AVAHO

The results of a phase 2 clinical trial of durvalumab with add-on therapies oleclumab or monalizumab, suggest this novel combination may prove beneficial in patients with unresectable stage 3 non–small-cell lung cancer.

Combinations of the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca) with the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A monoclonal antibody monalizumab led to improved overall response rate and progression-free survival compared to durvalumab alone.

The findings support further study in a phase 3 clinical trial, according to the authors of the study recently published in the Journal of Clinical Oncology.

Durvalumab is the standard treatment following consolidation therapy of chemoradiotherapy in unresectable stage 3 non–small-cell lung cancer (NSCLC). Although it extended progression-free survival (PFS) and overall survival in the PACIFIC phase 3 study, some patients experience a recurrence, which has led to exploration of immunotherapy combinations.

Oleclumab inhibits the enzyme CD73, found on the surfaces of both tumor and immune cells. Its activity leads to an immunosuppressive effect in the tumor microenvironment, and preclinical studies have shown that it can have an additive antitumor effect when combined with PD-1 or PD-L1 inhibitors. A phase 1 study also suggested efficacy. Monalizumab blocks interactions between major histocompatibility complex-E (HLA-E) and an inhibitor receptor. A number of tumors overexpress HLA-E, triggering inhibitor signals that inhibit natural killer and CD8+ T cells.

“COAST was an interesting study that, although not definitive, suggested that the combination of durvalumab with oleclumab or with monalizumab was more effective than durvalumab alone in the consolidation setting after definitive concurrent chemoradiation for patients with stage 3 unresectable NSCLC,” said Nathan Pennell, MD, PhD, who wrote an accompanying editorial.

Despite the positive signal, Dr. Pennell expressed some skepticism that the combinations would pass a phase 3 test. He questioned the choice of response rate as the primary endpoint of the phase 2 study, and noted that the durvalumab arm had worse progression-free survival (PFS) than the previous PACIFIC trial. It could be that the clinical characteristics of the study population differed between the two trials, in which case the improved objective response rate (ORR) and PFS results should be encouraging. It’s also possible the COAST trial’s small sample size led to a mismatch between the control and treatment group despite randomization, in which case the findings may not be valid.

“These are the kinds of issues that keep drug developers up at night. There really is no way to know which scenario is correct without doing the larger trial. I do hope though that the phase 3 trials have robust biomarker analysis including PDL1 to make sure the arms are as well matched for known prognostic and predictive markers as possible,” said Dr. Pennell, who is vice chair of clinical research at Taussig Cancer Institute.
 

The study details

The researchers randomized 189 patients to durvalumab, durvalumab plus oleclumab, or durvalumab plus monalizumab between January 2019 and July 2020. After a median follow-up of 11.5 months, there was a higher confirmed objective response rate in the durvalumab plus oleclumab group (30.0%; 95% confidence interval, 18.8%-43.2%) and the durvalumab plus monalizumab group (35.5%; 95% CI, 23.7%-48.7%) versus durvalumab alone (17.9%; 95% CI, 9.6%-29.2%).

Compared to durvalumab alone, there was improved PFS in both durvalumab plus oleclumab (stratified hazard ratio, 0.44; 95% CI, 0.26-0.75) and durvalumab plus monalizumab (HR, 0.42; 95% CI, 0.24-0.72). At 12 months, PFS was 62.6% (95% CI, 48.1-74.2%) for durvalumab plus oleclumab, 72.7% (95% CI, 58.8-82.6%) for durvalumab plus monalizumab, and 33.9% (95% CI, 21.2-47.1%) for durvalumab alone.

The study was funded by AstraZeneca.

The results of a phase 2 clinical trial of durvalumab with add-on therapies oleclumab or monalizumab, suggest this novel combination may prove beneficial in patients with unresectable stage 3 non–small-cell lung cancer.

Combinations of the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca) with the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A monoclonal antibody monalizumab led to improved overall response rate and progression-free survival compared to durvalumab alone.

The findings support further study in a phase 3 clinical trial, according to the authors of the study recently published in the Journal of Clinical Oncology.

Durvalumab is the standard treatment following consolidation therapy of chemoradiotherapy in unresectable stage 3 non–small-cell lung cancer (NSCLC). Although it extended progression-free survival (PFS) and overall survival in the PACIFIC phase 3 study, some patients experience a recurrence, which has led to exploration of immunotherapy combinations.

Oleclumab inhibits the enzyme CD73, found on the surfaces of both tumor and immune cells. Its activity leads to an immunosuppressive effect in the tumor microenvironment, and preclinical studies have shown that it can have an additive antitumor effect when combined with PD-1 or PD-L1 inhibitors. A phase 1 study also suggested efficacy. Monalizumab blocks interactions between major histocompatibility complex-E (HLA-E) and an inhibitor receptor. A number of tumors overexpress HLA-E, triggering inhibitor signals that inhibit natural killer and CD8+ T cells.

“COAST was an interesting study that, although not definitive, suggested that the combination of durvalumab with oleclumab or with monalizumab was more effective than durvalumab alone in the consolidation setting after definitive concurrent chemoradiation for patients with stage 3 unresectable NSCLC,” said Nathan Pennell, MD, PhD, who wrote an accompanying editorial.

Despite the positive signal, Dr. Pennell expressed some skepticism that the combinations would pass a phase 3 test. He questioned the choice of response rate as the primary endpoint of the phase 2 study, and noted that the durvalumab arm had worse progression-free survival (PFS) than the previous PACIFIC trial. It could be that the clinical characteristics of the study population differed between the two trials, in which case the improved objective response rate (ORR) and PFS results should be encouraging. It’s also possible the COAST trial’s small sample size led to a mismatch between the control and treatment group despite randomization, in which case the findings may not be valid.

“These are the kinds of issues that keep drug developers up at night. There really is no way to know which scenario is correct without doing the larger trial. I do hope though that the phase 3 trials have robust biomarker analysis including PDL1 to make sure the arms are as well matched for known prognostic and predictive markers as possible,” said Dr. Pennell, who is vice chair of clinical research at Taussig Cancer Institute.
 

The study details

The researchers randomized 189 patients to durvalumab, durvalumab plus oleclumab, or durvalumab plus monalizumab between January 2019 and July 2020. After a median follow-up of 11.5 months, there was a higher confirmed objective response rate in the durvalumab plus oleclumab group (30.0%; 95% confidence interval, 18.8%-43.2%) and the durvalumab plus monalizumab group (35.5%; 95% CI, 23.7%-48.7%) versus durvalumab alone (17.9%; 95% CI, 9.6%-29.2%).

Compared to durvalumab alone, there was improved PFS in both durvalumab plus oleclumab (stratified hazard ratio, 0.44; 95% CI, 0.26-0.75) and durvalumab plus monalizumab (HR, 0.42; 95% CI, 0.24-0.72). At 12 months, PFS was 62.6% (95% CI, 48.1-74.2%) for durvalumab plus oleclumab, 72.7% (95% CI, 58.8-82.6%) for durvalumab plus monalizumab, and 33.9% (95% CI, 21.2-47.1%) for durvalumab alone.

The study was funded by AstraZeneca.

The results of a phase 2 clinical trial of durvalumab with add-on therapies oleclumab or monalizumab, suggest this novel combination may prove beneficial in patients with unresectable stage 3 non–small-cell lung cancer.

Combinations of the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca) with the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A monoclonal antibody monalizumab led to improved overall response rate and progression-free survival compared to durvalumab alone.

The findings support further study in a phase 3 clinical trial, according to the authors of the study recently published in the Journal of Clinical Oncology.

Durvalumab is the standard treatment following consolidation therapy of chemoradiotherapy in unresectable stage 3 non–small-cell lung cancer (NSCLC). Although it extended progression-free survival (PFS) and overall survival in the PACIFIC phase 3 study, some patients experience a recurrence, which has led to exploration of immunotherapy combinations.

