Patient & Survivor Care

TOPLINE:

A dietary pattern linked to the microbial signature of colorectal cancer (CRC) is positively correlated with an increased risk for CRC, particularly for tumors with detectable Fusobacterium nucleatum, the pks strain of Escherichia coli, and enterotoxigenic Bacteroides fragilis (ETBF).

METHODOLOGY:

• To date, no known studies have investigated how a dietary pattern (rather than just individual foods or nutrients) specifically directed at CRC-related microbes may contribute to an increased CRC risk.
• Using stool metagenomes and dietary information from 307 men and 212 women, researchers identified and then validated a dietary pattern specifically linked to an established CRC-related gut microbial signature, which they termed the CRC Microbial Dietary Score (CMDS).
• They then investigated the association between CMDS and the risk for CRC in 259,200 participants (50,637 men and 208,563 women) from three large US cohorts where health professionals provided detailed information on various lifestyle factors over long follow-up periods.
• Researchers also analyzed the risk for CRC on the basis of the presence of gut bacteria, such as F nucleatum, pks+ E coli, and ETBF, in the tumor tissues of the participants who underwent surgical resection for CRC.

TAKEAWAY:

• The CMDS was characterized by high intake of processed foods and low intake of fiber-rich foods.
• Over 6,467,378 person-years assessed in the three US cohorts, 3854 cases of incident CRC were documented, with 1172, 1096, and 1119 cases measured for F nucleatum, pks+ E coli, and ETBF, respectively.
• A higher CMDS was associated with an increased risk for CRC after adjusting for putative CRC risk factors (adjusted hazard ratio [HR], 1.25; P_trend < .001).
• The association between CMDS and the risk for CRC was stronger for tumors with detectable levels of F nucleatum (HR, 2.51; P_trend < .001), pks+ E coli (HR, 1.68; P_trend = .005), and ETBF (HR, 2.06; P_trend = .016).

IN PRACTICE:

“A dietary pattern with a low consumption of processed foods may help prevent colorectal cancer through modulation of the gut microbiome. The dietary pattern modulating the colorectal cancer–related gut microbial signature may particularly help prevent tumoral microbial positive colorectal cancer, which tends to have a worse prognosis,” the authors wrote.

SOURCE:

This study, led by Kai Wang and Chun-Han Lo, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, was published online in Gastroenterology.

LIMITATIONS:

The study’s observational design may have limited the ability to establish causality between dietary patterns and the risk for CRC. The inclusion of participants who were all health professionals from a predominantly White US population may have limited the generalizability of the findings to other populations. The reliance on self-reported dietary data may have introduced recall bias and affected the accuracy of the dietary pattern assessed.

DISCLOSURES:

This work was supported by various sources, including the National Institutes of Health and the Cancer Research UK Grand Challenge Award. One author served as a consultant for some pharmaceutical companies, and another received funding from various sources, both unrelated to this study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A dietary pattern linked to the microbial signature of colorectal cancer (CRC) is positively correlated with an increased risk for CRC, particularly for tumors with detectable Fusobacterium nucleatum, the pks strain of Escherichia coli, and enterotoxigenic Bacteroides fragilis (ETBF).

METHODOLOGY:

• To date, no known studies have investigated how a dietary pattern (rather than just individual foods or nutrients) specifically directed at CRC-related microbes may contribute to an increased CRC risk.
• Using stool metagenomes and dietary information from 307 men and 212 women, researchers identified and then validated a dietary pattern specifically linked to an established CRC-related gut microbial signature, which they termed the CRC Microbial Dietary Score (CMDS).
• They then investigated the association between CMDS and the risk for CRC in 259,200 participants (50,637 men and 208,563 women) from three large US cohorts where health professionals provided detailed information on various lifestyle factors over long follow-up periods.
• Researchers also analyzed the risk for CRC on the basis of the presence of gut bacteria, such as F nucleatum, pks+ E coli, and ETBF, in the tumor tissues of the participants who underwent surgical resection for CRC.

