, traditionally, a poor prognosis. Overall survival data remain immature.
TROPION-Breast02 studied datopotamab deruxtecan (Dato-DXd) against investigator’s choice of chemotherapy. The PFS improvement with the ADC was 43%, while patients also experienced a 21% improvement in overall survival. In both cases, the safety profile of the experimental drugs was deemed to be manageable.
Discussant Ana C. Garrido-Castro, MD, director, Triple-Negative Breast Cancer Research, Dana-Farber Cancer Institute, Boston, who was not involved in either study, said that both sacituzumab govitecan and Dato-DXd showed a PFS benefit. The choice between them, leaving aside overall survival until the data are mature, will be largely based on factors such as the safety profile and the patient preference, she continued.
Sacituzumab govitecan is associated with an increase in neutropenia, nausea, and diarrhea, she pointed out, while Dato-DXd has increased rates of ocular surface toxicity, oral mucositis/stomatitis, and requires monitoring for interstitial lung disease.
Dato-DXd has a higher objective response rate than chemotherapy, unlike sacituzumab govitecan, but, crucially, requires one infusion vs 2 for sacituzumab govitecan per 21-day cycle, and has a shorter total infusion time.
There are nevertheless a number of unanswered questions about the drugs, including how the ADCs affect quality of life, and how common patient adherence to the recommended prophylaxis is. Patients with early relapse of < 12 months remain an “urgent unmet need,” Garrido-Castro said, and the role of immunotherapy rechallenge remains to be explored.
ADCs are also being tested in the neo-adjuvant TNBC setting, and the potential impact of that on the use of the drugs in the metastatic setting is currently unclear. In addition, there are questions around access to therapy.
“Ultimately, it will be very important to have a better understanding of the biomarkers of response and resistance and toxicity to these agents, and whether we should be sequencing antibody drug conjugates,” Garrido-Castro said. “All of this will help shape the next wave of treatment strategies for this patient population.”
She concluded: “Today, marks a paradigm shift of metastatic TNBC, in my opinion. ASCENT-03 and TROPION-Breast02 support TROP2 ADC therapy as the new preferred first-line regimen for this patient population.”
Method and Results of ASCENT-03
ASCENT-03 study presenter Javier C. Cortés, MD, PhD, International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain, said there is currently an unmet clinical need in the approximately 60% of patients with previously untreated metastatic TNBC who are not candidates for immune checkpoint inhibitors.
Median PFS in previous first-line studies was < 6 months with chemotherapy — the current standard of care — and Cortés said that around half of the patients who receive that in the first-line do not receive second-line therapy because of clinical deterioration or death.
“The sobering truth is that across studies in the US and Europe, approximately 25% to 30% of patients diagnosed with metastatic TNBC are no longer alive at 6 months from their metastatic diagnosis,” said Garrido-Castro. “So if there is a new drug that is able to significantly improve PFS with an acceptable toxicity profile, this should be sufficient to change the current standard of care in the first-line setting.”
As sacituzumab govitecan is already approved for second-line metastatic TNBC and for pretreated hormone receptor positive/HER2- metastatic breast cancer, the ASCENT-03 researchers studied the drug in patients with previously untreated locally advanced inoperable, or metastatic TNBC.
The patients were deemed not to be candidates for PD-L1 inhibitors through having PD-L1-negative tumors, by having PD-L1-positive tumors that had previously been treated with PD-L1 inhibitors in the curative setting, or by having a comorbidity that precluded PD-L1 inhibitor use.
The patients were required to have finished any prior treatment in the curative setting at least 6 months previously. Previously treated, stable central nervous system metastases were allowed.
They were randomized to sacituzumab govitecan or chemotherapy, comprising paclitaxel or nab-paclitaxel, or gemcitabine plus carboplatin, until progression, as verified by blinded independent central review (BICR), or unacceptable toxicity. Patients who progressed on chemotherapy were offered crossover to second-line sacituzumab govitecan.
In all, 558 patients were randomized. The median age was 56 years in the sacituzumab govitecan group vs 54 years in the chemotherapy group. The majority (64% in both groups) of patients were White individuals. The most common metastatic site was the lung (59% vs 61%), and 58% of patients in both groups had previously received a taxane.
Cortés reported that sacituzumab govitecan was associated with a “statistically significant and clinically meaningful” improvement in PFS by BICR, at a median of 9.7 months vs 6.9 months, or a hazard ratio (HR) of 0.62 (P < .0001). This benefit was seen across prespecified subgroups.
The objective response rate was almost identical between the two treatment groups, at 48% with sacituzumab govitecan vs 46% with chemotherapy, although the median duration of response was longer with the ADC, at 12.2 months vs 7.2 months.
Cortés showed the latest results on overall survival. This showed no significant difference between the two treatments, although he underlined that the data are not yet mature.
He also reported that the rates of grade ≥ 3 treatment-emergent adverse events (TEAEs) were similar in the two groups, at 66% with sacituzumab govitecan vs 62% with chemotherapy. However, the rates of TEAEs leading to treatment discontinuation (4% vs 12%) or dose reduction (37% vs 45%) were lower with the ADC.
Cortés concluded that the results suggest that sacituzumab govitecan “is a good option for patients with triple negative breast cancer when they develop metastasis and are unable to receive immune checkpoint inhibitors.”
TROPION-Breast02 Methods and Results
Presenting TROPION-Breast02, Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, explained that the trial looked at a patient population similar to that of ASCENT-03, here focusing instead on Dato-DXd.
Patients were included if they had histologically or cytologically documented locally recurrent inoperable or metastatic TNBC, no prior chemotherapy or targeted systemic therapy in this setting, and in whom immunotherapy was not an option.
They were randomized to Dato-DXd or the investigator’s choice of chemotherapy, with treatment continued until investigator-assessed progressive disease on RECIST v1.1, unacceptable toxicity, or another criterion for discontinuation was met.
In total, 642 patients were enrolled. The median age was 56 years for those in the Dato-DXd group and 57 years for those in chemotherapy group, and less than half (41% in the Dato-DXd group and 48% in the chemotherapy group) were White individuals. The number of metastatic sites was less than three in 64% and 67% of patients, respectively.
Dent showed that Dato-DXd was associated with a statistically significant and clinically meaningful improvement in BICR-assessed PFS, at a median of 10.8 months vs 5.6 months with chemotherapy, at a HR of 0.57 (P < .0001). The findings were replicated across the prespecified subgroups.
There was a marked overall survival benefit with Dato-DXd, at a median of 23.7 months vs 18.7 months, at a HR of 0.79 (P = .0291). Dent reported that, at 18 months, 61.2% of patients in the Dato-DXd group were still alive vs 51.3% in the chemotherapy group. Again, the benefit was seen across subgroups.
The confirmed objective response rate with Dato-DXd was far higher than that with chemotherapy, at 62.5% vs 29.3%, or an odds ratio of 4.24. The duration of response was also longer, at 12.3 months vs 7.1 months.
Rates of grade ≥ 3 adverse events were comparable, at 33% with Dato-DXd vs 29% with chemotherapy, although there were more events associated with dose reduction (27% vs 18%) and dose interruption (24% vs 19%) with the ADC.
“These results support Dato-DXd as the first new first-line standard of care for patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy is not an option,” Dent said.
“What’s important is the patients enrolled into this trial are clearly representative of real world patients that we are treating in our clinics every day. These patients are often excluded from our current clinical trials,” she said.
ASCENT-03 was funded by Gilead Sciences.
TROPION-Breast02 was funded by AstraZeneca.Cortés declared relationships with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Lilly, Merck Sharpe & Dohme, Leuko, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, Scorpion Therapeutics, Bridgebio, Biocon, Biontech, Circle Pharma, Delcath Systems, Hexagon Bio, Novartis, Eisai, Pfizer, Stemline Therapeutics, MAJ3 Capital, Leuko, Ariad Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer healthcare, Guardant Health, and PIQUR Therapeutics.
Dent declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, and Gilead Sciences.
Garrido-Castro declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, Gilead Sciences, Pfizer, TD Cowen, and Roche/Genentech.
A version of this article first appeared on Medscape.com.
BERLIN — Patients with previously untreated locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) who are not candidates for immunotherapy may experience improved survival outcomes with TROP2-directed antibody-drug conjugates (ADCs), suggested two trials presented at European Society for Medical Oncology (ESMO) Annual Meeting 2025 on October 19.
ASCENT-03 compared sacituzumab govitecan with standard of care chemotherapy, finding that the drug was associated with a 38% improvement in progression-free survival (PFS) in this patient population that has, traditionally, a poor prognosis. Overall survival data remain immature.
TROPION-Breast02 studied datopotamab deruxtecan (Dato-DXd) against investigator’s choice of chemotherapy. The PFS improvement with the ADC was 43%, while patients also experienced a 21% improvement in overall survival. In both cases, the safety profile of the experimental drugs was deemed to be manageable.
Discussant Ana C. Garrido-Castro, MD, director, Triple-Negative Breast Cancer Research, Dana-Farber Cancer Institute, Boston, who was not involved in either study, said that both sacituzumab govitecan and Dato-DXd showed a PFS benefit. The choice between them, leaving aside overall survival until the data are mature, will be largely based on factors such as the safety profile and the patient preference, she continued.
Sacituzumab govitecan is associated with an increase in neutropenia, nausea, and diarrhea, she pointed out, while Dato-DXd has increased rates of ocular surface toxicity, oral mucositis/stomatitis, and requires monitoring for interstitial lung disease.
Dato-DXd has a higher objective response rate than chemotherapy, unlike sacituzumab govitecan, but, crucially, requires one infusion vs 2 for sacituzumab govitecan per 21-day cycle, and has a shorter total infusion time.
There are nevertheless a number of unanswered questions about the drugs, including how the ADCs affect quality of life, and how common patient adherence to the recommended prophylaxis is. Patients with early relapse of < 12 months remain an “urgent unmet need,” Garrido-Castro said, and the role of immunotherapy rechallenge remains to be explored.
ADCs are also being tested in the neo-adjuvant TNBC setting, and the potential impact of that on the use of the drugs in the metastatic setting is currently unclear. In addition, there are questions around access to therapy.
“Ultimately, it will be very important to have a better understanding of the biomarkers of response and resistance and toxicity to these agents, and whether we should be sequencing antibody drug conjugates,” Garrido-Castro said. “All of this will help shape the next wave of treatment strategies for this patient population.”
She concluded: “Today, marks a paradigm shift of metastatic TNBC, in my opinion. ASCENT-03 and TROPION-Breast02 support TROP2 ADC therapy as the new preferred first-line regimen for this patient population.”
Method and Results of ASCENT-03
ASCENT-03 study presenter Javier C. Cortés, MD, PhD, International Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain, said there is currently an unmet clinical need in the approximately 60% of patients with previously untreated metastatic TNBC who are not candidates for immune checkpoint inhibitors.
Median PFS in previous first-line studies was < 6 months with chemotherapy — the current standard of care — and Cortés said that around half of the patients who receive that in the first-line do not receive second-line therapy because of clinical deterioration or death.
“The sobering truth is that across studies in the US and Europe, approximately 25% to 30% of patients diagnosed with metastatic TNBC are no longer alive at 6 months from their metastatic diagnosis,” said Garrido-Castro. “So if there is a new drug that is able to significantly improve PFS with an acceptable toxicity profile, this should be sufficient to change the current standard of care in the first-line setting.”
As sacituzumab govitecan is already approved for second-line metastatic TNBC and for pretreated hormone receptor positive/HER2- metastatic breast cancer, the ASCENT-03 researchers studied the drug in patients with previously untreated locally advanced inoperable, or metastatic TNBC.
The patients were deemed not to be candidates for PD-L1 inhibitors through having PD-L1-negative tumors, by having PD-L1-positive tumors that had previously been treated with PD-L1 inhibitors in the curative setting, or by having a comorbidity that precluded PD-L1 inhibitor use.
The patients were required to have finished any prior treatment in the curative setting at least 6 months previously. Previously treated, stable central nervous system metastases were allowed.
They were randomized to sacituzumab govitecan or chemotherapy, comprising paclitaxel or nab-paclitaxel, or gemcitabine plus carboplatin, until progression, as verified by blinded independent central review (BICR), or unacceptable toxicity. Patients who progressed on chemotherapy were offered crossover to second-line sacituzumab govitecan.
In all, 558 patients were randomized. The median age was 56 years in the sacituzumab govitecan group vs 54 years in the chemotherapy group. The majority (64% in both groups) of patients were White individuals. The most common metastatic site was the lung (59% vs 61%), and 58% of patients in both groups had previously received a taxane.
Cortés reported that sacituzumab govitecan was associated with a “statistically significant and clinically meaningful” improvement in PFS by BICR, at a median of 9.7 months vs 6.9 months, or a hazard ratio (HR) of 0.62 (P < .0001). This benefit was seen across prespecified subgroups.
The objective response rate was almost identical between the two treatment groups, at 48% with sacituzumab govitecan vs 46% with chemotherapy, although the median duration of response was longer with the ADC, at 12.2 months vs 7.2 months.
Cortés showed the latest results on overall survival. This showed no significant difference between the two treatments, although he underlined that the data are not yet mature.
He also reported that the rates of grade ≥ 3 treatment-emergent adverse events (TEAEs) were similar in the two groups, at 66% with sacituzumab govitecan vs 62% with chemotherapy. However, the rates of TEAEs leading to treatment discontinuation (4% vs 12%) or dose reduction (37% vs 45%) were lower with the ADC.
Cortés concluded that the results suggest that sacituzumab govitecan “is a good option for patients with triple negative breast cancer when they develop metastasis and are unable to receive immune checkpoint inhibitors.”
TROPION-Breast02 Methods and Results
Presenting TROPION-Breast02, Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, explained that the trial looked at a patient population similar to that of ASCENT-03, here focusing instead on Dato-DXd.
Patients were included if they had histologically or cytologically documented locally recurrent inoperable or metastatic TNBC, no prior chemotherapy or targeted systemic therapy in this setting, and in whom immunotherapy was not an option.
They were randomized to Dato-DXd or the investigator’s choice of chemotherapy, with treatment continued until investigator-assessed progressive disease on RECIST v1.1, unacceptable toxicity, or another criterion for discontinuation was met.
In total, 642 patients were enrolled. The median age was 56 years for those in the Dato-DXd group and 57 years for those in chemotherapy group, and less than half (41% in the Dato-DXd group and 48% in the chemotherapy group) were White individuals. The number of metastatic sites was less than three in 64% and 67% of patients, respectively.
Dent showed that Dato-DXd was associated with a statistically significant and clinically meaningful improvement in BICR-assessed PFS, at a median of 10.8 months vs 5.6 months with chemotherapy, at a HR of 0.57 (P < .0001). The findings were replicated across the prespecified subgroups.
There was a marked overall survival benefit with Dato-DXd, at a median of 23.7 months vs 18.7 months, at a HR of 0.79 (P = .0291). Dent reported that, at 18 months, 61.2% of patients in the Dato-DXd group were still alive vs 51.3% in the chemotherapy group. Again, the benefit was seen across subgroups.
The confirmed objective response rate with Dato-DXd was far higher than that with chemotherapy, at 62.5% vs 29.3%, or an odds ratio of 4.24. The duration of response was also longer, at 12.3 months vs 7.1 months.
Rates of grade ≥ 3 adverse events were comparable, at 33% with Dato-DXd vs 29% with chemotherapy, although there were more events associated with dose reduction (27% vs 18%) and dose interruption (24% vs 19%) with the ADC.
“These results support Dato-DXd as the first new first-line standard of care for patients with locally recurrent inoperable or metastatic TNBC for whom immunotherapy is not an option,” Dent said.
“What’s important is the patients enrolled into this trial are clearly representative of real world patients that we are treating in our clinics every day. These patients are often excluded from our current clinical trials,” she said.
ASCENT-03 was funded by Gilead Sciences.
TROPION-Breast02 was funded by AstraZeneca.Cortés declared relationships with Roche, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Lilly, Merck Sharpe & Dohme, Leuko, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies, Jazz Pharmaceuticals, AbbVie, Scorpion Therapeutics, Bridgebio, Biocon, Biontech, Circle Pharma, Delcath Systems, Hexagon Bio, Novartis, Eisai, Pfizer, Stemline Therapeutics, MAJ3 Capital, Leuko, Ariad Pharmaceuticals, Baxalta GmbH/Servier Affaires, Bayer healthcare, Guardant Health, and PIQUR Therapeutics.
