Patient & Survivor Care

Adding platinum-based chemotherapy to osimertinib (Tagrisso) in the first-line treatment of EGFR-mutated advanced non–small cell lung cancer (NSCLC) improved progression-free survival (PFS), according to interim results from the FLAURA2 trial.

Combining the third-generation tyrosine kinase inhibitor (TKI) with platinum-based chemotherapy achieved “statistically significant and clinically meaningful improvement in PFS over osimertinib monotherapy,” said Pasi A. Jänne, MD, PhD, professor of medicine at Harvard Medical School and director of the Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, both in Boston, who presented the interim findings at the annual World Conference on Lung Cancer.

However, experts raised some questions about whether the combination would also offer improved overall survival and whether the accompanying toxicity would be acceptable to patients.

Yi-Long Wu, MD, PhD, who was not involved in the research, said that although the combination regimen does appear to offer a benefit, it may come at a steep cost.

Patients who received the combination had an almost fourfold greater risk of grade 3 or higher adverse events related to treatment, said Dr. Wu, professor of oncology, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangzhou, China.

And, notably, because the overall survival data in the interim analysis are immature, it’s unclear whether the combination will offer an overall survival benefit over osimertinib monotherapy, Dr. Wu said.

The 2019 FLAURA trial, which compared TKI monotherapy, demonstrated an overall survival advantage among patients who received osimertinib vs. a first-generation EGFR TKI, such as gefitinib (Iressa) or erlotinib (Tarceva). These data established the third-generation TKI as the preferred first-line treatment for patients with advanced EGFR NSCLC.

But resistance to EGFR TKIs remains a problem, which has led experts to explore combination strategies that might overcome resistance and improve clinical outcomes. Recent data indicate that combining first-generation EGFR TKIs with chemotherapy may have an additive effect and further improve outcomes with the drugs. And a recent study of untreated EGFR-mutated advanced NSCLC found patients receiving osimertinib plus platinum-pemetrexed demonstrated a promising objective response rate; however, Dr. Jänne noted that the combination has not been tested in a randomized trial.

To better understand the potential additive benefit of osimertinib and chemotherapy, the team conduced a global, open-label study in patients with pathologically confirmed nonsquamous NSCLC who had received no prior systemic therapy for advanced NSCLC and had a performance status of 0 or 1.

The team randomly assigned 557 patients to daily osimertinib alone or osimertinib plus chemotherapy with pemetrexed and carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance osimertinib plus pemetrexed every 3 weeks.

Treatment was continued until radiological disease progression, as defined using the RECIST 1.1 criteria, or other withdrawal criteria were met. The patients were assessed at weeks 6 and 12, and again every 12 weeks.

The median age of the patients was about 61 years, approximately 61% were female, and about 25% were Asian. Around two-thirds were never-smokers, about 60% had either Ex19del or L858R EGFR mutations, and about 40% had central nervous system metastases.

At the data cutoff, the median follow-up was 16.5 months in the osimertinib monotherapy arm and 19.5 months in the combination arm. Overall, 45% of patients on monotherapy and 56% in the combination arm were still on treatment.

Dr. Jänne reported that osimertinib plus chemotherapy was associated with a greater objective response rate than monotherapy – 83.2% vs. 75.5% – and a longer median duration of response – 24 months vs. 15.3 months.

Patients receiving the combination showed significant improvements in PFS – 25.5 months vs. 16.7 months (hazard ratio, 0.62; P < .0001). At 24 months, 57% of the patients in the combination arm were disease-free vs. 41% in the monotherapy group.

The benefit held across all patient subgroups, including age, sex, smoking history, and EGFR mutation type at baseline.

The PFS benefit appeared most pronounced among patients with CNS metastases at baseline – a median of 24.9 months in the combination arm vs. 13.8 months with monotherapy (HR, 0.47). But patients without CNS metastases who received the combination therapy also showed improvements in PFS (HR, 0.75).

Should there be an overall survival improvement, then the regimen used in FLAURA2 could become the “new standard of care in EGFR-mutated NSCLC in the first-line setting,” particularly in patients with CNS metastases and/or an exon21 mutation, Dr. Wu said. If, however, further analysis indicates no overall survival benefit, then patients will have experienced chemotherapy side effects earlier and longer than those receiving monotherapy, with no life gain.

Dr. Wu pointed out that the future role and sequence of the combination will also hinge on understanding how patients become resistant to it as well as whether the toxicity is manageable.

The FLAURA2 safety data indicated that the combination led to higher rates of grade 3 or higher adverse events overall – 64% vs. 27% – and higher rates of grade 3 or higher adverse events possibly related to treatment – 53% vs. 11%.

Experts who commented on the study findings via X (formerly Twitter) echoed Dr. Wu’s sentiments about the study findings and implications.

Mohana Roy, MD, said she did not find the results surprising, given that “many of us are adding chemo on slow progression on osimertinib already,” but noted that “questions of sequencing” remain.

Christian Rolfo, MD, PhD, MBA, commented that questions about the “real benefit” of osimertinib plus chemotherapy in subgroups and degree of resistance remain. Further toxicity and overall survival data “will clarify the future of the combination,” said Dr. Rolfo, of Icahn School of Medicine at Mount Sinai, New York.

The study was funded by AstraZeneca. Dr. Jänne declared relationships with Gatekeeper Pharmaceuticals, Labcorp, Astellas Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, PUMA, Revolution Medicines, Takeda Oncology, Biocartis, Mirati Therapeutics, Transcenta, ACEA Biosciences, Araxes, Bayer, Chugai Pharmaceuticals, Eisai, Ignyta, Novartis, Nuvalent, Pfizer, Roche/Genentech, Sanofi, SFJ Pharmaceuticals, Silicon Therapeutics, Syndax, and Voronoi.

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

Adding platinum-based chemotherapy to osimertinib (Tagrisso) in the first-line treatment of EGFR-mutated advanced non–small cell lung cancer (NSCLC) improved progression-free survival (PFS), according to interim results from the FLAURA2 trial.

Combining the third-generation tyrosine kinase inhibitor (TKI) with platinum-based chemotherapy achieved “statistically significant and clinically meaningful improvement in PFS over osimertinib monotherapy,” said Pasi A. Jänne, MD, PhD, professor of medicine at Harvard Medical School and director of the Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, both in Boston, who presented the interim findings at the annual World Conference on Lung Cancer.

However, experts raised some questions about whether the combination would also offer improved overall survival and whether the accompanying toxicity would be acceptable to patients.

Yi-Long Wu, MD, PhD, who was not involved in the research, said that although the combination regimen does appear to offer a benefit, it may come at a steep cost.

Patients who received the combination had an almost fourfold greater risk of grade 3 or higher adverse events related to treatment, said Dr. Wu, professor of oncology, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangzhou, China.

And, notably, because the overall survival data in the interim analysis are immature, it’s unclear whether the combination will offer an overall survival benefit over osimertinib monotherapy, Dr. Wu said.

The 2019 FLAURA trial, which compared TKI monotherapy, demonstrated an overall survival advantage among patients who received osimertinib vs. a first-generation EGFR TKI, such as gefitinib (Iressa) or erlotinib (Tarceva). These data established the third-generation TKI as the preferred first-line treatment for patients with advanced EGFR NSCLC.

But resistance to EGFR TKIs remains a problem, which has led experts to explore combination strategies that might overcome resistance and improve clinical outcomes. Recent data indicate that combining first-generation EGFR TKIs with chemotherapy may have an additive effect and further improve outcomes with the drugs. And a recent study of untreated EGFR-mutated advanced NSCLC found patients receiving osimertinib plus platinum-pemetrexed demonstrated a promising objective response rate; however, Dr. Jänne noted that the combination has not been tested in a randomized trial.

To better understand the potential additive benefit of osimertinib and chemotherapy, the team conduced a global, open-label study in patients with pathologically confirmed nonsquamous NSCLC who had received no prior systemic therapy for advanced NSCLC and had a performance status of 0 or 1.

The team randomly assigned 557 patients to daily osimertinib alone or osimertinib plus chemotherapy with pemetrexed and carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance osimertinib plus pemetrexed every 3 weeks.

Treatment was continued until radiological disease progression, as defined using the RECIST 1.1 criteria, or other withdrawal criteria were met. The patients were assessed at weeks 6 and 12, and again every 12 weeks.

The median age of the patients was about 61 years, approximately 61% were female, and about 25% were Asian. Around two-thirds were never-smokers, about 60% had either Ex19del or L858R EGFR mutations, and about 40% had central nervous system metastases.

At the data cutoff, the median follow-up was 16.5 months in the osimertinib monotherapy arm and 19.5 months in the combination arm. Overall, 45% of patients on monotherapy and 56% in the combination arm were still on treatment.

Dr. Jänne reported that osimertinib plus chemotherapy was associated with a greater objective response rate than monotherapy – 83.2% vs. 75.5% – and a longer median duration of response – 24 months vs. 15.3 months.

