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Advanced NSCLC: Pembrolizumab-treated never-smokers have a shorter survival than ever-smokers
Key clinical point: Ever-smokers treated with the first-line pembrolizumab for advanced nonsmall cell lung cancer (NSCLC) have a significantly longer overall survival (OS) compared with never-smokers.
Major finding: Ever-smokers vs. never-smokers treated with the first-line pembrolizumab for advanced NSCLC had a 31% longer median OS (12.8 vs. 6.5 months; hazard ratio 0.69; 95% CI 0.50-0.95) after adjusting for covariates.
Study details: The data come from a real-world retrospective cohort study of 1166 patients with advanced NSCLC (91 never-smokers and 1075 current or former smokers [ever-smokers]) treated with the first-line pembrolizumab in the U.S.
Disclosures: No funding source was identified. The authors reported ties with one or more pharmaceutical companies or research organizations.
Source: Popat S et al. Association between smoking history and overall survival in patients receiving pembrolizumab for first-line treatment of advanced non–small cell lung cancer. JAMA Netw Open. 2022;5(5):e2214046 (May 25). Doi: 10.1001/jamanetworkopen.2022.14046
Key clinical point: Ever-smokers treated with the first-line pembrolizumab for advanced nonsmall cell lung cancer (NSCLC) have a significantly longer overall survival (OS) compared with never-smokers.
Major finding: Ever-smokers vs. never-smokers treated with the first-line pembrolizumab for advanced NSCLC had a 31% longer median OS (12.8 vs. 6.5 months; hazard ratio 0.69; 95% CI 0.50-0.95) after adjusting for covariates.
Study details: The data come from a real-world retrospective cohort study of 1166 patients with advanced NSCLC (91 never-smokers and 1075 current or former smokers [ever-smokers]) treated with the first-line pembrolizumab in the U.S.
Disclosures: No funding source was identified. The authors reported ties with one or more pharmaceutical companies or research organizations.
Source: Popat S et al. Association between smoking history and overall survival in patients receiving pembrolizumab for first-line treatment of advanced non–small cell lung cancer. JAMA Netw Open. 2022;5(5):e2214046 (May 25). Doi: 10.1001/jamanetworkopen.2022.14046
Key clinical point: Ever-smokers treated with the first-line pembrolizumab for advanced nonsmall cell lung cancer (NSCLC) have a significantly longer overall survival (OS) compared with never-smokers.
Major finding: Ever-smokers vs. never-smokers treated with the first-line pembrolizumab for advanced NSCLC had a 31% longer median OS (12.8 vs. 6.5 months; hazard ratio 0.69; 95% CI 0.50-0.95) after adjusting for covariates.
Study details: The data come from a real-world retrospective cohort study of 1166 patients with advanced NSCLC (91 never-smokers and 1075 current or former smokers [ever-smokers]) treated with the first-line pembrolizumab in the U.S.
Disclosures: No funding source was identified. The authors reported ties with one or more pharmaceutical companies or research organizations.
Source: Popat S et al. Association between smoking history and overall survival in patients receiving pembrolizumab for first-line treatment of advanced non–small cell lung cancer. JAMA Netw Open. 2022;5(5):e2214046 (May 25). Doi: 10.1001/jamanetworkopen.2022.14046
ALK+ advanced NSCLC with brain mets: Lorlatinib boosts PFS, reduces CNS progression
Key clinical point: Lorlatinib extends progression-free survival (PFS) and reduces central nervous system (CNS) progression compared with crizotinib in patients with anaplastic lymphoma kinase positive (ALK+) advanced nonsmall cell lung cancer (NSCLC) and with or without brain metastases at baseline.
Major finding: In patients with and without baseline brain metastasis, lorlatinib vs. crizotinib improved the 12-month PFS (78% vs. 22% and 78% vs. 45%, respectively) and 12-month cumulative incidence of CNS progression (7% vs. 72% and 1% vs. 18%, respectively).
Study details: The data come from a post hoc analysis of the CROWN trial including patients with ALK+ NSCLC and with (n = 78) or without (n = 218) brain metastasis at baseline.
Disclosures: The CROWN trial was funded by Pfizer. Many authors reported ties with multiple pharmaceutical companies, including Pfizer.
Source: Solomon BJ et al. Post hoc analysis of lorlatinib intracranial efficacy and safety in patients with ALK-positive advanced non–small-cell lung cancer from the phase III CROWN study. J Clin Oncol. 2022 (May 23). Doi: 10.1200/JCO.21.02278
Key clinical point: Lorlatinib extends progression-free survival (PFS) and reduces central nervous system (CNS) progression compared with crizotinib in patients with anaplastic lymphoma kinase positive (ALK+) advanced nonsmall cell lung cancer (NSCLC) and with or without brain metastases at baseline.
Major finding: In patients with and without baseline brain metastasis, lorlatinib vs. crizotinib improved the 12-month PFS (78% vs. 22% and 78% vs. 45%, respectively) and 12-month cumulative incidence of CNS progression (7% vs. 72% and 1% vs. 18%, respectively).
Study details: The data come from a post hoc analysis of the CROWN trial including patients with ALK+ NSCLC and with (n = 78) or without (n = 218) brain metastasis at baseline.
Disclosures: The CROWN trial was funded by Pfizer. Many authors reported ties with multiple pharmaceutical companies, including Pfizer.
Source: Solomon BJ et al. Post hoc analysis of lorlatinib intracranial efficacy and safety in patients with ALK-positive advanced non–small-cell lung cancer from the phase III CROWN study. J Clin Oncol. 2022 (May 23). Doi: 10.1200/JCO.21.02278
Key clinical point: Lorlatinib extends progression-free survival (PFS) and reduces central nervous system (CNS) progression compared with crizotinib in patients with anaplastic lymphoma kinase positive (ALK+) advanced nonsmall cell lung cancer (NSCLC) and with or without brain metastases at baseline.