Dent declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, and Gilead Sciences.
Garrido-Castro declared relationships with AstraZeneca, MSD, Pfizer, Eisai, Novartis, Daiichi Sankyo/AstraZeneca, Roche, Gilead Sciences, Pfizer, TD Cowen, and Roche/Genentech.
A version of this article first appeared on Medscape.com.
FROM ESMO 2025
Is High Quality VA Psychiatric Care Keeping Readmissions Rates Low?
Repeated and frequent hospitalizations—sometimes referred to as the revolving door phenomenon— are a particular risk for patients during the first month after discharge. Early psychiatric readmission is a standard indicator of adverse outcomes. However, the results
The quality of previous care has long been thought to be a driver of readmission. If that’s the case, a 2025 study suggests that on average veterans received high-quality inpatient psychiatric services at Veterans Health Administration (VHA) facilities across the nation and that may have been key to keeping readmissions down. Analyzing data from 88,954 veterans who received care at VHA Inpatient Mental Health (IMH) services, the researchers found a “relatively low” rate of readmission within 30 days: 7.1% compared with 8% to 31% of other psychiatric patients in the US. With 40,220 unique patients receiving IMH care per year on average between October 2019 and September 2022, a 7.1% readmission rate means > 2800 30-day readmissions annually.
Research has found that veterans who receive care at the VA have better outcomes than those treated in the private sector. Part of that has to do with practitioners who understand the unique needs of their patients. Veterans may have posttraumatic stress disorder or multiple diagnoses, such as depression, panic disorder, and a substance use disorder. Their mental health issues may also coexist with physical health problems, such as traumatic brain injuries due to explosions.
“If you’re trained at the VA, you learn something important about veteran mental health care that you’ll never get if you’re trained someplace else,” Rodney R. Baker, PhD, retired mental health director and chief of psychology for the South Texas VA Health Care System, said recently. Community clinicians may not know how to collect and incorporate information about a patient’s military history, including details about deployments, combat exposure, injuries, military sexual trauma, and unit culture. They may also lack expertise in navigating the transition between military and veteran life, now considered a critical adjustment period.
“This is a unique population,” said Conwell Smith, the American Psychological Association’s deputy chief of military and veteran policy. “Sending veterans out to the community without requiring that mental health care providers understand them is concerning.”
IMH services aim to stabilize mental health crises and improve veterans’ functioning through patient-centered, evidence-based, and recovery-oriented approaches shown to reduce readmission rates. Treatment generally involves a minimum of 4 hours of interdisciplinary, therapeutic programming each day. And upon discharge, the inpatient care team facilitates the patient’s transition to appropriate outpatient services.
Follow-up care, particularly during the first 30 days, has proved critical in reducing readmissions. In studies that have analyzed postdischarge interventions (psychoeducation, mentoring, community-based hospital treatment, use of continuous follow-up and compulsory community treatment), all found fewer hospitalizations when compared to a control group, or a smaller number of admissions after the intervention.
Mental health care for veterans should be provided by experienced practitioners—but those practitioners are leaving VA. According to the VA Office of Inspector General, 57% of medical centers report a shortage of psychologists. And according to the VA’s monthly Workforce Dashboard, the VHA lost 234 psychologists in the first 9 months of 2025. The VA has also announced plans to cut 30,000 jobs by the end of the year and impose caps on staff at every medical center.
“This approach locks in permanent VA understaffing just as demand for mental health services is projected to continue growing through 2030,” said Russell Lemle, PhD, a clinical psychologist and senior policy analyst for the Veterans Healthcare Policy Institute. “The private sector can’t fill this gap either—over a third of Americans live in areas already facing mental health professional shortages. That’s not taking care of our veterans.
“Unless actions are taken quickly to reverse the trend, its mental health services could easily diminish substantially within 10 to 20 years.”
Repeated and frequent hospitalizations—sometimes referred to as the revolving door phenomenon— are a particular risk for patients during the first month after discharge. Early psychiatric readmission is a standard indicator of adverse outcomes. However, the results
The quality of previous care has long been thought to be a driver of readmission. If that’s the case, a 2025 study suggests that on average veterans received high-quality inpatient psychiatric services at Veterans Health Administration (VHA) facilities across the nation and that may have been key to keeping readmissions down. Analyzing data from 88,954 veterans who received care at VHA Inpatient Mental Health (IMH) services, the researchers found a “relatively low” rate of readmission within 30 days: 7.1% compared with 8% to 31% of other psychiatric patients in the US. With 40,220 unique patients receiving IMH care per year on average between October 2019 and September 2022, a 7.1% readmission rate means > 2800 30-day readmissions annually.
Research has found that veterans who receive care at the VA have better outcomes than those treated in the private sector. Part of that has to do with practitioners who understand the unique needs of their patients. Veterans may have posttraumatic stress disorder or multiple diagnoses, such as depression, panic disorder, and a substance use disorder. Their mental health issues may also coexist with physical health problems, such as traumatic brain injuries due to explosions.
“If you’re trained at the VA, you learn something important about veteran mental health care that you’ll never get if you’re trained someplace else,” Rodney R. Baker, PhD, retired mental health director and chief of psychology for the South Texas VA Health Care System, said recently. Community clinicians may not know how to collect and incorporate information about a patient’s military history, including details about deployments, combat exposure, injuries, military sexual trauma, and unit culture. They may also lack expertise in navigating the transition between military and veteran life, now considered a critical adjustment period.
“This is a unique population,” said Conwell Smith, the American Psychological Association’s deputy chief of military and veteran policy. “Sending veterans out to the community without requiring that mental health care providers understand them is concerning.”
IMH services aim to stabilize mental health crises and improve veterans’ functioning through patient-centered, evidence-based, and recovery-oriented approaches shown to reduce readmission rates. Treatment generally involves a minimum of 4 hours of interdisciplinary, therapeutic programming each day. And upon discharge, the inpatient care team facilitates the patient’s transition to appropriate outpatient services.
Follow-up care, particularly during the first 30 days, has proved critical in reducing readmissions. In studies that have analyzed postdischarge interventions (psychoeducation, mentoring, community-based hospital treatment, use of continuous follow-up and compulsory community treatment), all found fewer hospitalizations when compared to a control group, or a smaller number of admissions after the intervention.
Mental health care for veterans should be provided by experienced practitioners—but those practitioners are leaving VA. According to the VA Office of Inspector General, 57% of medical centers report a shortage of psychologists. And according to the VA’s monthly Workforce Dashboard, the VHA lost 234 psychologists in the first 9 months of 2025. The VA has also announced plans to cut 30,000 jobs by the end of the year and impose caps on staff at every medical center.
“This approach locks in permanent VA understaffing just as demand for mental health services is projected to continue growing through 2030,” said Russell Lemle, PhD, a clinical psychologist and senior policy analyst for the Veterans Healthcare Policy Institute. “The private sector can’t fill this gap either—over a third of Americans live in areas already facing mental health professional shortages. That’s not taking care of our veterans.
“Unless actions are taken quickly to reverse the trend, its mental health services could easily diminish substantially within 10 to 20 years.”
Repeated and frequent hospitalizations—sometimes referred to as the revolving door phenomenon— are a particular risk for patients during the first month after discharge. Early psychiatric readmission is a standard indicator of adverse outcomes. However, the results
The quality of previous care has long been thought to be a driver of readmission. If that’s the case, a 2025 study suggests that on average veterans received high-quality inpatient psychiatric services at Veterans Health Administration (VHA) facilities across the nation and that may have been key to keeping readmissions down. Analyzing data from 88,954 veterans who received care at VHA Inpatient Mental Health (IMH) services, the researchers found a “relatively low” rate of readmission within 30 days: 7.1% compared with 8% to 31% of other psychiatric patients in the US. With 40,220 unique patients receiving IMH care per year on average between October 2019 and September 2022, a 7.1% readmission rate means > 2800 30-day readmissions annually.
Research has found that veterans who receive care at the VA have better outcomes than those treated in the private sector. Part of that has to do with practitioners who understand the unique needs of their patients. Veterans may have posttraumatic stress disorder or multiple diagnoses, such as depression, panic disorder, and a substance use disorder. Their mental health issues may also coexist with physical health problems, such as traumatic brain injuries due to explosions.
“If you’re trained at the VA, you learn something important about veteran mental health care that you’ll never get if you’re trained someplace else,” Rodney R. Baker, PhD, retired mental health director and chief of psychology for the South Texas VA Health Care System, said recently. Community clinicians may not know how to collect and incorporate information about a patient’s military history, including details about deployments, combat exposure, injuries, military sexual trauma, and unit culture. They may also lack expertise in navigating the transition between military and veteran life, now considered a critical adjustment period.
“This is a unique population,” said Conwell Smith, the American Psychological Association’s deputy chief of military and veteran policy. “Sending veterans out to the community without requiring that mental health care providers understand them is concerning.”
IMH services aim to stabilize mental health crises and improve veterans’ functioning through patient-centered, evidence-based, and recovery-oriented approaches shown to reduce readmission rates. Treatment generally involves a minimum of 4 hours of interdisciplinary, therapeutic programming each day. And upon discharge, the inpatient care team facilitates the patient’s transition to appropriate outpatient services.
Follow-up care, particularly during the first 30 days, has proved critical in reducing readmissions. In studies that have analyzed postdischarge interventions (psychoeducation, mentoring, community-based hospital treatment, use of continuous follow-up and compulsory community treatment), all found fewer hospitalizations when compared to a control group, or a smaller number of admissions after the intervention.
Mental health care for veterans should be provided by experienced practitioners—but those practitioners are leaving VA. According to the VA Office of Inspector General, 57% of medical centers report a shortage of psychologists. And according to the VA’s monthly Workforce Dashboard, the VHA lost 234 psychologists in the first 9 months of 2025. The VA has also announced plans to cut 30,000 jobs by the end of the year and impose caps on staff at every medical center.
“This approach locks in permanent VA understaffing just as demand for mental health services is projected to continue growing through 2030,” said Russell Lemle, PhD, a clinical psychologist and senior policy analyst for the Veterans Healthcare Policy Institute. “The private sector can’t fill this gap either—over a third of Americans live in areas already facing mental health professional shortages. That’s not taking care of our veterans.
“Unless actions are taken quickly to reverse the trend, its mental health services could easily diminish substantially within 10 to 20 years.”
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
It's hardly news that the United States is experiencing a mental health crisis -- the CDC says as much. But experts in the field say that the current administration has severely compounded the problem by eliminating agency funding and national programs, slashing research grants and data resources, and creating new barriers to behavioral health care.
Philanthropic foundations aim to do what they can to address the shortfall. The numbers, however, just don't add up.
"Some big foundations and philanthropies have said they're going to increase what they give out in the next 4 years, but they'll never be able to fill the gap," said Morgan F. McDonald, MD, national director of population health at the Milbank Memorial Fund in New York City, which works with states on health policy. "Even if every one of them were to spend down their endowments, they still couldn't."
Given the financial limitations, some foundations are taking a different tack. While looking for ways to join forces with fellow nonprofits, they are providing emergency grants to bridge funding in the short term to keep research from grinding to a halt.
Budget Cuts Reach Far and Wide
Mental health research certainly didn't escape the extensive grant cancellations at the National Institutes of Health and the National Science Foundation.
"It's already affecting our ability to stay on the cutting edge of research, best practices, and treatment approaches," said Zainab Okolo, EdD, senior vice president of policy, advocacy, and government relations at The Jed Foundation in New York City, which focuses on the emotional health of teens and young adults.
The upheaval is evident in an array of government agencies. The Health Resources and Services Administration, which last year awarded $12 billion in grants to community health centers and addiction treatment services, has seen > one-fourth of its staff eliminated. The Substance Abuse and Mental Health Services Administration has lost more than a third of its staff as federal cuts took a $1 billion bite out of its operating budget. The Education Department has halted $1 billion in grants used to hire mental health workers in school districts nationwide.
"We're very, very concerned about cuts to behavioral health systems," said Alonzo Plough, PhD, chief science officer at the Robert Wood Johnson Foundation in Princeton, New Jersey. "Doctors and nurses working in safety-net clinics are seeing tremendous reductions."
All in all, the new tax and spending law means $1 trillion in cuts to health care programs including Medicaid -- the nation's largest payer for mental health services -- Medicare, and Affordable Care Act insurance. An estimated 10 million Americans are expected to lose their health coverage as a result.
"When accessibility to care goes down, there's a chance that more people will die by suicide," said Jill Harkavy-Friedman, PhD, senior vice president of research at the American Foundation for Suicide Prevention. "But it also means people will come into care later in the course of their difficulties. Health professionals will be dealing with worse problems."
Foundations Take Emergency Measures
Even if private dollars can't replace what's been lost, philanthropic and medical foundations are stepping up.
We're seeing a lot of foundations and funders that are shifting their funding," said Alyson Niemann, CEO of Mindful Philanthropy, an organization that works with > 1000 private funders to marshal resources for mental health. This year, in response to federal cuts, "many increased funding to health and well-being, doubling or even tripling it," Niemann noted.
"They're making a great deal of effort to respond with emergency funds, really getting in the trenches and being good partners to their grantees," she said. "We've seen them asking deliberate questions, thinking about where their funding can have the most impact."
The American Psychological Foundation (APF), a longtime supporter of research and innovation, is addressing the current crisis with 2 initiatives, Michelle Quist Ryder, PhD, the organization's CEO, explained in an email. The first is APF Director Action, which funds innovative interventions at the community level. The second, Direct Action Crisis Funding Grants, will help continue research that is at risk of stalling because of budget cuts.
"Studies that are 'paused' or lose funding often cannot simply pick back up where they left off. Having to halt progress on a project can invalidate the work already completed," Ryder wrote. "These Direct Action Crisis Grants help bridge funding gaps and keep research viable."
At the same time, collaboration between foundations is becoming more widespread as they seek to maximize their impact. Philanthropic organizations are sharing ideas and best practices as well as pooling fundings.
"The goal of philanthropy is to help people," Harkavy-Friedman said. "There's strength in numbers and more dollars in numbers."
Some See Hope in Raised Voices
Despite the emergency scrambling, many of those in the trenches remain surprisingly optimistic. Some point out that the current turmoil has put a helpful spotlight on behavioral health care. Practitioners, meanwhile, have an essential role to play.
"There's a reason that things were the way they were: People advocated for many years to get where we've gotten," Harkavy-Friedman said, citing veterans' mental health care, the national violent death reporting system, and 988 as examples. "We have to raise our voices louder -- professionals in particular, because they know the impact a person in the general public many not fully grasp."
As a growing numbers of health professionals call attention to the damage wrought by deep cuts in the federal budget, foundation executives see an opportunity.
"In the mental health field, there's a deficit in the narrative, where there's a lot of focus on crisis. What we're hoping to do is shift the narrative toward 'How do we flourish together?'" Niemann said. "Sometimes deficits are where the most incredible innovations appear."
Debbie Koenig is a health writer whose work has been published by WebMD, The New York Times, and The Washington Post.
A version of this article first appeared on Medscape.com.
It's hardly news that the United States is experiencing a mental health crisis -- the CDC says as much. But experts in the field say that the current administration has severely compounded the problem by eliminating agency funding and national programs, slashing research grants and data resources, and creating new barriers to behavioral health care.
Philanthropic foundations aim to do what they can to address the shortfall. The numbers, however, just don't add up.
"Some big foundations and philanthropies have said they're going to increase what they give out in the next 4 years, but they'll never be able to fill the gap," said Morgan F. McDonald, MD, national director of population health at the Milbank Memorial Fund in New York City, which works with states on health policy. "Even if every one of them were to spend down their endowments, they still couldn't."
Given the financial limitations, some foundations are taking a different tack. While looking for ways to join forces with fellow nonprofits, they are providing emergency grants to bridge funding in the short term to keep research from grinding to a halt.
Budget Cuts Reach Far and Wide
Mental health research certainly didn't escape the extensive grant cancellations at the National Institutes of Health and the National Science Foundation.
"It's already affecting our ability to stay on the cutting edge of research, best practices, and treatment approaches," said Zainab Okolo, EdD, senior vice president of policy, advocacy, and government relations at The Jed Foundation in New York City, which focuses on the emotional health of teens and young adults.