TAKEAWAY:

• The CMDS was characterized by high intake of processed foods and low intake of fiber-rich foods.
• Over 6,467,378 person-years assessed in the three US cohorts, 3854 cases of incident CRC were documented, with 1172, 1096, and 1119 cases measured for F nucleatum, pks+ E coli, and ETBF, respectively.
• A higher CMDS was associated with an increased risk for CRC after adjusting for putative CRC risk factors (adjusted hazard ratio [HR], 1.25; P_trend < .001).
• The association between CMDS and the risk for CRC was stronger for tumors with detectable levels of F nucleatum (HR, 2.51; P_trend < .001), pks+ E coli (HR, 1.68; P_trend = .005), and ETBF (HR, 2.06; P_trend = .016).

IN PRACTICE:

“A dietary pattern with a low consumption of processed foods may help prevent colorectal cancer through modulation of the gut microbiome. The dietary pattern modulating the colorectal cancer–related gut microbial signature may particularly help prevent tumoral microbial positive colorectal cancer, which tends to have a worse prognosis,” the authors wrote.

SOURCE:

This study, led by Kai Wang and Chun-Han Lo, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, was published online in Gastroenterology.

LIMITATIONS:

The study’s observational design may have limited the ability to establish causality between dietary patterns and the risk for CRC. The inclusion of participants who were all health professionals from a predominantly White US population may have limited the generalizability of the findings to other populations. The reliance on self-reported dietary data may have introduced recall bias and affected the accuracy of the dietary pattern assessed.

DISCLOSURES:

This work was supported by various sources, including the National Institutes of Health and the Cancer Research UK Grand Challenge Award. One author served as a consultant for some pharmaceutical companies, and another received funding from various sources, both unrelated to this study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A dietary pattern linked to the microbial signature of colorectal cancer (CRC) is positively correlated with an increased risk for CRC, particularly for tumors with detectable Fusobacterium nucleatum, the pks strain of Escherichia coli, and enterotoxigenic Bacteroides fragilis (ETBF).

METHODOLOGY:

• To date, no known studies have investigated how a dietary pattern (rather than just individual foods or nutrients) specifically directed at CRC-related microbes may contribute to an increased CRC risk.
• Using stool metagenomes and dietary information from 307 men and 212 women, researchers identified and then validated a dietary pattern specifically linked to an established CRC-related gut microbial signature, which they termed the CRC Microbial Dietary Score (CMDS).
• They then investigated the association between CMDS and the risk for CRC in 259,200 participants (50,637 men and 208,563 women) from three large US cohorts where health professionals provided detailed information on various lifestyle factors over long follow-up periods.
• Researchers also analyzed the risk for CRC on the basis of the presence of gut bacteria, such as F nucleatum, pks+ E coli, and ETBF, in the tumor tissues of the participants who underwent surgical resection for CRC.

TAKEAWAY:

• The CMDS was characterized by high intake of processed foods and low intake of fiber-rich foods.
• Over 6,467,378 person-years assessed in the three US cohorts, 3854 cases of incident CRC were documented, with 1172, 1096, and 1119 cases measured for F nucleatum, pks+ E coli, and ETBF, respectively.
• A higher CMDS was associated with an increased risk for CRC after adjusting for putative CRC risk factors (adjusted hazard ratio [HR], 1.25; P_trend < .001).
• The association between CMDS and the risk for CRC was stronger for tumors with detectable levels of F nucleatum (HR, 2.51; P_trend < .001), pks+ E coli (HR, 1.68; P_trend = .005), and ETBF (HR, 2.06; P_trend = .016).

IN PRACTICE:

“A dietary pattern with a low consumption of processed foods may help prevent colorectal cancer through modulation of the gut microbiome. The dietary pattern modulating the colorectal cancer–related gut microbial signature may particularly help prevent tumoral microbial positive colorectal cancer, which tends to have a worse prognosis,” the authors wrote.

SOURCE:

This study, led by Kai Wang and Chun-Han Lo, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, was published online in Gastroenterology.

LIMITATIONS:

The study’s observational design may have limited the ability to establish causality between dietary patterns and the risk for CRC. The inclusion of participants who were all health professionals from a predominantly White US population may have limited the generalizability of the findings to other populations. The reliance on self-reported dietary data may have introduced recall bias and affected the accuracy of the dietary pattern assessed.

DISCLOSURES:

This work was supported by various sources, including the National Institutes of Health and the Cancer Research UK Grand Challenge Award. One author served as a consultant for some pharmaceutical companies, and another received funding from various sources, both unrelated to this study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Gastrointestinal stromal tumors (GISTs) have increased in incidence over the past 2 decades, with notable survival disparities among racial and ethnic groups, particularly among Black patients who face higher mortality rates from esophageal and gastric GISTs.