Patients receiving the combination showed significant improvements in PFS – 25.5 months vs. 16.7 months (hazard ratio, 0.62; P < .0001). At 24 months, 57% of the patients in the combination arm were disease-free vs. 41% in the monotherapy group.

The benefit held across all patient subgroups, including age, sex, smoking history, and EGFR mutation type at baseline.

The PFS benefit appeared most pronounced among patients with CNS metastases at baseline – a median of 24.9 months in the combination arm vs. 13.8 months with monotherapy (HR, 0.47). But patients without CNS metastases who received the combination therapy also showed improvements in PFS (HR, 0.75).

Should there be an overall survival improvement, then the regimen used in FLAURA2 could become the “new standard of care in EGFR-mutated NSCLC in the first-line setting,” particularly in patients with CNS metastases and/or an exon21 mutation, Dr. Wu said. If, however, further analysis indicates no overall survival benefit, then patients will have experienced chemotherapy side effects earlier and longer than those receiving monotherapy, with no life gain.

Dr. Wu pointed out that the future role and sequence of the combination will also hinge on understanding how patients become resistant to it as well as whether the toxicity is manageable.

The FLAURA2 safety data indicated that the combination led to higher rates of grade 3 or higher adverse events overall – 64% vs. 27% – and higher rates of grade 3 or higher adverse events possibly related to treatment – 53% vs. 11%.

Experts who commented on the study findings via X (formerly Twitter) echoed Dr. Wu’s sentiments about the study findings and implications.

Mohana Roy, MD, said she did not find the results surprising, given that “many of us are adding chemo on slow progression on osimertinib already,” but noted that “questions of sequencing” remain.

Christian Rolfo, MD, PhD, MBA, commented that questions about the “real benefit” of osimertinib plus chemotherapy in subgroups and degree of resistance remain. Further toxicity and overall survival data “will clarify the future of the combination,” said Dr. Rolfo, of Icahn School of Medicine at Mount Sinai, New York.

The study was funded by AstraZeneca. Dr. Jänne declared relationships with Gatekeeper Pharmaceuticals, Labcorp, Astellas Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, PUMA, Revolution Medicines, Takeda Oncology, Biocartis, Mirati Therapeutics, Transcenta, ACEA Biosciences, Araxes, Bayer, Chugai Pharmaceuticals, Eisai, Ignyta, Novartis, Nuvalent, Pfizer, Roche/Genentech, Sanofi, SFJ Pharmaceuticals, Silicon Therapeutics, Syndax, and Voronoi.

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

Adding platinum-based chemotherapy to osimertinib (Tagrisso) in the first-line treatment of EGFR-mutated advanced non–small cell lung cancer (NSCLC) improved progression-free survival (PFS), according to interim results from the FLAURA2 trial.

Combining the third-generation tyrosine kinase inhibitor (TKI) with platinum-based chemotherapy achieved “statistically significant and clinically meaningful improvement in PFS over osimertinib monotherapy,” said Pasi A. Jänne, MD, PhD, professor of medicine at Harvard Medical School and director of the Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, both in Boston, who presented the interim findings at the annual World Conference on Lung Cancer.

However, experts raised some questions about whether the combination would also offer improved overall survival and whether the accompanying toxicity would be acceptable to patients.

Yi-Long Wu, MD, PhD, who was not involved in the research, said that although the combination regimen does appear to offer a benefit, it may come at a steep cost.

Patients who received the combination had an almost fourfold greater risk of grade 3 or higher adverse events related to treatment, said Dr. Wu, professor of oncology, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangzhou, China.

And, notably, because the overall survival data in the interim analysis are immature, it’s unclear whether the combination will offer an overall survival benefit over osimertinib monotherapy, Dr. Wu said.

The 2019 FLAURA trial, which compared TKI monotherapy, demonstrated an overall survival advantage among patients who received osimertinib vs. a first-generation EGFR TKI, such as gefitinib (Iressa) or erlotinib (Tarceva). These data established the third-generation TKI as the preferred first-line treatment for patients with advanced EGFR NSCLC.

But resistance to EGFR TKIs remains a problem, which has led experts to explore combination strategies that might overcome resistance and improve clinical outcomes. Recent data indicate that combining first-generation EGFR TKIs with chemotherapy may have an additive effect and further improve outcomes with the drugs. And a recent study of untreated EGFR-mutated advanced NSCLC found patients receiving osimertinib plus platinum-pemetrexed demonstrated a promising objective response rate; however, Dr. Jänne noted that the combination has not been tested in a randomized trial.

To better understand the potential additive benefit of osimertinib and chemotherapy, the team conduced a global, open-label study in patients with pathologically confirmed nonsquamous NSCLC who had received no prior systemic therapy for advanced NSCLC and had a performance status of 0 or 1.

The team randomly assigned 557 patients to daily osimertinib alone or osimertinib plus chemotherapy with pemetrexed and carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance osimertinib plus pemetrexed every 3 weeks.

Treatment was continued until radiological disease progression, as defined using the RECIST 1.1 criteria, or other withdrawal criteria were met. The patients were assessed at weeks 6 and 12, and again every 12 weeks.

The median age of the patients was about 61 years, approximately 61% were female, and about 25% were Asian. Around two-thirds were never-smokers, about 60% had either Ex19del or L858R EGFR mutations, and about 40% had central nervous system metastases.

At the data cutoff, the median follow-up was 16.5 months in the osimertinib monotherapy arm and 19.5 months in the combination arm. Overall, 45% of patients on monotherapy and 56% in the combination arm were still on treatment.

Dr. Jänne reported that osimertinib plus chemotherapy was associated with a greater objective response rate than monotherapy – 83.2% vs. 75.5% – and a longer median duration of response – 24 months vs. 15.3 months.

Patients receiving the combination showed significant improvements in PFS – 25.5 months vs. 16.7 months (hazard ratio, 0.62; P < .0001). At 24 months, 57% of the patients in the combination arm were disease-free vs. 41% in the monotherapy group.

The benefit held across all patient subgroups, including age, sex, smoking history, and EGFR mutation type at baseline.

The PFS benefit appeared most pronounced among patients with CNS metastases at baseline – a median of 24.9 months in the combination arm vs. 13.8 months with monotherapy (HR, 0.47). But patients without CNS metastases who received the combination therapy also showed improvements in PFS (HR, 0.75).

Should there be an overall survival improvement, then the regimen used in FLAURA2 could become the “new standard of care in EGFR-mutated NSCLC in the first-line setting,” particularly in patients with CNS metastases and/or an exon21 mutation, Dr. Wu said. If, however, further analysis indicates no overall survival benefit, then patients will have experienced chemotherapy side effects earlier and longer than those receiving monotherapy, with no life gain.

Dr. Wu pointed out that the future role and sequence of the combination will also hinge on understanding how patients become resistant to it as well as whether the toxicity is manageable.

The FLAURA2 safety data indicated that the combination led to higher rates of grade 3 or higher adverse events overall – 64% vs. 27% – and higher rates of grade 3 or higher adverse events possibly related to treatment – 53% vs. 11%.

Experts who commented on the study findings via X (formerly Twitter) echoed Dr. Wu’s sentiments about the study findings and implications.

Mohana Roy, MD, said she did not find the results surprising, given that “many of us are adding chemo on slow progression on osimertinib already,” but noted that “questions of sequencing” remain.

Christian Rolfo, MD, PhD, MBA, commented that questions about the “real benefit” of osimertinib plus chemotherapy in subgroups and degree of resistance remain. Further toxicity and overall survival data “will clarify the future of the combination,” said Dr. Rolfo, of Icahn School of Medicine at Mount Sinai, New York.

The study was funded by AstraZeneca. Dr. Jänne declared relationships with Gatekeeper Pharmaceuticals, Labcorp, Astellas Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, PUMA, Revolution Medicines, Takeda Oncology, Biocartis, Mirati Therapeutics, Transcenta, ACEA Biosciences, Araxes, Bayer, Chugai Pharmaceuticals, Eisai, Ignyta, Novartis, Nuvalent, Pfizer, Roche/Genentech, Sanofi, SFJ Pharmaceuticals, Silicon Therapeutics, Syndax, and Voronoi.

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

Pleural mesothelioma is generally treated by extended pleurectomy decortication, and there has been little improvement in systemic treatment of early-stage, resectable mesothelioma, which has led to the recommendations of maximum cytoreduction. U.S. and European guidelines, as well as an international consensus statement, support this approach, but it has never been tested in a randomized, controlled trial.

Now it has, and the result is surprising: Surgery led to reduced survival and more serious adverse events, compared with chemotherapy alone. The conclusion was uncomfortable for Eric Lim, MD, who presented the results of the MARS2 trial at the annual World Conference on Lung Cancer. “Ladies and gentlemen, as a surgeon standing here, you have no idea how much it pains me to conclude that extended pleurectomy decortication, an operation that we have been offering for over 70 years, has been associated with a higher risk of death, more serious complications, poorer quality of life, and higher costs, compared to mesothelioma patients who were randomized to chemotherapy alone,” said Dr. Lim of the Royal Brompton Hospital, London, during his presentation.