The upheaval is evident in an array of government agencies. The Health Resources and Services Administration, which last year awarded $12 billion in grants to community health centers and addiction treatment services, has seen > one-fourth of its staff eliminated. The Substance Abuse and Mental Health Services Administration has lost more than a third of its staff as federal cuts took a $1 billion bite out of its operating budget. The Education Department has halted $1 billion in grants used to hire mental health workers in school districts nationwide.
"We're very, very concerned about cuts to behavioral health systems," said Alonzo Plough, PhD, chief science officer at the Robert Wood Johnson Foundation in Princeton, New Jersey. "Doctors and nurses working in safety-net clinics are seeing tremendous reductions."
All in all, the new tax and spending law means $1 trillion in cuts to health care programs including Medicaid -- the nation's largest payer for mental health services -- Medicare, and Affordable Care Act insurance. An estimated 10 million Americans are expected to lose their health coverage as a result.
"When accessibility to care goes down, there's a chance that more people will die by suicide," said Jill Harkavy-Friedman, PhD, senior vice president of research at the American Foundation for Suicide Prevention. "But it also means people will come into care later in the course of their difficulties. Health professionals will be dealing with worse problems."
Foundations Take Emergency Measures
Even if private dollars can't replace what's been lost, philanthropic and medical foundations are stepping up.
We're seeing a lot of foundations and funders that are shifting their funding," said Alyson Niemann, CEO of Mindful Philanthropy, an organization that works with > 1000 private funders to marshal resources for mental health. This year, in response to federal cuts, "many increased funding to health and well-being, doubling or even tripling it," Niemann noted.
"They're making a great deal of effort to respond with emergency funds, really getting in the trenches and being good partners to their grantees," she said. "We've seen them asking deliberate questions, thinking about where their funding can have the most impact."
The American Psychological Foundation (APF), a longtime supporter of research and innovation, is addressing the current crisis with 2 initiatives, Michelle Quist Ryder, PhD, the organization's CEO, explained in an email. The first is APF Director Action, which funds innovative interventions at the community level. The second, Direct Action Crisis Funding Grants, will help continue research that is at risk of stalling because of budget cuts.
"Studies that are 'paused' or lose funding often cannot simply pick back up where they left off. Having to halt progress on a project can invalidate the work already completed," Ryder wrote. "These Direct Action Crisis Grants help bridge funding gaps and keep research viable."
At the same time, collaboration between foundations is becoming more widespread as they seek to maximize their impact. Philanthropic organizations are sharing ideas and best practices as well as pooling fundings.
"The goal of philanthropy is to help people," Harkavy-Friedman said. "There's strength in numbers and more dollars in numbers."
Some See Hope in Raised Voices
Despite the emergency scrambling, many of those in the trenches remain surprisingly optimistic. Some point out that the current turmoil has put a helpful spotlight on behavioral health care. Practitioners, meanwhile, have an essential role to play.
"There's a reason that things were the way they were: People advocated for many years to get where we've gotten," Harkavy-Friedman said, citing veterans' mental health care, the national violent death reporting system, and 988 as examples. "We have to raise our voices louder -- professionals in particular, because they know the impact a person in the general public many not fully grasp."
As a growing numbers of health professionals call attention to the damage wrought by deep cuts in the federal budget, foundation executives see an opportunity.
"In the mental health field, there's a deficit in the narrative, where there's a lot of focus on crisis. What we're hoping to do is shift the narrative toward 'How do we flourish together?'" Niemann said. "Sometimes deficits are where the most incredible innovations appear."
Debbie Koenig is a health writer whose work has been published by WebMD, The New York Times, and The Washington Post.
A version of this article first appeared on Medscape.com.
It's hardly news that the United States is experiencing a mental health crisis -- the CDC says as much. But experts in the field say that the current administration has severely compounded the problem by eliminating agency funding and national programs, slashing research grants and data resources, and creating new barriers to behavioral health care.
Philanthropic foundations aim to do what they can to address the shortfall. The numbers, however, just don't add up.
"Some big foundations and philanthropies have said they're going to increase what they give out in the next 4 years, but they'll never be able to fill the gap," said Morgan F. McDonald, MD, national director of population health at the Milbank Memorial Fund in New York City, which works with states on health policy. "Even if every one of them were to spend down their endowments, they still couldn't."
Given the financial limitations, some foundations are taking a different tack. While looking for ways to join forces with fellow nonprofits, they are providing emergency grants to bridge funding in the short term to keep research from grinding to a halt.
Budget Cuts Reach Far and Wide
Mental health research certainly didn't escape the extensive grant cancellations at the National Institutes of Health and the National Science Foundation.
"It's already affecting our ability to stay on the cutting edge of research, best practices, and treatment approaches," said Zainab Okolo, EdD, senior vice president of policy, advocacy, and government relations at The Jed Foundation in New York City, which focuses on the emotional health of teens and young adults.
The upheaval is evident in an array of government agencies. The Health Resources and Services Administration, which last year awarded $12 billion in grants to community health centers and addiction treatment services, has seen > one-fourth of its staff eliminated. The Substance Abuse and Mental Health Services Administration has lost more than a third of its staff as federal cuts took a $1 billion bite out of its operating budget. The Education Department has halted $1 billion in grants used to hire mental health workers in school districts nationwide.
"We're very, very concerned about cuts to behavioral health systems," said Alonzo Plough, PhD, chief science officer at the Robert Wood Johnson Foundation in Princeton, New Jersey. "Doctors and nurses working in safety-net clinics are seeing tremendous reductions."
All in all, the new tax and spending law means $1 trillion in cuts to health care programs including Medicaid -- the nation's largest payer for mental health services -- Medicare, and Affordable Care Act insurance. An estimated 10 million Americans are expected to lose their health coverage as a result.
"When accessibility to care goes down, there's a chance that more people will die by suicide," said Jill Harkavy-Friedman, PhD, senior vice president of research at the American Foundation for Suicide Prevention. "But it also means people will come into care later in the course of their difficulties. Health professionals will be dealing with worse problems."
Foundations Take Emergency Measures
Even if private dollars can't replace what's been lost, philanthropic and medical foundations are stepping up.
We're seeing a lot of foundations and funders that are shifting their funding," said Alyson Niemann, CEO of Mindful Philanthropy, an organization that works with > 1000 private funders to marshal resources for mental health. This year, in response to federal cuts, "many increased funding to health and well-being, doubling or even tripling it," Niemann noted.
"They're making a great deal of effort to respond with emergency funds, really getting in the trenches and being good partners to their grantees," she said. "We've seen them asking deliberate questions, thinking about where their funding can have the most impact."
The American Psychological Foundation (APF), a longtime supporter of research and innovation, is addressing the current crisis with 2 initiatives, Michelle Quist Ryder, PhD, the organization's CEO, explained in an email. The first is APF Director Action, which funds innovative interventions at the community level. The second, Direct Action Crisis Funding Grants, will help continue research that is at risk of stalling because of budget cuts.
"Studies that are 'paused' or lose funding often cannot simply pick back up where they left off. Having to halt progress on a project can invalidate the work already completed," Ryder wrote. "These Direct Action Crisis Grants help bridge funding gaps and keep research viable."
At the same time, collaboration between foundations is becoming more widespread as they seek to maximize their impact. Philanthropic organizations are sharing ideas and best practices as well as pooling fundings.
"The goal of philanthropy is to help people," Harkavy-Friedman said. "There's strength in numbers and more dollars in numbers."
Some See Hope in Raised Voices
Despite the emergency scrambling, many of those in the trenches remain surprisingly optimistic. Some point out that the current turmoil has put a helpful spotlight on behavioral health care. Practitioners, meanwhile, have an essential role to play.
"There's a reason that things were the way they were: People advocated for many years to get where we've gotten," Harkavy-Friedman said, citing veterans' mental health care, the national violent death reporting system, and 988 as examples. "We have to raise our voices louder -- professionals in particular, because they know the impact a person in the general public many not fully grasp."
As a growing numbers of health professionals call attention to the damage wrought by deep cuts in the federal budget, foundation executives see an opportunity.
"In the mental health field, there's a deficit in the narrative, where there's a lot of focus on crisis. What we're hoping to do is shift the narrative toward 'How do we flourish together?'" Niemann said. "Sometimes deficits are where the most incredible innovations appear."
Debbie Koenig is a health writer whose work has been published by WebMD, The New York Times, and The Washington Post.
A version of this article first appeared on Medscape.com.
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
As Federal Cuts Deepen Mental Health Crisis, Philanthropy Scrambles to Fill the Gap
Taking Therapy Home With Mobile Mental Health Apps
For Kelly, a retired Navy operations specialist, coping with depression and anxiety hindered her ability to enjoy everyday life. Then she elected to enter therapy, a decision she calls “transformative.”
“When I started doing therapy, it was like releasing the toxins, releasing the buildup of the fear or the rage or the overwhelming feelings of shame,” she says. “We can’t just hold on to it. Just telling the truth, it helps me every single day. It is so worth it.”
Kurt, an Army veteran, tried to power through his anxiety, depression, and survivor guilt. He didn’t have much faith in mental health therapy, thinking no one could relate to him. He was surprised, though, once he started treatment, how much his life improved. He now encourages other veterans to face their own mental health challenges, be it through virtual/mental health apps or in-person care.
“From getting help, every day of my life is better,” he says, “and I couldn’t be more grateful for it.”
Stories from Kelly and Kurt are 2 of 7 the US Department of Veterans Affairs (VA) highlighted during National Recovery Month, outlining how their lives were forever changed with the support of mental health care.
But for every Kelly and Kurt, there are thousands of individuals reluctant to seek mental health care. A analysis of 2019-2020 data from the National Health and Resilience in Veterans Study found that 924 (26%) of 4069 veterans met criteria for ≥ 1 psychological disorders, but only 12% reported engagement in mental health care. The researchers considered the role of protective psychosocial characteristics, such as grit (ie, “trait perseverance that extends to one’s decision or commitment to address mental health needs on one’s own; dispositional optimism; and purpose in life”). Veterans who reported mental dysfunction but scored highly on grit were less likely to be engaged in treatment. This pattern suggests higher levels of grit may reduce the likelihood of seeking treatment, “even in the presence of clinically meaningful distress.”
A 2004 study found only 23% to 40% of service members who screened positive for a mental disorder sought care. They often believed they would be seen as weak, or their unit leadership might treat them differently, and unit members would have less confidence in them.
Given that military members and veterans are at increased risk of posttraumatic stress disorder (PTSD) in addition to mood, anxiety, and substance use disorders, any alternatives that increase their access to support and services are crucial. For those who aren’t disposed to office visits and group therapy, the answer may lie in mobile apps.
In a recent randomized controlled trial, 201 veterans who screened positive for PTSD and alcohol use disorder were divided into 2 groups: a mobile mindfulness-based intervention group enhanced with brief alcohol intervention content (Mind Guide), and an active stress management program group. Mind Guide engagement was excellent, according to the study, with averages of > 31 logins and 5 hours of app use. At 16 weeks, the Mind Guide group showed significant reductions in PTSD symptoms (no differences emerged for alcohol use frequency). Mind Guide may be a valuable adjunct to more intensive in-person PTSD treatment by facilitating interest in services, integration into care, and/or sustainment of posttreatment improvements. The VA currently offers 16 apps, including MHA for Veterans, an app designed for patients to complete mental health assessments after their clinician assigned them. Other apps address a variety of issues, such as anger management, insomnia, chronic pain, and PTSD.
Two apps were created with an eye toward specific communities. One, Veterans Wellness Path, was designed for American Indians and Alaska Natives with input from those veterans, their family members, and health care practitioners. It supports the transition from military service to home and encourages balance and connection with self, family, community, and environment. Similarly, WellWithin Coach was designed by the VA National Center for PTSD with input from women veterans and subject matter experts in women’s mental health.
Whatever form it takes—in-person or virtual—finding support that works can make all the difference for veterans. Kelly founded and serves as the executive director of Acta Non Verba: Youth Urban Farm Project, an organization that brings together > 3000 low-income youth and families annually to learn about urban farming, aiming to fill a gap in an area known as a food desert: “We do have the power and the right to wake up the next day and try to do something different,” she said.
For Kelly, a retired Navy operations specialist, coping with depression and anxiety hindered her ability to enjoy everyday life. Then she elected to enter therapy, a decision she calls “transformative.”
“When I started doing therapy, it was like releasing the toxins, releasing the buildup of the fear or the rage or the overwhelming feelings of shame,” she says. “We can’t just hold on to it. Just telling the truth, it helps me every single day. It is so worth it.”
Kurt, an Army veteran, tried to power through his anxiety, depression, and survivor guilt. He didn’t have much faith in mental health therapy, thinking no one could relate to him. He was surprised, though, once he started treatment, how much his life improved. He now encourages other veterans to face their own mental health challenges, be it through virtual/mental health apps or in-person care.
“From getting help, every day of my life is better,” he says, “and I couldn’t be more grateful for it.”
Stories from Kelly and Kurt are 2 of 7 the US Department of Veterans Affairs (VA) highlighted during National Recovery Month, outlining how their lives were forever changed with the support of mental health care.
But for every Kelly and Kurt, there are thousands of individuals reluctant to seek mental health care. A analysis of 2019-2020 data from the National Health and Resilience in Veterans Study found that 924 (26%) of 4069 veterans met criteria for ≥ 1 psychological disorders, but only 12% reported engagement in mental health care. The researchers considered the role of protective psychosocial characteristics, such as grit (ie, “trait perseverance that extends to one’s decision or commitment to address mental health needs on one’s own; dispositional optimism; and purpose in life”). Veterans who reported mental dysfunction but scored highly on grit were less likely to be engaged in treatment. This pattern suggests higher levels of grit may reduce the likelihood of seeking treatment, “even in the presence of clinically meaningful distress.”
A 2004 study found only 23% to 40% of service members who screened positive for a mental disorder sought care. They often believed they would be seen as weak, or their unit leadership might treat them differently, and unit members would have less confidence in them.
Given that military members and veterans are at increased risk of posttraumatic stress disorder (PTSD) in addition to mood, anxiety, and substance use disorders, any alternatives that increase their access to support and services are crucial. For those who aren’t disposed to office visits and group therapy, the answer may lie in mobile apps.
In a recent randomized controlled trial, 201 veterans who screened positive for PTSD and alcohol use disorder were divided into 2 groups: a mobile mindfulness-based intervention group enhanced with brief alcohol intervention content (Mind Guide), and an active stress management program group. Mind Guide engagement was excellent, according to the study, with averages of > 31 logins and 5 hours of app use. At 16 weeks, the Mind Guide group showed significant reductions in PTSD symptoms (no differences emerged for alcohol use frequency). Mind Guide may be a valuable adjunct to more intensive in-person PTSD treatment by facilitating interest in services, integration into care, and/or sustainment of posttreatment improvements. The VA currently offers 16 apps, including MHA for Veterans, an app designed for patients to complete mental health assessments after their clinician assigned them. Other apps address a variety of issues, such as anger management, insomnia, chronic pain, and PTSD.
Two apps were created with an eye toward specific communities. One, Veterans Wellness Path, was designed for American Indians and Alaska Natives with input from those veterans, their family members, and health care practitioners. It supports the transition from military service to home and encourages balance and connection with self, family, community, and environment. Similarly, WellWithin Coach was designed by the VA National Center for PTSD with input from women veterans and subject matter experts in women’s mental health.
Whatever form it takes—in-person or virtual—finding support that works can make all the difference for veterans. Kelly founded and serves as the executive director of Acta Non Verba: Youth Urban Farm Project, an organization that brings together > 3000 low-income youth and families annually to learn about urban farming, aiming to fill a gap in an area known as a food desert: “We do have the power and the right to wake up the next day and try to do something different,” she said.
For Kelly, a retired Navy operations specialist, coping with depression and anxiety hindered her ability to enjoy everyday life. Then she elected to enter therapy, a decision she calls “transformative.”
“When I started doing therapy, it was like releasing the toxins, releasing the buildup of the fear or the rage or the overwhelming feelings of shame,” she says. “We can’t just hold on to it. Just telling the truth, it helps me every single day. It is so worth it.”