METHODOLOGY:

• A steep increase in GIST incidence was observed from 2000 to 2005, largely due to the reclassification of sarcomas as GISTs. The classification of GISTs has changed over time, with all GISTs now considered malignant instead of benign, likely further increasing the incidence. However, updated data on GIST trends are lacking.
• This study assessed recent trends in GIST incidence and survival outcomes across different racial and ethnic groups using data from the National Cancer Institute’s SEER database, including the SEER-22 and SEER-17 registries.
• Researchers evaluated annual percentage changes and incidences among 23,001 patients from SEER-22 (mean age, 64 years) and median overall and cancer-specific survival rates in 12,109 patients from SEER-17 (mean age, 64 years).
• More than half of the patients in both cohorts were White, 17.8%-19.6% were Black, 11.6%-12.3% were Hispanic, and 9.7%-13.2% were Asian or Pacific Islander.

TAKEAWAY:

• The rates of GISTs increased annually between 2000 and 2019 for all organ sites, except the colon, where it decreased by 0.2% per year. Esophageal GISTs increased by 7.3%, gastric by 5.1%, small intestine by 2.7%, and rectal by 1.9%.
• Black patients had significantly lower median overall survival than other racial groups. For example, the median survival for Black patients with esophageal GISTs was 3.6 years vs 15.3 years for White patients (hazard ratio [HR], 6.4; 95% CI, 2.0-20.3). Similar patterns were seen for gastric GISTs — 9.1 years for Black patients vs 11.8 years for White patients (HR, 1.4). GIST-specific mortality was also higher in Black patients for these two organ sites.
• Additionally, Asian or Pacific Islander patients with esophageal GISTs had lower survival rates, with a median of 8.8 years (HR, 5.6) vs 15.3 years for White patients. Similarly, American Indian or Alaska Native patients with gastric GIST had lower survival rates, with a median of 8.5 years (HR, 1.6) vs 11.8 years for White patients.
• Over the 20-year study period, 5-year relative survival rates improved for most patient groups but remained the lowest among American Indian or Alaska Native patients across various GIST sites.

IN PRACTICE:

“We observed a continued increase in the incidence of GISTs after 2005” with a “substantial increase in the last two decades,” the authors wrote. Therefore, “future research should explore lifestyle-related or environmental factors underlying the unfavorable trends” which “could not fully be explained by coding reclassification and advances in diagnostic technologies,” they further added.

SOURCE:

The study was led by Christian S. Alvarez, PhD, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland. It was published online on August 19, 2024, in JAMA Network Open.

LIMITATIONS:

A lack of individual-level data on socioeconomic factors and healthcare access could have influenced the findings. Although the SEER registries used standardized codes and procedures for classifying the data on race and ethnicity, misclassification was possible. Additionally, data on prognostic factors were incomplete or missing, which limited the inferences of the analysis.

DISCLOSURES:

This work was supported by the National Institutes of Health Intramural Research Program of the National Cancer Institute. Two authors reported receiving grants or personal fees and having other ties with various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Gastrointestinal stromal tumors (GISTs) have increased in incidence over the past 2 decades, with notable survival disparities among racial and ethnic groups, particularly among Black patients who face higher mortality rates from esophageal and gastric GISTs.

METHODOLOGY:

• A steep increase in GIST incidence was observed from 2000 to 2005, largely due to the reclassification of sarcomas as GISTs. The classification of GISTs has changed over time, with all GISTs now considered malignant instead of benign, likely further increasing the incidence. However, updated data on GIST trends are lacking.
• This study assessed recent trends in GIST incidence and survival outcomes across different racial and ethnic groups using data from the National Cancer Institute’s SEER database, including the SEER-22 and SEER-17 registries.
• Researchers evaluated annual percentage changes and incidences among 23,001 patients from SEER-22 (mean age, 64 years) and median overall and cancer-specific survival rates in 12,109 patients from SEER-17 (mean age, 64 years).
• More than half of the patients in both cohorts were White, 17.8%-19.6% were Black, 11.6%-12.3% were Hispanic, and 9.7%-13.2% were Asian or Pacific Islander.