Major finding: In patients with and without baseline brain metastasis, lorlatinib vs. crizotinib improved the 12-month PFS (78% vs. 22% and 78% vs. 45%, respectively) and 12-month cumulative incidence of CNS progression (7% vs. 72% and 1% vs. 18%, respectively).
Study details: The data come from a post hoc analysis of the CROWN trial including patients with ALK+ NSCLC and with (n = 78) or without (n = 218) brain metastasis at baseline.
Disclosures: The CROWN trial was funded by Pfizer. Many authors reported ties with multiple pharmaceutical companies, including Pfizer.
Source: Solomon BJ et al. Post hoc analysis of lorlatinib intracranial efficacy and safety in patients with ALK-positive advanced non–small-cell lung cancer from the phase III CROWN study. J Clin Oncol. 2022 (May 23). Doi: 10.1200/JCO.21.02278
EGFR-mutated NSCLC: Aumolertinib vs. gefitinib extends PFS
Key clinical point: Aumolertinib vs. gefitinib as the first-line therapy significantly improves progression-free survival (PFS) in patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutation (i.e., exon 19 deletion or L858R mutation).
Major finding: The aumolertinib vs. gefitinib group had a significantly longer median PFS (19.3 vs. 9.9 months; hazard ratio [HR] 0.46; P < .0001). The PFS advantage of aumolertinib over gefitinib was substantial in the subgroup of patients with central nervous system metastases (15.3 vs. 8.2 months; HR 0.38; P < .0001).
Study details: This randomized, double-blind, multicenter, phase 3 AENEAS trial included 429 patients with EGFR-mutated NSCLC who were randomly assigned (1:1) to receive either the first-line aumolertinib or gefitinib once daily orally.
Disclosures: The study was funded by Hansoh Pharmaceutical Group Co, Ltd. Many authors reported ties with one or more pharmaceutical companies, including Hansoh Pharma.
Source: Lu S et al. AENEAS: A randomized phase III trial of aumolertinib versus gefitinib as first-line therapy for locally advanced or metastatic non–small-cell lung cancer with EGFR exon 19 deletion or L858R mutations. J Clin Oncol. 2022 (May 17). Doi: 10.1200/JCO.21.02641
Key clinical point: Aumolertinib vs. gefitinib as the first-line therapy significantly improves progression-free survival (PFS) in patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutation (i.e., exon 19 deletion or L858R mutation).
Major finding: The aumolertinib vs. gefitinib group had a significantly longer median PFS (19.3 vs. 9.9 months; hazard ratio [HR] 0.46; P < .0001). The PFS advantage of aumolertinib over gefitinib was substantial in the subgroup of patients with central nervous system metastases (15.3 vs. 8.2 months; HR 0.38; P < .0001).
Study details: This randomized, double-blind, multicenter, phase 3 AENEAS trial included 429 patients with EGFR-mutated NSCLC who were randomly assigned (1:1) to receive either the first-line aumolertinib or gefitinib once daily orally.
Disclosures: The study was funded by Hansoh Pharmaceutical Group Co, Ltd. Many authors reported ties with one or more pharmaceutical companies, including Hansoh Pharma.
Source: Lu S et al. AENEAS: A randomized phase III trial of aumolertinib versus gefitinib as first-line therapy for locally advanced or metastatic non–small-cell lung cancer with EGFR exon 19 deletion or L858R mutations. J Clin Oncol. 2022 (May 17). Doi: 10.1200/JCO.21.02641
Key clinical point: Aumolertinib vs. gefitinib as the first-line therapy significantly improves progression-free survival (PFS) in patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutation (i.e., exon 19 deletion or L858R mutation).
Major finding: The aumolertinib vs. gefitinib group had a significantly longer median PFS (19.3 vs. 9.9 months; hazard ratio [HR] 0.46; P < .0001). The PFS advantage of aumolertinib over gefitinib was substantial in the subgroup of patients with central nervous system metastases (15.3 vs. 8.2 months; HR 0.38; P < .0001).
Study details: This randomized, double-blind, multicenter, phase 3 AENEAS trial included 429 patients with EGFR-mutated NSCLC who were randomly assigned (1:1) to receive either the first-line aumolertinib or gefitinib once daily orally.
Disclosures: The study was funded by Hansoh Pharmaceutical Group Co, Ltd. Many authors reported ties with one or more pharmaceutical companies, including Hansoh Pharma.
Source: Lu S et al. AENEAS: A randomized phase III trial of aumolertinib versus gefitinib as first-line therapy for locally advanced or metastatic non–small-cell lung cancer with EGFR exon 19 deletion or L858R mutations. J Clin Oncol. 2022 (May 17). Doi: 10.1200/JCO.21.02641
Recurrent or metastatic NSCLC: Tiragolumab plus atezolizumab combo shows promise
Key clinical point: First-line tiragolumab plus atezolizumab vs. placebo plus atezolizumab is associated with a better objective response rate (ORR) and progression-free survival (PFS) in patients with programmed cell death-ligand 1 (PD-L1)-positive, recurrent, or metastatic nonsmall cell lung cancer (NSCLC).
Major finding: The tiragolumab vs. placebo group demonstrated a superior ORR (31.3% vs. 16.2%; P = .031) and median PFS (5.4 vs. 3.6 months; stratified hazard ratio 0.57; P = .015). The rates of serious treatment-related adverse events in the tiragolumab and placebo groups were 21% and 18%, respectively.
Study details: This phase 2 randomized, double-blind, placebo-controlled CITYSCAPE trial included chemotherapy-naive patients with PD-L1-positive recurrent or metastatic NSCLC (with no EGFR or ALK alterations) who were randomly assigned to receive either tiragolumab plus atezolizumab (n = 67) or placebo plus atezolizumab (n = 68) once every 3 weeks.