Kurt, an Army veteran, tried to power through his anxiety, depression, and survivor guilt. He didn’t have much faith in mental health therapy, thinking no one could relate to him. He was surprised, though, once he started treatment, how much his life improved. He now encourages other veterans to face their own mental health challenges, be it through virtual/mental health apps or in-person care.
“From getting help, every day of my life is better,” he says, “and I couldn’t be more grateful for it.”
Stories from Kelly and Kurt are 2 of 7 the US Department of Veterans Affairs (VA) highlighted during National Recovery Month, outlining how their lives were forever changed with the support of mental health care.
But for every Kelly and Kurt, there are thousands of individuals reluctant to seek mental health care. A analysis of 2019-2020 data from the National Health and Resilience in Veterans Study found that 924 (26%) of 4069 veterans met criteria for ≥ 1 psychological disorders, but only 12% reported engagement in mental health care. The researchers considered the role of protective psychosocial characteristics, such as grit (ie, “trait perseverance that extends to one’s decision or commitment to address mental health needs on one’s own; dispositional optimism; and purpose in life”). Veterans who reported mental dysfunction but scored highly on grit were less likely to be engaged in treatment. This pattern suggests higher levels of grit may reduce the likelihood of seeking treatment, “even in the presence of clinically meaningful distress.”
A 2004 study found only 23% to 40% of service members who screened positive for a mental disorder sought care. They often believed they would be seen as weak, or their unit leadership might treat them differently, and unit members would have less confidence in them.
Given that military members and veterans are at increased risk of posttraumatic stress disorder (PTSD) in addition to mood, anxiety, and substance use disorders, any alternatives that increase their access to support and services are crucial. For those who aren’t disposed to office visits and group therapy, the answer may lie in mobile apps.
In a recent randomized controlled trial, 201 veterans who screened positive for PTSD and alcohol use disorder were divided into 2 groups: a mobile mindfulness-based intervention group enhanced with brief alcohol intervention content (Mind Guide), and an active stress management program group. Mind Guide engagement was excellent, according to the study, with averages of > 31 logins and 5 hours of app use. At 16 weeks, the Mind Guide group showed significant reductions in PTSD symptoms (no differences emerged for alcohol use frequency). Mind Guide may be a valuable adjunct to more intensive in-person PTSD treatment by facilitating interest in services, integration into care, and/or sustainment of posttreatment improvements. The VA currently offers 16 apps, including MHA for Veterans, an app designed for patients to complete mental health assessments after their clinician assigned them. Other apps address a variety of issues, such as anger management, insomnia, chronic pain, and PTSD.
Two apps were created with an eye toward specific communities. One, Veterans Wellness Path, was designed for American Indians and Alaska Natives with input from those veterans, their family members, and health care practitioners. It supports the transition from military service to home and encourages balance and connection with self, family, community, and environment. Similarly, WellWithin Coach was designed by the VA National Center for PTSD with input from women veterans and subject matter experts in women’s mental health.
Whatever form it takes—in-person or virtual—finding support that works can make all the difference for veterans. Kelly founded and serves as the executive director of Acta Non Verba: Youth Urban Farm Project, an organization that brings together > 3000 low-income youth and families annually to learn about urban farming, aiming to fill a gap in an area known as a food desert: “We do have the power and the right to wake up the next day and try to do something different,” she said.
Durvalumab Plus FLOT Ups Survival in Early Upper-GI Cancer
BERLIN — , according to findings presented at the 2025 annual meeting of the European Society for Medical Oncology (ESMO).
Experts said the survival benefit further supports perioperative durvalumab plus FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as the new standard of care for patients with localized gastric or gastroesophageal adenocarcinoma. Earlier results from the phase 3 MATTERHORN trial, reported at the American Society of Clinical Oncology meeting (ASCO) in June, showed that the addition of durvalumab improved event-free survival compared with FLOT alone.
The findings presented at ESMO show that at 36 months, overall survival was 68.6% among patients who received durvalumab + FLOT vs 61.9% among those given FLOT plus a placebo. After a median of 43 months, the survival advantage in the durvalumab group was statistically significant (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96; P = .021) and “more importantly, clinically meaningful,” said lead investigator Josep Tabernero, MD, PhD, of Vall d’Hebron University Hospital in Barcelona.
The results “strongly support the use of perioperative durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized gastric and gastroesophageal adenocarcinoma,” Tabernero said.
Speaking as discussant for the session, Sylvie Lorenzen, MD, PhD, Technische Universität München in Munich, Germany, was enthusiastic that the previously reported trends in MATTERHORN held strong.
“The shape of the curves presented at ASCO was already very positive,” she said. “And now, with a longer follow-up, more events, and a higher overall survival maturity, they reach statistical significance. It looks like the magnitude of the effect increases with longer follow-up, and this is important for our patients.”
The trial randomly assigned 948 patients with resectable gastric or gastroesophageal adenocarcinoma to receive either durvalumab (1500 mg) or placebo every 4 weeks, plus FLOT for 2 cycles before surgery and then again after, followed by durvalumab or placebo every 4 weeks for 10 cycles.
Patients were stratified according to lymph node status, as well as PD-L1 expression (≥ 1% or < 1%, according to the Tumor Area Positivity score.)
The improvement in overall survival with durvalumab was seen regardless of PD-L1 expression, Tabernero said, with the same hazard ratios (0.79) in both the positive and negative subgroups.
However, there was no clear overall survival benefit in certain other subgroups, including women (n = 266; HR, 0.91), those with node-negative disease (n = 277; HR, 1.01), and those with diffuse histology (n = 249; HR, 0.98).
Lorenzen said that clinicians should “pay attention” to those patient subgroups, as they seem to benefit less from the addition of durvalumab. However, she cautioned that the findings were based on small patient numbers and the confidence intervals were wide.
Tabernero also reported additional data on event-free survival (EFS). Overall, the durvalumab/FLOT combination improved EFS among patients with any degree of pathological response and irrespective of lymph node status at surgery.
Regarding nodal staging, which was done in 800 patients, the percentage who achieved negative nodal status was higher in the durvalumab group (58.2%) vs the placebo group (44.8%). However, the improvement in EFS with durvalumab was comparable for node-negative (HR, 0.74) and node-positive (HR, 0.77) patients.
Lorenzen said that overall, the results provide a solid answer to the question, “Is it time to change practice?”
“I think MATTERHORN gives us the largest dataset and answers this question satisfactorily,” she said. Given that overall survival improved regardless of PD-L1 expression, she added, the combination of durvalumab and FLOT should be offered to “all our patient subgroups.”
The study was funded by AstraZeneca. Tabernero made numerous disclosures, including relationships with AstraZeneca, Boehringer Ingelheim, Chugai, and Daichii Sankyo. Lorenzen disclosed financial interests in or serving as an invited speaker for Servier, Lilly, MSD, and BMS.
A version of this article appeared on Medscape.com .
BERLIN — , according to findings presented at the 2025 annual meeting of the European Society for Medical Oncology (ESMO).
Experts said the survival benefit further supports perioperative durvalumab plus FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as the new standard of care for patients with localized gastric or gastroesophageal adenocarcinoma. Earlier results from the phase 3 MATTERHORN trial, reported at the American Society of Clinical Oncology meeting (ASCO) in June, showed that the addition of durvalumab improved event-free survival compared with FLOT alone.
The findings presented at ESMO show that at 36 months, overall survival was 68.6% among patients who received durvalumab + FLOT vs 61.9% among those given FLOT plus a placebo. After a median of 43 months, the survival advantage in the durvalumab group was statistically significant (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96; P = .021) and “more importantly, clinically meaningful,” said lead investigator Josep Tabernero, MD, PhD, of Vall d’Hebron University Hospital in Barcelona.
The results “strongly support the use of perioperative durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized gastric and gastroesophageal adenocarcinoma,” Tabernero said.
Speaking as discussant for the session, Sylvie Lorenzen, MD, PhD, Technische Universität München in Munich, Germany, was enthusiastic that the previously reported trends in MATTERHORN held strong.
“The shape of the curves presented at ASCO was already very positive,” she said. “And now, with a longer follow-up, more events, and a higher overall survival maturity, they reach statistical significance. It looks like the magnitude of the effect increases with longer follow-up, and this is important for our patients.”
The trial randomly assigned 948 patients with resectable gastric or gastroesophageal adenocarcinoma to receive either durvalumab (1500 mg) or placebo every 4 weeks, plus FLOT for 2 cycles before surgery and then again after, followed by durvalumab or placebo every 4 weeks for 10 cycles.
Patients were stratified according to lymph node status, as well as PD-L1 expression (≥ 1% or < 1%, according to the Tumor Area Positivity score.)
The improvement in overall survival with durvalumab was seen regardless of PD-L1 expression, Tabernero said, with the same hazard ratios (0.79) in both the positive and negative subgroups.
However, there was no clear overall survival benefit in certain other subgroups, including women (n = 266; HR, 0.91), those with node-negative disease (n = 277; HR, 1.01), and those with diffuse histology (n = 249; HR, 0.98).
Lorenzen said that clinicians should “pay attention” to those patient subgroups, as they seem to benefit less from the addition of durvalumab. However, she cautioned that the findings were based on small patient numbers and the confidence intervals were wide.
Tabernero also reported additional data on event-free survival (EFS). Overall, the durvalumab/FLOT combination improved EFS among patients with any degree of pathological response and irrespective of lymph node status at surgery.
Regarding nodal staging, which was done in 800 patients, the percentage who achieved negative nodal status was higher in the durvalumab group (58.2%) vs the placebo group (44.8%). However, the improvement in EFS with durvalumab was comparable for node-negative (HR, 0.74) and node-positive (HR, 0.77) patients.
Lorenzen said that overall, the results provide a solid answer to the question, “Is it time to change practice?”
“I think MATTERHORN gives us the largest dataset and answers this question satisfactorily,” she said. Given that overall survival improved regardless of PD-L1 expression, she added, the combination of durvalumab and FLOT should be offered to “all our patient subgroups.”
The study was funded by AstraZeneca. Tabernero made numerous disclosures, including relationships with AstraZeneca, Boehringer Ingelheim, Chugai, and Daichii Sankyo. Lorenzen disclosed financial interests in or serving as an invited speaker for Servier, Lilly, MSD, and BMS.
A version of this article appeared on Medscape.com .
BERLIN — , according to findings presented at the 2025 annual meeting of the European Society for Medical Oncology (ESMO).
Experts said the survival benefit further supports perioperative durvalumab plus FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as the new standard of care for patients with localized gastric or gastroesophageal adenocarcinoma. Earlier results from the phase 3 MATTERHORN trial, reported at the American Society of Clinical Oncology meeting (ASCO) in June, showed that the addition of durvalumab improved event-free survival compared with FLOT alone.
The findings presented at ESMO show that at 36 months, overall survival was 68.6% among patients who received durvalumab + FLOT vs 61.9% among those given FLOT plus a placebo. After a median of 43 months, the survival advantage in the durvalumab group was statistically significant (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96; P = .021) and “more importantly, clinically meaningful,” said lead investigator Josep Tabernero, MD, PhD, of Vall d’Hebron University Hospital in Barcelona.
The results “strongly support the use of perioperative durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized gastric and gastroesophageal adenocarcinoma,” Tabernero said.
Speaking as discussant for the session, Sylvie Lorenzen, MD, PhD, Technische Universität München in Munich, Germany, was enthusiastic that the previously reported trends in MATTERHORN held strong.
“The shape of the curves presented at ASCO was already very positive,” she said. “And now, with a longer follow-up, more events, and a higher overall survival maturity, they reach statistical significance. It looks like the magnitude of the effect increases with longer follow-up, and this is important for our patients.”
The trial randomly assigned 948 patients with resectable gastric or gastroesophageal adenocarcinoma to receive either durvalumab (1500 mg) or placebo every 4 weeks, plus FLOT for 2 cycles before surgery and then again after, followed by durvalumab or placebo every 4 weeks for 10 cycles.
Patients were stratified according to lymph node status, as well as PD-L1 expression (≥ 1% or < 1%, according to the Tumor Area Positivity score.)
The improvement in overall survival with durvalumab was seen regardless of PD-L1 expression, Tabernero said, with the same hazard ratios (0.79) in both the positive and negative subgroups.
However, there was no clear overall survival benefit in certain other subgroups, including women (n = 266; HR, 0.91), those with node-negative disease (n = 277; HR, 1.01), and those with diffuse histology (n = 249; HR, 0.98).
Lorenzen said that clinicians should “pay attention” to those patient subgroups, as they seem to benefit less from the addition of durvalumab. However, she cautioned that the findings were based on small patient numbers and the confidence intervals were wide.
Tabernero also reported additional data on event-free survival (EFS). Overall, the durvalumab/FLOT combination improved EFS among patients with any degree of pathological response and irrespective of lymph node status at surgery.
Regarding nodal staging, which was done in 800 patients, the percentage who achieved negative nodal status was higher in the durvalumab group (58.2%) vs the placebo group (44.8%). However, the improvement in EFS with durvalumab was comparable for node-negative (HR, 0.74) and node-positive (HR, 0.77) patients.
Lorenzen said that overall, the results provide a solid answer to the question, “Is it time to change practice?”
“I think MATTERHORN gives us the largest dataset and answers this question satisfactorily,” she said. Given that overall survival improved regardless of PD-L1 expression, she added, the combination of durvalumab and FLOT should be offered to “all our patient subgroups.”
The study was funded by AstraZeneca. Tabernero made numerous disclosures, including relationships with AstraZeneca, Boehringer Ingelheim, Chugai, and Daichii Sankyo. Lorenzen disclosed financial interests in or serving as an invited speaker for Servier, Lilly, MSD, and BMS.
A version of this article appeared on Medscape.com .
COVID-19 Vaccines: Navigating the Chaos of Conflicting Guidance
Hi, everyone. I’m Dr Kenny Lin. I am a family physician and associate director of the Lancaster General Hospital Family Medicine Residency, and I blog at Common Sense Family Doctor.
The receding of the pandemic and the understandable desire to return to normalcy has made COVID-19 vaccines a lower priority for many of our patients. However, family physicians should keep in mind that from October 1, 2024, to September 6, 2025, COVID-19 was responsible for an estimated 3.2 to 4.6 million outpatient visits, 360,000 to 520,000 hospitalizations, and 42,000 to 60,000 deaths.
In a previous commentary, I discussed the worsening disconnect between the evidence supporting the effectiveness and safety of vaccinations and increasing reluctance of patients and parents to receive them, fueled by misinformation from federal health agencies and the packing of the Advisory Committee on Immunization Practices (ACIP) with vaccine skeptics. Since then, Secretary of Health and Human Services (HHS), Robert F. Kennedy, Jr, has fired Dr Susan Monarez, his handpicked director of the CDC. This caused three senior CDC officials to resign in protest and precipitated further turmoil at the embattled agency.
The FDA has approved 3 updated COVID-19 vaccines targeted to currently circulating strains: an mRNA vaccine from Moderna (Spikevax) for those aged 6 months or older; an mRNA vaccine from Pfizer/BioNTech (Comirnaty) for those aged ≥ 5 years; and a protein subunit vaccine from Novavax (Nuvaxovid) for those aged ≥ 12 years. However, approvals restricting the scope of these approvals to certain high-risk groups, combined with the ACIP’s recent decision to not explicitly recommend them for any group, have complicated access for many patients.
Medical groups, including the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG), have published their own recommendations (Table). Of note, in opposition to the FDA and ACIP, the AAP and AAFP strongly recommend routine vaccination for children aged 6 to 23 months because they have the highest risk for hospitalization. The AAFP and ACOG both recommend COVID-19 vaccination in pregnancy to protect the pregnant patient and provide passive antibody protection to their infants up to 6 months of age. The Vaccine Integrity Project’s review of 12 safety studies published since June 2024 found that mRNA vaccines were not associated with increases in any adverse maternal or infant outcomes and had a possible protective effect against preterm birth.
