AVAHO

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved motixafortide (Aphexda, BioLineRx) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma.

The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.

The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.

“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.

The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.

BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.

Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.

However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.

Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.

Labeling for the subcutaneous injection is available online.

A version of this article first appeared on Medscape.com.

Should patients with acute myeloid leukemia (AML) for whom induction therapy fails to induce complete remission proceed to allogeneic hematopoietic stem cell transplant anyway? Or do these patients fare better when they receive an intensive salvage induction regimen to bring them into remission before transplant?

This critically important question was debated at the annual meeting of the Society of Hematologic Oncology, held in Houston and online.

Johannes Schetelig, MD, argued in favor of proceeding to transplant, even without a complete remission.

“In the past, I’ve told many patients with relapsed or refractory AML that we do need to induce a [complete remission] prior to transplantation,” said Dr. Schetelig, from the Clinical Trials Unit at DKMS in Dresden, Germany. “But is it true?”

According to findings from a recent randomized trial, it may not be. The trial, led by Dr. Schetelig, found that patients with AML who received immediate allogeneic transplant without first having achieved a complete response following induction therapy did just as well as those who received intensive salvage induction therapy to establish remission before transplant.

If this finding holds, it “completely upends” how experts have traditionally approached patients with AML, Mikkael A. Sekeres, MD, of the University of Miami said at a conference press briefing last year.

The phase 3 ASAP trial, presented at last year’s American Society of Hematology meeting, included patients with AML who had had a poor response or who had experienced a relapse after first induction therapy. Patients were randomly assigned to a remission-induction strategy prior to allogeneic stem cell transplant (alloHCT) or a disease-control approach of watchful waiting followed by sequential conditioning and alloHCT. The primary endpoint was treatment success, defined as a complete response at day 56 following alloHCT.

In an intention-to-treat analysis, 83.5% of patients in the disease-control group and 81% in the remission-induction group achieved treatment success. Similarly, in the per-protocol analysis, 84.1% and 81.3%, respectively, achieved a complete response at day 56 after alloHCT. After a median follow-up of 4 years, there were no differences in leukemia-free survival or overall survival between the two groups.

Another advantage to forgoing an intensive salvage induction regimen: Patients in the disease-control arm experienced significantly fewer severe adverse events (23% vs. 64% in the remission induction arm) and spent a mean of 27 fewer days in the hospital prior to transplantation.

At last year’s press briefing, Dr. Schetelig said his team did not expect that a complete response on day 56 after transplantation would translate into “equal long-term benefit” for these groups. “This is what I was really astonished about,” he said.

Delving further into the findings, Dr. Schetelig explained that in the remission-induction arm patients who had had a complete response prior to transplantation demonstrated significantly better overall survival at 4 years than those who had not had a complete response at that point: 60% vs. 40%.

The study also revealed that in the disease-control arm, for patients under watchful waiting who did not need low-dose cytarabine and mitoxantrone for disease control, overall survival outcomes were similar to those of patients in the remission-induction arm who achieved a complete response.

These findings suggest that patients who can be bridged with watchful waiting may have a more favorable disease biology, and chemosensitivity could just be a biomarker for disease biology. In other words, “AML biology matters for transplant outcome and not tumor load,” Dr. Schetelig explained.

A recent study that found that having minimal residual disease (MRD) prior to transplant “had no independent effect on leukemia-free survival” supports this idea, he added.

Overall, Dr. Schetelig concluded that data from the ASAP trial suggest that watchful waiting prior to alloHCT represents “an alternative” for some patients.
 

Counterpoint: Aim for complete remission

Ronald B. Walter, MD, PhD, argued the counterpoint: that residual disease before transplantation is associated with worse posttransplant outcomes and represents a meaningful pretransplant therapeutic target.

The goal of intensifying treatment for patients with residual disease is to erase disease vestiges prior to transplantation.

“The idea is that by doing so you might optimize the benefit-to-risk ratio and ultimately improve outcomes,” said Dr. Walter, of the translational science and therapeutics division at the Fred Hutchinson Cancer Research Center in Seattle.

Several reports support this view that patients who are MRD negative at the time of transplant have significantly better survival outcomes than patients with residual disease who undergo transplant.

A 2016 study from Dr. Walter and colleagues at Fred Hutchinson, for instance, found that 3-year overall survival was significantly higher among patients with no MRD who underwent myeloablative alloHCT: 73% vs. 26% of those in MRD-positive morphologic remission and 23% of patients with active AML.

Another study, published the year before by a different research team, also revealed that “adult patients with AML in morphologic [complete remission] but with detectable MRD who undergo alloHCT have poor outcomes, which approximates those who undergo transplantation with active disease,” the authors of the 2015 study wrote in a commentary highlighting findings from both studies.

Still, providing intensive therapy prior to transplant comes with drawbacks, Dr. Walter noted. These downsides include potential toxicity from more intense therapy, which may prevent further therapy with curative intent, as well as the possibility that deintensifying therapy could lead to difficult-to-treat relapse.

It may, however, be possible to reduce the intensity of therapy before transplant and still achieve good outcomes after transplant, though the data remain mixed.

One trial found that a reduced-intensity conditioning regimen was associated with a greater risk of relapse post transplant and worse overall survival, compared with standard myeloablative conditioning.

However, another recent trial in which patients with AML or high-risk myelodysplastic syndrome were randomly assigned to either a reduced-intensity conditioning regimen or an intensified version of that regimen prior to transplant demonstrated no difference in relapse rates and overall survival, regardless of patients’ MRD status prior to transplant.

“To me, it’s still key to go into transplant with as little disease as possible,” Dr. Walter said. How much value there is in targeted treatment to further reduce disease burden prior to transplant “will really require further careful study,” he said.

The ASAP trial was sponsored by DKMS. Dr. Schetelig has received honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Walter reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Should patients with acute myeloid leukemia (AML) for whom induction therapy fails to induce complete remission proceed to allogeneic hematopoietic stem cell transplant anyway? Or do these patients fare better when they receive an intensive salvage induction regimen to bring them into remission before transplant?

This critically important question was debated at the annual meeting of the Society of Hematologic Oncology, held in Houston and online.

Johannes Schetelig, MD, argued in favor of proceeding to transplant, even without a complete remission.

“In the past, I’ve told many patients with relapsed or refractory AML that we do need to induce a [complete remission] prior to transplantation,” said Dr. Schetelig, from the Clinical Trials Unit at DKMS in Dresden, Germany. “But is it true?”

According to findings from a recent randomized trial, it may not be. The trial, led by Dr. Schetelig, found that patients with AML who received immediate allogeneic transplant without first having achieved a complete response following induction therapy did just as well as those who received intensive salvage induction therapy to establish remission before transplant.

If this finding holds, it “completely upends” how experts have traditionally approached patients with AML, Mikkael A. Sekeres, MD, of the University of Miami said at a conference press briefing last year.

The phase 3 ASAP trial, presented at last year’s American Society of Hematology meeting, included patients with AML who had had a poor response or who had experienced a relapse after first induction therapy. Patients were randomly assigned to a remission-induction strategy prior to allogeneic stem cell transplant (alloHCT) or a disease-control approach of watchful waiting followed by sequential conditioning and alloHCT. The primary endpoint was treatment success, defined as a complete response at day 56 following alloHCT.

In an intention-to-treat analysis, 83.5% of patients in the disease-control group and 81% in the remission-induction group achieved treatment success. Similarly, in the per-protocol analysis, 84.1% and 81.3%, respectively, achieved a complete response at day 56 after alloHCT. After a median follow-up of 4 years, there were no differences in leukemia-free survival or overall survival between the two groups.

Another advantage to forgoing an intensive salvage induction regimen: Patients in the disease-control arm experienced significantly fewer severe adverse events (23% vs. 64% in the remission induction arm) and spent a mean of 27 fewer days in the hospital prior to transplantation.

At last year’s press briefing, Dr. Schetelig said his team did not expect that a complete response on day 56 after transplantation would translate into “equal long-term benefit” for these groups. “This is what I was really astonished about,” he said.

Delving further into the findings, Dr. Schetelig explained that in the remission-induction arm patients who had had a complete response prior to transplantation demonstrated significantly better overall survival at 4 years than those who had not had a complete response at that point: 60% vs. 40%.

The study also revealed that in the disease-control arm, for patients under watchful waiting who did not need low-dose cytarabine and mitoxantrone for disease control, overall survival outcomes were similar to those of patients in the remission-induction arm who achieved a complete response.

These findings suggest that patients who can be bridged with watchful waiting may have a more favorable disease biology, and chemosensitivity could just be a biomarker for disease biology. In other words, “AML biology matters for transplant outcome and not tumor load,” Dr. Schetelig explained.

A recent study that found that having minimal residual disease (MRD) prior to transplant “had no independent effect on leukemia-free survival” supports this idea, he added.

Overall, Dr. Schetelig concluded that data from the ASAP trial suggest that watchful waiting prior to alloHCT represents “an alternative” for some patients.
 

Counterpoint: Aim for complete remission

Ronald B. Walter, MD, PhD, argued the counterpoint: that residual disease before transplantation is associated with worse posttransplant outcomes and represents a meaningful pretransplant therapeutic target.

The goal of intensifying treatment for patients with residual disease is to erase disease vestiges prior to transplantation.