TAKEAWAY:

• The rates of GISTs increased annually between 2000 and 2019 for all organ sites, except the colon, where it decreased by 0.2% per year. Esophageal GISTs increased by 7.3%, gastric by 5.1%, small intestine by 2.7%, and rectal by 1.9%.
• Black patients had significantly lower median overall survival than other racial groups. For example, the median survival for Black patients with esophageal GISTs was 3.6 years vs 15.3 years for White patients (hazard ratio [HR], 6.4; 95% CI, 2.0-20.3). Similar patterns were seen for gastric GISTs — 9.1 years for Black patients vs 11.8 years for White patients (HR, 1.4). GIST-specific mortality was also higher in Black patients for these two organ sites.
• Additionally, Asian or Pacific Islander patients with esophageal GISTs had lower survival rates, with a median of 8.8 years (HR, 5.6) vs 15.3 years for White patients. Similarly, American Indian or Alaska Native patients with gastric GIST had lower survival rates, with a median of 8.5 years (HR, 1.6) vs 11.8 years for White patients.
• Over the 20-year study period, 5-year relative survival rates improved for most patient groups but remained the lowest among American Indian or Alaska Native patients across various GIST sites.

IN PRACTICE:

“We observed a continued increase in the incidence of GISTs after 2005” with a “substantial increase in the last two decades,” the authors wrote. Therefore, “future research should explore lifestyle-related or environmental factors underlying the unfavorable trends” which “could not fully be explained by coding reclassification and advances in diagnostic technologies,” they further added.

SOURCE:

The study was led by Christian S. Alvarez, PhD, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland. It was published online on August 19, 2024, in JAMA Network Open.

LIMITATIONS:

A lack of individual-level data on socioeconomic factors and healthcare access could have influenced the findings. Although the SEER registries used standardized codes and procedures for classifying the data on race and ethnicity, misclassification was possible. Additionally, data on prognostic factors were incomplete or missing, which limited the inferences of the analysis.

DISCLOSURES:

This work was supported by the National Institutes of Health Intramural Research Program of the National Cancer Institute. Two authors reported receiving grants or personal fees and having other ties with various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Gastrointestinal stromal tumors (GISTs) have increased in incidence over the past 2 decades, with notable survival disparities among racial and ethnic groups, particularly among Black patients who face higher mortality rates from esophageal and gastric GISTs.

METHODOLOGY:

• A steep increase in GIST incidence was observed from 2000 to 2005, largely due to the reclassification of sarcomas as GISTs. The classification of GISTs has changed over time, with all GISTs now considered malignant instead of benign, likely further increasing the incidence. However, updated data on GIST trends are lacking.
• This study assessed recent trends in GIST incidence and survival outcomes across different racial and ethnic groups using data from the National Cancer Institute’s SEER database, including the SEER-22 and SEER-17 registries.
• Researchers evaluated annual percentage changes and incidences among 23,001 patients from SEER-22 (mean age, 64 years) and median overall and cancer-specific survival rates in 12,109 patients from SEER-17 (mean age, 64 years).
• More than half of the patients in both cohorts were White, 17.8%-19.6% were Black, 11.6%-12.3% were Hispanic, and 9.7%-13.2% were Asian or Pacific Islander.

TAKEAWAY:

• The rates of GISTs increased annually between 2000 and 2019 for all organ sites, except the colon, where it decreased by 0.2% per year. Esophageal GISTs increased by 7.3%, gastric by 5.1%, small intestine by 2.7%, and rectal by 1.9%.
• Black patients had significantly lower median overall survival than other racial groups. For example, the median survival for Black patients with esophageal GISTs was 3.6 years vs 15.3 years for White patients (hazard ratio [HR], 6.4; 95% CI, 2.0-20.3). Similar patterns were seen for gastric GISTs — 9.1 years for Black patients vs 11.8 years for White patients (HR, 1.4). GIST-specific mortality was also higher in Black patients for these two organ sites.
• Additionally, Asian or Pacific Islander patients with esophageal GISTs had lower survival rates, with a median of 8.8 years (HR, 5.6) vs 15.3 years for White patients. Similarly, American Indian or Alaska Native patients with gastric GIST had lower survival rates, with a median of 8.5 years (HR, 1.6) vs 11.8 years for White patients.
• Over the 20-year study period, 5-year relative survival rates improved for most patient groups but remained the lowest among American Indian or Alaska Native patients across various GIST sites.