In my previous commentary, 70% of Medscape readers indicated that they would follow vaccination recommendations from AAP even if they differed from CDC guidance. Administering vaccines outside of FDA labeling indications (i.e., “off label”) typically requires a physician’s prescription, which will almost certainly reduce COVID-19 vaccine uptake in children and pregnant patients, given that most people received these shots in pharmacies during the 2024-25 season. CVS and Walgreens, the country’s two largest pharmacy chains, are requiring physician prescriptions or waiting for ACIP guidance to make the new vaccines available in many states. However, an increasing number of states have implemented executive orders or passed legislation to permit pharmacists to provide vaccines to anyone who wants them. For example, the Pennsylvania State Board of Pharmacy voted unanimously to issue guidance that would allow pharmacists to administer any vaccines recommended by AAFP, AAP, or ACOG.
Erosion of vaccine uptake could easily worsen the burden of illness for our patients and the health system. Navigating the unnecessarily complex landscape of COVID-19 vaccines will be challenging, but it remains worthwhile.
Risk group | FDA | ACIP/HHS | AAFP | AAP | ACOG |
|---|---|---|---|---|---|
Adults aged > 65 | Approved | Shared decision-making | Recommend | N/A | N/A |
6 months to 64 years with high-risk condition | Approved | Shared decision-making | Recommend | Recommend | NA |
Pregnant patients | Unclear, but pregnancy included as high-risk condition | Not approved | Recommend | NA | Recommend |
Children and adults without risk factors | Not approved | Shared decision-making | Recommend for age 6-23 months and administer to all others who desire it | Recommend for age 6-23 months and administer to all others who desire it | NA |
Kenneth W. Lin, MD, MPH, Associate Director, Department of Family Medicine, Lancaster General Hospital, Lancaster, Pennsylvania, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: UpToDate; American Academy of Family Physicians; Archdiocese of Washington; Association of Prevention Teaching and Research.
A version of this article appeared on Medscape.com.
Hi, everyone. I’m Dr Kenny Lin. I am a family physician and associate director of the Lancaster General Hospital Family Medicine Residency, and I blog at Common Sense Family Doctor.
The receding of the pandemic and the understandable desire to return to normalcy has made COVID-19 vaccines a lower priority for many of our patients. However, family physicians should keep in mind that from October 1, 2024, to September 6, 2025, COVID-19 was responsible for an estimated 3.2 to 4.6 million outpatient visits, 360,000 to 520,000 hospitalizations, and 42,000 to 60,000 deaths.
In a previous commentary, I discussed the worsening disconnect between the evidence supporting the effectiveness and safety of vaccinations and increasing reluctance of patients and parents to receive them, fueled by misinformation from federal health agencies and the packing of the Advisory Committee on Immunization Practices (ACIP) with vaccine skeptics. Since then, Secretary of Health and Human Services (HHS), Robert F. Kennedy, Jr, has fired Dr Susan Monarez, his handpicked director of the CDC. This caused three senior CDC officials to resign in protest and precipitated further turmoil at the embattled agency.
The FDA has approved 3 updated COVID-19 vaccines targeted to currently circulating strains: an mRNA vaccine from Moderna (Spikevax) for those aged 6 months or older; an mRNA vaccine from Pfizer/BioNTech (Comirnaty) for those aged ≥ 5 years; and a protein subunit vaccine from Novavax (Nuvaxovid) for those aged ≥ 12 years. However, approvals restricting the scope of these approvals to certain high-risk groups, combined with the ACIP’s recent decision to not explicitly recommend them for any group, have complicated access for many patients.
Medical groups, including the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG), have published their own recommendations (Table). Of note, in opposition to the FDA and ACIP, the AAP and AAFP strongly recommend routine vaccination for children aged 6 to 23 months because they have the highest risk for hospitalization. The AAFP and ACOG both recommend COVID-19 vaccination in pregnancy to protect the pregnant patient and provide passive antibody protection to their infants up to 6 months of age. The Vaccine Integrity Project’s review of 12 safety studies published since June 2024 found that mRNA vaccines were not associated with increases in any adverse maternal or infant outcomes and had a possible protective effect against preterm birth.
In my previous commentary, 70% of Medscape readers indicated that they would follow vaccination recommendations from AAP even if they differed from CDC guidance. Administering vaccines outside of FDA labeling indications (i.e., “off label”) typically requires a physician’s prescription, which will almost certainly reduce COVID-19 vaccine uptake in children and pregnant patients, given that most people received these shots in pharmacies during the 2024-25 season. CVS and Walgreens, the country’s two largest pharmacy chains, are requiring physician prescriptions or waiting for ACIP guidance to make the new vaccines available in many states. However, an increasing number of states have implemented executive orders or passed legislation to permit pharmacists to provide vaccines to anyone who wants them. For example, the Pennsylvania State Board of Pharmacy voted unanimously to issue guidance that would allow pharmacists to administer any vaccines recommended by AAFP, AAP, or ACOG.
Erosion of vaccine uptake could easily worsen the burden of illness for our patients and the health system. Navigating the unnecessarily complex landscape of COVID-19 vaccines will be challenging, but it remains worthwhile.
Risk group | FDA | ACIP/HHS | AAFP | AAP | ACOG |
|---|---|---|---|---|---|
Adults aged > 65 | Approved | Shared decision-making | Recommend | N/A | N/A |
6 months to 64 years with high-risk condition | Approved | Shared decision-making | Recommend | Recommend | NA |
Pregnant patients | Unclear, but pregnancy included as high-risk condition | Not approved | Recommend | NA | Recommend |
Children and adults without risk factors | Not approved | Shared decision-making | Recommend for age 6-23 months and administer to all others who desire it | Recommend for age 6-23 months and administer to all others who desire it | NA |
Kenneth W. Lin, MD, MPH, Associate Director, Department of Family Medicine, Lancaster General Hospital, Lancaster, Pennsylvania, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: UpToDate; American Academy of Family Physicians; Archdiocese of Washington; Association of Prevention Teaching and Research.
A version of this article appeared on Medscape.com.
Hi, everyone. I’m Dr Kenny Lin. I am a family physician and associate director of the Lancaster General Hospital Family Medicine Residency, and I blog at Common Sense Family Doctor.
The receding of the pandemic and the understandable desire to return to normalcy has made COVID-19 vaccines a lower priority for many of our patients. However, family physicians should keep in mind that from October 1, 2024, to September 6, 2025, COVID-19 was responsible for an estimated 3.2 to 4.6 million outpatient visits, 360,000 to 520,000 hospitalizations, and 42,000 to 60,000 deaths.
In a previous commentary, I discussed the worsening disconnect between the evidence supporting the effectiveness and safety of vaccinations and increasing reluctance of patients and parents to receive them, fueled by misinformation from federal health agencies and the packing of the Advisory Committee on Immunization Practices (ACIP) with vaccine skeptics. Since then, Secretary of Health and Human Services (HHS), Robert F. Kennedy, Jr, has fired Dr Susan Monarez, his handpicked director of the CDC. This caused three senior CDC officials to resign in protest and precipitated further turmoil at the embattled agency.
The FDA has approved 3 updated COVID-19 vaccines targeted to currently circulating strains: an mRNA vaccine from Moderna (Spikevax) for those aged 6 months or older; an mRNA vaccine from Pfizer/BioNTech (Comirnaty) for those aged ≥ 5 years; and a protein subunit vaccine from Novavax (Nuvaxovid) for those aged ≥ 12 years. However, approvals restricting the scope of these approvals to certain high-risk groups, combined with the ACIP’s recent decision to not explicitly recommend them for any group, have complicated access for many patients.
Medical groups, including the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG), have published their own recommendations (Table). Of note, in opposition to the FDA and ACIP, the AAP and AAFP strongly recommend routine vaccination for children aged 6 to 23 months because they have the highest risk for hospitalization. The AAFP and ACOG both recommend COVID-19 vaccination in pregnancy to protect the pregnant patient and provide passive antibody protection to their infants up to 6 months of age. The Vaccine Integrity Project’s review of 12 safety studies published since June 2024 found that mRNA vaccines were not associated with increases in any adverse maternal or infant outcomes and had a possible protective effect against preterm birth.
In my previous commentary, 70% of Medscape readers indicated that they would follow vaccination recommendations from AAP even if they differed from CDC guidance. Administering vaccines outside of FDA labeling indications (i.e., “off label”) typically requires a physician’s prescription, which will almost certainly reduce COVID-19 vaccine uptake in children and pregnant patients, given that most people received these shots in pharmacies during the 2024-25 season. CVS and Walgreens, the country’s two largest pharmacy chains, are requiring physician prescriptions or waiting for ACIP guidance to make the new vaccines available in many states. However, an increasing number of states have implemented executive orders or passed legislation to permit pharmacists to provide vaccines to anyone who wants them. For example, the Pennsylvania State Board of Pharmacy voted unanimously to issue guidance that would allow pharmacists to administer any vaccines recommended by AAFP, AAP, or ACOG.
Erosion of vaccine uptake could easily worsen the burden of illness for our patients and the health system. Navigating the unnecessarily complex landscape of COVID-19 vaccines will be challenging, but it remains worthwhile.
Risk group | FDA | ACIP/HHS | AAFP | AAP | ACOG |
|---|---|---|---|---|---|
Adults aged > 65 | Approved | Shared decision-making | Recommend | N/A | N/A |
6 months to 64 years with high-risk condition | Approved | Shared decision-making | Recommend | Recommend | NA |
Pregnant patients | Unclear, but pregnancy included as high-risk condition | Not approved | Recommend | NA | Recommend |
Children and adults without risk factors | Not approved | Shared decision-making | Recommend for age 6-23 months and administer to all others who desire it | Recommend for age 6-23 months and administer to all others who desire it | NA |
Kenneth W. Lin, MD, MPH, Associate Director, Department of Family Medicine, Lancaster General Hospital, Lancaster, Pennsylvania, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: UpToDate; American Academy of Family Physicians; Archdiocese of Washington; Association of Prevention Teaching and Research.
A version of this article appeared on Medscape.com.
AI in Mammography: Inside the Tangible Benefits Ready Now
In this Practical AI column, we’ve explored everything from large language models to the nuances of trial matching, but one of the most immediate and impactful applications of AI is unfolding right now in breast imaging. For oncologists, this isn’t an abstract future — with new screening guidelines, dense-breast mandates, and a shrinking radiology workforce, it’s the imaging reports and patient questions landing in your clinic today.
Here is what oncologists need to know, and how to put it to work for their patients.
Why AI in Mammography Matters
More than 200 million women undergo breast cancer screening each year. In the US alone, 10% of the 40 million women screened annually require additional diagnostic imaging, and 4%–5% of these women are eventually diagnosed with breast cancer.
Two major shifts are redefining breast cancer screening in the US: The US Preventive Services Task Force (USPSTF) now recommends biennial screening from age 40 to 74 years, and notifying patients of breast density is a federal requirement as of September 10, 2024. That means more mammograms, more patient questions, and more downstream oncology decisions. Patients will increasingly ask about “dense” breast results and what to do next. Add a national radiologist shortage into the mix, and the pressure on timely callbacks, biopsies, and treatment planning will only grow.
Can AI Help Without Compromising Care?
The short answer is yes. With AI, we may be able to transform these rate-limiting steps into opportunities for earlier detection, decentralized screening, and smarter triage and save hundreds of thousands of women from an unnecessary diagnostic procedure, if implemented deliberately.
Don’t Confuse Today’s AI With Yesterday’s CAD
Think of older computer-aided detection (CAD) like a 1990s chemotherapy drug: It sometimes helped, but it came with significant toxicity and rarely delivered consistent survival benefits. Today’s deep-learning AI is closer to targeted therapy — trained on millions of “trial participants” (mammograms), more precise, and applied in specific contexts where it adds value. If you once dismissed CAD as noise, it’s time to revisit what AI can now offer.
The role of AI is broader than drawing boxes. It provides second readings, worklist triage, risk prediction, density assessment, and decision support. FDA has cleared several AI tools for both 2D and digital breast tomosynthesis (DBT), which include iCAD ProFound (DBT), ScreenPoint Transpara (2D/DBT), and Lunit INSIGHT DBT.
Some of the strongest evidence for AI in mammography is as a second reader during screening. Large trials show that AI plus one radiologist can match reading from two radiologists, cutting workload by about 40%. For example, the MASAI randomized trial showed that AI-supported screening achieved similar cancer detection but cut human screen-reading workload about 44% vs standard double reading (39,996 vs 40,024 participants). The primary interval cancer outcomes are maturing, but the safety analysis is reassuring.
Reducing second reads and arbitration time are important for clinicians because it frees capacity for callbacks and diagnostic workups. This will be especially key given that screening now starts at age 40. That will mean about 21 to 22 million more women are newly eligible, translating to about 10 to 11 million additional mammograms each year under biennial screening.
Another important area where AI can make its mark in mammography is triage and time to diagnosis. The results from a randomized implementation study showed that AI-prioritized worklists accelerated time to additional imaging and biopsy diagnosis without harming efficiency for others — exactly the kind of outcome patients feel.
Multiple studies have demonstrated improved diagnostic performance and shorter reading times when AI supports DBT interpretation, which is important because DBT can otherwise be time intensive.
We are also seeing rapid advancement in risk-based screening, moving beyond a single dense vs not dense approach. Deep-learning risk models, such as Mirai, predict 1- to 5-year breast cancer risk directly from the mammogram, and these tools are now being assessed prospectively to guide supplemental MRI. Cost-effectiveness modeling supports risk-stratified intervals vs one-size-fits-all schedules.
Finally, automated density tools, such as Transpara Density and Volpara, offer objective, reproducible volumetric measures that map to the Breast Imaging-Reporting and Data System, which is useful for Mammography Quality Standards Act-required reporting and as inputs to risk calculators.
While early evidence suggests AI may help surface future or interval cancers earlier, including more invasive tumors, the definitive impacts on interval cancer rates and mortality require longitudinal follow-up, which is now in progress.
Pitfalls to Watch For
Bias is real. Studies show false-positive differences by race, age, and density. AI can even infer racial identity from images, potentially amplifying disparities. Performance can also shift by vendor, demographics, and prevalence.
A Radiology study of 4855 DBT exams showed that an algorithm produced more false-positive case scores in Black patients and older patients (aged 71-80 years) patients and in women with extremely dense breasts. This can happen because AI can infer proxies for race directly from images, even when humans cannot, and this can propagate disparities if not addressed. External validations and reviews emphasize that performance can shift with device manufacturer, demographics, and prevalence, which is why all tools need to undergo local validation and calibration.
Here’s a pragmatic adoption checklist before going live with an AI tool.
- Confirm FDA clearance: Verify the name and version of the algorithm, imaging modes (2D vs DBT), and operating points. Confirm 510(k) numbers.
- Local validation: Test on your patient mix and vendor stack (Hologic, GE, Siemens, Fuji). Compare this to your baseline recall rate, positive predictive value of recall (PPV1), cancer detection rate, and reading time. Commit to recalibration if drift occurs.
- Equity plan: Monitor false-positive and negative false-rates by age, race/ethnicity, and density; document corrective actions if disparities emerge. (This isn’t optional.)
- Workflow clarity: Is AI a second reader, an additional reader, or a triage tool? Who arbitrates discordance? What’s the escalation path for high-risk or interval cancer-like patterns?
- Regulatory strategy: Confirm whether the vendor has (or will file) a Predetermined Change Control Plan so models can be updated safely without repeated submissions. Also confirm how you’ll be notified about performance-relevant changes.
- Data governance: Audit logs of AI outputs, retention, protected health information handling, and the patient communication policy for AI-assisted reads.
After going live, set up a quarterly dashboard. It should include cancer detection rate per 1000 patients, recall rate, PPV1, interval cancer rate (as it matures), reading time, and turnaround time to diagnostic imaging or biopsy — all stratified by age, race/ethnicity, and density.
Here, I dissect what this discussion means through the lens of Moravec’s paradox (machines excel at what clinicians find hard, and vice versa) and offer a possible playbook for putting these tools to work.
What to Tell Patients
When speaking with patients, emphasize that a radiologist still reads their mammogram. AI helps with consistency and efficiency; it doesn’t replace human oversight. Patients with dense breasts should still expect a standard notice; discussion of individualized risk factors, such as family history, genetics, and prior biopsies; and consideration of supplemental imaging if risk warrants. But it’s also important to tell these patients that while dense breasts are common, they do not automatically mean high cancer risk.
As for screening schedules, remind patients that screening is at least biennial from 40 to 74 years of age per the USPSTF guidelines; however, specialty groups may recommend starting on an annual schedule at 40.