Oleclumab inhibits the enzyme CD73, found on the surfaces of both tumor and immune cells. Its activity leads to an immunosuppressive effect in the tumor microenvironment, and preclinical studies have shown that it can have an additive antitumor effect when combined with PD-1 or PD-L1 inhibitors. A phase 1 study also suggested efficacy. Monalizumab blocks interactions between major histocompatibility complex-E (HLA-E) and an inhibitor receptor. A number of tumors overexpress HLA-E, triggering inhibitor signals that inhibit natural killer and CD8+ T cells.

“COAST was an interesting study that, although not definitive, suggested that the combination of durvalumab with oleclumab or with monalizumab was more effective than durvalumab alone in the consolidation setting after definitive concurrent chemoradiation for patients with stage 3 unresectable NSCLC,” said Nathan Pennell, MD, PhD, who wrote an accompanying editorial.

Despite the positive signal, Dr. Pennell expressed some skepticism that the combinations would pass a phase 3 test. He questioned the choice of response rate as the primary endpoint of the phase 2 study, and noted that the durvalumab arm had worse progression-free survival (PFS) than the previous PACIFIC trial. It could be that the clinical characteristics of the study population differed between the two trials, in which case the improved objective response rate (ORR) and PFS results should be encouraging. It’s also possible the COAST trial’s small sample size led to a mismatch between the control and treatment group despite randomization, in which case the findings may not be valid.

“These are the kinds of issues that keep drug developers up at night. There really is no way to know which scenario is correct without doing the larger trial. I do hope though that the phase 3 trials have robust biomarker analysis including PDL1 to make sure the arms are as well matched for known prognostic and predictive markers as possible,” said Dr. Pennell, who is vice chair of clinical research at Taussig Cancer Institute.
 

The study details

The researchers randomized 189 patients to durvalumab, durvalumab plus oleclumab, or durvalumab plus monalizumab between January 2019 and July 2020. After a median follow-up of 11.5 months, there was a higher confirmed objective response rate in the durvalumab plus oleclumab group (30.0%; 95% confidence interval, 18.8%-43.2%) and the durvalumab plus monalizumab group (35.5%; 95% CI, 23.7%-48.7%) versus durvalumab alone (17.9%; 95% CI, 9.6%-29.2%).

Compared to durvalumab alone, there was improved PFS in both durvalumab plus oleclumab (stratified hazard ratio, 0.44; 95% CI, 0.26-0.75) and durvalumab plus monalizumab (HR, 0.42; 95% CI, 0.24-0.72). At 12 months, PFS was 62.6% (95% CI, 48.1-74.2%) for durvalumab plus oleclumab, 72.7% (95% CI, 58.8-82.6%) for durvalumab plus monalizumab, and 33.9% (95% CI, 21.2-47.1%) for durvalumab alone.

The study was funded by AstraZeneca.

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.

Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.

Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.

“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”

Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.

To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.

The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.

Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.

The Food and Drug Administration has approved a new immunotherapy combination for use in the treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

The new combination comprises a single dose of tremelimumab (Imjudo, AstraZeneca) followed by treatment with durvalumab (Imfinzi, AstraZeneca) in what is known as the STRIDE (single-tremelimumab regular-interval durvalumab) regimen.

This marks the first worldwide approval for tremelimumab, which is a CTLA-4 antibody.

The other drug in the combination, durvalumab, is an anti-PDL1 antibody and is already approved by the FDA for use in several tumor types, including lung cancer, bladder cancer, and biliary tract cancers.

The STRIDE regimen is composed of a single 300-mg dose of tremelimumab followed by durvalumab 1,500 mg given every 4 weeks.

This regimen was used in the HIMALAYA phase 3 trial, which was published in June 2022 in the New England Journal of Medicine.

Results from this trial showed that 30% of patients treated with that combination were still alive at 3 years, compared with 20% of patients who were treated with the standard regimen, sorafenib.

“In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” commented the principal investigator of this trial, Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center, New York.

“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” he commented in a press release from the drug’s manufacturer, AstraZeneca.

When the results from this trial were presented earlier this year at the ASCO Gastrointestinal Cancers meeting, the discussant for that abstract, Anthony B. El-Khoueiry, MD, from the University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, suggested that the STRIDE regimen offers a new first-line treatment option for patients with advanced HCC.

He also made several comments about the design of the HIMALAYA trial, which has a third treatment arm in which patients received durvalumab alone. Dr. El-Khoueiry noted that single-agent durvalumab was noninferior to sorafenib, but he added that no conclusions could be drawn about the STRIDE regimen in comparison with durvalumab as a single agent, because the trial was not powered for that.

The STRIDE regimen showed a lower risk of bleeding in comparison with combinations that include VEGF inhibitors (such as bevacizumab), he said, but he also pointed out that this trial excluded patients with main portal vein thrombosis, who are at high risk of bleeding.

Details of adverse events

In the NEJM article, the trialists report that grade 3/4 treatment-emergent adverse events occurred in 50.5% of patients with STRIDE, 37.1% with durvalumab alone, and 52.4% of patients with sorafenib.

The manufacturer noted that severe and fatal immune-mediated adverse reactions may occur, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and others.

The company also noted that among the patients with unresectable HCC in the HIMALAYA study who received the STRIDE regimen, the most common adverse reactions (occurring in ≥ 20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.

Serious adverse reactions occurred in 41% of patients and included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).

Fatal adverse reactions occurred in 8% of patients who received the combination, including death (1%), intracranial hemorrhage (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%).

Permanent discontinuation of the treatment regimen because of an adverse reaction occurred in 14% of patients.

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

The Food and Drug Administration has approved a new immunotherapy combination for use in the treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

The new combination comprises a single dose of tremelimumab (Imjudo, AstraZeneca) followed by treatment with durvalumab (Imfinzi, AstraZeneca) in what is known as the STRIDE (single-tremelimumab regular-interval durvalumab) regimen.

This marks the first worldwide approval for tremelimumab, which is a CTLA-4 antibody.

The other drug in the combination, durvalumab, is an anti-PDL1 antibody and is already approved by the FDA for use in several tumor types, including lung cancer, bladder cancer, and biliary tract cancers.

The STRIDE regimen is composed of a single 300-mg dose of tremelimumab followed by durvalumab 1,500 mg given every 4 weeks.

This regimen was used in the HIMALAYA phase 3 trial, which was published in June 2022 in the New England Journal of Medicine.

Results from this trial showed that 30% of patients treated with that combination were still alive at 3 years, compared with 20% of patients who were treated with the standard regimen, sorafenib.

“In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” commented the principal investigator of this trial, Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center, New York.

“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” he commented in a press release from the drug’s manufacturer, AstraZeneca.

When the results from this trial were presented earlier this year at the ASCO Gastrointestinal Cancers meeting, the discussant for that abstract, Anthony B. El-Khoueiry, MD, from the University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, suggested that the STRIDE regimen offers a new first-line treatment option for patients with advanced HCC.

He also made several comments about the design of the HIMALAYA trial, which has a third treatment arm in which patients received durvalumab alone. Dr. El-Khoueiry noted that single-agent durvalumab was noninferior to sorafenib, but he added that no conclusions could be drawn about the STRIDE regimen in comparison with durvalumab as a single agent, because the trial was not powered for that.

The STRIDE regimen showed a lower risk of bleeding in comparison with combinations that include VEGF inhibitors (such as bevacizumab), he said, but he also pointed out that this trial excluded patients with main portal vein thrombosis, who are at high risk of bleeding.

Details of adverse events

In the NEJM article, the trialists report that grade 3/4 treatment-emergent adverse events occurred in 50.5% of patients with STRIDE, 37.1% with durvalumab alone, and 52.4% of patients with sorafenib.

The manufacturer noted that severe and fatal immune-mediated adverse reactions may occur, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and others.

The company also noted that among the patients with unresectable HCC in the HIMALAYA study who received the STRIDE regimen, the most common adverse reactions (occurring in ≥ 20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.