Although the line drew laughter and applause from the audience, Paula Ugalde Figueroa, MD, who served as a discussant, raised some concerns about the study. Disease presence in one hemithorax was assessed only by chest CT scan, which is notorious for underestimating the volume of disease during surgery. There was also no information on pleural effusion or how many patients received it prior to intervention. Existing guidelines suggest staging of mesothelioma should also use PET scans, and invasive mediastinal staging should be assessed with endobronchial ultrasound. “None of these were performed during the trial,” said Dr. Figueroa, who is an associate thoracic surgeon at Brigham and Women’s Hospital, Boston. “At this point, my question is, are the arms of this study well balanced in regard to tumor volume? We don’t know,” she added.

Dr. Figueroa noted that the 90-day mortality seemed higher than that seen in other studies. “So, does the surgeon’s experience and center volume affect the outcome of this study?” she asked. Dr. Figueroa personally made phone calls to the participating centers and found that 45% of the patients in the trial were treated at low-volume centers, defined by her as two to three patients per year. “Should we assume that their surgical outcomes are similar between those centers? In this trial, with approximately half of patients from low-volume centers, extended pleurectomy decortication for mesothelioma had no significant difference when compared to those patients that underwent chemotherapy alone. Would the outcome be different in exclusively high-volume centers?” she concluded.

The study randomized 335 patients to receive surgery and chemotherapy, or chemotherapy alone. They received two cycles of platinum-based chemotherapy and pemetrexed prior to surgery and up to four cycles after surgery. The average age was 69 years; 86.9% were male, and 85.7% of tumors were epithelioid only. Among those in the surgery group, 88.5% underwent extended pleurectomy/decortication, 8.3% underwent pleurectomy decortication, 1.9% underwent partial pleurectomy, 0.6% exploration with no pleurodesis, and 0.6% were classified as “other” surgery. Completeness of resection was R0 in 3.2% of surgeries, R1 in 80.9%, and R2 in 15.9%. In-hospital mortality occurred in 3.8% of patients, and postsurgical 90-day mortality was 8.9%.

Over the first 42 months of follow-up, the hazard ratio for overall survival was 1.28 in the no-surgery group (P = .03). “The survival was so good in this early-stage cohort that we had to extend the trial by 6 months to get the prerequisite number of deaths, underscoring the phenomenal importance of having a randomized comparative cohort for all future studies on surgery for mesothelioma,” said Dr. Lim.

After 42 months, there was no survival difference between the two groups (hazard ratio, 0.48; P = .15). Dr. Lim attributed the change at 42 months to the fact that only 15 patients remained in each arm at that stage. There was no significant difference between the two groups with respect to progression-free survival.

The survival benefit of the no-surgery group was sustained after additional analyses, including adjustment of the number of first-line chemotherapy cycles and immunotherapy received after completion of the trial protocol.

Adverse events were more common in the surgery group (incidence rate ratio, 3.6; P < .001), including any cardiac disorder (IRR, 2.73; 95% confidence interval, 1.11-6.67); any infection or infestation (IRR, 1.99; 95% CI, 1.33-2.99); any respiratory, thoracic, or mediastinal disorder (IRR, 2.40; 95% CI, 1.52-3.80); and any surgical or medical procedure (IRR, 2.23; 95% CI, 1.04-4.78). The EORTC quality of life score favored the nonsurgery group at 6 weeks, but there was no significant difference at other time points.

Dr. Lim and Dr. Figueroa have no relevant financial disclosures.

Pleural mesothelioma is generally treated by extended pleurectomy decortication, and there has been little improvement in systemic treatment of early-stage, resectable mesothelioma, which has led to the recommendations of maximum cytoreduction. U.S. and European guidelines, as well as an international consensus statement, support this approach, but it has never been tested in a randomized, controlled trial.

Now it has, and the result is surprising: Surgery led to reduced survival and more serious adverse events, compared with chemotherapy alone. The conclusion was uncomfortable for Eric Lim, MD, who presented the results of the MARS2 trial at the annual World Conference on Lung Cancer. “Ladies and gentlemen, as a surgeon standing here, you have no idea how much it pains me to conclude that extended pleurectomy decortication, an operation that we have been offering for over 70 years, has been associated with a higher risk of death, more serious complications, poorer quality of life, and higher costs, compared to mesothelioma patients who were randomized to chemotherapy alone,” said Dr. Lim of the Royal Brompton Hospital, London, during his presentation.

Although the line drew laughter and applause from the audience, Paula Ugalde Figueroa, MD, who served as a discussant, raised some concerns about the study. Disease presence in one hemithorax was assessed only by chest CT scan, which is notorious for underestimating the volume of disease during surgery. There was also no information on pleural effusion or how many patients received it prior to intervention. Existing guidelines suggest staging of mesothelioma should also use PET scans, and invasive mediastinal staging should be assessed with endobronchial ultrasound. “None of these were performed during the trial,” said Dr. Figueroa, who is an associate thoracic surgeon at Brigham and Women’s Hospital, Boston. “At this point, my question is, are the arms of this study well balanced in regard to tumor volume? We don’t know,” she added.

Dr. Figueroa noted that the 90-day mortality seemed higher than that seen in other studies. “So, does the surgeon’s experience and center volume affect the outcome of this study?” she asked. Dr. Figueroa personally made phone calls to the participating centers and found that 45% of the patients in the trial were treated at low-volume centers, defined by her as two to three patients per year. “Should we assume that their surgical outcomes are similar between those centers? In this trial, with approximately half of patients from low-volume centers, extended pleurectomy decortication for mesothelioma had no significant difference when compared to those patients that underwent chemotherapy alone. Would the outcome be different in exclusively high-volume centers?” she concluded.

The study randomized 335 patients to receive surgery and chemotherapy, or chemotherapy alone. They received two cycles of platinum-based chemotherapy and pemetrexed prior to surgery and up to four cycles after surgery. The average age was 69 years; 86.9% were male, and 85.7% of tumors were epithelioid only. Among those in the surgery group, 88.5% underwent extended pleurectomy/decortication, 8.3% underwent pleurectomy decortication, 1.9% underwent partial pleurectomy, 0.6% exploration with no pleurodesis, and 0.6% were classified as “other” surgery. Completeness of resection was R0 in 3.2% of surgeries, R1 in 80.9%, and R2 in 15.9%. In-hospital mortality occurred in 3.8% of patients, and postsurgical 90-day mortality was 8.9%.

Over the first 42 months of follow-up, the hazard ratio for overall survival was 1.28 in the no-surgery group (P = .03). “The survival was so good in this early-stage cohort that we had to extend the trial by 6 months to get the prerequisite number of deaths, underscoring the phenomenal importance of having a randomized comparative cohort for all future studies on surgery for mesothelioma,” said Dr. Lim.

After 42 months, there was no survival difference between the two groups (hazard ratio, 0.48; P = .15). Dr. Lim attributed the change at 42 months to the fact that only 15 patients remained in each arm at that stage. There was no significant difference between the two groups with respect to progression-free survival.

The survival benefit of the no-surgery group was sustained after additional analyses, including adjustment of the number of first-line chemotherapy cycles and immunotherapy received after completion of the trial protocol.

Adverse events were more common in the surgery group (incidence rate ratio, 3.6; P < .001), including any cardiac disorder (IRR, 2.73; 95% confidence interval, 1.11-6.67); any infection or infestation (IRR, 1.99; 95% CI, 1.33-2.99); any respiratory, thoracic, or mediastinal disorder (IRR, 2.40; 95% CI, 1.52-3.80); and any surgical or medical procedure (IRR, 2.23; 95% CI, 1.04-4.78). The EORTC quality of life score favored the nonsurgery group at 6 weeks, but there was no significant difference at other time points.

Dr. Lim and Dr. Figueroa have no relevant financial disclosures.

Pleural mesothelioma is generally treated by extended pleurectomy decortication, and there has been little improvement in systemic treatment of early-stage, resectable mesothelioma, which has led to the recommendations of maximum cytoreduction. U.S. and European guidelines, as well as an international consensus statement, support this approach, but it has never been tested in a randomized, controlled trial.

Now it has, and the result is surprising: Surgery led to reduced survival and more serious adverse events, compared with chemotherapy alone. The conclusion was uncomfortable for Eric Lim, MD, who presented the results of the MARS2 trial at the annual World Conference on Lung Cancer. “Ladies and gentlemen, as a surgeon standing here, you have no idea how much it pains me to conclude that extended pleurectomy decortication, an operation that we have been offering for over 70 years, has been associated with a higher risk of death, more serious complications, poorer quality of life, and higher costs, compared to mesothelioma patients who were randomized to chemotherapy alone,” said Dr. Lim of the Royal Brompton Hospital, London, during his presentation.