Disclosures: The study was funded by F Hoffmann-La Roche and Genentech. M Cobo, N Secen, and X Yang declared no competing interests. The other authors reported ties with one or more pharmaceutical companies, including employment or stock options in the funding companies.
Source: Cho BC et al. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): Primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022;23(6):781-792 (May 13). Doi: 10.1016/S1470-2045(22)00226-1
Key clinical point: First-line tiragolumab plus atezolizumab vs. placebo plus atezolizumab is associated with a better objective response rate (ORR) and progression-free survival (PFS) in patients with programmed cell death-ligand 1 (PD-L1)-positive, recurrent, or metastatic nonsmall cell lung cancer (NSCLC).
Major finding: The tiragolumab vs. placebo group demonstrated a superior ORR (31.3% vs. 16.2%; P = .031) and median PFS (5.4 vs. 3.6 months; stratified hazard ratio 0.57; P = .015). The rates of serious treatment-related adverse events in the tiragolumab and placebo groups were 21% and 18%, respectively.
Study details: This phase 2 randomized, double-blind, placebo-controlled CITYSCAPE trial included chemotherapy-naive patients with PD-L1-positive recurrent or metastatic NSCLC (with no EGFR or ALK alterations) who were randomly assigned to receive either tiragolumab plus atezolizumab (n = 67) or placebo plus atezolizumab (n = 68) once every 3 weeks.
Disclosures: The study was funded by F Hoffmann-La Roche and Genentech. M Cobo, N Secen, and X Yang declared no competing interests. The other authors reported ties with one or more pharmaceutical companies, including employment or stock options in the funding companies.
Source: Cho BC et al. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): Primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022;23(6):781-792 (May 13). Doi: 10.1016/S1470-2045(22)00226-1
Key clinical point: First-line tiragolumab plus atezolizumab vs. placebo plus atezolizumab is associated with a better objective response rate (ORR) and progression-free survival (PFS) in patients with programmed cell death-ligand 1 (PD-L1)-positive, recurrent, or metastatic nonsmall cell lung cancer (NSCLC).
Major finding: The tiragolumab vs. placebo group demonstrated a superior ORR (31.3% vs. 16.2%; P = .031) and median PFS (5.4 vs. 3.6 months; stratified hazard ratio 0.57; P = .015). The rates of serious treatment-related adverse events in the tiragolumab and placebo groups were 21% and 18%, respectively.
Study details: This phase 2 randomized, double-blind, placebo-controlled CITYSCAPE trial included chemotherapy-naive patients with PD-L1-positive recurrent or metastatic NSCLC (with no EGFR or ALK alterations) who were randomly assigned to receive either tiragolumab plus atezolizumab (n = 67) or placebo plus atezolizumab (n = 68) once every 3 weeks.
Disclosures: The study was funded by F Hoffmann-La Roche and Genentech. M Cobo, N Secen, and X Yang declared no competing interests. The other authors reported ties with one or more pharmaceutical companies, including employment or stock options in the funding companies.
Source: Cho BC et al. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): Primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022;23(6):781-792 (May 13). Doi: 10.1016/S1470-2045(22)00226-1
Severity of diabetes tied to lung cancer prognosis
Key clinical point: Patients with squamous cell lung carcinoma (SqCLC) and moderate-to-severe diabetes may have a higher risk for all-cause mortality than those with SqCLC and mild diabetes.
Major finding: Patients with SqCLC and moderate to severe diabetes had a 17% higher risk for all-cause death than those with SqCLC and mild diabetes (adjusted hazard ratio 1.17; P = .0005).
Study details: The data come from a retrospective cohort study including patients with both SqCLC and diabetes (n = 5742) from the Taiwan Cancer Registry database.
Disclosures: The study was funded by grants from Lo-Hsu Medical Foundation, LotungPoh-Ai Hospital, and Fu Jen Catholic University. The authors declared no conflicts of interest.
Source: Su C-H et al. Association of diabetes severity and mortality with lung squamous cell carcinoma. Cancers (Basel). 2022;14(10):2553 (May 22). Doi: 10.3390/cancers14102553
Key clinical point: Patients with squamous cell lung carcinoma (SqCLC) and moderate-to-severe diabetes may have a higher risk for all-cause mortality than those with SqCLC and mild diabetes.
Major finding: Patients with SqCLC and moderate to severe diabetes had a 17% higher risk for all-cause death than those with SqCLC and mild diabetes (adjusted hazard ratio 1.17; P = .0005).
Study details: The data come from a retrospective cohort study including patients with both SqCLC and diabetes (n = 5742) from the Taiwan Cancer Registry database.
Disclosures: The study was funded by grants from Lo-Hsu Medical Foundation, LotungPoh-Ai Hospital, and Fu Jen Catholic University. The authors declared no conflicts of interest.
Source: Su C-H et al. Association of diabetes severity and mortality with lung squamous cell carcinoma. Cancers (Basel). 2022;14(10):2553 (May 22). Doi: 10.3390/cancers14102553
Key clinical point: Patients with squamous cell lung carcinoma (SqCLC) and moderate-to-severe diabetes may have a higher risk for all-cause mortality than those with SqCLC and mild diabetes.
Major finding: Patients with SqCLC and moderate to severe diabetes had a 17% higher risk for all-cause death than those with SqCLC and mild diabetes (adjusted hazard ratio 1.17; P = .0005).
Study details: The data come from a retrospective cohort study including patients with both SqCLC and diabetes (n = 5742) from the Taiwan Cancer Registry database.
Disclosures: The study was funded by grants from Lo-Hsu Medical Foundation, LotungPoh-Ai Hospital, and Fu Jen Catholic University. The authors declared no conflicts of interest.
Source: Su C-H et al. Association of diabetes severity and mortality with lung squamous cell carcinoma. Cancers (Basel). 2022;14(10):2553 (May 22). Doi: 10.3390/cancers14102553
Advance directives for psychiatric care reduce compulsory admissions
, new research shows.