What You Can Implement Now
There are multiple practical use cases you can introduce now. One is to use AI as a second reader or an additional reader safety net to preserve detection while reducing human workload. This helps your breast center absorb screening expansion to age 40 without diluting quality. Another is to turn on AI triage to shorten the time to callback and biopsy for the few who need it most — patients notice and appreciate faster answers. You can also begin adopting automated density plus risk models to move beyond “dense/not dense.” For selected patients, AI-informed risk can justify MRI or tailored intervals.
Here’s a quick cheat sheet (for your next leadership or tumor-board meeting).
Do:
- Use AI as a second or additional reader or triage tool, not as a black box.
- Track cancer detection rate, recall, PPV1, interval cancers, and reading time, stratified by age, race, and breast density.
- Pair automated density with AI risk to personalize screening and supplemental imaging.
- Enroll patients in future clinical trials, such as PRISM, the first large-scale randomized controlled trial of AI for screening mammography. This US-based, $16 million, seven-site study is funded by the Patient-Centered Outcomes Research Institute.
Don’t:
- Assume “AI = CAD.” The 2015 CAD story is over; modern deep learning systems are different and require different oversight.
- Go live without a local validation and equity plan or without clarity on software updates.
- Forget to remind patients that screening starts at age 40, and dense breast notifications are now universal. Use the visit to discuss risk, supplemental imaging, and why a human still directs their care.
The Bottom Line
AI won’t replace radiologists or read mammograms for us — just as PET scans didn’t replace oncologists and stethoscopes didn’t make cardiologists obsolete. What it will do is catch what the tired human eye might miss, shave days off anxious waiting, and turn breast density into data instead of doubt. For oncologists, that means staging sooner, enrolling smarter, and spending more time talking with patients instead of chasing callbacks.
In short, AI may not take the picture, but it helps us frame the story, making it sharper, faster, and with fewer blind spots. By pairing this powerful technology with rigorous, equity-focused local validation and transparent governance under the FDA’s emerging Predetermined Change Control Plan framework, we can realize the tangible benefits of practical AI for our patients without widening disparities.
Now, during Breast Cancer Awareness Month, how about we add on AI to that pink ribbon — how cool would that be?
Thoughts? Drop me a line at [email protected]. Let’s keep the conversation — and pink ribbons — going.
Arturo Loaiza-Bonilla, MD, MSEd, is the co-founder and chief medical AI officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as Systemwide Chief of Hematology and Oncology at St. Luke’s University Health Network, where he maintains a connection to patient care by attending to patients 2 days a week.
A version of this article first appeared on Medscape.com.
In this Practical AI column, we’ve explored everything from large language models to the nuances of trial matching, but one of the most immediate and impactful applications of AI is unfolding right now in breast imaging. For oncologists, this isn’t an abstract future — with new screening guidelines, dense-breast mandates, and a shrinking radiology workforce, it’s the imaging reports and patient questions landing in your clinic today.
Here is what oncologists need to know, and how to put it to work for their patients.
Why AI in Mammography Matters
More than 200 million women undergo breast cancer screening each year. In the US alone, 10% of the 40 million women screened annually require additional diagnostic imaging, and 4%–5% of these women are eventually diagnosed with breast cancer.
Two major shifts are redefining breast cancer screening in the US: The US Preventive Services Task Force (USPSTF) now recommends biennial screening from age 40 to 74 years, and notifying patients of breast density is a federal requirement as of September 10, 2024. That means more mammograms, more patient questions, and more downstream oncology decisions. Patients will increasingly ask about “dense” breast results and what to do next. Add a national radiologist shortage into the mix, and the pressure on timely callbacks, biopsies, and treatment planning will only grow.
Can AI Help Without Compromising Care?
The short answer is yes. With AI, we may be able to transform these rate-limiting steps into opportunities for earlier detection, decentralized screening, and smarter triage and save hundreds of thousands of women from an unnecessary diagnostic procedure, if implemented deliberately.
Don’t Confuse Today’s AI With Yesterday’s CAD
Think of older computer-aided detection (CAD) like a 1990s chemotherapy drug: It sometimes helped, but it came with significant toxicity and rarely delivered consistent survival benefits. Today’s deep-learning AI is closer to targeted therapy — trained on millions of “trial participants” (mammograms), more precise, and applied in specific contexts where it adds value. If you once dismissed CAD as noise, it’s time to revisit what AI can now offer.
The role of AI is broader than drawing boxes. It provides second readings, worklist triage, risk prediction, density assessment, and decision support. FDA has cleared several AI tools for both 2D and digital breast tomosynthesis (DBT), which include iCAD ProFound (DBT), ScreenPoint Transpara (2D/DBT), and Lunit INSIGHT DBT.
Some of the strongest evidence for AI in mammography is as a second reader during screening. Large trials show that AI plus one radiologist can match reading from two radiologists, cutting workload by about 40%. For example, the MASAI randomized trial showed that AI-supported screening achieved similar cancer detection but cut human screen-reading workload about 44% vs standard double reading (39,996 vs 40,024 participants). The primary interval cancer outcomes are maturing, but the safety analysis is reassuring.
Reducing second reads and arbitration time are important for clinicians because it frees capacity for callbacks and diagnostic workups. This will be especially key given that screening now starts at age 40. That will mean about 21 to 22 million more women are newly eligible, translating to about 10 to 11 million additional mammograms each year under biennial screening.
Another important area where AI can make its mark in mammography is triage and time to diagnosis. The results from a randomized implementation study showed that AI-prioritized worklists accelerated time to additional imaging and biopsy diagnosis without harming efficiency for others — exactly the kind of outcome patients feel.
Multiple studies have demonstrated improved diagnostic performance and shorter reading times when AI supports DBT interpretation, which is important because DBT can otherwise be time intensive.
We are also seeing rapid advancement in risk-based screening, moving beyond a single dense vs not dense approach. Deep-learning risk models, such as Mirai, predict 1- to 5-year breast cancer risk directly from the mammogram, and these tools are now being assessed prospectively to guide supplemental MRI. Cost-effectiveness modeling supports risk-stratified intervals vs one-size-fits-all schedules.
Finally, automated density tools, such as Transpara Density and Volpara, offer objective, reproducible volumetric measures that map to the Breast Imaging-Reporting and Data System, which is useful for Mammography Quality Standards Act-required reporting and as inputs to risk calculators.
While early evidence suggests AI may help surface future or interval cancers earlier, including more invasive tumors, the definitive impacts on interval cancer rates and mortality require longitudinal follow-up, which is now in progress.
Pitfalls to Watch For
Bias is real. Studies show false-positive differences by race, age, and density. AI can even infer racial identity from images, potentially amplifying disparities. Performance can also shift by vendor, demographics, and prevalence.
A Radiology study of 4855 DBT exams showed that an algorithm produced more false-positive case scores in Black patients and older patients (aged 71-80 years) patients and in women with extremely dense breasts. This can happen because AI can infer proxies for race directly from images, even when humans cannot, and this can propagate disparities if not addressed. External validations and reviews emphasize that performance can shift with device manufacturer, demographics, and prevalence, which is why all tools need to undergo local validation and calibration.
Here’s a pragmatic adoption checklist before going live with an AI tool.
- Confirm FDA clearance: Verify the name and version of the algorithm, imaging modes (2D vs DBT), and operating points. Confirm 510(k) numbers.
- Local validation: Test on your patient mix and vendor stack (Hologic, GE, Siemens, Fuji). Compare this to your baseline recall rate, positive predictive value of recall (PPV1), cancer detection rate, and reading time. Commit to recalibration if drift occurs.
- Equity plan: Monitor false-positive and negative false-rates by age, race/ethnicity, and density; document corrective actions if disparities emerge. (This isn’t optional.)
- Workflow clarity: Is AI a second reader, an additional reader, or a triage tool? Who arbitrates discordance? What’s the escalation path for high-risk or interval cancer-like patterns?
- Regulatory strategy: Confirm whether the vendor has (or will file) a Predetermined Change Control Plan so models can be updated safely without repeated submissions. Also confirm how you’ll be notified about performance-relevant changes.
- Data governance: Audit logs of AI outputs, retention, protected health information handling, and the patient communication policy for AI-assisted reads.
After going live, set up a quarterly dashboard. It should include cancer detection rate per 1000 patients, recall rate, PPV1, interval cancer rate (as it matures), reading time, and turnaround time to diagnostic imaging or biopsy — all stratified by age, race/ethnicity, and density.
Here, I dissect what this discussion means through the lens of Moravec’s paradox (machines excel at what clinicians find hard, and vice versa) and offer a possible playbook for putting these tools to work.
What to Tell Patients
When speaking with patients, emphasize that a radiologist still reads their mammogram. AI helps with consistency and efficiency; it doesn’t replace human oversight. Patients with dense breasts should still expect a standard notice; discussion of individualized risk factors, such as family history, genetics, and prior biopsies; and consideration of supplemental imaging if risk warrants. But it’s also important to tell these patients that while dense breasts are common, they do not automatically mean high cancer risk.
As for screening schedules, remind patients that screening is at least biennial from 40 to 74 years of age per the USPSTF guidelines; however, specialty groups may recommend starting on an annual schedule at 40.
What You Can Implement Now
There are multiple practical use cases you can introduce now. One is to use AI as a second reader or an additional reader safety net to preserve detection while reducing human workload. This helps your breast center absorb screening expansion to age 40 without diluting quality. Another is to turn on AI triage to shorten the time to callback and biopsy for the few who need it most — patients notice and appreciate faster answers. You can also begin adopting automated density plus risk models to move beyond “dense/not dense.” For selected patients, AI-informed risk can justify MRI or tailored intervals.
Here’s a quick cheat sheet (for your next leadership or tumor-board meeting).
Do:
- Use AI as a second or additional reader or triage tool, not as a black box.
- Track cancer detection rate, recall, PPV1, interval cancers, and reading time, stratified by age, race, and breast density.
- Pair automated density with AI risk to personalize screening and supplemental imaging.
- Enroll patients in future clinical trials, such as PRISM, the first large-scale randomized controlled trial of AI for screening mammography. This US-based, $16 million, seven-site study is funded by the Patient-Centered Outcomes Research Institute.
Don’t:
- Assume “AI = CAD.” The 2015 CAD story is over; modern deep learning systems are different and require different oversight.
- Go live without a local validation and equity plan or without clarity on software updates.
- Forget to remind patients that screening starts at age 40, and dense breast notifications are now universal. Use the visit to discuss risk, supplemental imaging, and why a human still directs their care.
The Bottom Line
AI won’t replace radiologists or read mammograms for us — just as PET scans didn’t replace oncologists and stethoscopes didn’t make cardiologists obsolete. What it will do is catch what the tired human eye might miss, shave days off anxious waiting, and turn breast density into data instead of doubt. For oncologists, that means staging sooner, enrolling smarter, and spending more time talking with patients instead of chasing callbacks.
In short, AI may not take the picture, but it helps us frame the story, making it sharper, faster, and with fewer blind spots. By pairing this powerful technology with rigorous, equity-focused local validation and transparent governance under the FDA’s emerging Predetermined Change Control Plan framework, we can realize the tangible benefits of practical AI for our patients without widening disparities.
Now, during Breast Cancer Awareness Month, how about we add on AI to that pink ribbon — how cool would that be?
Thoughts? Drop me a line at [email protected]. Let’s keep the conversation — and pink ribbons — going.
Arturo Loaiza-Bonilla, MD, MSEd, is the co-founder and chief medical AI officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as Systemwide Chief of Hematology and Oncology at St. Luke’s University Health Network, where he maintains a connection to patient care by attending to patients 2 days a week.
A version of this article first appeared on Medscape.com.
In this Practical AI column, we’ve explored everything from large language models to the nuances of trial matching, but one of the most immediate and impactful applications of AI is unfolding right now in breast imaging. For oncologists, this isn’t an abstract future — with new screening guidelines, dense-breast mandates, and a shrinking radiology workforce, it’s the imaging reports and patient questions landing in your clinic today.
Here is what oncologists need to know, and how to put it to work for their patients.
Why AI in Mammography Matters
More than 200 million women undergo breast cancer screening each year. In the US alone, 10% of the 40 million women screened annually require additional diagnostic imaging, and 4%–5% of these women are eventually diagnosed with breast cancer.
Two major shifts are redefining breast cancer screening in the US: The US Preventive Services Task Force (USPSTF) now recommends biennial screening from age 40 to 74 years, and notifying patients of breast density is a federal requirement as of September 10, 2024. That means more mammograms, more patient questions, and more downstream oncology decisions. Patients will increasingly ask about “dense” breast results and what to do next. Add a national radiologist shortage into the mix, and the pressure on timely callbacks, biopsies, and treatment planning will only grow.
Can AI Help Without Compromising Care?
The short answer is yes. With AI, we may be able to transform these rate-limiting steps into opportunities for earlier detection, decentralized screening, and smarter triage and save hundreds of thousands of women from an unnecessary diagnostic procedure, if implemented deliberately.
Don’t Confuse Today’s AI With Yesterday’s CAD
Think of older computer-aided detection (CAD) like a 1990s chemotherapy drug: It sometimes helped, but it came with significant toxicity and rarely delivered consistent survival benefits. Today’s deep-learning AI is closer to targeted therapy — trained on millions of “trial participants” (mammograms), more precise, and applied in specific contexts where it adds value. If you once dismissed CAD as noise, it’s time to revisit what AI can now offer.
The role of AI is broader than drawing boxes. It provides second readings, worklist triage, risk prediction, density assessment, and decision support. FDA has cleared several AI tools for both 2D and digital breast tomosynthesis (DBT), which include iCAD ProFound (DBT), ScreenPoint Transpara (2D/DBT), and Lunit INSIGHT DBT.
Some of the strongest evidence for AI in mammography is as a second reader during screening. Large trials show that AI plus one radiologist can match reading from two radiologists, cutting workload by about 40%. For example, the MASAI randomized trial showed that AI-supported screening achieved similar cancer detection but cut human screen-reading workload about 44% vs standard double reading (39,996 vs 40,024 participants). The primary interval cancer outcomes are maturing, but the safety analysis is reassuring.
Reducing second reads and arbitration time are important for clinicians because it frees capacity for callbacks and diagnostic workups. This will be especially key given that screening now starts at age 40. That will mean about 21 to 22 million more women are newly eligible, translating to about 10 to 11 million additional mammograms each year under biennial screening.
Another important area where AI can make its mark in mammography is triage and time to diagnosis. The results from a randomized implementation study showed that AI-prioritized worklists accelerated time to additional imaging and biopsy diagnosis without harming efficiency for others — exactly the kind of outcome patients feel.
Multiple studies have demonstrated improved diagnostic performance and shorter reading times when AI supports DBT interpretation, which is important because DBT can otherwise be time intensive.
We are also seeing rapid advancement in risk-based screening, moving beyond a single dense vs not dense approach. Deep-learning risk models, such as Mirai, predict 1- to 5-year breast cancer risk directly from the mammogram, and these tools are now being assessed prospectively to guide supplemental MRI. Cost-effectiveness modeling supports risk-stratified intervals vs one-size-fits-all schedules.
Finally, automated density tools, such as Transpara Density and Volpara, offer objective, reproducible volumetric measures that map to the Breast Imaging-Reporting and Data System, which is useful for Mammography Quality Standards Act-required reporting and as inputs to risk calculators.
While early evidence suggests AI may help surface future or interval cancers earlier, including more invasive tumors, the definitive impacts on interval cancer rates and mortality require longitudinal follow-up, which is now in progress.
Pitfalls to Watch For
Bias is real. Studies show false-positive differences by race, age, and density. AI can even infer racial identity from images, potentially amplifying disparities. Performance can also shift by vendor, demographics, and prevalence.
A Radiology study of 4855 DBT exams showed that an algorithm produced more false-positive case scores in Black patients and older patients (aged 71-80 years) patients and in women with extremely dense breasts. This can happen because AI can infer proxies for race directly from images, even when humans cannot, and this can propagate disparities if not addressed. External validations and reviews emphasize that performance can shift with device manufacturer, demographics, and prevalence, which is why all tools need to undergo local validation and calibration.
Here’s a pragmatic adoption checklist before going live with an AI tool.
- Confirm FDA clearance: Verify the name and version of the algorithm, imaging modes (2D vs DBT), and operating points. Confirm 510(k) numbers.