Serious adverse reactions occurred in 41% of patients and included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).

Fatal adverse reactions occurred in 8% of patients who received the combination, including death (1%), intracranial hemorrhage (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%).

Permanent discontinuation of the treatment regimen because of an adverse reaction occurred in 14% of patients.

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

The Food and Drug Administration has approved a new immunotherapy combination for use in the treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

The new combination comprises a single dose of tremelimumab (Imjudo, AstraZeneca) followed by treatment with durvalumab (Imfinzi, AstraZeneca) in what is known as the STRIDE (single-tremelimumab regular-interval durvalumab) regimen.

This marks the first worldwide approval for tremelimumab, which is a CTLA-4 antibody.

The other drug in the combination, durvalumab, is an anti-PDL1 antibody and is already approved by the FDA for use in several tumor types, including lung cancer, bladder cancer, and biliary tract cancers.

The STRIDE regimen is composed of a single 300-mg dose of tremelimumab followed by durvalumab 1,500 mg given every 4 weeks.

This regimen was used in the HIMALAYA phase 3 trial, which was published in June 2022 in the New England Journal of Medicine.

Results from this trial showed that 30% of patients treated with that combination were still alive at 3 years, compared with 20% of patients who were treated with the standard regimen, sorafenib.

“In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” commented the principal investigator of this trial, Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center, New York.

“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” he commented in a press release from the drug’s manufacturer, AstraZeneca.

When the results from this trial were presented earlier this year at the ASCO Gastrointestinal Cancers meeting, the discussant for that abstract, Anthony B. El-Khoueiry, MD, from the University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, suggested that the STRIDE regimen offers a new first-line treatment option for patients with advanced HCC.

He also made several comments about the design of the HIMALAYA trial, which has a third treatment arm in which patients received durvalumab alone. Dr. El-Khoueiry noted that single-agent durvalumab was noninferior to sorafenib, but he added that no conclusions could be drawn about the STRIDE regimen in comparison with durvalumab as a single agent, because the trial was not powered for that.

The STRIDE regimen showed a lower risk of bleeding in comparison with combinations that include VEGF inhibitors (such as bevacizumab), he said, but he also pointed out that this trial excluded patients with main portal vein thrombosis, who are at high risk of bleeding.

Details of adverse events

In the NEJM article, the trialists report that grade 3/4 treatment-emergent adverse events occurred in 50.5% of patients with STRIDE, 37.1% with durvalumab alone, and 52.4% of patients with sorafenib.

The manufacturer noted that severe and fatal immune-mediated adverse reactions may occur, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and others.

The company also noted that among the patients with unresectable HCC in the HIMALAYA study who received the STRIDE regimen, the most common adverse reactions (occurring in ≥ 20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.

Serious adverse reactions occurred in 41% of patients and included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).

Fatal adverse reactions occurred in 8% of patients who received the combination, including death (1%), intracranial hemorrhage (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%).

Permanent discontinuation of the treatment regimen because of an adverse reaction occurred in 14% of patients.

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

A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.

The Indiana statewide study, conducted at the beginning of the pandemic, found that unvaccinated adults with cancer and SARS-CoV-2 infection were nearly seven times more likely to die from any cause than uninfected adults with cancer.

“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.

The study was published online in JMIR Cancer.

Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.

A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”

Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.

In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.

Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).

During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.

In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).

During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).

When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).

Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.

Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).

“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.

“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.

Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.

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

A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.

The Indiana statewide study, conducted at the beginning of the pandemic, found that unvaccinated adults with cancer and SARS-CoV-2 infection were nearly seven times more likely to die from any cause than uninfected adults with cancer.

“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.

The study was published online in JMIR Cancer.

Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.

A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”

Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.

In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.

Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).

During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.

In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).

During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).

When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).

Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.

Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).

“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.

“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.

Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.

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

A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.

The Indiana statewide study, conducted at the beginning of the pandemic, found that unvaccinated adults with cancer and SARS-CoV-2 infection were nearly seven times more likely to die from any cause than uninfected adults with cancer.

“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.

The study was published online in JMIR Cancer.

Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.

A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”

Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.

In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.

Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).

During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.

In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).

During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).

When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).

Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.

Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).

“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.

“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.

Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.

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

SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.

The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.

The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.

As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”

The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.

The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.

In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”

The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.

After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).

The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”

There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”

And, Stimpert added, patients are familiar with the infusion center and will see faces they know.

As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.

No disclosures are reported.

SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.

The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.

The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.

As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”

The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.

The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.

In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”

The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.

After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).

The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”

There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”

And, Stimpert added, patients are familiar with the infusion center and will see faces they know.

As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.

No disclosures are reported.

SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.

The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.

The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.

As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”

The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.

The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.

In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”

The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.

After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).

The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”

There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”

And, Stimpert added, patients are familiar with the infusion center and will see faces they know.

As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.

No disclosures are reported.

SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.

At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.

Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy. 

The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.

Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”

At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”

Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.

The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”

The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.

As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”

Dr. Perry has no disclosures.

SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.

At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.

Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy. 

The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.

Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”

At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”

Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.

The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”

The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.

As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”

Dr. Perry has no disclosures.

SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.

At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.

Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy. 

The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.

Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”

At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”

Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.

The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”

The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.

As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”

Dr. Perry has no disclosures.

Signs of pancreatic cancer that were missed on earlier imaging scans represent a “huge window of lost opportunity,” say United Kingdom researchers who report a novel analysis. 

The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.

The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.

They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.

The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).

In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.

The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.

In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.

Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
 

Details of missed imaging signs

The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.

Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.

The PIPC cases were categorized by type:

• Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
• Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
• Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
• Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)

“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”

The authors reported no relevant financial relationships.

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

Signs of pancreatic cancer that were missed on earlier imaging scans represent a “huge window of lost opportunity,” say United Kingdom researchers who report a novel analysis. 

The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.

The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.

They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.

The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).

In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.

The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.

In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.

Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
 

Details of missed imaging signs

The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.

Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.

The PIPC cases were categorized by type:

• Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
• Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
• Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
• Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)

“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”

The authors reported no relevant financial relationships.

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

Signs of pancreatic cancer that were missed on earlier imaging scans represent a “huge window of lost opportunity,” say United Kingdom researchers who report a novel analysis. 

The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.

The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.

They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.

The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).

In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.

The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.

In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.

Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
 

Details of missed imaging signs

The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.

Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.

The PIPC cases were categorized by type:

• Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
• Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
• Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
• Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)

“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”

The authors reported no relevant financial relationships.

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

SAN DIEGO—Before the pandemic, an estimated one-third of oncologists worldwide suffered a high level of burnout. Cancer physicians face many of the same risk factors as their colleagues—high workloads, lack of autonomy, and no support—along with the added pressure of working in a medical field where patients often die. Then COVID-19 hit, and the burnout crisis got even worse.

This tide can be reversed with a focus on best practices and resilience, a mental health researcher told cancer professionals at the September 2022 annual meeting of the Association of VA Hematology/Oncology. Assessments, long-term interventions, and communication are all key, said Fay J. Hlubocky, PhD, MA, a clinical health psychologist and ethicist at the University of Chicago.

Even simple actions like taking time for “mindful moments” and checking in with a colleague can make a difference, she said. But institutions must act, she said. “Long-term tailored strategies are incredibly important to promote well-being.”

Hlubocky, who led an American Society of Clinical Oncology committee on burnout prior to the pandemic, noted that statistics about burnout in American medicine and oncology specifically, are grim. In 2017, a systematic review and meta-analysis found that significant numbers of oncologists suffered from high burnout (32%), high psychiatric morbidity (27%), depression (at least 12%), and alcohol misuse (as many as 30%).

The pandemic piled on more stressors. In the second half of 2020, researchers interviewed 25 American oncologists in focus groups and found that their “underlying oncologist burnout exacerbated stressors associated with disruptions in care, education, research, financial practice health, and telemedicine. Many feared delays in cancer screening, diagnosis, and treatment [and] strongly considered working part-time or taking early retirement.”