Results of a randomized trial showed the peer worker PAD group had a 42% reduction in compulsory admission over the following 12 months. This study group also had lower symptom scores, greater rates of recovery, and increased empowerment, compared with patients assigned to usual care.
In addition to proving that PADs are effective in reducing compulsory admission, the results show that facilitation by peer workers is relevant, study investigator Aurélie Tinland, MD, PhD, Faculté de Médecine Timone, Aix-Marseille University, Marseille, France, told delegates attending the virtual European Psychiatric Association (EPA) 2022 Congress. The study was simultaneously published online in JAMA Psychiatry.
However, Dr. Tinland noted that more research that includes “harder to reach” populations is needed. In addition, greater use of PADs is also key to reducing compulsory admissions.
‘Most coercive’ country
The researchers note that respect for patient autonomy is a strong pillar of health care, such that “involuntary treatment should be unusual.” However, they point out that “compulsory psychiatric admissions are far too common in countries of all income levels.”
In France, said Dr. Tinland, 24% of psychiatric hospitalizations are compulsory. The country is ranked the sixth “most coercive” country in the world, and there are concerns about human rights in French psychiatric facilities.
She added that advance care statements are the most efficient tool for reducing coercion, with one study suggesting they could cut rates by 25%, compared with usual care.
However, she noted there is an “asymmetry” between medical professionals and patients and a risk of “undue influence” when clinicians facilitate the completion of care statements.
To examine the impact on clinical outcomes of peer-worker facilitated PADs, the researchers studied adults with a diagnosis of schizophrenia, bipolar I disorder, or schizoaffective disorder who were admitted to a psychiatric hospital within the previous 12 months. Peer workers are individuals who have lived experience with mental illness and help inform and guide current patients about care options in the event of a mental health crisis.
Study participants were randomly assigned 1:1 to an intervention group or a usual care control group. The intervention group received a PAD document and were assigned a peer worker while the usual care group received comprehensive information about the PAD concept at study entry and were free to complete it, but they were not connected with a peer worker.
The PAD document included information about future treatment and support preferences, early signs of relapse, and coping strategies. Participants could meet the peer worker in a place of their choice and be supported in drafting the document and in sharing it with health care professionals.
In all, 394 individuals completed the study. The majority (61%) of participants were male and 66% had completed post-secondary education. Schizophrenia was diagnosed in 45%, bipolar I disorder in 36%, and schizoaffective disorder in 19%.
Participants in the intervention group were significantly younger than those in the control group, with a mean of 37.4 years versus 41 years (P = .003) and were less likely to have one or more somatic comorbidities, at 61.2% versus 69.2%.
A PAD was completed by 54.6% of individuals in the intervention group versus 7.1% of controls (P < .001). The PAD was written with peer worker support by 41.3% of those in the intervention and by 2% of controls. Of those who completed a PAD, 75.7% met care facilitators, and 27.1% used it during a crisis over the following 12 months.
Results showed that the rate of compulsory admissions was significantly lower in the peer worker PAD group, at 27% versus 39.9% in control participants, at an odds ratio of 0.58 (P = .007).
Participants in the intervention group had lower symptoms on the modified Colorado Symptom Score than usual care patients with an effect size of -0.20 (P = .03) and higher scores on the Empowerment Scale (effect size 0.30, P = .003).
Scores on the Recovery Assessment Scale were also significantly higher in the peer worker PAD group versus controls with an effect size of 0.44 (P < .001). There were no significant differences, however, in overall admission rates, the quality of the therapeutic alliance, or quality of life.
Putting patients in the driver’s seat
Commenting on the findings, Robert Dabney Jr., MA, MDiv, peer apprentice program manager at the Depression and Bipolar Support Alliance, Chicago, said the study “tells us there are many benefits to completing a psychiatric advance directive, but perhaps the most powerful one is putting the person receiving mental health care in the driver’s seat of their own recovery.”
However, he noted that “many people living with mental health conditions don’t know the option exists to decide on their treatment plan in advance of a crisis.”
“This is where peer support specialists can come in. Having a peer who has been through similar experiences and can guide you through the process is as comforting as it is empowering. I have witnessed and experienced firsthand the power of peer support,” he said.
“It’s my personal hope and the goal of the Depression and Bipolar Support Alliance to empower more people to either become peer support specialists or seek out peer support services, because we know it improves and even saves lives,” Mr. Dabney added.
Virginia A. Brown, PhD, department of psychiatry & behavioral sciences, University of Texas at Austin Dell Medical School, noted there are huge differences between the health care systems in France and the United States.
She explained that two of the greatest barriers to PADs in the United States is that until 2016, filling one out was not billable and that “practitioners don’t know anything about advanced care plans.”
Dr. Brown said her own work shows that individuals who support patients during a crisis believe it would be “really helpful if we had some kind of document that we could share with the health care system that says: ‘Hey, look, I’m the designated person to speak for this patient, they’ve identified me through a document.’ So, people were actually describing a need for this document but didn’t know that it existed.”
Another problem is that in the United States, hospitals operate in a “closed system” and cannot talk to an unrelated hospital or to the police department “to get information to those first responders during an emergency about who to talk to about their wishes and preferences.”
“There are a lot of hurdles that we’ve got to get over to make a more robust system that protects the autonomy of people who live with serious mental illness,” Dr. Brown said, as “losing capacity during a crisis is time-limited, and it requires us to respond to it as a medical emergency.”
The study was supported by an institutional grant from the French 2017 National Program of Health Services Research. The Clinical Research Direction of Assistance Publique Hôpitaux de Marseille sponsored the trial. Dr. Tinland declares grants from the French Ministry of Health Directorate General of Health Care Services during the conduct of the study.
A version of this article first appeared on Medscape.com.
, new research shows.
Results of a randomized trial showed the peer worker PAD group had a 42% reduction in compulsory admission over the following 12 months. This study group also had lower symptom scores, greater rates of recovery, and increased empowerment, compared with patients assigned to usual care.