Although the line drew laughter and applause from the audience, Paula Ugalde Figueroa, MD, who served as a discussant, raised some concerns about the study. Disease presence in one hemithorax was assessed only by chest CT scan, which is notorious for underestimating the volume of disease during surgery. There was also no information on pleural effusion or how many patients received it prior to intervention. Existing guidelines suggest staging of mesothelioma should also use PET scans, and invasive mediastinal staging should be assessed with endobronchial ultrasound. “None of these were performed during the trial,” said Dr. Figueroa, who is an associate thoracic surgeon at Brigham and Women’s Hospital, Boston. “At this point, my question is, are the arms of this study well balanced in regard to tumor volume? We don’t know,” she added.

Dr. Figueroa noted that the 90-day mortality seemed higher than that seen in other studies. “So, does the surgeon’s experience and center volume affect the outcome of this study?” she asked. Dr. Figueroa personally made phone calls to the participating centers and found that 45% of the patients in the trial were treated at low-volume centers, defined by her as two to three patients per year. “Should we assume that their surgical outcomes are similar between those centers? In this trial, with approximately half of patients from low-volume centers, extended pleurectomy decortication for mesothelioma had no significant difference when compared to those patients that underwent chemotherapy alone. Would the outcome be different in exclusively high-volume centers?” she concluded.

The study randomized 335 patients to receive surgery and chemotherapy, or chemotherapy alone. They received two cycles of platinum-based chemotherapy and pemetrexed prior to surgery and up to four cycles after surgery. The average age was 69 years; 86.9% were male, and 85.7% of tumors were epithelioid only. Among those in the surgery group, 88.5% underwent extended pleurectomy/decortication, 8.3% underwent pleurectomy decortication, 1.9% underwent partial pleurectomy, 0.6% exploration with no pleurodesis, and 0.6% were classified as “other” surgery. Completeness of resection was R0 in 3.2% of surgeries, R1 in 80.9%, and R2 in 15.9%. In-hospital mortality occurred in 3.8% of patients, and postsurgical 90-day mortality was 8.9%.

Over the first 42 months of follow-up, the hazard ratio for overall survival was 1.28 in the no-surgery group (P = .03). “The survival was so good in this early-stage cohort that we had to extend the trial by 6 months to get the prerequisite number of deaths, underscoring the phenomenal importance of having a randomized comparative cohort for all future studies on surgery for mesothelioma,” said Dr. Lim.

After 42 months, there was no survival difference between the two groups (hazard ratio, 0.48; P = .15). Dr. Lim attributed the change at 42 months to the fact that only 15 patients remained in each arm at that stage. There was no significant difference between the two groups with respect to progression-free survival.

The survival benefit of the no-surgery group was sustained after additional analyses, including adjustment of the number of first-line chemotherapy cycles and immunotherapy received after completion of the trial protocol.

Adverse events were more common in the surgery group (incidence rate ratio, 3.6; P < .001), including any cardiac disorder (IRR, 2.73; 95% confidence interval, 1.11-6.67); any infection or infestation (IRR, 1.99; 95% CI, 1.33-2.99); any respiratory, thoracic, or mediastinal disorder (IRR, 2.40; 95% CI, 1.52-3.80); and any surgical or medical procedure (IRR, 2.23; 95% CI, 1.04-4.78). The EORTC quality of life score favored the nonsurgery group at 6 weeks, but there was no significant difference at other time points.

Dr. Lim and Dr. Figueroa have no relevant financial disclosures.

TOPLINE:

Implementing a post-surgery protocol that has undergone incremental changes over time significantly reduced inpatient and discharge opioid volumes while maintaining pain control after pancreatic cancer surgery.
 

METHODOLOGY:

• To reduce opioid dependence, misuse, and diversion, Centers for Disease Control and Prevention guidelines emphasize strategies to minimize opioid prescribing for managing pain. Still, opioid prescribing following surgery remains common practice.
• In the current study, a team of researchers implemented a recovery care pathway to reduce opioid use among 832 patients undergoing pancreatic resection at a comprehensive cancer center.
• The study evaluated three sequential protocols implemented over a period of about 6 years, from 2016 to 2022.
• In the final version, a standardized three-drug nonopioid bundle (acetaminophen, celecoxib, and methocarbamol) was initiated intravenously in the recovery room, after which the patient was given oral agents on postoperative day 1.
• The primary outcome measure was inpatient and discharge opioid volume in oral morphine equivalents (OMEs) across the three pathways.

TAKEAWAY:

• Opioid use significantly decreased with each sequential pathway refinement.
• For inpatients, total OME decreased by more than 55% across the pathways from a median of 290 mg to 184 mg and finally to 129 mg (P < .001).
• Median discharge OME dropped from 150 mg to 25 mg and then to 0 mg across the pathways (P < .001).
• With the final version of the pathway, more than half of patients (52.5%) had opioid-free discharges, compared with only 7.2% in the first pathway. Pain scores remained stable at 3 or less; the number of postdischarge refill requests was unchanged.

IN PRACTICE:

“Our findings suggest that reduction of postoperative opioid dissemination through opioid-free discharge after pancreatectomy and other major cancer operations may be realistic and feasible by following this no-cost blueprint,” the authors concluded. In an accompanying editorial, Melissa Hogg, MD, from NorthShore University Health System in Evanston, Ill., said the “study inspired me to update our institution’s [early recovery after surgery] protocol to reduce and eliminate opioid prescriptions.”
 

SOURCE:

The study was led by Ching-Wei D. Tzeng, MD, of the University of Texas MD Anderson Cancer Center, Houston. It was published online in JAMA Surgery.
 

LIMITATIONS:

The study evaluated the opioid protocol at a single center, which may limit the generalizability of the findings. The researchers did not receive patient feedback on pain control expectations or postoperative quality of life.
 

DISCLOSURES:

Dr. Tzeng reported receiving consultant fees and a sponsored research agreement from PanTher outside the submitted work. Dr. Hogg reported receiving training and travel funds from Intuitive Money. No other disclosures or outside funding were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Implementing a post-surgery protocol that has undergone incremental changes over time significantly reduced inpatient and discharge opioid volumes while maintaining pain control after pancreatic cancer surgery.
 

METHODOLOGY:

• To reduce opioid dependence, misuse, and diversion, Centers for Disease Control and Prevention guidelines emphasize strategies to minimize opioid prescribing for managing pain. Still, opioid prescribing following surgery remains common practice.
• In the current study, a team of researchers implemented a recovery care pathway to reduce opioid use among 832 patients undergoing pancreatic resection at a comprehensive cancer center.
• The study evaluated three sequential protocols implemented over a period of about 6 years, from 2016 to 2022.
• In the final version, a standardized three-drug nonopioid bundle (acetaminophen, celecoxib, and methocarbamol) was initiated intravenously in the recovery room, after which the patient was given oral agents on postoperative day 1.
• The primary outcome measure was inpatient and discharge opioid volume in oral morphine equivalents (OMEs) across the three pathways.

TAKEAWAY:

• Opioid use significantly decreased with each sequential pathway refinement.
• For inpatients, total OME decreased by more than 55% across the pathways from a median of 290 mg to 184 mg and finally to 129 mg (P < .001).
• Median discharge OME dropped from 150 mg to 25 mg and then to 0 mg across the pathways (P < .001).
• With the final version of the pathway, more than half of patients (52.5%) had opioid-free discharges, compared with only 7.2% in the first pathway. Pain scores remained stable at 3 or less; the number of postdischarge refill requests was unchanged.

IN PRACTICE:

“Our findings suggest that reduction of postoperative opioid dissemination through opioid-free discharge after pancreatectomy and other major cancer operations may be realistic and feasible by following this no-cost blueprint,” the authors concluded. In an accompanying editorial, Melissa Hogg, MD, from NorthShore University Health System in Evanston, Ill., said the “study inspired me to update our institution’s [early recovery after surgery] protocol to reduce and eliminate opioid prescriptions.”
 

SOURCE:

The study was led by Ching-Wei D. Tzeng, MD, of the University of Texas MD Anderson Cancer Center, Houston. It was published online in JAMA Surgery.
 

LIMITATIONS:

The study evaluated the opioid protocol at a single center, which may limit the generalizability of the findings. The researchers did not receive patient feedback on pain control expectations or postoperative quality of life.
 

DISCLOSURES:

Dr. Tzeng reported receiving consultant fees and a sponsored research agreement from PanTher outside the submitted work. Dr. Hogg reported receiving training and travel funds from Intuitive Money. No other disclosures or outside funding were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

Implementing a post-surgery protocol that has undergone incremental changes over time significantly reduced inpatient and discharge opioid volumes while maintaining pain control after pancreatic cancer surgery.
 

METHODOLOGY:

• To reduce opioid dependence, misuse, and diversion, Centers for Disease Control and Prevention guidelines emphasize strategies to minimize opioid prescribing for managing pain. Still, opioid prescribing following surgery remains common practice.
• In the current study, a team of researchers implemented a recovery care pathway to reduce opioid use among 832 patients undergoing pancreatic resection at a comprehensive cancer center.
• The study evaluated three sequential protocols implemented over a period of about 6 years, from 2016 to 2022.
• In the final version, a standardized three-drug nonopioid bundle (acetaminophen, celecoxib, and methocarbamol) was initiated intravenously in the recovery room, after which the patient was given oral agents on postoperative day 1.
• The primary outcome measure was inpatient and discharge opioid volume in oral morphine equivalents (OMEs) across the three pathways.