“The idea is that by doing so you might optimize the benefit-to-risk ratio and ultimately improve outcomes,” said Dr. Walter, of the translational science and therapeutics division at the Fred Hutchinson Cancer Research Center in Seattle.

Several reports support this view that patients who are MRD negative at the time of transplant have significantly better survival outcomes than patients with residual disease who undergo transplant.

A 2016 study from Dr. Walter and colleagues at Fred Hutchinson, for instance, found that 3-year overall survival was significantly higher among patients with no MRD who underwent myeloablative alloHCT: 73% vs. 26% of those in MRD-positive morphologic remission and 23% of patients with active AML.

Another study, published the year before by a different research team, also revealed that “adult patients with AML in morphologic [complete remission] but with detectable MRD who undergo alloHCT have poor outcomes, which approximates those who undergo transplantation with active disease,” the authors of the 2015 study wrote in a commentary highlighting findings from both studies.

Still, providing intensive therapy prior to transplant comes with drawbacks, Dr. Walter noted. These downsides include potential toxicity from more intense therapy, which may prevent further therapy with curative intent, as well as the possibility that deintensifying therapy could lead to difficult-to-treat relapse.

It may, however, be possible to reduce the intensity of therapy before transplant and still achieve good outcomes after transplant, though the data remain mixed.

One trial found that a reduced-intensity conditioning regimen was associated with a greater risk of relapse post transplant and worse overall survival, compared with standard myeloablative conditioning.

However, another recent trial in which patients with AML or high-risk myelodysplastic syndrome were randomly assigned to either a reduced-intensity conditioning regimen or an intensified version of that regimen prior to transplant demonstrated no difference in relapse rates and overall survival, regardless of patients’ MRD status prior to transplant.

“To me, it’s still key to go into transplant with as little disease as possible,” Dr. Walter said. How much value there is in targeted treatment to further reduce disease burden prior to transplant “will really require further careful study,” he said.

The ASAP trial was sponsored by DKMS. Dr. Schetelig has received honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Walter reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Should patients with acute myeloid leukemia (AML) for whom induction therapy fails to induce complete remission proceed to allogeneic hematopoietic stem cell transplant anyway? Or do these patients fare better when they receive an intensive salvage induction regimen to bring them into remission before transplant?

This critically important question was debated at the annual meeting of the Society of Hematologic Oncology, held in Houston and online.

Johannes Schetelig, MD, argued in favor of proceeding to transplant, even without a complete remission.

“In the past, I’ve told many patients with relapsed or refractory AML that we do need to induce a [complete remission] prior to transplantation,” said Dr. Schetelig, from the Clinical Trials Unit at DKMS in Dresden, Germany. “But is it true?”

According to findings from a recent randomized trial, it may not be. The trial, led by Dr. Schetelig, found that patients with AML who received immediate allogeneic transplant without first having achieved a complete response following induction therapy did just as well as those who received intensive salvage induction therapy to establish remission before transplant.

If this finding holds, it “completely upends” how experts have traditionally approached patients with AML, Mikkael A. Sekeres, MD, of the University of Miami said at a conference press briefing last year.

The phase 3 ASAP trial, presented at last year’s American Society of Hematology meeting, included patients with AML who had had a poor response or who had experienced a relapse after first induction therapy. Patients were randomly assigned to a remission-induction strategy prior to allogeneic stem cell transplant (alloHCT) or a disease-control approach of watchful waiting followed by sequential conditioning and alloHCT. The primary endpoint was treatment success, defined as a complete response at day 56 following alloHCT.

In an intention-to-treat analysis, 83.5% of patients in the disease-control group and 81% in the remission-induction group achieved treatment success. Similarly, in the per-protocol analysis, 84.1% and 81.3%, respectively, achieved a complete response at day 56 after alloHCT. After a median follow-up of 4 years, there were no differences in leukemia-free survival or overall survival between the two groups.

Another advantage to forgoing an intensive salvage induction regimen: Patients in the disease-control arm experienced significantly fewer severe adverse events (23% vs. 64% in the remission induction arm) and spent a mean of 27 fewer days in the hospital prior to transplantation.

At last year’s press briefing, Dr. Schetelig said his team did not expect that a complete response on day 56 after transplantation would translate into “equal long-term benefit” for these groups. “This is what I was really astonished about,” he said.

Delving further into the findings, Dr. Schetelig explained that in the remission-induction arm patients who had had a complete response prior to transplantation demonstrated significantly better overall survival at 4 years than those who had not had a complete response at that point: 60% vs. 40%.

The study also revealed that in the disease-control arm, for patients under watchful waiting who did not need low-dose cytarabine and mitoxantrone for disease control, overall survival outcomes were similar to those of patients in the remission-induction arm who achieved a complete response.

These findings suggest that patients who can be bridged with watchful waiting may have a more favorable disease biology, and chemosensitivity could just be a biomarker for disease biology. In other words, “AML biology matters for transplant outcome and not tumor load,” Dr. Schetelig explained.

A recent study that found that having minimal residual disease (MRD) prior to transplant “had no independent effect on leukemia-free survival” supports this idea, he added.

Overall, Dr. Schetelig concluded that data from the ASAP trial suggest that watchful waiting prior to alloHCT represents “an alternative” for some patients.
 

Counterpoint: Aim for complete remission

Ronald B. Walter, MD, PhD, argued the counterpoint: that residual disease before transplantation is associated with worse posttransplant outcomes and represents a meaningful pretransplant therapeutic target.

The goal of intensifying treatment for patients with residual disease is to erase disease vestiges prior to transplantation.

“The idea is that by doing so you might optimize the benefit-to-risk ratio and ultimately improve outcomes,” said Dr. Walter, of the translational science and therapeutics division at the Fred Hutchinson Cancer Research Center in Seattle.

Several reports support this view that patients who are MRD negative at the time of transplant have significantly better survival outcomes than patients with residual disease who undergo transplant.

A 2016 study from Dr. Walter and colleagues at Fred Hutchinson, for instance, found that 3-year overall survival was significantly higher among patients with no MRD who underwent myeloablative alloHCT: 73% vs. 26% of those in MRD-positive morphologic remission and 23% of patients with active AML.

Another study, published the year before by a different research team, also revealed that “adult patients with AML in morphologic [complete remission] but with detectable MRD who undergo alloHCT have poor outcomes, which approximates those who undergo transplantation with active disease,” the authors of the 2015 study wrote in a commentary highlighting findings from both studies.

Still, providing intensive therapy prior to transplant comes with drawbacks, Dr. Walter noted. These downsides include potential toxicity from more intense therapy, which may prevent further therapy with curative intent, as well as the possibility that deintensifying therapy could lead to difficult-to-treat relapse.

It may, however, be possible to reduce the intensity of therapy before transplant and still achieve good outcomes after transplant, though the data remain mixed.

One trial found that a reduced-intensity conditioning regimen was associated with a greater risk of relapse post transplant and worse overall survival, compared with standard myeloablative conditioning.

However, another recent trial in which patients with AML or high-risk myelodysplastic syndrome were randomly assigned to either a reduced-intensity conditioning regimen or an intensified version of that regimen prior to transplant demonstrated no difference in relapse rates and overall survival, regardless of patients’ MRD status prior to transplant.

“To me, it’s still key to go into transplant with as little disease as possible,” Dr. Walter said. How much value there is in targeted treatment to further reduce disease burden prior to transplant “will really require further careful study,” he said.

The ASAP trial was sponsored by DKMS. Dr. Schetelig has received honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Walter reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A hemostatic powder was shown superior to standard endoscopic treatment in stopping and preventing recurrence of gastrointestinal bleeding caused by malignant tumors.

The findings, published online in Gastroenterology (2023 Jun 3. doi: 10.1053/j.gastro.2023.05.042), come from the largest randomized trial to date of TC-325 (Hemospray, Cook Medical), compared with standard endoscopic hemostatic interventions for tumor bleeding.

For their research, Rapat Pittayanon, MD, of Chulalongkorn University in Bangkok and her colleagues, randomized patients (60% male, mean age 63) with active malignant upper or lower GI bleeding and low disability levels related to their cancers (ECOG score 0-2). The study was conducted at nine hospitals in Thailand.

The 106 patients who passed screening underwent either TC-325 or standard endoscopic hemostasis, which could involve use of thermal or mechanical methods or adrenaline injection, alone or combined with another modality, at the endoscopist’s discretion. Crossover between treatment allocations was permitted if hemostasis was not achieved. Investigators assessed rates of immediate hemostasis and rebleeding at 30 days.

Dr. Pittayanon and colleagues found rebleeding to be significantly lower among TC-325 treated patients, at 2.1%, compared with 21.3% for standard care (odds ratio, 0.09; 95% confidence interval, 0.01-0.80; P = .03). Rates of immediate hemostasis were 100% for TC-325–treated subjects, compared with 68.6% in the conventional-treatment group (OR, 1.45; 95% CI, 0.93-2.29; P < .001).

None of the 55 patients in the TC-325 group underwent crossover treatment, but 15 patients in the standard care group were crossed over to TC-325 after their endoscopic treatment was deemed to have failed. One-fifth of patients who got TC-325 as a crossover treatment developed rebleeding at 30 days, which the investigators surmised was related to mucosal damage incurred during the endoscopic procedure.