In addition to proving that PADs are effective in reducing compulsory admission, the results show that facilitation by peer workers is relevant, study investigator Aurélie Tinland, MD, PhD, Faculté de Médecine Timone, Aix-Marseille University, Marseille, France, told delegates attending the virtual European Psychiatric Association (EPA) 2022 Congress. The study was simultaneously published online in JAMA Psychiatry.
However, Dr. Tinland noted that more research that includes “harder to reach” populations is needed. In addition, greater use of PADs is also key to reducing compulsory admissions.
‘Most coercive’ country
The researchers note that respect for patient autonomy is a strong pillar of health care, such that “involuntary treatment should be unusual.” However, they point out that “compulsory psychiatric admissions are far too common in countries of all income levels.”
In France, said Dr. Tinland, 24% of psychiatric hospitalizations are compulsory. The country is ranked the sixth “most coercive” country in the world, and there are concerns about human rights in French psychiatric facilities.
She added that advance care statements are the most efficient tool for reducing coercion, with one study suggesting they could cut rates by 25%, compared with usual care.
However, she noted there is an “asymmetry” between medical professionals and patients and a risk of “undue influence” when clinicians facilitate the completion of care statements.
To examine the impact on clinical outcomes of peer-worker facilitated PADs, the researchers studied adults with a diagnosis of schizophrenia, bipolar I disorder, or schizoaffective disorder who were admitted to a psychiatric hospital within the previous 12 months. Peer workers are individuals who have lived experience with mental illness and help inform and guide current patients about care options in the event of a mental health crisis.
Study participants were randomly assigned 1:1 to an intervention group or a usual care control group. The intervention group received a PAD document and were assigned a peer worker while the usual care group received comprehensive information about the PAD concept at study entry and were free to complete it, but they were not connected with a peer worker.
The PAD document included information about future treatment and support preferences, early signs of relapse, and coping strategies. Participants could meet the peer worker in a place of their choice and be supported in drafting the document and in sharing it with health care professionals.
In all, 394 individuals completed the study. The majority (61%) of participants were male and 66% had completed post-secondary education. Schizophrenia was diagnosed in 45%, bipolar I disorder in 36%, and schizoaffective disorder in 19%.
Participants in the intervention group were significantly younger than those in the control group, with a mean of 37.4 years versus 41 years (P = .003) and were less likely to have one or more somatic comorbidities, at 61.2% versus 69.2%.
A PAD was completed by 54.6% of individuals in the intervention group versus 7.1% of controls (P < .001). The PAD was written with peer worker support by 41.3% of those in the intervention and by 2% of controls. Of those who completed a PAD, 75.7% met care facilitators, and 27.1% used it during a crisis over the following 12 months.
Results showed that the rate of compulsory admissions was significantly lower in the peer worker PAD group, at 27% versus 39.9% in control participants, at an odds ratio of 0.58 (P = .007).
Participants in the intervention group had lower symptoms on the modified Colorado Symptom Score than usual care patients with an effect size of -0.20 (P = .03) and higher scores on the Empowerment Scale (effect size 0.30, P = .003).
Scores on the Recovery Assessment Scale were also significantly higher in the peer worker PAD group versus controls with an effect size of 0.44 (P < .001). There were no significant differences, however, in overall admission rates, the quality of the therapeutic alliance, or quality of life.
Putting patients in the driver’s seat
Commenting on the findings, Robert Dabney Jr., MA, MDiv, peer apprentice program manager at the Depression and Bipolar Support Alliance, Chicago, said the study “tells us there are many benefits to completing a psychiatric advance directive, but perhaps the most powerful one is putting the person receiving mental health care in the driver’s seat of their own recovery.”
However, he noted that “many people living with mental health conditions don’t know the option exists to decide on their treatment plan in advance of a crisis.”
“This is where peer support specialists can come in. Having a peer who has been through similar experiences and can guide you through the process is as comforting as it is empowering. I have witnessed and experienced firsthand the power of peer support,” he said.
“It’s my personal hope and the goal of the Depression and Bipolar Support Alliance to empower more people to either become peer support specialists or seek out peer support services, because we know it improves and even saves lives,” Mr. Dabney added.
Virginia A. Brown, PhD, department of psychiatry & behavioral sciences, University of Texas at Austin Dell Medical School, noted there are huge differences between the health care systems in France and the United States.
She explained that two of the greatest barriers to PADs in the United States is that until 2016, filling one out was not billable and that “practitioners don’t know anything about advanced care plans.”
Dr. Brown said her own work shows that individuals who support patients during a crisis believe it would be “really helpful if we had some kind of document that we could share with the health care system that says: ‘Hey, look, I’m the designated person to speak for this patient, they’ve identified me through a document.’ So, people were actually describing a need for this document but didn’t know that it existed.”
Another problem is that in the United States, hospitals operate in a “closed system” and cannot talk to an unrelated hospital or to the police department “to get information to those first responders during an emergency about who to talk to about their wishes and preferences.”
“There are a lot of hurdles that we’ve got to get over to make a more robust system that protects the autonomy of people who live with serious mental illness,” Dr. Brown said, as “losing capacity during a crisis is time-limited, and it requires us to respond to it as a medical emergency.”
The study was supported by an institutional grant from the French 2017 National Program of Health Services Research. The Clinical Research Direction of Assistance Publique Hôpitaux de Marseille sponsored the trial. Dr. Tinland declares grants from the French Ministry of Health Directorate General of Health Care Services during the conduct of the study.
A version of this article first appeared on Medscape.com.
, new research shows.
Results of a randomized trial showed the peer worker PAD group had a 42% reduction in compulsory admission over the following 12 months. This study group also had lower symptom scores, greater rates of recovery, and increased empowerment, compared with patients assigned to usual care.