As one participant put it, “everyone is seeing a lot of death and heartache and social isolation and anger that they’re not used to encountering and in very new and different ways.”

Major contributors to oncologist burnout, Hlubocky said, include moral distress, moral injury, and compassion fatigue. “Moral distress occurs when that individual believes he or she knows the right thing to do, but institutional constraints make it really difficult to do what is right,” Hlubocky said. “The individual is aware of the moral problem, acknowledges and takes moral responsibility, makes some moral judgments, but yet—as a result of these constraints — participates in perceived moral wrongdoing.”

Moral injury refers to the damage that can be caused by moral distress or by witnessing acts that violate morals, such as during military service. Compassion fatigue, meanwhile, is defined by the American Stress Institute as “a low level, chronic clouding of caring and concern for others in your life.”

What can be done? Hlubocky highlighted multiple interventions, such as adjustment of work patterns, cognitive behavioral therapy, and training in mindfulness, relaxation, and communication. One strategy is to adopt multiple in-person interventions simultaneously.

But first it’s crucial for administrators to understand the problem in a specific workplace: “You have to know what’s going on in your organization to intervene on it,” she said. “There are multiple tools that have been validated in other health care fields and can be used on a regular basis over time to measure burnout, satisfaction, and engagement.”

For individuals, other strategies include daily check-ins with colleagues to catch signs of stress, she said, as Toronto oncologists started doing amid the pandemic. The check-ins can include simple questions like: How are you doing? How are you feeling? Are you sleeping, eating and exercising? Do you need help?

As for resilience, Hlubocky said it must grow at the individual level. “We can't rely so much on the organization. We need to develop our personal resilience in order for professional resilience to flourish again, and we have to do a lot to protect ourselves. It’s about focusing on the strength of the individual—that empowerment to rise above adversity, that vitality, that engagement, that self-efficacy. It supports health and enhances coping, and it is the key element of physician and clinician well-being.”

Research into resilience offers guidance about how to achieve it, she said. A 2013 German study of 200 physicians found that the most resilient physicians change their attitudes and behaviors, take time off, set boundaries, spend time with family and friends, and ask colleagues for help. And they gained resilience, the study found, by getting older and becoming more experienced.

Hlubocky pointed to several useful resources for burned-out medical professionals, including mindfulness, cognitive behavioral therapy and breathing apps: She highlighted Breathe2Relax, Headspace, MoodGYM, Stress Gym, and guided audio files from the University of California at San Diego. And she said ASCO has resources on combatting burnout and promoting well-being.

Hlubocky has no relevant disclosures.

SAN DIEGO—Before the pandemic, an estimated one-third of oncologists worldwide suffered a high level of burnout. Cancer physicians face many of the same risk factors as their colleagues—high workloads, lack of autonomy, and no support—along with the added pressure of working in a medical field where patients often die. Then COVID-19 hit, and the burnout crisis got even worse.

This tide can be reversed with a focus on best practices and resilience, a mental health researcher told cancer professionals at the September 2022 annual meeting of the Association of VA Hematology/Oncology. Assessments, long-term interventions, and communication are all key, said Fay J. Hlubocky, PhD, MA, a clinical health psychologist and ethicist at the University of Chicago.

Even simple actions like taking time for “mindful moments” and checking in with a colleague can make a difference, she said. But institutions must act, she said. “Long-term tailored strategies are incredibly important to promote well-being.”

Hlubocky, who led an American Society of Clinical Oncology committee on burnout prior to the pandemic, noted that statistics about burnout in American medicine and oncology specifically, are grim. In 2017, a systematic review and meta-analysis found that significant numbers of oncologists suffered from high burnout (32%), high psychiatric morbidity (27%), depression (at least 12%), and alcohol misuse (as many as 30%).

The pandemic piled on more stressors. In the second half of 2020, researchers interviewed 25 American oncologists in focus groups and found that their “underlying oncologist burnout exacerbated stressors associated with disruptions in care, education, research, financial practice health, and telemedicine. Many feared delays in cancer screening, diagnosis, and treatment [and] strongly considered working part-time or taking early retirement.”

As one participant put it, “everyone is seeing a lot of death and heartache and social isolation and anger that they’re not used to encountering and in very new and different ways.”

Major contributors to oncologist burnout, Hlubocky said, include moral distress, moral injury, and compassion fatigue. “Moral distress occurs when that individual believes he or she knows the right thing to do, but institutional constraints make it really difficult to do what is right,” Hlubocky said. “The individual is aware of the moral problem, acknowledges and takes moral responsibility, makes some moral judgments, but yet—as a result of these constraints — participates in perceived moral wrongdoing.”

Moral injury refers to the damage that can be caused by moral distress or by witnessing acts that violate morals, such as during military service. Compassion fatigue, meanwhile, is defined by the American Stress Institute as “a low level, chronic clouding of caring and concern for others in your life.”

What can be done? Hlubocky highlighted multiple interventions, such as adjustment of work patterns, cognitive behavioral therapy, and training in mindfulness, relaxation, and communication. One strategy is to adopt multiple in-person interventions simultaneously.

But first it’s crucial for administrators to understand the problem in a specific workplace: “You have to know what’s going on in your organization to intervene on it,” she said. “There are multiple tools that have been validated in other health care fields and can be used on a regular basis over time to measure burnout, satisfaction, and engagement.”

For individuals, other strategies include daily check-ins with colleagues to catch signs of stress, she said, as Toronto oncologists started doing amid the pandemic. The check-ins can include simple questions like: How are you doing? How are you feeling? Are you sleeping, eating and exercising? Do you need help?

As for resilience, Hlubocky said it must grow at the individual level. “We can't rely so much on the organization. We need to develop our personal resilience in order for professional resilience to flourish again, and we have to do a lot to protect ourselves. It’s about focusing on the strength of the individual—that empowerment to rise above adversity, that vitality, that engagement, that self-efficacy. It supports health and enhances coping, and it is the key element of physician and clinician well-being.”

Research into resilience offers guidance about how to achieve it, she said. A 2013 German study of 200 physicians found that the most resilient physicians change their attitudes and behaviors, take time off, set boundaries, spend time with family and friends, and ask colleagues for help. And they gained resilience, the study found, by getting older and becoming more experienced.

Hlubocky pointed to several useful resources for burned-out medical professionals, including mindfulness, cognitive behavioral therapy and breathing apps: She highlighted Breathe2Relax, Headspace, MoodGYM, Stress Gym, and guided audio files from the University of California at San Diego. And she said ASCO has resources on combatting burnout and promoting well-being.

Hlubocky has no relevant disclosures.

SAN DIEGO—Before the pandemic, an estimated one-third of oncologists worldwide suffered a high level of burnout. Cancer physicians face many of the same risk factors as their colleagues—high workloads, lack of autonomy, and no support—along with the added pressure of working in a medical field where patients often die. Then COVID-19 hit, and the burnout crisis got even worse.

This tide can be reversed with a focus on best practices and resilience, a mental health researcher told cancer professionals at the September 2022 annual meeting of the Association of VA Hematology/Oncology. Assessments, long-term interventions, and communication are all key, said Fay J. Hlubocky, PhD, MA, a clinical health psychologist and ethicist at the University of Chicago.

Even simple actions like taking time for “mindful moments” and checking in with a colleague can make a difference, she said. But institutions must act, she said. “Long-term tailored strategies are incredibly important to promote well-being.”

Hlubocky, who led an American Society of Clinical Oncology committee on burnout prior to the pandemic, noted that statistics about burnout in American medicine and oncology specifically, are grim. In 2017, a systematic review and meta-analysis found that significant numbers of oncologists suffered from high burnout (32%), high psychiatric morbidity (27%), depression (at least 12%), and alcohol misuse (as many as 30%).