TAKEAWAY:

• Opioid use significantly decreased with each sequential pathway refinement.
• For inpatients, total OME decreased by more than 55% across the pathways from a median of 290 mg to 184 mg and finally to 129 mg (P < .001).
• Median discharge OME dropped from 150 mg to 25 mg and then to 0 mg across the pathways (P < .001).
• With the final version of the pathway, more than half of patients (52.5%) had opioid-free discharges, compared with only 7.2% in the first pathway. Pain scores remained stable at 3 or less; the number of postdischarge refill requests was unchanged.

IN PRACTICE:

“Our findings suggest that reduction of postoperative opioid dissemination through opioid-free discharge after pancreatectomy and other major cancer operations may be realistic and feasible by following this no-cost blueprint,” the authors concluded. In an accompanying editorial, Melissa Hogg, MD, from NorthShore University Health System in Evanston, Ill., said the “study inspired me to update our institution’s [early recovery after surgery] protocol to reduce and eliminate opioid prescriptions.”
 

SOURCE:

The study was led by Ching-Wei D. Tzeng, MD, of the University of Texas MD Anderson Cancer Center, Houston. It was published online in JAMA Surgery.
 

LIMITATIONS:

The study evaluated the opioid protocol at a single center, which may limit the generalizability of the findings. The researchers did not receive patient feedback on pain control expectations or postoperative quality of life.
 

DISCLOSURES:

Dr. Tzeng reported receiving consultant fees and a sponsored research agreement from PanTher outside the submitted work. Dr. Hogg reported receiving training and travel funds from Intuitive Money. No other disclosures or outside funding were reported.

A version of this article 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.

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.

It’s important to have counselors available for people diagnosed with clonal hematopoiesis of indeterminate potential (CHIP) or clonal cytopenia of undetermined significance (CCUS), according to medical oncologist Lachelle D. Weeks, MD, PhD, a specialist in both conditions at the Dana Farber Cancer Institute, Boston.

The reason is that patients will inevitably “go online and see that [the conditions are] associated with lots of bad things; it can really cause patients psychosocial harm if there is no one to explain what their risk is and also provide risk-specific management,” Dr. Weeks said at the annual meeting of the Society of Hematologic Oncology in Houston.

CHIP and CCUS are precursors of myeloid malignancies but for most patients, the risk of progression is less than 1%. CHIPS and CCUS are also associated with cardiovascular, rheumatologic, hepatic, and other diseases.

CHIP is defined by somatic mutations in myeloid malignancy driver genes with a variant allele fraction of 2% or more; CCUS is when those molecular features are accompanied by an unexplained and persistent anemia, thrombocytopenia, or neutropenia.

A small 2017 study suggested that about a third of patients with otherwise unexplained cytopenias have CCUS.

With the increasing use of next generation sequencing for tissue and liquid biopsies and other uses, the incidental diagnosis of both conditions is increasing.

Fortunately, Dr. Weeks’ group recently published a tool for predicting the risk of progression to myeloid malignancy.

Their “clonal hematopoiesis risk score” (CHRS) was developed and validated in over 400,000 healthy volunteers in the UK Biobank, with additional validation in cohorts from Dana Farber and the University of Pavia, Italy.

The CHRS incorporates eight high-risk genetic and clinical prognostic factors, including the type and number of genetic mutations in blood cells, factors related to red blood cell volume, and age over 65. It’s available online.

“You just input the patient’s information and it spits out if the patient is low, intermediate, or high risk for progression to any myeloid malignancy,” Dr. Weeks told her audience.

High-risk patients have about a 50% 10-year cumulative incidence of myeloid malignancy. The large majority of patients are low risk, however, and have a 10-year cumulative incidence of less than 1%. Patients in the middle have a 10-year risk of about 8%.

The low-risk group “is the population of people who probably don’t need to see a specialist,” and can be followed with an annual CBC with their primary care doctors plus further workup with any clinical change. Patients should also be evaluated for cardiovascular and other comorbidity risks.

“It’s the high-risk group we worry most about,” Dr. Weeks said. “We see them more often and repeat the next-generation sequencing” annually with a CBC at least every 6 months and a bone marrow biopsy with any clinical change.

“This is the population we would shuttle towards a clinical trial, as this is the population most likely to benefit,” she said.

The overarching goal of the several ongoing studies in CHIP/CCUS is to find a way to prevent progression to blood cancer. They range from prospective cohorts and single arm pilot studies to randomized clinical trials. One trial is evaluating canakinumab to prevent progression. “Intervention in clonal hematopoiesis might have the dual benefit of both preventing hematologic malignancy as well as reducing [the] inflammatory comorbidities,” Dr. Weeks said.

It’s important to have counselors available for people diagnosed with clonal hematopoiesis of indeterminate potential (CHIP) or clonal cytopenia of undetermined significance (CCUS), according to medical oncologist Lachelle D. Weeks, MD, PhD, a specialist in both conditions at the Dana Farber Cancer Institute, Boston.

The reason is that patients will inevitably “go online and see that [the conditions are] associated with lots of bad things; it can really cause patients psychosocial harm if there is no one to explain what their risk is and also provide risk-specific management,” Dr. Weeks said at the annual meeting of the Society of Hematologic Oncology in Houston.

CHIP and CCUS are precursors of myeloid malignancies but for most patients, the risk of progression is less than 1%. CHIPS and CCUS are also associated with cardiovascular, rheumatologic, hepatic, and other diseases.

CHIP is defined by somatic mutations in myeloid malignancy driver genes with a variant allele fraction of 2% or more; CCUS is when those molecular features are accompanied by an unexplained and persistent anemia, thrombocytopenia, or neutropenia.

A small 2017 study suggested that about a third of patients with otherwise unexplained cytopenias have CCUS.

With the increasing use of next generation sequencing for tissue and liquid biopsies and other uses, the incidental diagnosis of both conditions is increasing.

Fortunately, Dr. Weeks’ group recently published a tool for predicting the risk of progression to myeloid malignancy.

Their “clonal hematopoiesis risk score” (CHRS) was developed and validated in over 400,000 healthy volunteers in the UK Biobank, with additional validation in cohorts from Dana Farber and the University of Pavia, Italy.

The CHRS incorporates eight high-risk genetic and clinical prognostic factors, including the type and number of genetic mutations in blood cells, factors related to red blood cell volume, and age over 65. It’s available online.

“You just input the patient’s information and it spits out if the patient is low, intermediate, or high risk for progression to any myeloid malignancy,” Dr. Weeks told her audience.

High-risk patients have about a 50% 10-year cumulative incidence of myeloid malignancy. The large majority of patients are low risk, however, and have a 10-year cumulative incidence of less than 1%. Patients in the middle have a 10-year risk of about 8%.

The low-risk group “is the population of people who probably don’t need to see a specialist,” and can be followed with an annual CBC with their primary care doctors plus further workup with any clinical change. Patients should also be evaluated for cardiovascular and other comorbidity risks.

“It’s the high-risk group we worry most about,” Dr. Weeks said. “We see them more often and repeat the next-generation sequencing” annually with a CBC at least every 6 months and a bone marrow biopsy with any clinical change.

“This is the population we would shuttle towards a clinical trial, as this is the population most likely to benefit,” she said.

The overarching goal of the several ongoing studies in CHIP/CCUS is to find a way to prevent progression to blood cancer. They range from prospective cohorts and single arm pilot studies to randomized clinical trials. One trial is evaluating canakinumab to prevent progression. “Intervention in clonal hematopoiesis might have the dual benefit of both preventing hematologic malignancy as well as reducing [the] inflammatory comorbidities,” Dr. Weeks said.

It’s important to have counselors available for people diagnosed with clonal hematopoiesis of indeterminate potential (CHIP) or clonal cytopenia of undetermined significance (CCUS), according to medical oncologist Lachelle D. Weeks, MD, PhD, a specialist in both conditions at the Dana Farber Cancer Institute, Boston.

The reason is that patients will inevitably “go online and see that [the conditions are] associated with lots of bad things; it can really cause patients psychosocial harm if there is no one to explain what their risk is and also provide risk-specific management,” Dr. Weeks said at the annual meeting of the Society of Hematologic Oncology in Houston.

CHIP and CCUS are precursors of myeloid malignancies but for most patients, the risk of progression is less than 1%. CHIPS and CCUS are also associated with cardiovascular, rheumatologic, hepatic, and other diseases.

CHIP is defined by somatic mutations in myeloid malignancy driver genes with a variant allele fraction of 2% or more; CCUS is when those molecular features are accompanied by an unexplained and persistent anemia, thrombocytopenia, or neutropenia.

A small 2017 study suggested that about a third of patients with otherwise unexplained cytopenias have CCUS.

With the increasing use of next generation sequencing for tissue and liquid biopsies and other uses, the incidental diagnosis of both conditions is increasing.