The study was not powered to adequately assess survival outcomes. Seven patients in the TC-325 group and four in the conventional care group died before 30 days’ follow-up, and no death was directly related to recurrent tumor bleeding.

“To our knowledge, our trial is the first to show such significant findings in an RCT setting, which now provide a long-awaited efficacious hemostatic approach where one had been lacking when managing patients with malignant GI bleeding,” the investigators wrote in their analysis.

“Perhaps most importantly, this carefully controlled study also highlights the unreliable hemostatic effect of standard endoscopic modalities available for GI tumor hemostasis, with high 30-day rebleeding rates in our patient population.”

Dr. Pittayanon and colleagues noted several limitations of their study. These included the inability to blind patients to an endoscopist, which “may have influenced subsequent management decisions … including the decision to cross over.”

Only in 5 of 15 cases of crossover did the treating endoscopist provide photo evidence of treatment failure as required by the trial’s protocol. Also, the use of adrenaline injection alone was permitted in the study, in contrast to best practice guidelines for endoscopic hemostasis to treat peptic ulcer bleeding. Finally, the study was conducted in Thailand, potentially reducing the generalizability of the results.

The study was funded by King Chulalongkorn Memorial Hospital; the Thai Red Cross; and Chulalongkorn University. Cook Medical donated some of the TC-325 kits used in the study.

One study coauthor, Alan N. Barkun, disclosed consulting work for Medtronic and past paid work for Cook Medical. The remaining authors disclosed no conflicts of interest.

A hemostatic powder was shown superior to standard endoscopic treatment in stopping and preventing recurrence of gastrointestinal bleeding caused by malignant tumors.

The findings, published online in Gastroenterology (2023 Jun 3. doi: 10.1053/j.gastro.2023.05.042), come from the largest randomized trial to date of TC-325 (Hemospray, Cook Medical), compared with standard endoscopic hemostatic interventions for tumor bleeding.

For their research, Rapat Pittayanon, MD, of Chulalongkorn University in Bangkok and her colleagues, randomized patients (60% male, mean age 63) with active malignant upper or lower GI bleeding and low disability levels related to their cancers (ECOG score 0-2). The study was conducted at nine hospitals in Thailand.

The 106 patients who passed screening underwent either TC-325 or standard endoscopic hemostasis, which could involve use of thermal or mechanical methods or adrenaline injection, alone or combined with another modality, at the endoscopist’s discretion. Crossover between treatment allocations was permitted if hemostasis was not achieved. Investigators assessed rates of immediate hemostasis and rebleeding at 30 days.

Dr. Pittayanon and colleagues found rebleeding to be significantly lower among TC-325 treated patients, at 2.1%, compared with 21.3% for standard care (odds ratio, 0.09; 95% confidence interval, 0.01-0.80; P = .03). Rates of immediate hemostasis were 100% for TC-325–treated subjects, compared with 68.6% in the conventional-treatment group (OR, 1.45; 95% CI, 0.93-2.29; P < .001).

None of the 55 patients in the TC-325 group underwent crossover treatment, but 15 patients in the standard care group were crossed over to TC-325 after their endoscopic treatment was deemed to have failed. One-fifth of patients who got TC-325 as a crossover treatment developed rebleeding at 30 days, which the investigators surmised was related to mucosal damage incurred during the endoscopic procedure.

The study was not powered to adequately assess survival outcomes. Seven patients in the TC-325 group and four in the conventional care group died before 30 days’ follow-up, and no death was directly related to recurrent tumor bleeding.

“To our knowledge, our trial is the first to show such significant findings in an RCT setting, which now provide a long-awaited efficacious hemostatic approach where one had been lacking when managing patients with malignant GI bleeding,” the investigators wrote in their analysis.

“Perhaps most importantly, this carefully controlled study also highlights the unreliable hemostatic effect of standard endoscopic modalities available for GI tumor hemostasis, with high 30-day rebleeding rates in our patient population.”

Dr. Pittayanon and colleagues noted several limitations of their study. These included the inability to blind patients to an endoscopist, which “may have influenced subsequent management decisions … including the decision to cross over.”

Only in 5 of 15 cases of crossover did the treating endoscopist provide photo evidence of treatment failure as required by the trial’s protocol. Also, the use of adrenaline injection alone was permitted in the study, in contrast to best practice guidelines for endoscopic hemostasis to treat peptic ulcer bleeding. Finally, the study was conducted in Thailand, potentially reducing the generalizability of the results.

The study was funded by King Chulalongkorn Memorial Hospital; the Thai Red Cross; and Chulalongkorn University. Cook Medical donated some of the TC-325 kits used in the study.

One study coauthor, Alan N. Barkun, disclosed consulting work for Medtronic and past paid work for Cook Medical. The remaining authors disclosed no conflicts of interest.

A hemostatic powder was shown superior to standard endoscopic treatment in stopping and preventing recurrence of gastrointestinal bleeding caused by malignant tumors.

The findings, published online in Gastroenterology (2023 Jun 3. doi: 10.1053/j.gastro.2023.05.042), come from the largest randomized trial to date of TC-325 (Hemospray, Cook Medical), compared with standard endoscopic hemostatic interventions for tumor bleeding.

For their research, Rapat Pittayanon, MD, of Chulalongkorn University in Bangkok and her colleagues, randomized patients (60% male, mean age 63) with active malignant upper or lower GI bleeding and low disability levels related to their cancers (ECOG score 0-2). The study was conducted at nine hospitals in Thailand.

The 106 patients who passed screening underwent either TC-325 or standard endoscopic hemostasis, which could involve use of thermal or mechanical methods or adrenaline injection, alone or combined with another modality, at the endoscopist’s discretion. Crossover between treatment allocations was permitted if hemostasis was not achieved. Investigators assessed rates of immediate hemostasis and rebleeding at 30 days.

Dr. Pittayanon and colleagues found rebleeding to be significantly lower among TC-325 treated patients, at 2.1%, compared with 21.3% for standard care (odds ratio, 0.09; 95% confidence interval, 0.01-0.80; P = .03). Rates of immediate hemostasis were 100% for TC-325–treated subjects, compared with 68.6% in the conventional-treatment group (OR, 1.45; 95% CI, 0.93-2.29; P < .001).

None of the 55 patients in the TC-325 group underwent crossover treatment, but 15 patients in the standard care group were crossed over to TC-325 after their endoscopic treatment was deemed to have failed. One-fifth of patients who got TC-325 as a crossover treatment developed rebleeding at 30 days, which the investigators surmised was related to mucosal damage incurred during the endoscopic procedure.

The study was not powered to adequately assess survival outcomes. Seven patients in the TC-325 group and four in the conventional care group died before 30 days’ follow-up, and no death was directly related to recurrent tumor bleeding.

“To our knowledge, our trial is the first to show such significant findings in an RCT setting, which now provide a long-awaited efficacious hemostatic approach where one had been lacking when managing patients with malignant GI bleeding,” the investigators wrote in their analysis.

“Perhaps most importantly, this carefully controlled study also highlights the unreliable hemostatic effect of standard endoscopic modalities available for GI tumor hemostasis, with high 30-day rebleeding rates in our patient population.”

Dr. Pittayanon and colleagues noted several limitations of their study. These included the inability to blind patients to an endoscopist, which “may have influenced subsequent management decisions … including the decision to cross over.”

Only in 5 of 15 cases of crossover did the treating endoscopist provide photo evidence of treatment failure as required by the trial’s protocol. Also, the use of adrenaline injection alone was permitted in the study, in contrast to best practice guidelines for endoscopic hemostasis to treat peptic ulcer bleeding. Finally, the study was conducted in Thailand, potentially reducing the generalizability of the results.

The study was funded by King Chulalongkorn Memorial Hospital; the Thai Red Cross; and Chulalongkorn University. Cook Medical donated some of the TC-325 kits used in the study.

One study coauthor, Alan N. Barkun, disclosed consulting work for Medtronic and past paid work for Cook Medical. The remaining authors disclosed no conflicts of interest.

TOPLINE:

Regular exercise can significantly reduce a cancer survivor’s mortality from cancer or other causes, a large analysis finds.

METHODOLOGY:

• Following a cancer diagnosis, the impact of exercise on all cause and cause-specific mortality among survivors, and whether the benefit of exercise differs by cancer site, remains unclear.
• To investigate, researchers leveraged data from 11,480 cancer survivors in the Prostate, Lung, Colorectal, and Ovarian cancer screening trial.
• Postdiagnosis exercise levels were quantified via a questionnaire. The primary outcome was all-cause mortality; secondary endpoints were deaths from cancer and other causes.
• Cox models estimated cause-specific hazard ratio for all-cause mortality as well as cancer and noncancer mortality based on whether survivors met or did not meet exercise guidelines.
• Meeting national exercise guidelines meant moderate-intensity exercise 4 or more days per week with sessions lasting, on average, 30 minutes or longer; and/or strenuous-intensity exercise 2 or more days per week with sessions lasting, on average, 20 minutes or longer.