The pandemic piled on more stressors. In the second half of 2020, researchers interviewed 25 American oncologists in focus groups and found that their “underlying oncologist burnout exacerbated stressors associated with disruptions in care, education, research, financial practice health, and telemedicine. Many feared delays in cancer screening, diagnosis, and treatment [and] strongly considered working part-time or taking early retirement.”

As one participant put it, “everyone is seeing a lot of death and heartache and social isolation and anger that they’re not used to encountering and in very new and different ways.”

Major contributors to oncologist burnout, Hlubocky said, include moral distress, moral injury, and compassion fatigue. “Moral distress occurs when that individual believes he or she knows the right thing to do, but institutional constraints make it really difficult to do what is right,” Hlubocky said. “The individual is aware of the moral problem, acknowledges and takes moral responsibility, makes some moral judgments, but yet—as a result of these constraints — participates in perceived moral wrongdoing.”

Moral injury refers to the damage that can be caused by moral distress or by witnessing acts that violate morals, such as during military service. Compassion fatigue, meanwhile, is defined by the American Stress Institute as “a low level, chronic clouding of caring and concern for others in your life.”

What can be done? Hlubocky highlighted multiple interventions, such as adjustment of work patterns, cognitive behavioral therapy, and training in mindfulness, relaxation, and communication. One strategy is to adopt multiple in-person interventions simultaneously.

But first it’s crucial for administrators to understand the problem in a specific workplace: “You have to know what’s going on in your organization to intervene on it,” she said. “There are multiple tools that have been validated in other health care fields and can be used on a regular basis over time to measure burnout, satisfaction, and engagement.”

For individuals, other strategies include daily check-ins with colleagues to catch signs of stress, she said, as Toronto oncologists started doing amid the pandemic. The check-ins can include simple questions like: How are you doing? How are you feeling? Are you sleeping, eating and exercising? Do you need help?

As for resilience, Hlubocky said it must grow at the individual level. “We can't rely so much on the organization. We need to develop our personal resilience in order for professional resilience to flourish again, and we have to do a lot to protect ourselves. It’s about focusing on the strength of the individual—that empowerment to rise above adversity, that vitality, that engagement, that self-efficacy. It supports health and enhances coping, and it is the key element of physician and clinician well-being.”

Research into resilience offers guidance about how to achieve it, she said. A 2013 German study of 200 physicians found that the most resilient physicians change their attitudes and behaviors, take time off, set boundaries, spend time with family and friends, and ask colleagues for help. And they gained resilience, the study found, by getting older and becoming more experienced.

Hlubocky pointed to several useful resources for burned-out medical professionals, including mindfulness, cognitive behavioral therapy and breathing apps: She highlighted Breathe2Relax, Headspace, MoodGYM, Stress Gym, and guided audio files from the University of California at San Diego. And she said ASCO has resources on combatting burnout and promoting well-being.

Hlubocky has no relevant disclosures.

VIENNA – The real-world risk of colorectal cancer and associated mortality was lower among people who underwent a single screening colonoscopy than among those who did not have a colonoscopy, though only modestly so, the 10-year follow-up of the large, multicenter, randomized Northern-European Initiative on Colorectal Cancer (NordICC) trial shows.

In effect, this means the number needed to invite to undergo screening to prevent one case of colorectal cancer is 455 (95% confidence interval, 270-1,429), the researchers determined.

The results were presented at the United European Gastroenterology Week 2022 meeting and were published simultaneously in The New England Journal of Medicine.

The results of the study, which was designed to be truly population based and to mimic national colorectal cancer screening programs, provide an estimate of the effect of screening colonoscopy in the general population.

The primary outcome was determined on an intention-to-screen basis. All persons who were invited to undergo colonoscopy screening were compared with people who received usual care (that is, received no invitation or screening). At UEG 2022, the researchers presented the interim 10-year colorectal cancer risk, which was found to be 0.98%, compared to 1.20%. This represents a risk reduction of 18% among colonoscopy invitees (risk ratio, 0.82; 95% CI, 0.70-0.93). During the study period, 259 cases of colorectal cancer were diagnosed in the invited group versus622 in the usual-care group.

The risk of death from colorectal cancer was 0.28% in the invited group and 0.31% in the usual-care group (RR, 0.90; 95% CI, 0.64-1.16). The risk of death from any cause was similar in both the invited group and the usual-care group, at 11.03% and 11.04%, respectively (RR, 0.99; 95% CI, 0.96-1.04).

The authors noted that the benefit would have been greater had more people undergone screening; only 42% of those who were invited actually underwent colonoscopy. In an adjusted analysis, had all those who had been invited to undergo screening undergone colonoscopy, the 10-year risk of colorectal cancer would have decreased from 1.22% to 0.84%, and the risk of colorectal cancer–related death would have fallen from 0.30% to 0.15%.

The researchers, led by gastroenterologist Michael Bretthauer, MD, from the department of medicine, gastrointestinal endoscopy, University of Oslo, who presented the data at UEG 2022 on behalf of the NordICC study group, acknowledged that, despite the “observed appreciable reductions in relative risks, the absolute risks of the risk of colorectal cancer and even more so of colorectal cancer–related death were lower than those in previous screening trials and lower than what we anticipated when the trial was planned.”

However, they add that “optimism related to the effects of screening on colorectal cancer–related death may be warranted in light of the 50% decrease observed in adjusted per-protocol analyses.”

With his coauthors, Dr. Bretthauer wrote that even their adjusted findings “probably underestimated the benefit because, as in most other large-scale trials of colorectal cancer screening, we could not adjust for all important confounders in all countries.”

Dr. Bretthauer also noted that results were similar to those achieved through sigmoidoscopy screening. By close comparison, sigmoidoscopy studies show the risk of colorectal cancer is reduced between 33% and 40%, according to per protocol analyses. “These results suggest that colonoscopy screening might not be substantially better in reducing the risk of colorectal cancer than sigmoidoscopy.”
 

Real-world, population-based study

NordICC is an ongoing, pragmatic study and is the first randomized trial to quantify the possible benefit of colonoscopy screening on risk of colorectal cancer and related death.

Researchers recruited healthy men and women from registries in Poland, Norway, Sweden, and the Netherlands between 2009 and 2014. Most participants came from Poland (54,258), followed by Norway (26,411) and Sweden (3,646). Data from the Netherlands could not be included owing to data protection law.

At baseline, 84,585 participants aged 55-64 years were randomly assigned in a 1:2 ratio either to receive an invitation to undergo a single screening colonoscopy (28,220; invited) or to undergo usual care in each participant country (56,365; no invitation or screening).

Any colorectal cancer lesions detected were removed, whenever possible. The primary endpoints were the risks of colorectal cancer and colorectal cancer–related death. The secondary endpoint was death from any cause.
 

‘Modest effectiveness,’ but longer follow-up to give fuller picture

In an editorial that accompanied publication of the study, Jason A. Dominitz, MD, from the division of gastroenterology, University of Washington, Seattle, and Douglas J. Robertson, MD, from White River Junction (Vt.) Veterans Affairs Medical Center, commented on the possible reasons for the low reduction in incident cancer and deaths seen in NordICC.

They pointed out that cohort studies suggest a 40%-69% decrease in the incidence of colorectal cancer and a 29%-88% decrease in the risk of death with colonoscopy. However, they noted that “cohort studies probably overestimate the real-world effectiveness of colonoscopy because of the inability to adjust for important factors such as incomplete adherence to testing and the tendency of healthier persons to seek preventive care.”

Referring to Dr. Bretthauer’s point about attendance to screening, Dr. Dominitz and Dr. Robertson added that, in the United States, colonoscopy is the predominant form of screening for colorectal cancer and that in countries where colonoscopy is less established, participation may be very different.

“The actual effectiveness of colonoscopy in populations that are more accepting of colonoscopy could more closely resemble the effectiveness shown in the per-protocol analysis in this trial,” they wrote.

The editorialists also pointed out that the benefits of screening colonoscopy take time to be realized “because the incidence of colorectal cancer is initially increased when presymptomatic cancers are identified.” A repeat and final analysis of the NordICC data is due at 15 years’ follow-up.