Fortunately, Dr. Weeks’ group recently published a tool for predicting the risk of progression to myeloid malignancy.

Their “clonal hematopoiesis risk score” (CHRS) was developed and validated in over 400,000 healthy volunteers in the UK Biobank, with additional validation in cohorts from Dana Farber and the University of Pavia, Italy.

The CHRS incorporates eight high-risk genetic and clinical prognostic factors, including the type and number of genetic mutations in blood cells, factors related to red blood cell volume, and age over 65. It’s available online.

“You just input the patient’s information and it spits out if the patient is low, intermediate, or high risk for progression to any myeloid malignancy,” Dr. Weeks told her audience.

High-risk patients have about a 50% 10-year cumulative incidence of myeloid malignancy. The large majority of patients are low risk, however, and have a 10-year cumulative incidence of less than 1%. Patients in the middle have a 10-year risk of about 8%.

The low-risk group “is the population of people who probably don’t need to see a specialist,” and can be followed with an annual CBC with their primary care doctors plus further workup with any clinical change. Patients should also be evaluated for cardiovascular and other comorbidity risks.

“It’s the high-risk group we worry most about,” Dr. Weeks said. “We see them more often and repeat the next-generation sequencing” annually with a CBC at least every 6 months and a bone marrow biopsy with any clinical change.

“This is the population we would shuttle towards a clinical trial, as this is the population most likely to benefit,” she said.

The overarching goal of the several ongoing studies in CHIP/CCUS is to find a way to prevent progression to blood cancer. They range from prospective cohorts and single arm pilot studies to randomized clinical trials. One trial is evaluating canakinumab to prevent progression. “Intervention in clonal hematopoiesis might have the dual benefit of both preventing hematologic malignancy as well as reducing [the] inflammatory comorbidities,” Dr. Weeks said.

TOPLINE:

Patients with cancer who don’t speak English may have trouble accessing cancer care in the United States, especially at nonteaching hospitals, a new study suggests.

METHODOLOGY:

• Language barriers between patients and physicians negatively affect the quality of care patients receive; however, less is known about how language barriers may affect patients’ access to cancer care.
• Researchers examined the impact of patients’ spoken language on their access to care for three types of cancer that disproportionately affect Hispanic and Asian populations (colon, lung, and thyroid cancer).
• Trained investigators who speak English, Spanish, or Mandarin called the general information line of 144 US hospitals in 12 states seeking an appointment.
• The primary outcome was whether the simulated patient caller was provided with next steps to access cancer care, defined as being given a clinic number or clinic transfer.

TAKEAWAY:

• Of the 1,296 calls made (432 in each language), 53% resulted in the caller receiving next steps to access cancer care.
• Spanish- and Mandarin-speaking callers were significantly less likely to receive information on next steps (37.7% and 27.5%, respectively), compared with English-speaking callers (93.5%).
• In multivariable logistic regression, non–English-speaking callers had lower odds of being given next steps to access cancer care (odds ratio, 0.04 for Spanish speakers; OR, 0.02 for Mandarin speakers).
• Compared with calls to teaching hospitals, calls to nonteaching hospitals were associated with lower odds of simulated callers receiving this next-step information (OR, 0.43).

IN PRACTICE:

“Our study provides actionable insights into existing linguistic disparities in cancer care access due to systems-level barriers present prior to evaluation by a physician,” the authors concluded. It is essential to “engage in efforts to mitigate these communication barriers that disproportionately impact the health of vulnerable patient populations with cancer.”

SOURCE:

The study, led by Debbie Chen, MD, University of Michigan, Ann Arbor, was published online Sept. 5 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The researchers only assessed responses from the hospital general information line, and the findings do not reflect the type or quality of cancer care a patient may have received once seen and treated. The study did not capture the complexities of hospital call center workflows, which limited the authors’ ability to discern the reasons behind the observed outcomes.

DISCLOSURES:

The study was supported by the University of Michigan’s Rogel Cancer Center and the National Institute of Diabetes and Digestive and Kidney Diseases . The authors have disclosed no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with cancer who don’t speak English may have trouble accessing cancer care in the United States, especially at nonteaching hospitals, a new study suggests.

METHODOLOGY:

• Language barriers between patients and physicians negatively affect the quality of care patients receive; however, less is known about how language barriers may affect patients’ access to cancer care.
• Researchers examined the impact of patients’ spoken language on their access to care for three types of cancer that disproportionately affect Hispanic and Asian populations (colon, lung, and thyroid cancer).
• Trained investigators who speak English, Spanish, or Mandarin called the general information line of 144 US hospitals in 12 states seeking an appointment.
• The primary outcome was whether the simulated patient caller was provided with next steps to access cancer care, defined as being given a clinic number or clinic transfer.

TAKEAWAY:

• Of the 1,296 calls made (432 in each language), 53% resulted in the caller receiving next steps to access cancer care.
• Spanish- and Mandarin-speaking callers were significantly less likely to receive information on next steps (37.7% and 27.5%, respectively), compared with English-speaking callers (93.5%).
• In multivariable logistic regression, non–English-speaking callers had lower odds of being given next steps to access cancer care (odds ratio, 0.04 for Spanish speakers; OR, 0.02 for Mandarin speakers).
• Compared with calls to teaching hospitals, calls to nonteaching hospitals were associated with lower odds of simulated callers receiving this next-step information (OR, 0.43).

IN PRACTICE:

“Our study provides actionable insights into existing linguistic disparities in cancer care access due to systems-level barriers present prior to evaluation by a physician,” the authors concluded. It is essential to “engage in efforts to mitigate these communication barriers that disproportionately impact the health of vulnerable patient populations with cancer.”

SOURCE:

The study, led by Debbie Chen, MD, University of Michigan, Ann Arbor, was published online Sept. 5 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The researchers only assessed responses from the hospital general information line, and the findings do not reflect the type or quality of cancer care a patient may have received once seen and treated. The study did not capture the complexities of hospital call center workflows, which limited the authors’ ability to discern the reasons behind the observed outcomes.

DISCLOSURES:

The study was supported by the University of Michigan’s Rogel Cancer Center and the National Institute of Diabetes and Digestive and Kidney Diseases . The authors have disclosed no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with cancer who don’t speak English may have trouble accessing cancer care in the United States, especially at nonteaching hospitals, a new study suggests.

METHODOLOGY:

• Language barriers between patients and physicians negatively affect the quality of care patients receive; however, less is known about how language barriers may affect patients’ access to cancer care.
• Researchers examined the impact of patients’ spoken language on their access to care for three types of cancer that disproportionately affect Hispanic and Asian populations (colon, lung, and thyroid cancer).
• Trained investigators who speak English, Spanish, or Mandarin called the general information line of 144 US hospitals in 12 states seeking an appointment.
• The primary outcome was whether the simulated patient caller was provided with next steps to access cancer care, defined as being given a clinic number or clinic transfer.

TAKEAWAY:

• Of the 1,296 calls made (432 in each language), 53% resulted in the caller receiving next steps to access cancer care.
• Spanish- and Mandarin-speaking callers were significantly less likely to receive information on next steps (37.7% and 27.5%, respectively), compared with English-speaking callers (93.5%).
• In multivariable logistic regression, non–English-speaking callers had lower odds of being given next steps to access cancer care (odds ratio, 0.04 for Spanish speakers; OR, 0.02 for Mandarin speakers).
• Compared with calls to teaching hospitals, calls to nonteaching hospitals were associated with lower odds of simulated callers receiving this next-step information (OR, 0.43).

IN PRACTICE:

“Our study provides actionable insights into existing linguistic disparities in cancer care access due to systems-level barriers present prior to evaluation by a physician,” the authors concluded. It is essential to “engage in efforts to mitigate these communication barriers that disproportionately impact the health of vulnerable patient populations with cancer.”

SOURCE:

The study, led by Debbie Chen, MD, University of Michigan, Ann Arbor, was published online Sept. 5 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The researchers only assessed responses from the hospital general information line, and the findings do not reflect the type or quality of cancer care a patient may have received once seen and treated. The study did not capture the complexities of hospital call center workflows, which limited the authors’ ability to discern the reasons behind the observed outcomes.

DISCLOSURES:

The study was supported by the University of Michigan’s Rogel Cancer Center and the National Institute of Diabetes and Digestive and Kidney Diseases . The authors have disclosed no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Holding off on palliative chemotherapy until symptoms start appears to improve quality of life (QoL) without affecting survival for asymptomatic patients with advanced cancer.

METHODOLOGY:

• Traditionally, chemotherapy is started immediately when advanced cancer is diagnosed, but delaying chemotherapy until symptoms start could improve QoL.
• To find out, investigators performed a meta-analysis of five studies that explored the timing of palliative chemotherapy. The analysis included three randomized trials in advanced colorectal cancer (CRC), one in advanced ovarian cancer, and a review of patients with stage IV gastric cancer.
• Of the 919 patients, treatment was delayed for 467 patients (50.8%) until symptoms started in the colorectal trials. It was delayed until tumor recurrence in the ovarian cancer trial, and it was delayed until a month or more had passed in the gastric cancer study, regardless of symptoms.
• QoL was assessed largely by the EORTC-QLQ-C30 questionnaire. Median follow-up ranged from 11 to 60 months.