In addition to proving that PADs are effective in reducing compulsory admission, the results show that facilitation by peer workers is relevant, study investigator Aurélie Tinland, MD, PhD, Faculté de Médecine Timone, Aix-Marseille University, Marseille, France, told delegates attending the virtual European Psychiatric Association (EPA) 2022 Congress. The study was simultaneously published online in JAMA Psychiatry.
However, Dr. Tinland noted that more research that includes “harder to reach” populations is needed. In addition, greater use of PADs is also key to reducing compulsory admissions.
‘Most coercive’ country
The researchers note that respect for patient autonomy is a strong pillar of health care, such that “involuntary treatment should be unusual.” However, they point out that “compulsory psychiatric admissions are far too common in countries of all income levels.”
In France, said Dr. Tinland, 24% of psychiatric hospitalizations are compulsory. The country is ranked the sixth “most coercive” country in the world, and there are concerns about human rights in French psychiatric facilities.
She added that advance care statements are the most efficient tool for reducing coercion, with one study suggesting they could cut rates by 25%, compared with usual care.
However, she noted there is an “asymmetry” between medical professionals and patients and a risk of “undue influence” when clinicians facilitate the completion of care statements.
To examine the impact on clinical outcomes of peer-worker facilitated PADs, the researchers studied adults with a diagnosis of schizophrenia, bipolar I disorder, or schizoaffective disorder who were admitted to a psychiatric hospital within the previous 12 months. Peer workers are individuals who have lived experience with mental illness and help inform and guide current patients about care options in the event of a mental health crisis.
Study participants were randomly assigned 1:1 to an intervention group or a usual care control group. The intervention group received a PAD document and were assigned a peer worker while the usual care group received comprehensive information about the PAD concept at study entry and were free to complete it, but they were not connected with a peer worker.
The PAD document included information about future treatment and support preferences, early signs of relapse, and coping strategies. Participants could meet the peer worker in a place of their choice and be supported in drafting the document and in sharing it with health care professionals.
In all, 394 individuals completed the study. The majority (61%) of participants were male and 66% had completed post-secondary education. Schizophrenia was diagnosed in 45%, bipolar I disorder in 36%, and schizoaffective disorder in 19%.
Participants in the intervention group were significantly younger than those in the control group, with a mean of 37.4 years versus 41 years (P = .003) and were less likely to have one or more somatic comorbidities, at 61.2% versus 69.2%.
A PAD was completed by 54.6% of individuals in the intervention group versus 7.1% of controls (P < .001). The PAD was written with peer worker support by 41.3% of those in the intervention and by 2% of controls. Of those who completed a PAD, 75.7% met care facilitators, and 27.1% used it during a crisis over the following 12 months.
Results showed that the rate of compulsory admissions was significantly lower in the peer worker PAD group, at 27% versus 39.9% in control participants, at an odds ratio of 0.58 (P = .007).
Participants in the intervention group had lower symptoms on the modified Colorado Symptom Score than usual care patients with an effect size of -0.20 (P = .03) and higher scores on the Empowerment Scale (effect size 0.30, P = .003).
Scores on the Recovery Assessment Scale were also significantly higher in the peer worker PAD group versus controls with an effect size of 0.44 (P < .001). There were no significant differences, however, in overall admission rates, the quality of the therapeutic alliance, or quality of life.
Putting patients in the driver’s seat
Commenting on the findings, Robert Dabney Jr., MA, MDiv, peer apprentice program manager at the Depression and Bipolar Support Alliance, Chicago, said the study “tells us there are many benefits to completing a psychiatric advance directive, but perhaps the most powerful one is putting the person receiving mental health care in the driver’s seat of their own recovery.”
However, he noted that “many people living with mental health conditions don’t know the option exists to decide on their treatment plan in advance of a crisis.”
“This is where peer support specialists can come in. Having a peer who has been through similar experiences and can guide you through the process is as comforting as it is empowering. I have witnessed and experienced firsthand the power of peer support,” he said.
“It’s my personal hope and the goal of the Depression and Bipolar Support Alliance to empower more people to either become peer support specialists or seek out peer support services, because we know it improves and even saves lives,” Mr. Dabney added.
Virginia A. Brown, PhD, department of psychiatry & behavioral sciences, University of Texas at Austin Dell Medical School, noted there are huge differences between the health care systems in France and the United States.
She explained that two of the greatest barriers to PADs in the United States is that until 2016, filling one out was not billable and that “practitioners don’t know anything about advanced care plans.”
Dr. Brown said her own work shows that individuals who support patients during a crisis believe it would be “really helpful if we had some kind of document that we could share with the health care system that says: ‘Hey, look, I’m the designated person to speak for this patient, they’ve identified me through a document.’ So, people were actually describing a need for this document but didn’t know that it existed.”
Another problem is that in the United States, hospitals operate in a “closed system” and cannot talk to an unrelated hospital or to the police department “to get information to those first responders during an emergency about who to talk to about their wishes and preferences.”
“There are a lot of hurdles that we’ve got to get over to make a more robust system that protects the autonomy of people who live with serious mental illness,” Dr. Brown said, as “losing capacity during a crisis is time-limited, and it requires us to respond to it as a medical emergency.”
The study was supported by an institutional grant from the French 2017 National Program of Health Services Research. The Clinical Research Direction of Assistance Publique Hôpitaux de Marseille sponsored the trial. Dr. Tinland declares grants from the French Ministry of Health Directorate General of Health Care Services during the conduct of the study.
A version of this article first appeared on Medscape.com.
FROM EPA 2022
Gastric cancer: Epstein-Barr virus and H. pylori coinfection is not prognostic
Key clinical point: Epstein-Barr virus (EBV) and Helicobacter pylori coinfection is not an independent prognostic factor for gastric cancer. EBV infection was associated with survival, but not in patients with non-gastric carcinoma with lymphoid stroma (non-GCLS).