TAKEAWAY:

• Overall, 62% of participants were deemed nonexercisers (no exercise or exercise below guidelines) and 38% were classified as exercisers (meeting or exceeding guidelines). After a median follow-up of 16 years from diagnosis, researchers documented 4,665 deaths – 1,940 from cancer and 2,725 from other causes.
• Exercise at recommended levels was associated with “near-universal” all-cause mortality benefit for most cancers represented, including prostate, breast, endometrial, renal, and head and neck cancers.
• In multivariate analysis, compared with nonexercisers, exercisers had a 25% reduced risk of all-cause mortality (HR, 0.75), with the benefit apparent within 5 years and persisting for at least 20 years after diagnosis.
• Exercise was associated with a 21% reduction in cancer mortality and a 28% reduction in mortality from other causes, with more exercise demonstrating a greater benefit on cancer-specific mortality risk.

IN PRACTICE:

Overall, “our findings show exercise is a holistic strategy that may complement contemporary management approaches to further reduce cancer mortality (in select sites) while simultaneously lowering risk of death from other competing causes, which combine to improve all-cause mortality,” the authors conclude. “This benefit was observed within a few years after diagnosis and sustained for at least 20 years.”

SOURCE:

The study, led by Jessica Lavery, MS, Memorial Sloan Kettering Cancer Center, New York, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

Exercise habits were self-reported at one time point, not measured more objectively over time using wearable devices. The population studied was predominantly non-Hispanic White. The researchers could not determine whether exercise habits reflected lower disease and/or treatment-related toxicities as opposed to direct exercise-induced effects or better adherence to a healthy lifestyle.

DISCLOSURES:

Support for the study was provided by AKTIV Against Cancer and grants from Memorial Sloan Kettering Cancer Center and UCLA Jonsson Comprehensive Cancer Center. Disclosures for the study authors are available with the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

Regular exercise can significantly reduce a cancer survivor’s mortality from cancer or other causes, a large analysis finds.

METHODOLOGY:

• Following a cancer diagnosis, the impact of exercise on all cause and cause-specific mortality among survivors, and whether the benefit of exercise differs by cancer site, remains unclear.
• To investigate, researchers leveraged data from 11,480 cancer survivors in the Prostate, Lung, Colorectal, and Ovarian cancer screening trial.
• Postdiagnosis exercise levels were quantified via a questionnaire. The primary outcome was all-cause mortality; secondary endpoints were deaths from cancer and other causes.
• Cox models estimated cause-specific hazard ratio for all-cause mortality as well as cancer and noncancer mortality based on whether survivors met or did not meet exercise guidelines.
• Meeting national exercise guidelines meant moderate-intensity exercise 4 or more days per week with sessions lasting, on average, 30 minutes or longer; and/or strenuous-intensity exercise 2 or more days per week with sessions lasting, on average, 20 minutes or longer.

TAKEAWAY:

• Overall, 62% of participants were deemed nonexercisers (no exercise or exercise below guidelines) and 38% were classified as exercisers (meeting or exceeding guidelines). After a median follow-up of 16 years from diagnosis, researchers documented 4,665 deaths – 1,940 from cancer and 2,725 from other causes.
• Exercise at recommended levels was associated with “near-universal” all-cause mortality benefit for most cancers represented, including prostate, breast, endometrial, renal, and head and neck cancers.
• In multivariate analysis, compared with nonexercisers, exercisers had a 25% reduced risk of all-cause mortality (HR, 0.75), with the benefit apparent within 5 years and persisting for at least 20 years after diagnosis.
• Exercise was associated with a 21% reduction in cancer mortality and a 28% reduction in mortality from other causes, with more exercise demonstrating a greater benefit on cancer-specific mortality risk.

IN PRACTICE:

Overall, “our findings show exercise is a holistic strategy that may complement contemporary management approaches to further reduce cancer mortality (in select sites) while simultaneously lowering risk of death from other competing causes, which combine to improve all-cause mortality,” the authors conclude. “This benefit was observed within a few years after diagnosis and sustained for at least 20 years.”

SOURCE:

The study, led by Jessica Lavery, MS, Memorial Sloan Kettering Cancer Center, New York, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

Exercise habits were self-reported at one time point, not measured more objectively over time using wearable devices. The population studied was predominantly non-Hispanic White. The researchers could not determine whether exercise habits reflected lower disease and/or treatment-related toxicities as opposed to direct exercise-induced effects or better adherence to a healthy lifestyle.

DISCLOSURES:

Support for the study was provided by AKTIV Against Cancer and grants from Memorial Sloan Kettering Cancer Center and UCLA Jonsson Comprehensive Cancer Center. Disclosures for the study authors are available with the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

Regular exercise can significantly reduce a cancer survivor’s mortality from cancer or other causes, a large analysis finds.

METHODOLOGY:

• Following a cancer diagnosis, the impact of exercise on all cause and cause-specific mortality among survivors, and whether the benefit of exercise differs by cancer site, remains unclear.
• To investigate, researchers leveraged data from 11,480 cancer survivors in the Prostate, Lung, Colorectal, and Ovarian cancer screening trial.
• Postdiagnosis exercise levels were quantified via a questionnaire. The primary outcome was all-cause mortality; secondary endpoints were deaths from cancer and other causes.
• Cox models estimated cause-specific hazard ratio for all-cause mortality as well as cancer and noncancer mortality based on whether survivors met or did not meet exercise guidelines.
• Meeting national exercise guidelines meant moderate-intensity exercise 4 or more days per week with sessions lasting, on average, 30 minutes or longer; and/or strenuous-intensity exercise 2 or more days per week with sessions lasting, on average, 20 minutes or longer.

TAKEAWAY:

• Overall, 62% of participants were deemed nonexercisers (no exercise or exercise below guidelines) and 38% were classified as exercisers (meeting or exceeding guidelines). After a median follow-up of 16 years from diagnosis, researchers documented 4,665 deaths – 1,940 from cancer and 2,725 from other causes.
• Exercise at recommended levels was associated with “near-universal” all-cause mortality benefit for most cancers represented, including prostate, breast, endometrial, renal, and head and neck cancers.
• In multivariate analysis, compared with nonexercisers, exercisers had a 25% reduced risk of all-cause mortality (HR, 0.75), with the benefit apparent within 5 years and persisting for at least 20 years after diagnosis.
• Exercise was associated with a 21% reduction in cancer mortality and a 28% reduction in mortality from other causes, with more exercise demonstrating a greater benefit on cancer-specific mortality risk.

IN PRACTICE:

Overall, “our findings show exercise is a holistic strategy that may complement contemporary management approaches to further reduce cancer mortality (in select sites) while simultaneously lowering risk of death from other competing causes, which combine to improve all-cause mortality,” the authors conclude. “This benefit was observed within a few years after diagnosis and sustained for at least 20 years.”

SOURCE:

The study, led by Jessica Lavery, MS, Memorial Sloan Kettering Cancer Center, New York, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

Exercise habits were self-reported at one time point, not measured more objectively over time using wearable devices. The population studied was predominantly non-Hispanic White. The researchers could not determine whether exercise habits reflected lower disease and/or treatment-related toxicities as opposed to direct exercise-induced effects or better adherence to a healthy lifestyle.

DISCLOSURES:

Support for the study was provided by AKTIV Against Cancer and grants from Memorial Sloan Kettering Cancer Center and UCLA Jonsson Comprehensive Cancer Center. Disclosures for the study authors are available with the original article.

A version of this article first appeared on Medscape.com.

By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.

Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.

There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.

Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.

Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.

“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.

He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.

“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”

The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.

Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
 

A plea for help

In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”

Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.

But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.

Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.

After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.

Five days later, his job offer was revoked.

In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.

The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”

Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.

“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.

Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.

“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”

“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.

Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.” 

Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
 

Current state of physician burnout

The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).

A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.

Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.

“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.

Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.

Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.

“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
 

Helping doctors regain a sense of purpose

One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose. 

“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”

Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.

“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
 

The road ahead

Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.

The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes. 

“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.

A version of this article first appeared on Medscape.com.

By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.

Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.

There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.

Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.

Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.

“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.

He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.

“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”

The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.

Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
 

A plea for help

In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”

Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.

But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.

Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.

After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.

Five days later, his job offer was revoked.

In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.

The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”

Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.

“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.

Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.

“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”

“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.

Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.” 

Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
 

Current state of physician burnout

The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).

A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.

Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.

“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.

Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.

Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.

“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
 

Helping doctors regain a sense of purpose

One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose. 

“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”

Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.

“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
 

The road ahead

Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.

The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes. 

“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.

A version of this article first appeared on Medscape.com.

By the end of 2021, Anuj Peddada, MD, had hit a wall. He couldn’t sleep, couldn’t concentrate, erupted in anger, and felt isolated personally and professionally. To temper pandemic-driven pressures, the Colorado radiation oncologist took an 8-week stress management and resiliency course, but the feelings kept creeping back.

Still, Dr. Peddada, in his own private practice, pushed through, working 60-hour weeks and carrying the workload of two physicians. It wasn’t until he caught himself making uncharacteristic medical errors, including radiation planning for the wrong site, that he knew he needed help – and possibly a temporary break from medicine.

There was just one hitch: He was closing his private practice to start a new in-house job with Centura Health, the Colorado Springs hospital he’d contracted with for over 20 years.

Given the long-standing relationship – Dr. Peddada’s image graced some of the company’s marketing billboards – he expected Centura would understand when, on his doctor’s recommendation, he requested a short-term medical leave that would delay his start date by 1 month.

Instead, Centura abruptly rescinded the employment offer, leaving Dr. Peddada jobless and with no recourse but to sue.

“I was blindsided. The hospital had a physician resiliency program that claimed to encourage physicians to seek help, [so] I thought they would be completely supportive and understanding,” Dr. Peddada said.