IN PRACTICE:

“We observed a continued increase in the incidence of GISTs after 2005” with a “substantial increase in the last two decades,” the authors wrote. Therefore, “future research should explore lifestyle-related or environmental factors underlying the unfavorable trends” which “could not fully be explained by coding reclassification and advances in diagnostic technologies,” they further added.

SOURCE:

The study was led by Christian S. Alvarez, PhD, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland. It was published online on August 19, 2024, in JAMA Network Open.

LIMITATIONS:

A lack of individual-level data on socioeconomic factors and healthcare access could have influenced the findings. Although the SEER registries used standardized codes and procedures for classifying the data on race and ethnicity, misclassification was possible. Additionally, data on prognostic factors were incomplete or missing, which limited the inferences of the analysis.

DISCLOSURES:

This work was supported by the National Institutes of Health Intramural Research Program of the National Cancer Institute. Two authors reported receiving grants or personal fees and having other ties with various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Adjuvant everolimus does not improve recurrence-free or overall survival in patients with papillary and chromophobe subtypes of non–clear cell renal cell carcinoma (RCC) and is associated with higher rates of severe adverse events, compared with placebo.

METHODOLOGY:

• Non–clear cell RCC accounts for approximately 25% of RCC cases and includes various distinct tumor types such as papillary and chromophobe RCC. A common design flaw in clinical trials has been applying treatments effective in clear cell RCC to non–clear cell RCC subtypes without a strong biological rationale. The broad approval of drugs for RCC without considering subtype differences complicates treatment decisions.
• The EVEREST phase 3 randomized clinical trial evaluated everolimus in the adjuvant setting, enrolling patients with either clear cell (n = 1248) or non–clear cell (n = 208) RCC at high risk for recurrence after resection. The patients were randomly assigned to receive either everolimus or placebo.
• To assess the benefits of everolimus in patients with non–clear cell RCC, this analysis focused on the subgroup of 109 patients with papillary RCC (median age, 60 years) and 99 patients with chromophobe RCC (median age, 51 years).
• The primary outcome was recurrence-free survival, and the secondary outcome was overall survival. The median follow-up was 76 months.

TAKEAWAY:

• In the papillary RCC subgroup, the 5-year recurrence-free survival was lower among patients receiving everolimus vs placebo (62% vs 70%), but this difference was not significant (hazard ratio [HR], 1.19; 95% CI, 0.61-2.33; P = .61).
• In the chromophobe RCC subgroup, the 5-year recurrence-free survival was similar between the two groups — 79% for everolimus vs 77% for placebo (HR, 0.89; 95% CI, 0.37-2.13; P = .79).
• Everolimus was also not associated with a significant overall survival benefit in patients with papillary RCC (HR, 1.47; 95% CI, 0.67-3.24; P = .34) or chromophobe RCC (HR, 0.93; 95% CI, 0.33-2.65; P = .89). In the papillary RCC subgroup, 5-year overall survival rates were slightly lower in the everolimus group than in the placebo group (76% vs 82%); however, in the chromophobe RCC subgroup, the rates were the same for both arms (89%).
• Patients treated with everolimus reported an increased incidence of grade 3 or higher adverse events, compared with those treated with placebo (48% vs 9%). No treatment-related deaths were reported, but a significant number of patients — 54% with papillary RCC and 51% with chromophobe RCC — discontinued treatment early because of adverse events.

IN PRACTICE:

This secondary analysis “found that patients with papillary or chromophobe RCC did not benefit from treatment with everolimus in the adjuvant setting,” the authors wrote. “Our study highlights an area of unmet need in the kidney cancer field. It thus serves to provide a foundational background for future randomized clinical trials to address specific subgroups of RCC for risk mitigation strategies in the adjuvant setting.”

SOURCE:

The study was led by Shuchi Gulati, MD, MSc, University of California Davis Comprehensive Cancer Center, Sacramento, and was published online on August 6, 2024, in JAMA Network Open, along with an accompanying editorial.

LIMITATIONS:

The subgroup analyses were underpowered to detect a significant difference. Additionally, the study lacked a central pathology review to confirm non–clear cell histologies.

DISCLOSURES:

The study was supported by awards from the National Institutes of Health, National Cancer Institute, and National Clinical Trials Network. Several authors reported receiving grants or personal fees from various sources outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Adjuvant everolimus does not improve recurrence-free or overall survival in patients with papillary and chromophobe subtypes of non–clear cell renal cell carcinoma (RCC) and is associated with higher rates of severe adverse events, compared with placebo.