In addition, they noted that “colonoscopy is highly operator dependent” and that the adenoma detection rate is variable and affects cancer risk and related mortality.

Given the “modest effectiveness” of screening colonoscopy in the trial, they asserted that, “if the trial truly represents the real-world performance of population-based screening colonoscopy, it might be hard to justify the risk and expense of this form of screening when simpler, less-invasive strategies (e.g., sigmoidoscopy and FIT [fecal immunochemical test]) are available.”

However, they also noted that “additional analyses, including longer follow up and results from other ongoing comparative effectiveness trials, will help us to fully understand the benefits of this test.”

Also commenting on the study was Michiel Maas, MD, from the department of gastroenterology and hepatology, Radboud UMC, Nijmegen, the Netherlands, told this news organization that he agreed that the absolute effect on colorectal cancer risk or colorectal cancer–related death was not as high as expected and may be disappointing.

But Dr. Maas said that “around half of the patients in the study did not undergo colonoscopy, which may have negatively impacted the results.

“An additional factor, which can be influential in colonoscopy studies, is the potential variability in detection rates between operators/endoscopists,” he said.

Looking to the future, Dr. Maas noted that “AI [artificial intelligence] or computer-aided detection can level this playing field in detection rates.

“Nevertheless, this is a very interesting study, which sheds a new light on the efficacy on screening colonoscopies,” he said.

Dr. Bretthauer has relationships with Paion, Cybernet, and the Norwegian Council of Research. Dr. Dominitz is cochair of VA Cooperative Studies Program #577: “Colonoscopy vs. Fecal Immunochemical Test (FIT) in Reducing Mortality from Colorectal Cancer” (the CONFIRM Study), which is funded by the Department of Veterans Affairs. Dr. Robertson is national cochair (with Dr. Dominitz) of the CONFIRM trial and has received personal fees from Freenome outside of the submitted work. Dr. Maas reported no relevant financial relationships.

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

VIENNA – The real-world risk of colorectal cancer and associated mortality was lower among people who underwent a single screening colonoscopy than among those who did not have a colonoscopy, though only modestly so, the 10-year follow-up of the large, multicenter, randomized Northern-European Initiative on Colorectal Cancer (NordICC) trial shows.

In effect, this means the number needed to invite to undergo screening to prevent one case of colorectal cancer is 455 (95% confidence interval, 270-1,429), the researchers determined.

The results were presented at the United European Gastroenterology Week 2022 meeting and were published simultaneously in The New England Journal of Medicine.

The results of the study, which was designed to be truly population based and to mimic national colorectal cancer screening programs, provide an estimate of the effect of screening colonoscopy in the general population.

The primary outcome was determined on an intention-to-screen basis. All persons who were invited to undergo colonoscopy screening were compared with people who received usual care (that is, received no invitation or screening). At UEG 2022, the researchers presented the interim 10-year colorectal cancer risk, which was found to be 0.98%, compared to 1.20%. This represents a risk reduction of 18% among colonoscopy invitees (risk ratio, 0.82; 95% CI, 0.70-0.93). During the study period, 259 cases of colorectal cancer were diagnosed in the invited group versus622 in the usual-care group.

The risk of death from colorectal cancer was 0.28% in the invited group and 0.31% in the usual-care group (RR, 0.90; 95% CI, 0.64-1.16). The risk of death from any cause was similar in both the invited group and the usual-care group, at 11.03% and 11.04%, respectively (RR, 0.99; 95% CI, 0.96-1.04).

The authors noted that the benefit would have been greater had more people undergone screening; only 42% of those who were invited actually underwent colonoscopy. In an adjusted analysis, had all those who had been invited to undergo screening undergone colonoscopy, the 10-year risk of colorectal cancer would have decreased from 1.22% to 0.84%, and the risk of colorectal cancer–related death would have fallen from 0.30% to 0.15%.

The researchers, led by gastroenterologist Michael Bretthauer, MD, from the department of medicine, gastrointestinal endoscopy, University of Oslo, who presented the data at UEG 2022 on behalf of the NordICC study group, acknowledged that, despite the “observed appreciable reductions in relative risks, the absolute risks of the risk of colorectal cancer and even more so of colorectal cancer–related death were lower than those in previous screening trials and lower than what we anticipated when the trial was planned.”

However, they add that “optimism related to the effects of screening on colorectal cancer–related death may be warranted in light of the 50% decrease observed in adjusted per-protocol analyses.”

With his coauthors, Dr. Bretthauer wrote that even their adjusted findings “probably underestimated the benefit because, as in most other large-scale trials of colorectal cancer screening, we could not adjust for all important confounders in all countries.”

Dr. Bretthauer also noted that results were similar to those achieved through sigmoidoscopy screening. By close comparison, sigmoidoscopy studies show the risk of colorectal cancer is reduced between 33% and 40%, according to per protocol analyses. “These results suggest that colonoscopy screening might not be substantially better in reducing the risk of colorectal cancer than sigmoidoscopy.”
 

Real-world, population-based study

NordICC is an ongoing, pragmatic study and is the first randomized trial to quantify the possible benefit of colonoscopy screening on risk of colorectal cancer and related death.

Researchers recruited healthy men and women from registries in Poland, Norway, Sweden, and the Netherlands between 2009 and 2014. Most participants came from Poland (54,258), followed by Norway (26,411) and Sweden (3,646). Data from the Netherlands could not be included owing to data protection law.

At baseline, 84,585 participants aged 55-64 years were randomly assigned in a 1:2 ratio either to receive an invitation to undergo a single screening colonoscopy (28,220; invited) or to undergo usual care in each participant country (56,365; no invitation or screening).

Any colorectal cancer lesions detected were removed, whenever possible. The primary endpoints were the risks of colorectal cancer and colorectal cancer–related death. The secondary endpoint was death from any cause.
 

‘Modest effectiveness,’ but longer follow-up to give fuller picture

In an editorial that accompanied publication of the study, Jason A. Dominitz, MD, from the division of gastroenterology, University of Washington, Seattle, and Douglas J. Robertson, MD, from White River Junction (Vt.) Veterans Affairs Medical Center, commented on the possible reasons for the low reduction in incident cancer and deaths seen in NordICC.

They pointed out that cohort studies suggest a 40%-69% decrease in the incidence of colorectal cancer and a 29%-88% decrease in the risk of death with colonoscopy. However, they noted that “cohort studies probably overestimate the real-world effectiveness of colonoscopy because of the inability to adjust for important factors such as incomplete adherence to testing and the tendency of healthier persons to seek preventive care.”

Referring to Dr. Bretthauer’s point about attendance to screening, Dr. Dominitz and Dr. Robertson added that, in the United States, colonoscopy is the predominant form of screening for colorectal cancer and that in countries where colonoscopy is less established, participation may be very different.

“The actual effectiveness of colonoscopy in populations that are more accepting of colonoscopy could more closely resemble the effectiveness shown in the per-protocol analysis in this trial,” they wrote.

The editorialists also pointed out that the benefits of screening colonoscopy take time to be realized “because the incidence of colorectal cancer is initially increased when presymptomatic cancers are identified.” A repeat and final analysis of the NordICC data is due at 15 years’ follow-up.

In addition, they noted that “colonoscopy is highly operator dependent” and that the adenoma detection rate is variable and affects cancer risk and related mortality.

Given the “modest effectiveness” of screening colonoscopy in the trial, they asserted that, “if the trial truly represents the real-world performance of population-based screening colonoscopy, it might be hard to justify the risk and expense of this form of screening when simpler, less-invasive strategies (e.g., sigmoidoscopy and FIT [fecal immunochemical test]) are available.”

However, they also noted that “additional analyses, including longer follow up and results from other ongoing comparative effectiveness trials, will help us to fully understand the benefits of this test.”