- Local validation: Test on your patient mix and vendor stack (Hologic, GE, Siemens, Fuji). Compare this to your baseline recall rate, positive predictive value of recall (PPV1), cancer detection rate, and reading time. Commit to recalibration if drift occurs.
- Equity plan: Monitor false-positive and negative false-rates by age, race/ethnicity, and density; document corrective actions if disparities emerge. (This isn’t optional.)
- Workflow clarity: Is AI a second reader, an additional reader, or a triage tool? Who arbitrates discordance? What’s the escalation path for high-risk or interval cancer-like patterns?
- Regulatory strategy: Confirm whether the vendor has (or will file) a Predetermined Change Control Plan so models can be updated safely without repeated submissions. Also confirm how you’ll be notified about performance-relevant changes.
- Data governance: Audit logs of AI outputs, retention, protected health information handling, and the patient communication policy for AI-assisted reads.
After going live, set up a quarterly dashboard. It should include cancer detection rate per 1000 patients, recall rate, PPV1, interval cancer rate (as it matures), reading time, and turnaround time to diagnostic imaging or biopsy — all stratified by age, race/ethnicity, and density.
Here, I dissect what this discussion means through the lens of Moravec’s paradox (machines excel at what clinicians find hard, and vice versa) and offer a possible playbook for putting these tools to work.
What to Tell Patients
When speaking with patients, emphasize that a radiologist still reads their mammogram. AI helps with consistency and efficiency; it doesn’t replace human oversight. Patients with dense breasts should still expect a standard notice; discussion of individualized risk factors, such as family history, genetics, and prior biopsies; and consideration of supplemental imaging if risk warrants. But it’s also important to tell these patients that while dense breasts are common, they do not automatically mean high cancer risk.
As for screening schedules, remind patients that screening is at least biennial from 40 to 74 years of age per the USPSTF guidelines; however, specialty groups may recommend starting on an annual schedule at 40.
What You Can Implement Now
There are multiple practical use cases you can introduce now. One is to use AI as a second reader or an additional reader safety net to preserve detection while reducing human workload. This helps your breast center absorb screening expansion to age 40 without diluting quality. Another is to turn on AI triage to shorten the time to callback and biopsy for the few who need it most — patients notice and appreciate faster answers. You can also begin adopting automated density plus risk models to move beyond “dense/not dense.” For selected patients, AI-informed risk can justify MRI or tailored intervals.
Here’s a quick cheat sheet (for your next leadership or tumor-board meeting).
Do:
- Use AI as a second or additional reader or triage tool, not as a black box.
- Track cancer detection rate, recall, PPV1, interval cancers, and reading time, stratified by age, race, and breast density.
- Pair automated density with AI risk to personalize screening and supplemental imaging.
- Enroll patients in future clinical trials, such as PRISM, the first large-scale randomized controlled trial of AI for screening mammography. This US-based, $16 million, seven-site study is funded by the Patient-Centered Outcomes Research Institute.
Don’t:
- Assume “AI = CAD.” The 2015 CAD story is over; modern deep learning systems are different and require different oversight.
- Go live without a local validation and equity plan or without clarity on software updates.
- Forget to remind patients that screening starts at age 40, and dense breast notifications are now universal. Use the visit to discuss risk, supplemental imaging, and why a human still directs their care.
The Bottom Line
AI won’t replace radiologists or read mammograms for us — just as PET scans didn’t replace oncologists and stethoscopes didn’t make cardiologists obsolete. What it will do is catch what the tired human eye might miss, shave days off anxious waiting, and turn breast density into data instead of doubt. For oncologists, that means staging sooner, enrolling smarter, and spending more time talking with patients instead of chasing callbacks.
In short, AI may not take the picture, but it helps us frame the story, making it sharper, faster, and with fewer blind spots. By pairing this powerful technology with rigorous, equity-focused local validation and transparent governance under the FDA’s emerging Predetermined Change Control Plan framework, we can realize the tangible benefits of practical AI for our patients without widening disparities.
Now, during Breast Cancer Awareness Month, how about we add on AI to that pink ribbon — how cool would that be?
Thoughts? Drop me a line at [email protected]. Let’s keep the conversation — and pink ribbons — going.
Arturo Loaiza-Bonilla, MD, MSEd, is the co-founder and chief medical AI officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as Systemwide Chief of Hematology and Oncology at St. Luke’s University Health Network, where he maintains a connection to patient care by attending to patients 2 days a week.
A version of this article first appeared on Medscape.com.
Hospitalists Must Encourage Mental Stimulation for Patients
As a hospitalist, you are in a unique position to notice changes in your hospitalized patients. This frontline perspective can be used to improve inpatient attention and care, and differs from primary care, where a clinician might only see a patient once or twice a year, and subtle, gradual changes may be missed, said George Cao, MD, MBA, a hospitalist at the University of Vermont Medical Center in Burlington and assistant professor at UVM’s Larner College of Medicine.
But in the hospital, Cao said even small shifts — like becoming less active, eating less, or changes in personality — can become much more obvious.
“As hospitalists…we see patients throughout the day, in different situations, and often end up spending more time with them over the course of a week than their primary care provider might in a year,” Cao explained. “This gives us a real advantage in picking up on subtle changes in mental awareness.”
These assessments can also be evaluated with the benefit of daily labs, frequent bedside interactions, and 24–hour observations.
With older adults, Cao said it’s important to go beyond just what’s in the chart.
“I always start by reviewing notes from the primary care provider and previous admissions, but some of the most valuable insights come from talking with family and close friends to get a true sense of the patient’s baseline — how they usually think, move, and interact,” he said.
Why to Watch for Declining Mental Awareness
Declining mental awareness in the inpatient setting is often a sign of an underlying problem — whether that’s a reversible medical condition, unrecognized dementia, or the development of delirium, Cao said.
“On the inpatient side, I pay close attention to more than just memory loss,” he said.
Changes in how patients function day–to–day, shifts in their behavior, or even something as simple as not wanting to get out of bed can be early signs of an aging mind or untreated psychiatric issues, he noted.
“Of course, we always rule out infections and medication side effects, but I also look for other reversible causes like thyroid problems, electrolyte imbalances, low oxygen, pain, urinary retention, constipation, and nutritional deficiencies,” Cao said.
Of note, delirium is the most common cause of sudden mental status changes in the hospital, and “it’s easy to miss if you’re not looking for it.”
He summarized that classic signs are an acute and fluctuating course with changes in alertness, but added there are other red flags too: disorientation, hallucinations, changes in sleep patterns, sporadic unsafe behaviors, mood swings, and changes in activity level, whether that’s agitation or just being unusually quiet.
By combining what he notices bedside and what is learned from the medical record (and from the people who know the patient best), Cao said he’s able to catch these changes early, identify the underlying cause, and work toward the best possible outcome.
“One of the main interventions is providing mental stimulation,” he said.
Why Mental Stimulation Is So Vital
Mental stimulation of the patient is critical to recovery and may prevent prolonged illness, said Meghana R. Medavaram, MD, associate director of consultation liaison and emergency psychiatry at Montefiore Medical Center’s Weiler Hospital in New York City. “Keeping a patient active both physically and mentally can help prevent deconditioning and risks of prolonged immobility,” she said.
It’s important to note that when patients are out of their familiar routines, away from their usual environment and people, and their sleep is fragmented, this can make them even more vulnerable. Keeping patients mentally stimulated during their hospital stay can help maintain their attention, orientation, and a healthy sleep-wake cycle — all things that are easily thrown off in the hospital, Cao said.
“These disruptions hit the pathways that control attention, wakefulness, and the sleep–wake cycle. That’s when you see attention drifting, orientation fading, and circadian rhythms unraveling, especially at night, which is why “sundowning” is so common, Cao said, referring to the syndrome where older adults or people with dementia experience behavioral changes in late afternoon or evening. “Mental stimulation is critical in the hospital because when the brain isn’t active and gets disoriented, it becomes an easy target for delirium.”
He said delirium often develops in older adults when acute stressors like inflammation, low oxygen, metabolic imbalances, or sedating medications disrupt the brain’s arousal systems and networks, especially in older adults.
Therefore, Cao said, encourage your patients to be more engaged during the day through conversation, activities, or regular reorientation. “This supports the brain networks that help prevent inattention and confusion, which are the hallmarks of delirium. Daytime stimulation also helps build up the natural drive for nighttime sleep, so patients are less likely to nap during the day and be awake and disoriented at night.”
To support this, it’s helpful to schedule medications during waking hours instead of around–the–clock dosing that interrupts sleep, and to cluster nighttime care activities to minimize disturbances, Cao explained. Ensuring patients have their glasses, hearing aids, and familiar routines, along with encouraging mobility and hydration, further protects against delirium and supports patients’ cognitive health during hospitalization. “These same principles are just as important in outpatient subacute rehab settings and at home, so it’s essential to take home these strategies after discharge,” he said.
A Family Member or Friend May Help
Hospitalists can suggest straightforward ways to encourage families and friends to keep patients engaged during a hospital stay. Visits and chats can go a long way as conversations are incredibly grounding, Cao said. Other methods could be bringing in favorite foods or snacks, a phone chat or video call, or even showing prerecorded video messages. “These can be effective. Patients respond well to seeing and hearing familiar faces and voices, even if it’s just on a screen,” Cao said.
Beyond that, he said, activities such as watching and discussing the news, reading aloud, using tablets for games, watching movies, doing crossword puzzles, knitting, reminiscing, and playing word games can also be mentally stimulating for patients.
In addition, safe exercises/activities that patients can do in bed — with advice from physical therapy and occupational therapy — are beneficial, Medavaram said. “These often include gentle range–of-motion activities,” she said.
Share Importance of Mental Stimulation With Patients and Caregivers
If a hospitalist wants to motivate patients to keep their minds active, the framing should be simple, positive, and tied directly to their goals of getting better and getting home, said Medavaram. She provided this script suggestion:
“One of the best ways to help your recovery isn’t just taking your medicine, it’s keeping your mind active. When you’re in the hospital, it’s easy to spend the day lying in bed and staring at the TV in your room, but that can make your brain slow down and even cause confusion. Simple things — like reading, talking with visitors, doing puzzles, listening to music you enjoy, or telling a nurse about your favorite memories — can keep your brain sharp. Staying mentally active helps your thinking stay clear and can even help you get home sooner. Think of it like physical therapy for your brain.”
A version of this article first appeared on Medscape.com.
As a hospitalist, you are in a unique position to notice changes in your hospitalized patients. This frontline perspective can be used to improve inpatient attention and care, and differs from primary care, where a clinician might only see a patient once or twice a year, and subtle, gradual changes may be missed, said George Cao, MD, MBA, a hospitalist at the University of Vermont Medical Center in Burlington and assistant professor at UVM’s Larner College of Medicine.
But in the hospital, Cao said even small shifts — like becoming less active, eating less, or changes in personality — can become much more obvious.
“As hospitalists…we see patients throughout the day, in different situations, and often end up spending more time with them over the course of a week than their primary care provider might in a year,” Cao explained. “This gives us a real advantage in picking up on subtle changes in mental awareness.”
These assessments can also be evaluated with the benefit of daily labs, frequent bedside interactions, and 24–hour observations.
With older adults, Cao said it’s important to go beyond just what’s in the chart.
“I always start by reviewing notes from the primary care provider and previous admissions, but some of the most valuable insights come from talking with family and close friends to get a true sense of the patient’s baseline — how they usually think, move, and interact,” he said.
Why to Watch for Declining Mental Awareness
Declining mental awareness in the inpatient setting is often a sign of an underlying problem — whether that’s a reversible medical condition, unrecognized dementia, or the development of delirium, Cao said.
“On the inpatient side, I pay close attention to more than just memory loss,” he said.
Changes in how patients function day–to–day, shifts in their behavior, or even something as simple as not wanting to get out of bed can be early signs of an aging mind or untreated psychiatric issues, he noted.
“Of course, we always rule out infections and medication side effects, but I also look for other reversible causes like thyroid problems, electrolyte imbalances, low oxygen, pain, urinary retention, constipation, and nutritional deficiencies,” Cao said.
Of note, delirium is the most common cause of sudden mental status changes in the hospital, and “it’s easy to miss if you’re not looking for it.”
He summarized that classic signs are an acute and fluctuating course with changes in alertness, but added there are other red flags too: disorientation, hallucinations, changes in sleep patterns, sporadic unsafe behaviors, mood swings, and changes in activity level, whether that’s agitation or just being unusually quiet.
By combining what he notices bedside and what is learned from the medical record (and from the people who know the patient best), Cao said he’s able to catch these changes early, identify the underlying cause, and work toward the best possible outcome.
“One of the main interventions is providing mental stimulation,” he said.
Why Mental Stimulation Is So Vital
Mental stimulation of the patient is critical to recovery and may prevent prolonged illness, said Meghana R. Medavaram, MD, associate director of consultation liaison and emergency psychiatry at Montefiore Medical Center’s Weiler Hospital in New York City. “Keeping a patient active both physically and mentally can help prevent deconditioning and risks of prolonged immobility,” she said.
It’s important to note that when patients are out of their familiar routines, away from their usual environment and people, and their sleep is fragmented, this can make them even more vulnerable. Keeping patients mentally stimulated during their hospital stay can help maintain their attention, orientation, and a healthy sleep-wake cycle — all things that are easily thrown off in the hospital, Cao said.
“These disruptions hit the pathways that control attention, wakefulness, and the sleep–wake cycle. That’s when you see attention drifting, orientation fading, and circadian rhythms unraveling, especially at night, which is why “sundowning” is so common, Cao said, referring to the syndrome where older adults or people with dementia experience behavioral changes in late afternoon or evening. “Mental stimulation is critical in the hospital because when the brain isn’t active and gets disoriented, it becomes an easy target for delirium.”
He said delirium often develops in older adults when acute stressors like inflammation, low oxygen, metabolic imbalances, or sedating medications disrupt the brain’s arousal systems and networks, especially in older adults.
Therefore, Cao said, encourage your patients to be more engaged during the day through conversation, activities, or regular reorientation. “This supports the brain networks that help prevent inattention and confusion, which are the hallmarks of delirium. Daytime stimulation also helps build up the natural drive for nighttime sleep, so patients are less likely to nap during the day and be awake and disoriented at night.”
To support this, it’s helpful to schedule medications during waking hours instead of around–the–clock dosing that interrupts sleep, and to cluster nighttime care activities to minimize disturbances, Cao explained. Ensuring patients have their glasses, hearing aids, and familiar routines, along with encouraging mobility and hydration, further protects against delirium and supports patients’ cognitive health during hospitalization. “These same principles are just as important in outpatient subacute rehab settings and at home, so it’s essential to take home these strategies after discharge,” he said.
A Family Member or Friend May Help
Hospitalists can suggest straightforward ways to encourage families and friends to keep patients engaged during a hospital stay. Visits and chats can go a long way as conversations are incredibly grounding, Cao said. Other methods could be bringing in favorite foods or snacks, a phone chat or video call, or even showing prerecorded video messages. “These can be effective. Patients respond well to seeing and hearing familiar faces and voices, even if it’s just on a screen,” Cao said.
Beyond that, he said, activities such as watching and discussing the news, reading aloud, using tablets for games, watching movies, doing crossword puzzles, knitting, reminiscing, and playing word games can also be mentally stimulating for patients.
In addition, safe exercises/activities that patients can do in bed — with advice from physical therapy and occupational therapy — are beneficial, Medavaram said. “These often include gentle range–of-motion activities,” she said.
Share Importance of Mental Stimulation With Patients and Caregivers
If a hospitalist wants to motivate patients to keep their minds active, the framing should be simple, positive, and tied directly to their goals of getting better and getting home, said Medavaram. She provided this script suggestion:
“One of the best ways to help your recovery isn’t just taking your medicine, it’s keeping your mind active. When you’re in the hospital, it’s easy to spend the day lying in bed and staring at the TV in your room, but that can make your brain slow down and even cause confusion. Simple things — like reading, talking with visitors, doing puzzles, listening to music you enjoy, or telling a nurse about your favorite memories — can keep your brain sharp. Staying mentally active helps your thinking stay clear and can even help you get home sooner. Think of it like physical therapy for your brain.”
A version of this article first appeared on Medscape.com.