TAKEAWAY:

• The researchers found no significant differences in overall survival between patients for whom chemotherapy was delayed and those for whom chemotherapy began immediately (pooled hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.90-1.22; P = .52).
• Median overall survival was 11.9 to 25.7 months with immediate treatment, vs. 9 to 27.1 months with delayed treatment.
• In the three studies that evaluated QoL, the findings suggested that QoL was largely better among patients whose treatment was delayed. In the CRC studies that assessed QoL, for instance, global health status in the delayed treatment group was higher than that in the immediate treatment group at almost all time points, but not significantly so.
• Rates of grade 3/4 toxicities, evaluated in two studies, did not differ significantly between the groups.

IN PRACTICE:

There is limited evidence on the optimal timing for starting chemotherapy for asymptomatic patients with advanced cancer. In these studies, delaying chemotherapy until symptoms occurred did not result in worse overall survival compared with immediate treatment and may have resulted in better QoL, the researchers concluded. They noted that for asymptomatic patients, delaying the start of systemic therapy should be discussed with the patient.

SOURCE:

The study, led by Simone Augustinus of the University of Amsterdam, was published online Aug. 17 in The Oncologist.

LIMITATIONS:

• Only three types of cancer were included in the analysis, and the findings may not be generalizable to other types of cancer.
• Some of the studies were older and employed out-of-date treatment regimens.
• QoL was only evaluated in three of five studies and could not be evaluated overall in the meta-analysis because of the different time points measured in each trial.

DISCLOSURES:

The study received no external funding. Two investigators have advisory, speaker, and/or research ties to Celgene, Novartis, AstraZeneca, and other companies.

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

TOPLINE:

Holding off on palliative chemotherapy until symptoms start appears to improve quality of life (QoL) without affecting survival for asymptomatic patients with advanced cancer.

METHODOLOGY:

• Traditionally, chemotherapy is started immediately when advanced cancer is diagnosed, but delaying chemotherapy until symptoms start could improve QoL.
• To find out, investigators performed a meta-analysis of five studies that explored the timing of palliative chemotherapy. The analysis included three randomized trials in advanced colorectal cancer (CRC), one in advanced ovarian cancer, and a review of patients with stage IV gastric cancer.
• Of the 919 patients, treatment was delayed for 467 patients (50.8%) until symptoms started in the colorectal trials. It was delayed until tumor recurrence in the ovarian cancer trial, and it was delayed until a month or more had passed in the gastric cancer study, regardless of symptoms.
• QoL was assessed largely by the EORTC-QLQ-C30 questionnaire. Median follow-up ranged from 11 to 60 months.

TAKEAWAY:

• The researchers found no significant differences in overall survival between patients for whom chemotherapy was delayed and those for whom chemotherapy began immediately (pooled hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.90-1.22; P = .52).
• Median overall survival was 11.9 to 25.7 months with immediate treatment, vs. 9 to 27.1 months with delayed treatment.
• In the three studies that evaluated QoL, the findings suggested that QoL was largely better among patients whose treatment was delayed. In the CRC studies that assessed QoL, for instance, global health status in the delayed treatment group was higher than that in the immediate treatment group at almost all time points, but not significantly so.
• Rates of grade 3/4 toxicities, evaluated in two studies, did not differ significantly between the groups.

IN PRACTICE:

There is limited evidence on the optimal timing for starting chemotherapy for asymptomatic patients with advanced cancer. In these studies, delaying chemotherapy until symptoms occurred did not result in worse overall survival compared with immediate treatment and may have resulted in better QoL, the researchers concluded. They noted that for asymptomatic patients, delaying the start of systemic therapy should be discussed with the patient.

SOURCE:

The study, led by Simone Augustinus of the University of Amsterdam, was published online Aug. 17 in The Oncologist.

LIMITATIONS:

• Only three types of cancer were included in the analysis, and the findings may not be generalizable to other types of cancer.
• Some of the studies were older and employed out-of-date treatment regimens.
• QoL was only evaluated in three of five studies and could not be evaluated overall in the meta-analysis because of the different time points measured in each trial.

DISCLOSURES:

The study received no external funding. Two investigators have advisory, speaker, and/or research ties to Celgene, Novartis, AstraZeneca, and other companies.

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

TOPLINE:

Holding off on palliative chemotherapy until symptoms start appears to improve quality of life (QoL) without affecting survival for asymptomatic patients with advanced cancer.

METHODOLOGY:

• Traditionally, chemotherapy is started immediately when advanced cancer is diagnosed, but delaying chemotherapy until symptoms start could improve QoL.
• To find out, investigators performed a meta-analysis of five studies that explored the timing of palliative chemotherapy. The analysis included three randomized trials in advanced colorectal cancer (CRC), one in advanced ovarian cancer, and a review of patients with stage IV gastric cancer.
• Of the 919 patients, treatment was delayed for 467 patients (50.8%) until symptoms started in the colorectal trials. It was delayed until tumor recurrence in the ovarian cancer trial, and it was delayed until a month or more had passed in the gastric cancer study, regardless of symptoms.
• QoL was assessed largely by the EORTC-QLQ-C30 questionnaire. Median follow-up ranged from 11 to 60 months.

TAKEAWAY:

• The researchers found no significant differences in overall survival between patients for whom chemotherapy was delayed and those for whom chemotherapy began immediately (pooled hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.90-1.22; P = .52).
• Median overall survival was 11.9 to 25.7 months with immediate treatment, vs. 9 to 27.1 months with delayed treatment.
• In the three studies that evaluated QoL, the findings suggested that QoL was largely better among patients whose treatment was delayed. In the CRC studies that assessed QoL, for instance, global health status in the delayed treatment group was higher than that in the immediate treatment group at almost all time points, but not significantly so.
• Rates of grade 3/4 toxicities, evaluated in two studies, did not differ significantly between the groups.

IN PRACTICE:

There is limited evidence on the optimal timing for starting chemotherapy for asymptomatic patients with advanced cancer. In these studies, delaying chemotherapy until symptoms occurred did not result in worse overall survival compared with immediate treatment and may have resulted in better QoL, the researchers concluded. They noted that for asymptomatic patients, delaying the start of systemic therapy should be discussed with the patient.

SOURCE:

The study, led by Simone Augustinus of the University of Amsterdam, was published online Aug. 17 in The Oncologist.

LIMITATIONS:

• Only three types of cancer were included in the analysis, and the findings may not be generalizable to other types of cancer.
• Some of the studies were older and employed out-of-date treatment regimens.
• QoL was only evaluated in three of five studies and could not be evaluated overall in the meta-analysis because of the different time points measured in each trial.

DISCLOSURES:

The study received no external funding. Two investigators have advisory, speaker, and/or research ties to Celgene, Novartis, AstraZeneca, and other companies.

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

TOPLINE:

Patients undergoing systemic therapy for advanced cancer who received monthly screening for financial toxicity for up to 1 year were less likely to develop financial difficulties or have their financial issues get worse.

METHODOLOGY:

• About one in five cancer survivors report experiencing financial toxicity, but financial monitoring is not a routine part of clinical care.
• In the current analysis, researchers evaluated whether screening for financial toxicity during routine care could prevent patients with advanced cancer from developing financial difficulties.
• The study involved 1,191 patients undergoing systemic therapy for metastatic cancer at 52 community oncology practices in the United States. The practices were randomly assigned in a 1:1 ratio to use either digital symptom monitoring through patient-reported outcomes or usual care.
• With the digital monitoring, patients received online or automated telephone surveys between visits inquiring about symptoms, functioning, and financial toxicity for up to 1 year.
• The financial toxicity inquiry consisted of a single-item screening question, scored on a 0-5 scale, from the Functional Assessment of Chronic Illness Therapy COmprehensive Score for financial Toxicity (FACIT-COST): “In the last month, my illness has been a financial hardship to my family and me.” Scores higher than 2, indicating “quite a bit or very much,” triggered an automated alert to practice nurses.
• At different points, patients in both groups also received a question to assess a change in financial difficulties from baseline: “During the past week, has your physical condition or medical treatment caused you financial difficulties?”

TAKEAWAY:

• Among patients receiving financial toxicity screening, 30.2% developed or experienced worsening financial difficulties, compared with 39.0% of those treated at practices without the financial burden screening (P = .004).
• The results corresponded to a number needed to screen of 11.4, meaning that, on average, 11.4 patients would need to be screened for 1 additional patient to avoid developing financial difficulties or having their financial challenges get worse.
• Nurses and patients who were interviewed noted that financial screening helped them identify patients for financial counseling who otherwise may be reluctant to seek or were unaware of such assistance.
• The intervention had a similar positive impact among White patients, men, and women, compared with the overall study population, but appeared to have no effect among Black patients (38% for intervention vs. 39% for the control).