Also commenting on the study was Michiel Maas, MD, from the department of gastroenterology and hepatology, Radboud UMC, Nijmegen, the Netherlands, told this news organization that he agreed that the absolute effect on colorectal cancer risk or colorectal cancer–related death was not as high as expected and may be disappointing.

But Dr. Maas said that “around half of the patients in the study did not undergo colonoscopy, which may have negatively impacted the results.

“An additional factor, which can be influential in colonoscopy studies, is the potential variability in detection rates between operators/endoscopists,” he said.

Looking to the future, Dr. Maas noted that “AI [artificial intelligence] or computer-aided detection can level this playing field in detection rates.

“Nevertheless, this is a very interesting study, which sheds a new light on the efficacy on screening colonoscopies,” he said.

Dr. Bretthauer has relationships with Paion, Cybernet, and the Norwegian Council of Research. Dr. Dominitz is cochair of VA Cooperative Studies Program #577: “Colonoscopy vs. Fecal Immunochemical Test (FIT) in Reducing Mortality from Colorectal Cancer” (the CONFIRM Study), which is funded by the Department of Veterans Affairs. Dr. Robertson is national cochair (with Dr. Dominitz) of the CONFIRM trial and has received personal fees from Freenome outside of the submitted work. Dr. Maas reported no relevant financial relationships.

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

VIENNA – The real-world risk of colorectal cancer and associated mortality was lower among people who underwent a single screening colonoscopy than among those who did not have a colonoscopy, though only modestly so, the 10-year follow-up of the large, multicenter, randomized Northern-European Initiative on Colorectal Cancer (NordICC) trial shows.

In effect, this means the number needed to invite to undergo screening to prevent one case of colorectal cancer is 455 (95% confidence interval, 270-1,429), the researchers determined.

The results were presented at the United European Gastroenterology Week 2022 meeting and were published simultaneously in The New England Journal of Medicine.

The results of the study, which was designed to be truly population based and to mimic national colorectal cancer screening programs, provide an estimate of the effect of screening colonoscopy in the general population.

The primary outcome was determined on an intention-to-screen basis. All persons who were invited to undergo colonoscopy screening were compared with people who received usual care (that is, received no invitation or screening). At UEG 2022, the researchers presented the interim 10-year colorectal cancer risk, which was found to be 0.98%, compared to 1.20%. This represents a risk reduction of 18% among colonoscopy invitees (risk ratio, 0.82; 95% CI, 0.70-0.93). During the study period, 259 cases of colorectal cancer were diagnosed in the invited group versus622 in the usual-care group.

The risk of death from colorectal cancer was 0.28% in the invited group and 0.31% in the usual-care group (RR, 0.90; 95% CI, 0.64-1.16). The risk of death from any cause was similar in both the invited group and the usual-care group, at 11.03% and 11.04%, respectively (RR, 0.99; 95% CI, 0.96-1.04).

The authors noted that the benefit would have been greater had more people undergone screening; only 42% of those who were invited actually underwent colonoscopy. In an adjusted analysis, had all those who had been invited to undergo screening undergone colonoscopy, the 10-year risk of colorectal cancer would have decreased from 1.22% to 0.84%, and the risk of colorectal cancer–related death would have fallen from 0.30% to 0.15%.

The researchers, led by gastroenterologist Michael Bretthauer, MD, from the department of medicine, gastrointestinal endoscopy, University of Oslo, who presented the data at UEG 2022 on behalf of the NordICC study group, acknowledged that, despite the “observed appreciable reductions in relative risks, the absolute risks of the risk of colorectal cancer and even more so of colorectal cancer–related death were lower than those in previous screening trials and lower than what we anticipated when the trial was planned.”

However, they add that “optimism related to the effects of screening on colorectal cancer–related death may be warranted in light of the 50% decrease observed in adjusted per-protocol analyses.”

With his coauthors, Dr. Bretthauer wrote that even their adjusted findings “probably underestimated the benefit because, as in most other large-scale trials of colorectal cancer screening, we could not adjust for all important confounders in all countries.”

Dr. Bretthauer also noted that results were similar to those achieved through sigmoidoscopy screening. By close comparison, sigmoidoscopy studies show the risk of colorectal cancer is reduced between 33% and 40%, according to per protocol analyses. “These results suggest that colonoscopy screening might not be substantially better in reducing the risk of colorectal cancer than sigmoidoscopy.”
 

Real-world, population-based study

NordICC is an ongoing, pragmatic study and is the first randomized trial to quantify the possible benefit of colonoscopy screening on risk of colorectal cancer and related death.

Researchers recruited healthy men and women from registries in Poland, Norway, Sweden, and the Netherlands between 2009 and 2014. Most participants came from Poland (54,258), followed by Norway (26,411) and Sweden (3,646). Data from the Netherlands could not be included owing to data protection law.

At baseline, 84,585 participants aged 55-64 years were randomly assigned in a 1:2 ratio either to receive an invitation to undergo a single screening colonoscopy (28,220; invited) or to undergo usual care in each participant country (56,365; no invitation or screening).

Any colorectal cancer lesions detected were removed, whenever possible. The primary endpoints were the risks of colorectal cancer and colorectal cancer–related death. The secondary endpoint was death from any cause.
 

‘Modest effectiveness,’ but longer follow-up to give fuller picture

In an editorial that accompanied publication of the study, Jason A. Dominitz, MD, from the division of gastroenterology, University of Washington, Seattle, and Douglas J. Robertson, MD, from White River Junction (Vt.) Veterans Affairs Medical Center, commented on the possible reasons for the low reduction in incident cancer and deaths seen in NordICC.

They pointed out that cohort studies suggest a 40%-69% decrease in the incidence of colorectal cancer and a 29%-88% decrease in the risk of death with colonoscopy. However, they noted that “cohort studies probably overestimate the real-world effectiveness of colonoscopy because of the inability to adjust for important factors such as incomplete adherence to testing and the tendency of healthier persons to seek preventive care.”

Referring to Dr. Bretthauer’s point about attendance to screening, Dr. Dominitz and Dr. Robertson added that, in the United States, colonoscopy is the predominant form of screening for colorectal cancer and that in countries where colonoscopy is less established, participation may be very different.

“The actual effectiveness of colonoscopy in populations that are more accepting of colonoscopy could more closely resemble the effectiveness shown in the per-protocol analysis in this trial,” they wrote.

The editorialists also pointed out that the benefits of screening colonoscopy take time to be realized “because the incidence of colorectal cancer is initially increased when presymptomatic cancers are identified.” A repeat and final analysis of the NordICC data is due at 15 years’ follow-up.

In addition, they noted that “colonoscopy is highly operator dependent” and that the adenoma detection rate is variable and affects cancer risk and related mortality.

Given the “modest effectiveness” of screening colonoscopy in the trial, they asserted that, “if the trial truly represents the real-world performance of population-based screening colonoscopy, it might be hard to justify the risk and expense of this form of screening when simpler, less-invasive strategies (e.g., sigmoidoscopy and FIT [fecal immunochemical test]) are available.”

However, they also noted that “additional analyses, including longer follow up and results from other ongoing comparative effectiveness trials, will help us to fully understand the benefits of this test.”

Also commenting on the study was Michiel Maas, MD, from the department of gastroenterology and hepatology, Radboud UMC, Nijmegen, the Netherlands, told this news organization that he agreed that the absolute effect on colorectal cancer risk or colorectal cancer–related death was not as high as expected and may be disappointing.

But Dr. Maas said that “around half of the patients in the study did not undergo colonoscopy, which may have negatively impacted the results.

“An additional factor, which can be influential in colonoscopy studies, is the potential variability in detection rates between operators/endoscopists,” he said.

Looking to the future, Dr. Maas noted that “AI [artificial intelligence] or computer-aided detection can level this playing field in detection rates.

“Nevertheless, this is a very interesting study, which sheds a new light on the efficacy on screening colonoscopies,” he said.