As a hospitalist, you are in a unique position to notice changes in your hospitalized patients. This frontline perspective can be used to improve inpatient attention and care, and differs from primary care, where a clinician might only see a patient once or twice a year, and subtle, gradual changes may be missed, said George Cao, MD, MBA, a hospitalist at the University of Vermont Medical Center in Burlington and assistant professor at UVM’s Larner College of Medicine.
But in the hospital, Cao said even small shifts — like becoming less active, eating less, or changes in personality — can become much more obvious.
“As hospitalists…we see patients throughout the day, in different situations, and often end up spending more time with them over the course of a week than their primary care provider might in a year,” Cao explained. “This gives us a real advantage in picking up on subtle changes in mental awareness.”
These assessments can also be evaluated with the benefit of daily labs, frequent bedside interactions, and 24–hour observations.
With older adults, Cao said it’s important to go beyond just what’s in the chart.
“I always start by reviewing notes from the primary care provider and previous admissions, but some of the most valuable insights come from talking with family and close friends to get a true sense of the patient’s baseline — how they usually think, move, and interact,” he said.
Why to Watch for Declining Mental Awareness
Declining mental awareness in the inpatient setting is often a sign of an underlying problem — whether that’s a reversible medical condition, unrecognized dementia, or the development of delirium, Cao said.
“On the inpatient side, I pay close attention to more than just memory loss,” he said.
Changes in how patients function day–to–day, shifts in their behavior, or even something as simple as not wanting to get out of bed can be early signs of an aging mind or untreated psychiatric issues, he noted.
“Of course, we always rule out infections and medication side effects, but I also look for other reversible causes like thyroid problems, electrolyte imbalances, low oxygen, pain, urinary retention, constipation, and nutritional deficiencies,” Cao said.
Of note, delirium is the most common cause of sudden mental status changes in the hospital, and “it’s easy to miss if you’re not looking for it.”
He summarized that classic signs are an acute and fluctuating course with changes in alertness, but added there are other red flags too: disorientation, hallucinations, changes in sleep patterns, sporadic unsafe behaviors, mood swings, and changes in activity level, whether that’s agitation or just being unusually quiet.
By combining what he notices bedside and what is learned from the medical record (and from the people who know the patient best), Cao said he’s able to catch these changes early, identify the underlying cause, and work toward the best possible outcome.
“One of the main interventions is providing mental stimulation,” he said.
Why Mental Stimulation Is So Vital
Mental stimulation of the patient is critical to recovery and may prevent prolonged illness, said Meghana R. Medavaram, MD, associate director of consultation liaison and emergency psychiatry at Montefiore Medical Center’s Weiler Hospital in New York City. “Keeping a patient active both physically and mentally can help prevent deconditioning and risks of prolonged immobility,” she said.
It’s important to note that when patients are out of their familiar routines, away from their usual environment and people, and their sleep is fragmented, this can make them even more vulnerable. Keeping patients mentally stimulated during their hospital stay can help maintain their attention, orientation, and a healthy sleep-wake cycle — all things that are easily thrown off in the hospital, Cao said.
“These disruptions hit the pathways that control attention, wakefulness, and the sleep–wake cycle. That’s when you see attention drifting, orientation fading, and circadian rhythms unraveling, especially at night, which is why “sundowning” is so common, Cao said, referring to the syndrome where older adults or people with dementia experience behavioral changes in late afternoon or evening. “Mental stimulation is critical in the hospital because when the brain isn’t active and gets disoriented, it becomes an easy target for delirium.”
He said delirium often develops in older adults when acute stressors like inflammation, low oxygen, metabolic imbalances, or sedating medications disrupt the brain’s arousal systems and networks, especially in older adults.
Therefore, Cao said, encourage your patients to be more engaged during the day through conversation, activities, or regular reorientation. “This supports the brain networks that help prevent inattention and confusion, which are the hallmarks of delirium. Daytime stimulation also helps build up the natural drive for nighttime sleep, so patients are less likely to nap during the day and be awake and disoriented at night.”
To support this, it’s helpful to schedule medications during waking hours instead of around–the–clock dosing that interrupts sleep, and to cluster nighttime care activities to minimize disturbances, Cao explained. Ensuring patients have their glasses, hearing aids, and familiar routines, along with encouraging mobility and hydration, further protects against delirium and supports patients’ cognitive health during hospitalization. “These same principles are just as important in outpatient subacute rehab settings and at home, so it’s essential to take home these strategies after discharge,” he said.
A Family Member or Friend May Help
Hospitalists can suggest straightforward ways to encourage families and friends to keep patients engaged during a hospital stay. Visits and chats can go a long way as conversations are incredibly grounding, Cao said. Other methods could be bringing in favorite foods or snacks, a phone chat or video call, or even showing prerecorded video messages. “These can be effective. Patients respond well to seeing and hearing familiar faces and voices, even if it’s just on a screen,” Cao said.
Beyond that, he said, activities such as watching and discussing the news, reading aloud, using tablets for games, watching movies, doing crossword puzzles, knitting, reminiscing, and playing word games can also be mentally stimulating for patients.
In addition, safe exercises/activities that patients can do in bed — with advice from physical therapy and occupational therapy — are beneficial, Medavaram said. “These often include gentle range–of-motion activities,” she said.
Share Importance of Mental Stimulation With Patients and Caregivers
If a hospitalist wants to motivate patients to keep their minds active, the framing should be simple, positive, and tied directly to their goals of getting better and getting home, said Medavaram. She provided this script suggestion:
“One of the best ways to help your recovery isn’t just taking your medicine, it’s keeping your mind active. When you’re in the hospital, it’s easy to spend the day lying in bed and staring at the TV in your room, but that can make your brain slow down and even cause confusion. Simple things — like reading, talking with visitors, doing puzzles, listening to music you enjoy, or telling a nurse about your favorite memories — can keep your brain sharp. Staying mentally active helps your thinking stay clear and can even help you get home sooner. Think of it like physical therapy for your brain.”
A version of this article first appeared on Medscape.com.
T2DM Prevalence Rising in Native American Youth
A recent worldwide survey found the United States to have the highest reported prevalence of type 2 diabetes mellitus (T2DM) among young people aged 10 to 19 years. Research on the prevalence of the disease among Indigenous populations is scarce, however, leaving these individuals at a potentially greater risk.
The estimated prevalence of T2DM has nearly doubled over the past 2 decades, with cases per 1000 youths aged 10 to 19 years increasing from 0.34 in 2001 to 0.46 in 2009 to 0.67 in 2017, a relative increase of 95.3% over 16 years. In 2012, the SEARCH study of youth-onset T2DM found American Indians and non-Hispanic Black individuals had the highest incidence (46.5/100,000/year in American Indians and 32.6/100,000/year in non-Hispanic Black individuals), compared with non-Hispanic White individuals (3.9/100,000/year).
About 28,000 US youth aged < 20 years had T2DM in 2017, a figure expected to reach 48,000 in 2060 based on increasing prevalence and incidence rates. Assuming the trends observed between 2002 and 2017 continue, an estimated 220,000 young people will have T2DM.
However, the lack of recent research of T2DM in young indigenous populations may have masked a serious problem among Native Americans. A 2025 literature review of 49 studies call it a “type 2 diabetes crisis” among Indigenous communities; not because of the disease, but due to high rates of complications. Though Indigenous peoples are estimated to inhabit > 90 countries and collectively represent > 370 million people, the studies included in the review involved individuals from 6 countries and 2 self-governing states (US, Canada, Australia, Aotearoa New Zealand, Nauru, Argentina, the Cook Islands, and Niue) and at least 45 Indigenous populations after search criteria were satisfied. Data were derived from population-based screening and health databases, including from 432 IHS facilities and 6 IHS regions.
Of the study populations, 27 (75%) reported diabetes prevalence above 1 per 1000. Age-specific data, available in 44 studies, showed increased prevalence with age: 0 to 4 per 1000 at age < 10 years; 0 to 44 per 1000 at age 10 to 19 years; and 0 to 64 per 1000 at age 15 to 25 years.
In young adults aged 15 to 25 years, prevalence was highest in Akimel O’odham and Tohono O’odham Peoples from the Gila River Indian Community in Arizona. Among children aged < 10 years, the highest prevalence was reported in Cherokee Nation children. Some groups reported no diabetes, such as the Northern Plains Indians from Montana and Wyoming.
Statistics showing the speed of expanding prevalence were particularly notable. For Akimel O’odham and Tohono O’odham Indian youth, diabetes prevalence increased more than eightfold over 2 decades (particularly in those aged < 15).
A 2021 study of 500 participants who were diagnosed with T2DM in youth were followed for a mean of 13 years. By the time they were 26, 67.5% had hypertension, 51.6% had dyslipidemia, 54.8% had diabetic kidney disease, and 32.4% had nerve disease.
Indigenous North American children may also have an even greater risk for later complications. A Canadian study found that among Canadian First Nations Peoples the incidence of end-stage kidney disease was 2.8 times higher and the mortality rate was double that of non-Indigenous people with youth-onset T2DM despite similar age at diagnosis and duration of disease.
To combat the steady increase of T2DM prevalence among Indigenous youth, researchers advise “urgent action” to improve data equity through the inclusion of Indigenous populations in health surveillance, routine disaggregation by Indigenous status, and culturally safe research partnerships led by Indigenous communities. Standardized age group classifications, age- and gender-specific reporting, and assessment of comorbid obesity are essential, they add, to define health care needs and identify regions that would benefit from enhanced early detection and management.
A recent worldwide survey found the United States to have the highest reported prevalence of type 2 diabetes mellitus (T2DM) among young people aged 10 to 19 years. Research on the prevalence of the disease among Indigenous populations is scarce, however, leaving these individuals at a potentially greater risk.
The estimated prevalence of T2DM has nearly doubled over the past 2 decades, with cases per 1000 youths aged 10 to 19 years increasing from 0.34 in 2001 to 0.46 in 2009 to 0.67 in 2017, a relative increase of 95.3% over 16 years. In 2012, the SEARCH study of youth-onset T2DM found American Indians and non-Hispanic Black individuals had the highest incidence (46.5/100,000/year in American Indians and 32.6/100,000/year in non-Hispanic Black individuals), compared with non-Hispanic White individuals (3.9/100,000/year).
About 28,000 US youth aged < 20 years had T2DM in 2017, a figure expected to reach 48,000 in 2060 based on increasing prevalence and incidence rates. Assuming the trends observed between 2002 and 2017 continue, an estimated 220,000 young people will have T2DM.
However, the lack of recent research of T2DM in young indigenous populations may have masked a serious problem among Native Americans. A 2025 literature review of 49 studies call it a “type 2 diabetes crisis” among Indigenous communities; not because of the disease, but due to high rates of complications. Though Indigenous peoples are estimated to inhabit > 90 countries and collectively represent > 370 million people, the studies included in the review involved individuals from 6 countries and 2 self-governing states (US, Canada, Australia, Aotearoa New Zealand, Nauru, Argentina, the Cook Islands, and Niue) and at least 45 Indigenous populations after search criteria were satisfied. Data were derived from population-based screening and health databases, including from 432 IHS facilities and 6 IHS regions.
Of the study populations, 27 (75%) reported diabetes prevalence above 1 per 1000. Age-specific data, available in 44 studies, showed increased prevalence with age: 0 to 4 per 1000 at age < 10 years; 0 to 44 per 1000 at age 10 to 19 years; and 0 to 64 per 1000 at age 15 to 25 years.
In young adults aged 15 to 25 years, prevalence was highest in Akimel O’odham and Tohono O’odham Peoples from the Gila River Indian Community in Arizona. Among children aged < 10 years, the highest prevalence was reported in Cherokee Nation children. Some groups reported no diabetes, such as the Northern Plains Indians from Montana and Wyoming.
Statistics showing the speed of expanding prevalence were particularly notable. For Akimel O’odham and Tohono O’odham Indian youth, diabetes prevalence increased more than eightfold over 2 decades (particularly in those aged < 15).
A 2021 study of 500 participants who were diagnosed with T2DM in youth were followed for a mean of 13 years. By the time they were 26, 67.5% had hypertension, 51.6% had dyslipidemia, 54.8% had diabetic kidney disease, and 32.4% had nerve disease.
Indigenous North American children may also have an even greater risk for later complications. A Canadian study found that among Canadian First Nations Peoples the incidence of end-stage kidney disease was 2.8 times higher and the mortality rate was double that of non-Indigenous people with youth-onset T2DM despite similar age at diagnosis and duration of disease.
To combat the steady increase of T2DM prevalence among Indigenous youth, researchers advise “urgent action” to improve data equity through the inclusion of Indigenous populations in health surveillance, routine disaggregation by Indigenous status, and culturally safe research partnerships led by Indigenous communities. Standardized age group classifications, age- and gender-specific reporting, and assessment of comorbid obesity are essential, they add, to define health care needs and identify regions that would benefit from enhanced early detection and management.
A recent worldwide survey found the United States to have the highest reported prevalence of type 2 diabetes mellitus (T2DM) among young people aged 10 to 19 years. Research on the prevalence of the disease among Indigenous populations is scarce, however, leaving these individuals at a potentially greater risk.
The estimated prevalence of T2DM has nearly doubled over the past 2 decades, with cases per 1000 youths aged 10 to 19 years increasing from 0.34 in 2001 to 0.46 in 2009 to 0.67 in 2017, a relative increase of 95.3% over 16 years. In 2012, the SEARCH study of youth-onset T2DM found American Indians and non-Hispanic Black individuals had the highest incidence (46.5/100,000/year in American Indians and 32.6/100,000/year in non-Hispanic Black individuals), compared with non-Hispanic White individuals (3.9/100,000/year).
About 28,000 US youth aged < 20 years had T2DM in 2017, a figure expected to reach 48,000 in 2060 based on increasing prevalence and incidence rates. Assuming the trends observed between 2002 and 2017 continue, an estimated 220,000 young people will have T2DM.
However, the lack of recent research of T2DM in young indigenous populations may have masked a serious problem among Native Americans. A 2025 literature review of 49 studies call it a “type 2 diabetes crisis” among Indigenous communities; not because of the disease, but due to high rates of complications. Though Indigenous peoples are estimated to inhabit > 90 countries and collectively represent > 370 million people, the studies included in the review involved individuals from 6 countries and 2 self-governing states (US, Canada, Australia, Aotearoa New Zealand, Nauru, Argentina, the Cook Islands, and Niue) and at least 45 Indigenous populations after search criteria were satisfied. Data were derived from population-based screening and health databases, including from 432 IHS facilities and 6 IHS regions.
Of the study populations, 27 (75%) reported diabetes prevalence above 1 per 1000. Age-specific data, available in 44 studies, showed increased prevalence with age: 0 to 4 per 1000 at age < 10 years; 0 to 44 per 1000 at age 10 to 19 years; and 0 to 64 per 1000 at age 15 to 25 years.
In young adults aged 15 to 25 years, prevalence was highest in Akimel O’odham and Tohono O’odham Peoples from the Gila River Indian Community in Arizona. Among children aged < 10 years, the highest prevalence was reported in Cherokee Nation children. Some groups reported no diabetes, such as the Northern Plains Indians from Montana and Wyoming.
Statistics showing the speed of expanding prevalence were particularly notable. For Akimel O’odham and Tohono O’odham Indian youth, diabetes prevalence increased more than eightfold over 2 decades (particularly in those aged < 15).
A 2021 study of 500 participants who were diagnosed with T2DM in youth were followed for a mean of 13 years. By the time they were 26, 67.5% had hypertension, 51.6% had dyslipidemia, 54.8% had diabetic kidney disease, and 32.4% had nerve disease.
Indigenous North American children may also have an even greater risk for later complications. A Canadian study found that among Canadian First Nations Peoples the incidence of end-stage kidney disease was 2.8 times higher and the mortality rate was double that of non-Indigenous people with youth-onset T2DM despite similar age at diagnosis and duration of disease.
To combat the steady increase of T2DM prevalence among Indigenous youth, researchers advise “urgent action” to improve data equity through the inclusion of Indigenous populations in health surveillance, routine disaggregation by Indigenous status, and culturally safe research partnerships led by Indigenous communities. Standardized age group classifications, age- and gender-specific reporting, and assessment of comorbid obesity are essential, they add, to define health care needs and identify regions that would benefit from enhanced early detection and management.