IN PRACTICE:

The findings suggest that “remote symptom monitoring, including [financial toxicity] screening, protected patients undergoing systemic therapy from experiencing worsening financial difficulties,” the authors concluded. Given the relatively low number needed to screen, “financial toxicity screening appears to be a high-yield intervention.”

SOURCE:

The analysis, by Victoria S. Binder, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues was published online in the Journal of Clinical Oncology.

LIMITATIONS:

• The use of a single-item measure could call the replicability of the findings into question.
• Given that the financial toxicity monitoring did not appear to be effective among Black patients, the screening intervention may not adequately address all racial and ethnic groups.

DISCLOSURES:

The trial was sponsored by the Foundation of the Alliance for Clinical Trials in Oncology and was supported in part by a Patient-Centered Outcomes Research Institute Award IHS-1511-33, 392. The authors’ disclosures are detailed in the published study.

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

TOPLINE:

Patients undergoing systemic therapy for advanced cancer who received monthly screening for financial toxicity for up to 1 year were less likely to develop financial difficulties or have their financial issues get worse.

METHODOLOGY:

• About one in five cancer survivors report experiencing financial toxicity, but financial monitoring is not a routine part of clinical care.
• In the current analysis, researchers evaluated whether screening for financial toxicity during routine care could prevent patients with advanced cancer from developing financial difficulties.
• The study involved 1,191 patients undergoing systemic therapy for metastatic cancer at 52 community oncology practices in the United States. The practices were randomly assigned in a 1:1 ratio to use either digital symptom monitoring through patient-reported outcomes or usual care.
• With the digital monitoring, patients received online or automated telephone surveys between visits inquiring about symptoms, functioning, and financial toxicity for up to 1 year.
• The financial toxicity inquiry consisted of a single-item screening question, scored on a 0-5 scale, from the Functional Assessment of Chronic Illness Therapy COmprehensive Score for financial Toxicity (FACIT-COST): “In the last month, my illness has been a financial hardship to my family and me.” Scores higher than 2, indicating “quite a bit or very much,” triggered an automated alert to practice nurses.
• At different points, patients in both groups also received a question to assess a change in financial difficulties from baseline: “During the past week, has your physical condition or medical treatment caused you financial difficulties?”

TAKEAWAY:

• Among patients receiving financial toxicity screening, 30.2% developed or experienced worsening financial difficulties, compared with 39.0% of those treated at practices without the financial burden screening (P = .004).
• The results corresponded to a number needed to screen of 11.4, meaning that, on average, 11.4 patients would need to be screened for 1 additional patient to avoid developing financial difficulties or having their financial challenges get worse.
• Nurses and patients who were interviewed noted that financial screening helped them identify patients for financial counseling who otherwise may be reluctant to seek or were unaware of such assistance.
• The intervention had a similar positive impact among White patients, men, and women, compared with the overall study population, but appeared to have no effect among Black patients (38% for intervention vs. 39% for the control).

IN PRACTICE:

The findings suggest that “remote symptom monitoring, including [financial toxicity] screening, protected patients undergoing systemic therapy from experiencing worsening financial difficulties,” the authors concluded. Given the relatively low number needed to screen, “financial toxicity screening appears to be a high-yield intervention.”

SOURCE:

The analysis, by Victoria S. Binder, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues was published online in the Journal of Clinical Oncology.

LIMITATIONS:

• The use of a single-item measure could call the replicability of the findings into question.
• Given that the financial toxicity monitoring did not appear to be effective among Black patients, the screening intervention may not adequately address all racial and ethnic groups.

DISCLOSURES:

The trial was sponsored by the Foundation of the Alliance for Clinical Trials in Oncology and was supported in part by a Patient-Centered Outcomes Research Institute Award IHS-1511-33, 392. The authors’ disclosures are detailed in the published study.

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

TOPLINE:

Patients undergoing systemic therapy for advanced cancer who received monthly screening for financial toxicity for up to 1 year were less likely to develop financial difficulties or have their financial issues get worse.

METHODOLOGY:

• About one in five cancer survivors report experiencing financial toxicity, but financial monitoring is not a routine part of clinical care.
• In the current analysis, researchers evaluated whether screening for financial toxicity during routine care could prevent patients with advanced cancer from developing financial difficulties.
• The study involved 1,191 patients undergoing systemic therapy for metastatic cancer at 52 community oncology practices in the United States. The practices were randomly assigned in a 1:1 ratio to use either digital symptom monitoring through patient-reported outcomes or usual care.
• With the digital monitoring, patients received online or automated telephone surveys between visits inquiring about symptoms, functioning, and financial toxicity for up to 1 year.
• The financial toxicity inquiry consisted of a single-item screening question, scored on a 0-5 scale, from the Functional Assessment of Chronic Illness Therapy COmprehensive Score for financial Toxicity (FACIT-COST): “In the last month, my illness has been a financial hardship to my family and me.” Scores higher than 2, indicating “quite a bit or very much,” triggered an automated alert to practice nurses.
• At different points, patients in both groups also received a question to assess a change in financial difficulties from baseline: “During the past week, has your physical condition or medical treatment caused you financial difficulties?”

TAKEAWAY:

• Among patients receiving financial toxicity screening, 30.2% developed or experienced worsening financial difficulties, compared with 39.0% of those treated at practices without the financial burden screening (P = .004).
• The results corresponded to a number needed to screen of 11.4, meaning that, on average, 11.4 patients would need to be screened for 1 additional patient to avoid developing financial difficulties or having their financial challenges get worse.
• Nurses and patients who were interviewed noted that financial screening helped them identify patients for financial counseling who otherwise may be reluctant to seek or were unaware of such assistance.
• The intervention had a similar positive impact among White patients, men, and women, compared with the overall study population, but appeared to have no effect among Black patients (38% for intervention vs. 39% for the control).

IN PRACTICE:

The findings suggest that “remote symptom monitoring, including [financial toxicity] screening, protected patients undergoing systemic therapy from experiencing worsening financial difficulties,” the authors concluded. Given the relatively low number needed to screen, “financial toxicity screening appears to be a high-yield intervention.”

SOURCE:

The analysis, by Victoria S. Binder, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues was published online in the Journal of Clinical Oncology.

LIMITATIONS:

• The use of a single-item measure could call the replicability of the findings into question.
• Given that the financial toxicity monitoring did not appear to be effective among Black patients, the screening intervention may not adequately address all racial and ethnic groups.

DISCLOSURES:

The trial was sponsored by the Foundation of the Alliance for Clinical Trials in Oncology and was supported in part by a Patient-Centered Outcomes Research Institute Award IHS-1511-33, 392. The authors’ disclosures are detailed in the published study.

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

People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.

The Biden administration on Aug. 29 revealed the first 10 drugs selected for direct Medicare price negotiations in accordance with a process mandated by the Inflation Reduction Act of 2022.

It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.

While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.

CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
 

• Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
• Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
• Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
• Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
• Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
• Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
• Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
• Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
• Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.

A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.

“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.

According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.

Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.

The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.

Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.

In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.

This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).

Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.

“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.

In addition, AARP issued a statement of its continued support for Medicare drug negotiations.

“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”

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

People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.

The Biden administration on Aug. 29 revealed the first 10 drugs selected for direct Medicare price negotiations in accordance with a process mandated by the Inflation Reduction Act of 2022.

It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.

While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.

CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
 

• Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
• Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
• Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
• Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
• Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
• Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
• Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
• Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
• Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.

A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.

“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.

According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.

Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.

The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.

Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.

In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.

This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).

Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.

“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.

In addition, AARP issued a statement of its continued support for Medicare drug negotiations.

“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”

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

People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.

The Biden administration on Aug. 29 revealed the first 10 drugs selected for direct Medicare price negotiations in accordance with a process mandated by the Inflation Reduction Act of 2022.

It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.

While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.

CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
 

• Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
• Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
• Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
• Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
• Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
• Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
• Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
• Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
• Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.

A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.

“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.

According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.

Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.

The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.

Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.

In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.

This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).

Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.

“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.

In addition, AARP issued a statement of its continued support for Medicare drug negotiations.

“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”

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

Depression and anxiety were not associated with outcomes for most cancer types, including breast cancer, prostate cancer, and alcohol-related cancer, according to findings from a large, individual participant data meta-analysis.

An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.

The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.

“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.

Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).

For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”

“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.

An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.

The findings were published online in Cancer.

“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”

The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”

“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.

Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
 

Depression and anxiety were not associated with outcomes for most cancer types, including breast cancer, prostate cancer, and alcohol-related cancer, according to findings from a large, individual participant data meta-analysis.

An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.

The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.

“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.

Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).

For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”

“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.

An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.

The findings were published online in Cancer.

“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”

The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”

“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.

Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
 

Depression and anxiety were not associated with outcomes for most cancer types, including breast cancer, prostate cancer, and alcohol-related cancer, according to findings from a large, individual participant data meta-analysis.

An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.

The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.

“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.

Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).

For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”

“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.

An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.

The findings were published online in Cancer.

“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”

The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”

“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.

Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).