Dr. Bretthauer has relationships with Paion, Cybernet, and the Norwegian Council of Research. Dr. Dominitz is cochair of VA Cooperative Studies Program #577: “Colonoscopy vs. Fecal Immunochemical Test (FIT) in Reducing Mortality from Colorectal Cancer” (the CONFIRM Study), which is funded by the Department of Veterans Affairs. Dr. Robertson is national cochair (with Dr. Dominitz) of the CONFIRM trial and has received personal fees from Freenome outside of the submitted work. Dr. Maas reported no relevant financial relationships.

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

Using artificial intelligence, researchers have developed an algorithm that can help improve the prediction of colorectal cancer (CRC) recurrence.

The QuantCRC algorithm can identify patients with CRC who might be able to skip chemotherapy, given a low probability of recurrence, and identify those patients at high risk for recurrence who may benefit from more intensive treatment or follow-up, the researchers say.

“For patients with colon cancer, the algorithm gives oncologists another tool to help guide therapy and follow-up,” Rish Pai, MD, PhD, a pathologist at Mayo Clinic, Phoenix, who developed the tool, said in a news release.

The study was published online in the journal Gastroenterology.

The tool is a deep-learning segmentation algorithm developed using 6,468 digitized CRC images. It quantifies 15 features from a CRC image and uses them to improve prediction of recurrence.

“QuantCRC can identify different regions within the tumor and extract quantitative data from these regions,” Dr. Pai explained.

“The algorithm converts an image into a set of numbers that is unique to that tumor. The large number of tumors that we analyzed allowed us to learn which features were most predictive of tumor behavior. We can now apply what we have learned to new colon cancers to predict how the tumor will behave,” Dr. Pai said.

The researchers developed a prognostic model incorporating stage, mismatch repair, and QuantCRC that resulted in a concordance (c)-index of 0.714 in the internal test and 0.744 in the external cohort. Removing QuantCRC from the model reduced the c-index to 0.679 in the external cohort.

Using QuantCRC, they identified prognostic risk groups for recurrence, which provided a hazard ratio of 2.24 for low- versus high-risk stage III CRC and 2.36 for low- versus high-risk stage II CRC, in the external cohort after adjusting for established risk factors.

The predicted median 36-month recurrence rate for high-risk stage III CRC was 32.7% versus 13.4% for low-risk stage III CRC and 15.8% for high-risk stage II CRC versus 5.4% for low-risk stage II CRC, the researchers report.

QuantCRC provides a “powerful adjunct” to routine pathologic reporting of CRC, and a prognostic model using QuantCRC can improve prediction of recurrence-free survival, they write.

Looking ahead, Dr. Pai plans to use QuantCRC to better understand mechanisms of tumor recurrence and see if it can predict the response to certain treatments, like immunotherapy, he said.

Funding for this study was provided in part by the Colon Cancer Family Registry, which is supported in part by funding from the National Cancer Institute and National Institutes of Health. Dr. Pai reports consulting income from Alimentiv, Eli Lilly, AbbVie, Allergan, Genentech, and PathAI outside of the submitted work.

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

Using artificial intelligence, researchers have developed an algorithm that can help improve the prediction of colorectal cancer (CRC) recurrence.

The QuantCRC algorithm can identify patients with CRC who might be able to skip chemotherapy, given a low probability of recurrence, and identify those patients at high risk for recurrence who may benefit from more intensive treatment or follow-up, the researchers say.

“For patients with colon cancer, the algorithm gives oncologists another tool to help guide therapy and follow-up,” Rish Pai, MD, PhD, a pathologist at Mayo Clinic, Phoenix, who developed the tool, said in a news release.

The study was published online in the journal Gastroenterology.

The tool is a deep-learning segmentation algorithm developed using 6,468 digitized CRC images. It quantifies 15 features from a CRC image and uses them to improve prediction of recurrence.

“QuantCRC can identify different regions within the tumor and extract quantitative data from these regions,” Dr. Pai explained.

“The algorithm converts an image into a set of numbers that is unique to that tumor. The large number of tumors that we analyzed allowed us to learn which features were most predictive of tumor behavior. We can now apply what we have learned to new colon cancers to predict how the tumor will behave,” Dr. Pai said.

The researchers developed a prognostic model incorporating stage, mismatch repair, and QuantCRC that resulted in a concordance (c)-index of 0.714 in the internal test and 0.744 in the external cohort. Removing QuantCRC from the model reduced the c-index to 0.679 in the external cohort.

Using QuantCRC, they identified prognostic risk groups for recurrence, which provided a hazard ratio of 2.24 for low- versus high-risk stage III CRC and 2.36 for low- versus high-risk stage II CRC, in the external cohort after adjusting for established risk factors.

The predicted median 36-month recurrence rate for high-risk stage III CRC was 32.7% versus 13.4% for low-risk stage III CRC and 15.8% for high-risk stage II CRC versus 5.4% for low-risk stage II CRC, the researchers report.

QuantCRC provides a “powerful adjunct” to routine pathologic reporting of CRC, and a prognostic model using QuantCRC can improve prediction of recurrence-free survival, they write.

Looking ahead, Dr. Pai plans to use QuantCRC to better understand mechanisms of tumor recurrence and see if it can predict the response to certain treatments, like immunotherapy, he said.

Funding for this study was provided in part by the Colon Cancer Family Registry, which is supported in part by funding from the National Cancer Institute and National Institutes of Health. Dr. Pai reports consulting income from Alimentiv, Eli Lilly, AbbVie, Allergan, Genentech, and PathAI outside of the submitted work.

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

Using artificial intelligence, researchers have developed an algorithm that can help improve the prediction of colorectal cancer (CRC) recurrence.

The QuantCRC algorithm can identify patients with CRC who might be able to skip chemotherapy, given a low probability of recurrence, and identify those patients at high risk for recurrence who may benefit from more intensive treatment or follow-up, the researchers say.

“For patients with colon cancer, the algorithm gives oncologists another tool to help guide therapy and follow-up,” Rish Pai, MD, PhD, a pathologist at Mayo Clinic, Phoenix, who developed the tool, said in a news release.

The study was published online in the journal Gastroenterology.

The tool is a deep-learning segmentation algorithm developed using 6,468 digitized CRC images. It quantifies 15 features from a CRC image and uses them to improve prediction of recurrence.

“QuantCRC can identify different regions within the tumor and extract quantitative data from these regions,” Dr. Pai explained.

“The algorithm converts an image into a set of numbers that is unique to that tumor. The large number of tumors that we analyzed allowed us to learn which features were most predictive of tumor behavior. We can now apply what we have learned to new colon cancers to predict how the tumor will behave,” Dr. Pai said.

The researchers developed a prognostic model incorporating stage, mismatch repair, and QuantCRC that resulted in a concordance (c)-index of 0.714 in the internal test and 0.744 in the external cohort. Removing QuantCRC from the model reduced the c-index to 0.679 in the external cohort.

Using QuantCRC, they identified prognostic risk groups for recurrence, which provided a hazard ratio of 2.24 for low- versus high-risk stage III CRC and 2.36 for low- versus high-risk stage II CRC, in the external cohort after adjusting for established risk factors.

The predicted median 36-month recurrence rate for high-risk stage III CRC was 32.7% versus 13.4% for low-risk stage III CRC and 15.8% for high-risk stage II CRC versus 5.4% for low-risk stage II CRC, the researchers report.

QuantCRC provides a “powerful adjunct” to routine pathologic reporting of CRC, and a prognostic model using QuantCRC can improve prediction of recurrence-free survival, they write.

Looking ahead, Dr. Pai plans to use QuantCRC to better understand mechanisms of tumor recurrence and see if it can predict the response to certain treatments, like immunotherapy, he said.

Funding for this study was provided in part by the Colon Cancer Family Registry, which is supported in part by funding from the National Cancer Institute and National Institutes of Health. Dr. Pai reports consulting income from Alimentiv, Eli Lilly, AbbVie, Allergan, Genentech, and PathAI outside of the submitted work.

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