Major finding: EBV infection alone (hazard ratio 0.362; P = .049) showed an inverse correlation with overall survival (OS). The 5-year OS rate was not significantly different between the EBV and H. pylori coinfection vs. other groups (97.6% vs. 86.8%; P = .144). In patients with non-GCLS, the OS rate was not significantly different between the EBV-positive vs. other groups (96.9% vs. 86.4%; P = .126).
Study details: This retrospective study included 956 patients with gastric cancer who underwent surgery between September 2014 and August 2015 and were subdivided into groups according to the GCLS morphology and EBV and H. pylori infection statuses.
Disclosures: No funding source was identified for this study. Dr. JY Ahn is an editorial board member of the journal. The other authors reported no conflicts of interest.
Source: Noh JH et al. Clinical significance of Epstein-Barr virus and Helicobacter pylori infection in gastric carcinoma. Gut Liver. 2022 (May 25). Doi: 10.5009/gnl210593
Key clinical point: Epstein-Barr virus (EBV) and Helicobacter pylori coinfection is not an independent prognostic factor for gastric cancer. EBV infection was associated with survival, but not in patients with non-gastric carcinoma with lymphoid stroma (non-GCLS).
Major finding: EBV infection alone (hazard ratio 0.362; P = .049) showed an inverse correlation with overall survival (OS). The 5-year OS rate was not significantly different between the EBV and H. pylori coinfection vs. other groups (97.6% vs. 86.8%; P = .144). In patients with non-GCLS, the OS rate was not significantly different between the EBV-positive vs. other groups (96.9% vs. 86.4%; P = .126).
Study details: This retrospective study included 956 patients with gastric cancer who underwent surgery between September 2014 and August 2015 and were subdivided into groups according to the GCLS morphology and EBV and H. pylori infection statuses.
Disclosures: No funding source was identified for this study. Dr. JY Ahn is an editorial board member of the journal. The other authors reported no conflicts of interest.
Source: Noh JH et al. Clinical significance of Epstein-Barr virus and Helicobacter pylori infection in gastric carcinoma. Gut Liver. 2022 (May 25). Doi: 10.5009/gnl210593
Key clinical point: Epstein-Barr virus (EBV) and Helicobacter pylori coinfection is not an independent prognostic factor for gastric cancer. EBV infection was associated with survival, but not in patients with non-gastric carcinoma with lymphoid stroma (non-GCLS).
Major finding: EBV infection alone (hazard ratio 0.362; P = .049) showed an inverse correlation with overall survival (OS). The 5-year OS rate was not significantly different between the EBV and H. pylori coinfection vs. other groups (97.6% vs. 86.8%; P = .144). In patients with non-GCLS, the OS rate was not significantly different between the EBV-positive vs. other groups (96.9% vs. 86.4%; P = .126).
Study details: This retrospective study included 956 patients with gastric cancer who underwent surgery between September 2014 and August 2015 and were subdivided into groups according to the GCLS morphology and EBV and H. pylori infection statuses.
Disclosures: No funding source was identified for this study. Dr. JY Ahn is an editorial board member of the journal. The other authors reported no conflicts of interest.
Source: Noh JH et al. Clinical significance of Epstein-Barr virus and Helicobacter pylori infection in gastric carcinoma. Gut Liver. 2022 (May 25). Doi: 10.5009/gnl210593
Artificial intelligence may support the diagnosis of early gastric cancer
Key clinical point: Artificial intelligence (AI) shows high sensitivity, specificity, and accuracy for the diagnosis of early gastric cancer.
Major finding: The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 and 0.90, respectively. The accuracy of AI was 0.94. The pooled sensitivity and specificity of deep learning methods were 0.84 and 0.88, respectively, and those of nondeep learning methods were 0.91 and 0.90, respectively. The accuracy of the nondeep learning methods was higher compared with the deep learning methods (0.96 vs. 0.93).
Study details: This meta-analysis of 12 retrospective case-control studies (n = 11,685) assessed the performance of AI in the endoscopic diagnosis of early gastric cancer.
Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.
Source: Chen P-C et al. The accuracy of artificial intelligence in the endoscopic diagnosis of early gastric cancer: Pooled Analysis Study. J Med Internet Res. 2022;24(5):e27694 (May 16). Doi: 10.2196/27694
Key clinical point: Artificial intelligence (AI) shows high sensitivity, specificity, and accuracy for the diagnosis of early gastric cancer.
Major finding: The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 and 0.90, respectively. The accuracy of AI was 0.94. The pooled sensitivity and specificity of deep learning methods were 0.84 and 0.88, respectively, and those of nondeep learning methods were 0.91 and 0.90, respectively. The accuracy of the nondeep learning methods was higher compared with the deep learning methods (0.96 vs. 0.93).
Study details: This meta-analysis of 12 retrospective case-control studies (n = 11,685) assessed the performance of AI in the endoscopic diagnosis of early gastric cancer.
Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.
Source: Chen P-C et al. The accuracy of artificial intelligence in the endoscopic diagnosis of early gastric cancer: Pooled Analysis Study. J Med Internet Res. 2022;24(5):e27694 (May 16). Doi: 10.2196/27694
Key clinical point: Artificial intelligence (AI) shows high sensitivity, specificity, and accuracy for the diagnosis of early gastric cancer.
Major finding: The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 and 0.90, respectively. The accuracy of AI was 0.94. The pooled sensitivity and specificity of deep learning methods were 0.84 and 0.88, respectively, and those of nondeep learning methods were 0.91 and 0.90, respectively. The accuracy of the nondeep learning methods was higher compared with the deep learning methods (0.96 vs. 0.93).
Study details: This meta-analysis of 12 retrospective case-control studies (n = 11,685) assessed the performance of AI in the endoscopic diagnosis of early gastric cancer.
Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.
Source: Chen P-C et al. The accuracy of artificial intelligence in the endoscopic diagnosis of early gastric cancer: Pooled Analysis Study. J Med Internet Res. 2022;24(5):e27694 (May 16). Doi: 10.2196/27694
Artificial intelligence may support the diagnosis of early gastric cancer
Key clinical point: Artificial intelligence (AI) shows high sensitivity, specificity, and accuracy for the diagnosis of early gastric cancer.