He told this news organization that he was naive to have been so honest with the hospital he’d long served as a contractor, including the decade-plus he›d spent directing its radiation oncology department.

“It is exceedingly painful to see hospital leadership use me in their advertisement[s] ... trying to profit off my reputation and work after devastating my career.”

The lawsuit Dr. Peddada filed in July in Colorado federal district court may offer a rare glimpse of the potential career ramifications of seeking help for physician burnout. Despite employers’ oft-stated support for physician wellness, Dr. Peddada’s experience may serve as a cautionary tale for doctors who are open about their struggles.

Centura Health did not respond to requests for comment. In court documents, the health system’s attorneys asked for more time to respond to Dr. Peddada’s complaint.
 

A plea for help

In the complaint, Dr. Peddada and his attorneys claim that Centura violated the state’s Anti-Discrimination Act and the Americans with Disabilities Act (ADA) when it failed to offer reasonable accommodations after he began experiencing “physiological and psychological symptoms corresponding to burnout.”

Since 1999, Dr. Peddada had contracted exclusively with Centura to provide oncology services at its hospital, Penrose Cancer Center, and began covering a second Centura location in 2021. As medical director of Penrose’s radiation oncology department, he helped establish a community nurse navigator program and accounted for 75% of Centura’s radiation oncology referrals, according to the complaint.

But when his symptoms and fear for the safety of his patients became unbearable, Dr. Peddada requested an urgent evaluation from his primary care physician, who diagnosed him with “physician burnout” and recommended medical leave.

Shortly after presenting the leave request to Centura, rumors began circulating that he was having a “nervous breakdown,” the complaint noted. Dr. Peddada worried that perhaps his private health information was being shared with hospital employees.

After meeting with the hospital’s head of physician resiliency and agreeing to undergo a peer review evaluation by the Colorado Physician Health Program, which would decide the reinstatement timeline and if further therapy was necessary, Dr. Peddada was assured his leave would be approved.

Five days later, his job offer was revoked.

In an email from hospital leadership, the oncologist was informed that he had “declined employment” by failing to sign a revised employment contract sent to him 2 weeks prior when he was out of state on a preapproved vacation, according to the lawsuit.

The lawsuit alleges that Dr. Peddada was wrongfully discharged due to his disability after Centura “exploited [his] extensive patient base, referral network, and reputation to generate growth and profit.”

Colorado employment law attorney Deborah Yim, Esq., who is not involved in Peddada’s case, told this news organization that the ADA requires employers to provide reasonable accommodations for physical or mental impairments that substantially limit at least one major life activity, except when the request imposes an undue hardship on the employer.

“Depression and related mental health conditions would qualify, depending on the circumstances, and courts have certainly found them to be qualifying disabilities entitled to ADA protection in the past,” she said.

Not all employers are receptive to doctors’ needs, says the leadership team at Physicians Just Equity, an organization providing peer support to doctors experiencing workplace conflicts like discrimination and retaliation. They say that Dr. Peddada’s experience, where disclosing burnout results in being “ostracized, penalized, and ultimately ousted,” is the rule rather than the exception.

“Dr. Peddada’s case represents the unfortunate reality faced by many physicians in today’s clinical landscape,” the organization’s board of directors said in a written statement. “The imbalance of unreasonable professional demands, the lack of autonomy, moral injury, and disintegrating practice rewards is unsustainable for the medical professional.”

“Retaliation by employers after speaking up against this imbalance [and] requesting support and time to rejuvenate is a grave failure of health care systems that prioritize the business of delivering health care over the health, well-being, and satisfaction of their most valuable resource – the physician,” the board added in their statement.

Dr. Peddada has since closed his private practice and works as an independent contractor and consultant, his attorney, Iris Halpern, JD, said in an interview. She says Centura could have honored the accommodation request or suggested another option that met his needs, but “not only were they unsupportive, they terminated him.” 

Ms. Yim says the parties will have opportunities to reach a settlement and resolve the dispute as the case works through the court system. Otherwise, Dr. Peddada and Centura may eventually head to trial.
 

Current state of physician burnout

The state of physician burnout is certainly a concerning one. More than half (53%) of physicians responding to this year’s Medscape Physician Burnout & Depression Report said they are burned out. Nearly one-quarter reported feeling depressed. Some of the top reasons they cited were too many bureaucratic tasks (61%), too many work hours (37%), and lack of autonomy (31%).

A 2022 study by the Mayo Clinic found a substantial increase in physician burnout in the first 2 years of the pandemic, with doctors reporting rising emotional exhaustion and depersonalization.

Although burnout affects many physicians and is a priority focus of the National Academy of Medicine’s plan to restore workforce well-being, admitting it is often seen as taboo and can imperil a doctor’s career. In the Medscape report, for example, 39% of physicians said they would not even consider professional treatment for burnout, with many commenting that they would just deal with it themselves.

“Many physicians are frightened to take time out for self-care because [they] fear losing their job, being stigmatized, and potentially ending their careers,” said Dr. Peddada, adding that physicians are commonly asked questions about their mental health when applying for hospital privileges. He says this dynamic forces them to choose between getting help or ignoring their true feelings, leading to poor quality of care and patient safety risks.

Medical licensing boards probe physicians’ mental health, too. As part of its #FightingForDocs campaign, the American Medical Association hopes to remove the stigma around burnout and depression and advocates for licensing boards to revise questions that may discourage physicians from seeking assistance. The AMA recommends that physicians only disclose current physical or mental conditions affecting their ability to practice.

Pringl Miller, MD, founder and executive director of Physician Just Equity, told Medscape that improving physician wellness requires structural change.

“Physicians (who) experience burnout without the proper accommodations run the risk of personal harm, because most physicians will prioritize the health and well-being of their patients over themselves ... [resulting in] suboptimal and unsafe patient care,” she said.
 

Helping doctors regain a sense of purpose

One change involves reframing how the health care industry thinks about and approaches burnout, says Steven Siegel, MD, chief mental health and wellness officer with Keck Medicine of USC. He told this news organization that these discussions should enhance the physician’s sense of purpose. 

“Some people treat burnout as a concrete disorder like cancer, instead of saying, ‘I’m feeling exhausted, demoralized, and don’t enjoy my job anymore. What can we do to restore my enthusiasm for work?’ ”

Dr. Siegel recognizes that these issues existed before the pandemic and have only worsened as physicians feel less connected to and satisfied with their profession – a byproduct, he says, of the commercialization of medicine.

“We’ve moved from practices to systems, then from small to large systems, where it seems the path to survival is cutting costs and increasing margins, even among nonprofits.”
 

The road ahead

Making headway on these problems will take time. Last year, Keck Medicine received a $2 million grant to launch a 3-year randomized clinical trial to help reconnect physicians and other clinicians with their work. Dr. Siegel says the trial may serve as a national pilot program and will eventually grow to include 400 volunteers.

The trial will investigate the effectiveness of three possible interventions: (1) teaching people how to regulate their internal narratives and emotions through techniques like cognitive behavioral therapy and acceptance and commitment therapy; (2) providing customized EHR training to reduce the burden of navigating the system; and (3) allowing physicians to weigh in on workflow changes. 

“We put physicians on teams that make the decisions about workflows,” said Dr. Siegel. The arrangement can give people the agency they desire and help them understand why an idea might not be plausible, which enriches future suggestions and discussions, he says.

A version of this article first appeared on Medscape.com.

Findings from two recent studies could signal a paradigm shift in the way men are screened for prostate cancer.

In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI. 

Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.

Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.

David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”

PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.

The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.

In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.

Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.

Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.

Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.

But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.

Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.

“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.

Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.

But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.

Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.

“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.

The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”

Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.

A version of this article appeared on Medscape.com.

Findings from two recent studies could signal a paradigm shift in the way men are screened for prostate cancer.

In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI. 

Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.

Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.

David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”

PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.

The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.

In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.

Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.

Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.

Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.

But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.

Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.

“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.

Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.

But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.

Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.

“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.

The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”

Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.

A version of this article appeared on Medscape.com.

Findings from two recent studies could signal a paradigm shift in the way men are screened for prostate cancer.

In the ReIMAGINE study, a group of researchers from the United Kingdom found that half of men with apparently “safe” levels of prostate-specific antigen (PSA) below 3 ng/mL had clinically significant prostate cancers when multiparametric MRI was added to screening. The researchers, whose paper appeared in BMJ Oncology, also found that one in six screened men had a prostate lesion on MRI. 

Meanwhile, a large Swedish population-based study, published in JAMA Network Open, showed that pre-biopsy MRIs combined with PSA testing after adoption of guidelines recommending MRIs led to a decrease in the proportion of men with negative biopsies (28% to 7%) and the number of Gleason score 6 cancers (24% to 6%), while the proportion of Gleason score 7-10 cancers rose from 49% to 86%.

Researchers compared prostate MRI uptake rates in the Jönköping Region in southern Sweden over 9 years – 2011 through 2018 before prostate MRIs were recommended nationally, and 2018-2020 when MRIs became commonly used.

David Robinson, MD, PhD, associate professor at Linköping University and leader of the Swedish study, told this news organization: “MRI is now standard for men before biopsy” in that country. In Sweden, which has a high rate of mortality from prostate cancer – about 50 deaths per 100,000 men vs. 12 and 8 per 100,000 in the United Kingdom and United States, respectively – PSA testing is not routine. “Most men that are diagnosed with prostate cancer have no symptoms. They have asked for a PSA when they have visited their general practitioner,” Dr. Robinson said. “To take a PSA test is not encouraged but it is not discouraged either. It is up to each man to decide.”