Major finding: The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 and 0.90, respectively. The accuracy of AI was 0.94. The pooled sensitivity and specificity of deep learning methods were 0.84 and 0.88, respectively, and those of nondeep learning methods were 0.91 and 0.90, respectively. The accuracy of the nondeep learning methods was higher compared with the deep learning methods (0.96 vs. 0.93).
Study details: This meta-analysis of 12 retrospective case-control studies (n = 11,685) assessed the performance of AI in the endoscopic diagnosis of early gastric cancer.
Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.
Source: Chen P-C et al. The accuracy of artificial intelligence in the endoscopic diagnosis of early gastric cancer: Pooled Analysis Study. J Med Internet Res. 2022;24(5):e27694 (May 16). Doi: 10.2196/27694
Key clinical point: Artificial intelligence (AI) shows high sensitivity, specificity, and accuracy for the diagnosis of early gastric cancer.
Major finding: The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 and 0.90, respectively. The accuracy of AI was 0.94. The pooled sensitivity and specificity of deep learning methods were 0.84 and 0.88, respectively, and those of nondeep learning methods were 0.91 and 0.90, respectively. The accuracy of the nondeep learning methods was higher compared with the deep learning methods (0.96 vs. 0.93).
Study details: This meta-analysis of 12 retrospective case-control studies (n = 11,685) assessed the performance of AI in the endoscopic diagnosis of early gastric cancer.
Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.
Source: Chen P-C et al. The accuracy of artificial intelligence in the endoscopic diagnosis of early gastric cancer: Pooled Analysis Study. J Med Internet Res. 2022;24(5):e27694 (May 16). Doi: 10.2196/27694
Key clinical point: Artificial intelligence (AI) shows high sensitivity, specificity, and accuracy for the diagnosis of early gastric cancer.
Major finding: The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 and 0.90, respectively. The accuracy of AI was 0.94. The pooled sensitivity and specificity of deep learning methods were 0.84 and 0.88, respectively, and those of nondeep learning methods were 0.91 and 0.90, respectively. The accuracy of the nondeep learning methods was higher compared with the deep learning methods (0.96 vs. 0.93).
Study details: This meta-analysis of 12 retrospective case-control studies (n = 11,685) assessed the performance of AI in the endoscopic diagnosis of early gastric cancer.
Disclosures: No funding source was identified for this study. The authors declared no conflicts of interest.
Source: Chen P-C et al. The accuracy of artificial intelligence in the endoscopic diagnosis of early gastric cancer: Pooled Analysis Study. J Med Internet Res. 2022;24(5):e27694 (May 16). Doi: 10.2196/27694
Nonmetastatic gastric cancer survival trends in the United States and Europe
Key clinical point: There is no improvement in survival of patients with nonmetastatic gastric adenocarcinoma in selected European countries. The survival has slightly improved in the US and worsened in Sweden.
Major finding: The overall survival (OS) trend improved in the US (hazard ratio [HR] per year 0.99) and worsened in Sweden (HR per year 1.03). There was no improvement in OS trend in the Netherlands, Belgium, Norway, and Slovenia. After adjusting for resection, the OS trend became insignificant in Sweden and improved in the US, Slovenia, and Norway.
Study details: A real-world observational study of individual-level data of 66,398 patients diagnosed with nonmetastatic gastric adenocarcinoma during 2003-2016 in the US and 5 European countries.
Disclosures: This study was supported by Deutsche Krebshilfe. The authors declared no competing interests.
Source: Huang L et al. Survival trends of patients with non-metastatic gastric adenocarcinoma in the US and European countries: The impact of decreasing resection rates. Cancer Commun (Lond). 2022 (Jun 6). Doi: 10.1002/cac2.12318
Key clinical point: There is no improvement in survival of patients with nonmetastatic gastric adenocarcinoma in selected European countries. The survival has slightly improved in the US and worsened in Sweden.
Major finding: The overall survival (OS) trend improved in the US (hazard ratio [HR] per year 0.99) and worsened in Sweden (HR per year 1.03). There was no improvement in OS trend in the Netherlands, Belgium, Norway, and Slovenia. After adjusting for resection, the OS trend became insignificant in Sweden and improved in the US, Slovenia, and Norway.
Study details: A real-world observational study of individual-level data of 66,398 patients diagnosed with nonmetastatic gastric adenocarcinoma during 2003-2016 in the US and 5 European countries.
Disclosures: This study was supported by Deutsche Krebshilfe. The authors declared no competing interests.
Source: Huang L et al. Survival trends of patients with non-metastatic gastric adenocarcinoma in the US and European countries: The impact of decreasing resection rates. Cancer Commun (Lond). 2022 (Jun 6). Doi: 10.1002/cac2.12318
Key clinical point: There is no improvement in survival of patients with nonmetastatic gastric adenocarcinoma in selected European countries. The survival has slightly improved in the US and worsened in Sweden.
Major finding: The overall survival (OS) trend improved in the US (hazard ratio [HR] per year 0.99) and worsened in Sweden (HR per year 1.03). There was no improvement in OS trend in the Netherlands, Belgium, Norway, and Slovenia. After adjusting for resection, the OS trend became insignificant in Sweden and improved in the US, Slovenia, and Norway.
Study details: A real-world observational study of individual-level data of 66,398 patients diagnosed with nonmetastatic gastric adenocarcinoma during 2003-2016 in the US and 5 European countries.
Disclosures: This study was supported by Deutsche Krebshilfe. The authors declared no competing interests.
Source: Huang L et al. Survival trends of patients with non-metastatic gastric adenocarcinoma in the US and European countries: The impact of decreasing resection rates. Cancer Commun (Lond). 2022 (Jun 6). Doi: 10.1002/cac2.12318