PSA screening is not common in the United Kingdom. Caroline Moore, MD, chair of urology at University College London and principal investigator on ReIMAGINE, said only 20% of UK men older than age 50 undergo PSA tests because doctors in the United Kingdom are concerned about the sort of overdiagnosis and overtreatment of prostate cancer that has occurred in the United States since the mid-1990s, when PSA screening was adopted here.

The rate of PSA screening in the United States has declined with controversies over recommendations for screening, though they remain above European rates: 37% in 2019, down from 47% in 2005, according to a 2022 Veterans Administration study published in JAMA Oncology.

In the UK study, Dr. Moore’s hospital-based group asked general practitioners to send letters to 2,096 men aged 50-75 years who had not been diagnosed with prostate cancer, inviting them to undergo prostate health checks combining screening with PSA and 10-minute prostate MRIs.

Of the 457 men who responded to the letters, 303 completed both screening tests. Older White men were more likely to respond, and Black men responded 20% less often.

Of the men who completed screening, 29 (9.6%) were diagnosed with clinically significant cancer and 3 were diagnosed with clinically insignificant cancer, the researchers reported.

Dr. Moore said the PSA and MRI-first approach spared men from biopsies as well as the downsides of active surveillance, which include close monitoring with urology visits and occasional MRIs or biopsies over many years. Biopsies are considered undesirable because of pain and the risk for sepsis and other infections associated with transrectal biopsies.

But urologists in America were less convinced by the international data. William J. Catalona, MD, a urologist at Northwestern University in Chicago, who developed the PSA screening test in the 1990s, said he wasn’t surprised so many men in ReIMAGINE with low PSAs had advanced cancers. “Some of the most aggressive prostate cancers occur in men with a low PSA level – not new news,” he said.

Dr. Catalona also disagreed with the UK researchers’ emphasis on MRIs because the readings often are incorrect. A 2021 study in Prostate Cancer and Prostatic Diseases reported that multiparametric MRI had a false-negative rate of between 10% and 20%.

“MRI alone should not be considered more reliable than PSA. Rather, it should be considered complementary,” he said.

Michael S. Leapman, MD, MHS, associate professor of urology at the Yale Cancer Center, New Haven, Conn., said the UK findings point to a role for MRI as a “triage tool” to help identify men with elevated PSAs who should have a prostate biopsy.

But he said the research to date doesn’t support the use of MRI as a stand-alone test for prostate cancer. “In my opinion, it would have to demonstrate some tangible benefit to patients other than finding a greater number of cancers, such as improvement in cancer control, lower burden from the disease overall, or cancer-specific survival,” he said.

Major U.S. guidelines recommend including MRIs before biopsies. Dr. Leapman also pointed out that 2023 recommendations from the National Comprehensive Cancer Network state that MRI is “strongly recommended if available.” Yet fewer than half of U.S. urologists use MRIs as a screening tool, he said.

“My sense is that MRI is not available everywhere. We have also seen that wait times are too long in some centers, leading physicians and patients to opt for biopsy – particularly in cases with higher suspicion,” he said.

The studies from Sweden and the United Kingdom “demonstrate the strides being made in reducing overdetection of low-grade prostate cancer will increase detection of clinically significant Gleason 3+4 or higher” tumors, Dr. Leapman said. “It is unclear whether such patients in whom their otherwise low-risk disease is recast as ‘intermediate risk’ meaningfully stand to benefit in the long term from this detection.”

Dr. Robinson reported no relevant financial conflicts of interest. The Swedish Cancer Society, the Swedish Research Council, Region Jönköping, Futurum, and Clinical Cancer Research Foundation in Jönköping supported the Swedish study. Members of the ReIMAGINE study team disclosed research support from the United Kingdom’s National Institute of Health Research and various industry/other sources. The Medical Research Council and Cancer Research UK funded the ReIMAGINE study.

A version of this article appeared on Medscape.com.

PURPOSE

This project aims to describe the demographics of Veterans diagnosed with breast and gynecologic cancers and assess differences compared to the general population.

BACKGROUND

With an increasing number of women Veterans enrolling in the VA, it is crucial for oncologists to be prepared to provide care for VeterS32 • SEPTEMBER 2023 www.mdedge.com/fedprac/avaho NOTES ans diagnosed with breast and gynecologic cancers. Despite the rising incidence of these cancers among Veterans, there is limited characterization of the demographic profile of this population. Understanding the unique characteristics of Veterans with these malignancies, distinct from the general population, is essential for the Veterans Administration (VA) to develop programs and enhance care for these patients.

METHODS/DATA ANALYSIS

Consult records from the VA Corporate Data Warehouse between January 1, 2021, and December 31, 2022, were analyzed to identify Veterans with newly diagnosed breast, uterine, ovarian, cervical, and vulvovaginal cancer. Demographic were evaluated. Data on the general population were obtained data from SEER (Surveillance, Epidemiology, and End Results) 19 database for 2020.

RESULTS

A total of 3,304 Veterans diagnosed with breast cancer and 918 Veterans with gynecologic cancers were identified (uterine, n = 365; cervical, n = 344, ovarian, n = 177; vulvovaginal, n = 32). Veterans were found to be younger than the general population, with a mean age at diagnosis of 59 for Veterans with breast cancer to 63 for non-veterans. Among those with gynecologic cancers, the mean age at diagnosis for Veterans was 55 compared to 61 for non-veterans. Male breast cancer cases were more prevalent among Veterans, accounting for 11% in the VA compared to 1% in SEER. The Veteran cohort also displayed a higher proportion of Black patients, with 30% of breast cancer cases in the VA being Black compared to 12% in SEER.

CONCLUSIONS/IMPLICATIONS

Veterans diagnosed with breast and gynecologic cancers exhibit unique demographic characteristics compared to the general population. They tend to be younger and have a higher representation of Black patients. The incidence of male breast cancer is notably higher among Veterans. As the prevalence of these cancer types continue to rise among Veterans, it is vital for oncologists to be aware of and adequately address the unique health needs of this population. These findings emphasize the importance of tailored strategies and programs to provide optimal care for Veterans with breast and gynecologic cancers.

PURPOSE

This project aims to describe the demographics of Veterans diagnosed with breast and gynecologic cancers and assess differences compared to the general population.

BACKGROUND

With an increasing number of women Veterans enrolling in the VA, it is crucial for oncologists to be prepared to provide care for VeterS32 • SEPTEMBER 2023 www.mdedge.com/fedprac/avaho NOTES ans diagnosed with breast and gynecologic cancers. Despite the rising incidence of these cancers among Veterans, there is limited characterization of the demographic profile of this population. Understanding the unique characteristics of Veterans with these malignancies, distinct from the general population, is essential for the Veterans Administration (VA) to develop programs and enhance care for these patients.

METHODS/DATA ANALYSIS

Consult records from the VA Corporate Data Warehouse between January 1, 2021, and December 31, 2022, were analyzed to identify Veterans with newly diagnosed breast, uterine, ovarian, cervical, and vulvovaginal cancer. Demographic were evaluated. Data on the general population were obtained data from SEER (Surveillance, Epidemiology, and End Results) 19 database for 2020.

RESULTS

A total of 3,304 Veterans diagnosed with breast cancer and 918 Veterans with gynecologic cancers were identified (uterine, n = 365; cervical, n = 344, ovarian, n = 177; vulvovaginal, n = 32). Veterans were found to be younger than the general population, with a mean age at diagnosis of 59 for Veterans with breast cancer to 63 for non-veterans. Among those with gynecologic cancers, the mean age at diagnosis for Veterans was 55 compared to 61 for non-veterans. Male breast cancer cases were more prevalent among Veterans, accounting for 11% in the VA compared to 1% in SEER. The Veteran cohort also displayed a higher proportion of Black patients, with 30% of breast cancer cases in the VA being Black compared to 12% in SEER.

CONCLUSIONS/IMPLICATIONS

Veterans diagnosed with breast and gynecologic cancers exhibit unique demographic characteristics compared to the general population. They tend to be younger and have a higher representation of Black patients. The incidence of male breast cancer is notably higher among Veterans. As the prevalence of these cancer types continue to rise among Veterans, it is vital for oncologists to be aware of and adequately address the unique health needs of this population. These findings emphasize the importance of tailored strategies and programs to provide optimal care for Veterans with breast and gynecologic cancers.

PURPOSE

This project aims to describe the demographics of Veterans diagnosed with breast and gynecologic cancers and assess differences compared to the general population.

BACKGROUND

With an increasing number of women Veterans enrolling in the VA, it is crucial for oncologists to be prepared to provide care for VeterS32 • SEPTEMBER 2023 www.mdedge.com/fedprac/avaho NOTES ans diagnosed with breast and gynecologic cancers. Despite the rising incidence of these cancers among Veterans, there is limited characterization of the demographic profile of this population. Understanding the unique characteristics of Veterans with these malignancies, distinct from the general population, is essential for the Veterans Administration (VA) to develop programs and enhance care for these patients.

METHODS/DATA ANALYSIS

Consult records from the VA Corporate Data Warehouse between January 1, 2021, and December 31, 2022, were analyzed to identify Veterans with newly diagnosed breast, uterine, ovarian, cervical, and vulvovaginal cancer. Demographic were evaluated. Data on the general population were obtained data from SEER (Surveillance, Epidemiology, and End Results) 19 database for 2020.

RESULTS

A total of 3,304 Veterans diagnosed with breast cancer and 918 Veterans with gynecologic cancers were identified (uterine, n = 365; cervical, n = 344, ovarian, n = 177; vulvovaginal, n = 32). Veterans were found to be younger than the general population, with a mean age at diagnosis of 59 for Veterans with breast cancer to 63 for non-veterans. Among those with gynecologic cancers, the mean age at diagnosis for Veterans was 55 compared to 61 for non-veterans. Male breast cancer cases were more prevalent among Veterans, accounting for 11% in the VA compared to 1% in SEER. The Veteran cohort also displayed a higher proportion of Black patients, with 30% of breast cancer cases in the VA being Black compared to 12% in SEER.

CONCLUSIONS/IMPLICATIONS

Veterans diagnosed with breast and gynecologic cancers exhibit unique demographic characteristics compared to the general population. They tend to be younger and have a higher representation of Black patients. The incidence of male breast cancer is notably higher among Veterans. As the prevalence of these cancer types continue to rise among Veterans, it is vital for oncologists to be aware of and adequately address the unique health needs of this population. These findings emphasize the importance of tailored strategies and programs to provide optimal care for Veterans with breast and gynecologic cancers.

BACKGROUND

There are 5 germline mutations that lead to hypercoagulability in the general population including: Factor V Leiden (FVL), Prothrombin G20210A (F2A), Protein C Deficiency (PCD), Protein S Deficiency (PSD), and Antithrombin Deficiency (ATD). Typical guidance is to defer testing, as it is thought not to change management.

CASE REPORT

We present a case of a patient who was found to be compound heterozygous mutations for FVL and F2A, who presented with two episodes of arterial thromboembolism resulting in cerebrovascular accident (CVA). A 63-year-old male with past medical history of hypertension, a CVA four years prior, and medication non-compliance presents with new onset left sided hemiparesis after an episode of convulsions. MRI and CT imaging of the head revealed ischemic CVA secondary to thromboembolism in the right posterior cerebral artery’s (PCA), P1 branch. Following administration of tissue plasminogen activator (tPA) he had rapid symptom improvement. This second ischemic CVA prompted a workup which was notable for: negative echocardiogram, negative 30-day cardiac monitor, CT chest negative for malignancy, no significant vascular findings, negative for antiphospholipid syndrome, but genetic testing revealed the patient to be heterozygous for FVL and F2A mutations. He was started on apixaban 5 mg twice daily for ongoing secondary prevention. Though medication compliance continues to be difficult, after being placed on direct anticoagulant (DOAC), he has not had recurrent venous or arterial thrombotic events. A small case series found double heterozygosity for FVL and F2A further increases the risk of venous thromboembolism up to 17% or more in a lifetime.

CONCLUSIONS

Although current recommendations advocate against testing for specific mutations in most cases as it is likely not to change management1, this case suggests that it may be of some benefit in patients that have a workup that does not yield a clear etiology, especially in cryptogenic stroke which is typically managed with aspirin rather than direct oral anticoagulant.

BACKGROUND

There are 5 germline mutations that lead to hypercoagulability in the general population including: Factor V Leiden (FVL), Prothrombin G20210A (F2A), Protein C Deficiency (PCD), Protein S Deficiency (PSD), and Antithrombin Deficiency (ATD). Typical guidance is to defer testing, as it is thought not to change management.

CASE REPORT

We present a case of a patient who was found to be compound heterozygous mutations for FVL and F2A, who presented with two episodes of arterial thromboembolism resulting in cerebrovascular accident (CVA). A 63-year-old male with past medical history of hypertension, a CVA four years prior, and medication non-compliance presents with new onset left sided hemiparesis after an episode of convulsions. MRI and CT imaging of the head revealed ischemic CVA secondary to thromboembolism in the right posterior cerebral artery’s (PCA), P1 branch. Following administration of tissue plasminogen activator (tPA) he had rapid symptom improvement. This second ischemic CVA prompted a workup which was notable for: negative echocardiogram, negative 30-day cardiac monitor, CT chest negative for malignancy, no significant vascular findings, negative for antiphospholipid syndrome, but genetic testing revealed the patient to be heterozygous for FVL and F2A mutations. He was started on apixaban 5 mg twice daily for ongoing secondary prevention. Though medication compliance continues to be difficult, after being placed on direct anticoagulant (DOAC), he has not had recurrent venous or arterial thrombotic events. A small case series found double heterozygosity for FVL and F2A further increases the risk of venous thromboembolism up to 17% or more in a lifetime.

CONCLUSIONS

Although current recommendations advocate against testing for specific mutations in most cases as it is likely not to change management1, this case suggests that it may be of some benefit in patients that have a workup that does not yield a clear etiology, especially in cryptogenic stroke which is typically managed with aspirin rather than direct oral anticoagulant.

BACKGROUND

There are 5 germline mutations that lead to hypercoagulability in the general population including: Factor V Leiden (FVL), Prothrombin G20210A (F2A), Protein C Deficiency (PCD), Protein S Deficiency (PSD), and Antithrombin Deficiency (ATD). Typical guidance is to defer testing, as it is thought not to change management.

CASE REPORT

We present a case of a patient who was found to be compound heterozygous mutations for FVL and F2A, who presented with two episodes of arterial thromboembolism resulting in cerebrovascular accident (CVA). A 63-year-old male with past medical history of hypertension, a CVA four years prior, and medication non-compliance presents with new onset left sided hemiparesis after an episode of convulsions. MRI and CT imaging of the head revealed ischemic CVA secondary to thromboembolism in the right posterior cerebral artery’s (PCA), P1 branch. Following administration of tissue plasminogen activator (tPA) he had rapid symptom improvement. This second ischemic CVA prompted a workup which was notable for: negative echocardiogram, negative 30-day cardiac monitor, CT chest negative for malignancy, no significant vascular findings, negative for antiphospholipid syndrome, but genetic testing revealed the patient to be heterozygous for FVL and F2A mutations. He was started on apixaban 5 mg twice daily for ongoing secondary prevention. Though medication compliance continues to be difficult, after being placed on direct anticoagulant (DOAC), he has not had recurrent venous or arterial thrombotic events. A small case series found double heterozygosity for FVL and F2A further increases the risk of venous thromboembolism up to 17% or more in a lifetime.

CONCLUSIONS

Although current recommendations advocate against testing for specific mutations in most cases as it is likely not to change management1, this case suggests that it may be of some benefit in patients that have a workup that does not yield a clear etiology, especially in cryptogenic stroke which is typically managed with aspirin rather than direct oral anticoagulant.

PURPOSE

This study addresses a gap in knowledge regarding socioeconomic factors, facility type, and overall survival in stage I vs stage IV Amelanotic Melanoma.

BACKGROUND

Amelanotic Melanoma (AM) is a rare form of melanoma that lacks pigment and accounts for approximately 5% of melanomas. Light skin color and increasing age are important risk factors. Although curable when diagnosed early, it is often missed or mistaken for other benign conditions. A study investigating the impact of facility type on overall survival between stage I vs stage IV AM has yet to be done.

METHODS

This is a retrospective study of patients diagnosed with Amelanotic Melanoma (ICD-8730) between 2004 and 2020 in the National Cancer Database (NCDB) to compare demographic features and overall survival (n = 2147). Exclusion criteria included missing data.

DATA ANALYSIS

Descriptive statistics for all AM patients were collected. Median household income and facility type were compared between patients diagnosed with stage I and stage IV AM using Pearson Chi- Square test. Breslow thickness and overall survival between stage I and stage IV were evaluated using independent t-test and Kaplan-Meier test, respectively. All variables were evaluated for a significance of P < .05.

RESULTS

Most cases analyzed were White (98.1%), male (58.6%), and had Medicare as the primary payor at diagnosis (51.1%). Of 2147 cases, 497 were stage I (23.1%) and 164 were stage IV AM (7.6%) with a mean age at diagnosis of 66.05 and 63.72 years, respectively. There was a significant difference in overall survival between stage I (mean = 118.7 months) and stage 4 (mean = 42.4 months, P < 0.001). The average Breslow thickness was 1.17mm in stage I and 2.59mm in stage IV (P<0.05). More patients diagnosed at stage I used academic facilities than those diagnosed at stage IV (43.9% vs 33.8%, P<0.05). Most patients diagnosed at stage I were high income compared to patients diagnosed at stage IV (55% vs 43.2%, P<0.05).

CONCLUSIONS

With the overall survival of stage IV AM being significantly worse, we hope this study can provide a starting point in the study and prevention of disparities in the early diagnosis of AM.

PURPOSE

This study addresses a gap in knowledge regarding socioeconomic factors, facility type, and overall survival in stage I vs stage IV Amelanotic Melanoma.

BACKGROUND

Amelanotic Melanoma (AM) is a rare form of melanoma that lacks pigment and accounts for approximately 5% of melanomas. Light skin color and increasing age are important risk factors. Although curable when diagnosed early, it is often missed or mistaken for other benign conditions. A study investigating the impact of facility type on overall survival between stage I vs stage IV AM has yet to be done.

METHODS

This is a retrospective study of patients diagnosed with Amelanotic Melanoma (ICD-8730) between 2004 and 2020 in the National Cancer Database (NCDB) to compare demographic features and overall survival (n = 2147). Exclusion criteria included missing data.

DATA ANALYSIS

Descriptive statistics for all AM patients were collected. Median household income and facility type were compared between patients diagnosed with stage I and stage IV AM using Pearson Chi- Square test. Breslow thickness and overall survival between stage I and stage IV were evaluated using independent t-test and Kaplan-Meier test, respectively. All variables were evaluated for a significance of P < .05.

RESULTS

Most cases analyzed were White (98.1%), male (58.6%), and had Medicare as the primary payor at diagnosis (51.1%). Of 2147 cases, 497 were stage I (23.1%) and 164 were stage IV AM (7.6%) with a mean age at diagnosis of 66.05 and 63.72 years, respectively. There was a significant difference in overall survival between stage I (mean = 118.7 months) and stage 4 (mean = 42.4 months, P < 0.001). The average Breslow thickness was 1.17mm in stage I and 2.59mm in stage IV (P<0.05). More patients diagnosed at stage I used academic facilities than those diagnosed at stage IV (43.9% vs 33.8%, P<0.05). Most patients diagnosed at stage I were high income compared to patients diagnosed at stage IV (55% vs 43.2%, P<0.05).

CONCLUSIONS

With the overall survival of stage IV AM being significantly worse, we hope this study can provide a starting point in the study and prevention of disparities in the early diagnosis of AM.

PURPOSE

This study addresses a gap in knowledge regarding socioeconomic factors, facility type, and overall survival in stage I vs stage IV Amelanotic Melanoma.

BACKGROUND

Amelanotic Melanoma (AM) is a rare form of melanoma that lacks pigment and accounts for approximately 5% of melanomas. Light skin color and increasing age are important risk factors. Although curable when diagnosed early, it is often missed or mistaken for other benign conditions. A study investigating the impact of facility type on overall survival between stage I vs stage IV AM has yet to be done.

METHODS

This is a retrospective study of patients diagnosed with Amelanotic Melanoma (ICD-8730) between 2004 and 2020 in the National Cancer Database (NCDB) to compare demographic features and overall survival (n = 2147). Exclusion criteria included missing data.

DATA ANALYSIS

Descriptive statistics for all AM patients were collected. Median household income and facility type were compared between patients diagnosed with stage I and stage IV AM using Pearson Chi- Square test. Breslow thickness and overall survival between stage I and stage IV were evaluated using independent t-test and Kaplan-Meier test, respectively. All variables were evaluated for a significance of P < .05.

RESULTS

Most cases analyzed were White (98.1%), male (58.6%), and had Medicare as the primary payor at diagnosis (51.1%). Of 2147 cases, 497 were stage I (23.1%) and 164 were stage IV AM (7.6%) with a mean age at diagnosis of 66.05 and 63.72 years, respectively. There was a significant difference in overall survival between stage I (mean = 118.7 months) and stage 4 (mean = 42.4 months, P < 0.001). The average Breslow thickness was 1.17mm in stage I and 2.59mm in stage IV (P<0.05). More patients diagnosed at stage I used academic facilities than those diagnosed at stage IV (43.9% vs 33.8%, P<0.05). Most patients diagnosed at stage I were high income compared to patients diagnosed at stage IV (55% vs 43.2%, P<0.05).

CONCLUSIONS

With the overall survival of stage IV AM being significantly worse, we hope this study can provide a starting point in the study and prevention of disparities in the early diagnosis of AM.

INTRODUCTION

Follicular thyroid cancer (FTC) is a common endocrine malignancy that is mainly treated with surgical resection. Few prior studies have investigated the optimal type of surgery for this FTC, particularly at a national registry level. The aim of this study is to examine the differences between surgical subtypes in the management of FTC.

METHODS

Patients from the Surveillance, Epidemiology, and End Results (SEER) database who were diagnosed with FTC between 2000-2020 were selected. The surgeries were categorized into sublobectomy, lobectomy, subtotal thyroidectomy, or thyroidectomy groups based on the surgical procedure performed. Additional variables were collected including age, sex, race, stage, radiation status, time to treatment, household income, and population size. Kaplan-Meier, Chi-square and logistic regression analyses were performed.

RESULTS

A total of 9,983 patients were included. Using Kaplan-Meier, there was improved survival for patients that received surgery (p<0.001). Patients who underwent lobectomy had greater survival than all groups (p<0.001) while thyroidectomy had greater survival compared to sub-lobectomy (p=0.015). On Chi-square, differences at one- and five-year survival were present between surgical groups (p=0.022 and p<0.001, respectively). However, logistic regression showed no survival difference between surgery type at one- and five-years. Additional findings include regional and distal staging having worse survival at one- and five-years (p’s<0.001) while median household income >$75,000 and receipt of radiation improved survival at one-year (p’s<0.05). Household income >$75,000 and radiation status no longer improved survival at five-years. Patients living outside metropolitan areas showed an improved survival at fiveyears (p=0.036).

CONCLUSIONS

The results of the preliminary Kaplan- Meier and Chi-square analysis showed that there are significant differences in survival between different surgery subtypes. However, after controlling for multiple variables, no survival differences were observed between surgical types. Despite minimal differences in FTC survival based on the type of surgical intervention, clinical factors like stage and radiation and socioeconomic factors like household income and population size may influence FTC survival. Identifying and controlling for these variables should be considered in future research on FTC.

INTRODUCTION

Follicular thyroid cancer (FTC) is a common endocrine malignancy that is mainly treated with surgical resection. Few prior studies have investigated the optimal type of surgery for this FTC, particularly at a national registry level. The aim of this study is to examine the differences between surgical subtypes in the management of FTC.

METHODS

Patients from the Surveillance, Epidemiology, and End Results (SEER) database who were diagnosed with FTC between 2000-2020 were selected. The surgeries were categorized into sublobectomy, lobectomy, subtotal thyroidectomy, or thyroidectomy groups based on the surgical procedure performed. Additional variables were collected including age, sex, race, stage, radiation status, time to treatment, household income, and population size. Kaplan-Meier, Chi-square and logistic regression analyses were performed.

RESULTS

A total of 9,983 patients were included. Using Kaplan-Meier, there was improved survival for patients that received surgery (p<0.001). Patients who underwent lobectomy had greater survival than all groups (p<0.001) while thyroidectomy had greater survival compared to sub-lobectomy (p=0.015). On Chi-square, differences at one- and five-year survival were present between surgical groups (p=0.022 and p<0.001, respectively). However, logistic regression showed no survival difference between surgery type at one- and five-years. Additional findings include regional and distal staging having worse survival at one- and five-years (p’s<0.001) while median household income >$75,000 and receipt of radiation improved survival at one-year (p’s<0.05). Household income >$75,000 and radiation status no longer improved survival at five-years. Patients living outside metropolitan areas showed an improved survival at fiveyears (p=0.036).

CONCLUSIONS

The results of the preliminary Kaplan- Meier and Chi-square analysis showed that there are significant differences in survival between different surgery subtypes. However, after controlling for multiple variables, no survival differences were observed between surgical types. Despite minimal differences in FTC survival based on the type of surgical intervention, clinical factors like stage and radiation and socioeconomic factors like household income and population size may influence FTC survival. Identifying and controlling for these variables should be considered in future research on FTC.

INTRODUCTION

Follicular thyroid cancer (FTC) is a common endocrine malignancy that is mainly treated with surgical resection. Few prior studies have investigated the optimal type of surgery for this FTC, particularly at a national registry level. The aim of this study is to examine the differences between surgical subtypes in the management of FTC.

METHODS

Patients from the Surveillance, Epidemiology, and End Results (SEER) database who were diagnosed with FTC between 2000-2020 were selected. The surgeries were categorized into sublobectomy, lobectomy, subtotal thyroidectomy, or thyroidectomy groups based on the surgical procedure performed. Additional variables were collected including age, sex, race, stage, radiation status, time to treatment, household income, and population size. Kaplan-Meier, Chi-square and logistic regression analyses were performed.

RESULTS

A total of 9,983 patients were included. Using Kaplan-Meier, there was improved survival for patients that received surgery (p<0.001). Patients who underwent lobectomy had greater survival than all groups (p<0.001) while thyroidectomy had greater survival compared to sub-lobectomy (p=0.015). On Chi-square, differences at one- and five-year survival were present between surgical groups (p=0.022 and p<0.001, respectively). However, logistic regression showed no survival difference between surgery type at one- and five-years. Additional findings include regional and distal staging having worse survival at one- and five-years (p’s<0.001) while median household income >$75,000 and receipt of radiation improved survival at one-year (p’s<0.05). Household income >$75,000 and radiation status no longer improved survival at five-years. Patients living outside metropolitan areas showed an improved survival at fiveyears (p=0.036).

CONCLUSIONS

The results of the preliminary Kaplan- Meier and Chi-square analysis showed that there are significant differences in survival between different surgery subtypes. However, after controlling for multiple variables, no survival differences were observed between surgical types. Despite minimal differences in FTC survival based on the type of surgical intervention, clinical factors like stage and radiation and socioeconomic factors like household income and population size may influence FTC survival. Identifying and controlling for these variables should be considered in future research on FTC.