METHODOLOGY:

• Non–clear cell RCC accounts for approximately 25% of RCC cases and includes various distinct tumor types such as papillary and chromophobe RCC. A common design flaw in clinical trials has been applying treatments effective in clear cell RCC to non–clear cell RCC subtypes without a strong biological rationale. The broad approval of drugs for RCC without considering subtype differences complicates treatment decisions.
• The EVEREST phase 3 randomized clinical trial evaluated everolimus in the adjuvant setting, enrolling patients with either clear cell (n = 1248) or non–clear cell (n = 208) RCC at high risk for recurrence after resection. The patients were randomly assigned to receive either everolimus or placebo.
• To assess the benefits of everolimus in patients with non–clear cell RCC, this analysis focused on the subgroup of 109 patients with papillary RCC (median age, 60 years) and 99 patients with chromophobe RCC (median age, 51 years).
• The primary outcome was recurrence-free survival, and the secondary outcome was overall survival. The median follow-up was 76 months.

TAKEAWAY:

• In the papillary RCC subgroup, the 5-year recurrence-free survival was lower among patients receiving everolimus vs placebo (62% vs 70%), but this difference was not significant (hazard ratio [HR], 1.19; 95% CI, 0.61-2.33; P = .61).
• In the chromophobe RCC subgroup, the 5-year recurrence-free survival was similar between the two groups — 79% for everolimus vs 77% for placebo (HR, 0.89; 95% CI, 0.37-2.13; P = .79).
• Everolimus was also not associated with a significant overall survival benefit in patients with papillary RCC (HR, 1.47; 95% CI, 0.67-3.24; P = .34) or chromophobe RCC (HR, 0.93; 95% CI, 0.33-2.65; P = .89). In the papillary RCC subgroup, 5-year overall survival rates were slightly lower in the everolimus group than in the placebo group (76% vs 82%); however, in the chromophobe RCC subgroup, the rates were the same for both arms (89%).
• Patients treated with everolimus reported an increased incidence of grade 3 or higher adverse events, compared with those treated with placebo (48% vs 9%). No treatment-related deaths were reported, but a significant number of patients — 54% with papillary RCC and 51% with chromophobe RCC — discontinued treatment early because of adverse events.

IN PRACTICE:

This secondary analysis “found that patients with papillary or chromophobe RCC did not benefit from treatment with everolimus in the adjuvant setting,” the authors wrote. “Our study highlights an area of unmet need in the kidney cancer field. It thus serves to provide a foundational background for future randomized clinical trials to address specific subgroups of RCC for risk mitigation strategies in the adjuvant setting.”

SOURCE:

The study was led by Shuchi Gulati, MD, MSc, University of California Davis Comprehensive Cancer Center, Sacramento, and was published online on August 6, 2024, in JAMA Network Open, along with an accompanying editorial.

LIMITATIONS:

The subgroup analyses were underpowered to detect a significant difference. Additionally, the study lacked a central pathology review to confirm non–clear cell histologies.

DISCLOSURES:

The study was supported by awards from the National Institutes of Health, National Cancer Institute, and National Clinical Trials Network. Several authors reported receiving grants or personal fees from various sources outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Adjuvant everolimus does not improve recurrence-free or overall survival in patients with papillary and chromophobe subtypes of non–clear cell renal cell carcinoma (RCC) and is associated with higher rates of severe adverse events, compared with placebo.

METHODOLOGY:

• Non–clear cell RCC accounts for approximately 25% of RCC cases and includes various distinct tumor types such as papillary and chromophobe RCC. A common design flaw in clinical trials has been applying treatments effective in clear cell RCC to non–clear cell RCC subtypes without a strong biological rationale. The broad approval of drugs for RCC without considering subtype differences complicates treatment decisions.
• The EVEREST phase 3 randomized clinical trial evaluated everolimus in the adjuvant setting, enrolling patients with either clear cell (n = 1248) or non–clear cell (n = 208) RCC at high risk for recurrence after resection. The patients were randomly assigned to receive either everolimus or placebo.
• To assess the benefits of everolimus in patients with non–clear cell RCC, this analysis focused on the subgroup of 109 patients with papillary RCC (median age, 60 years) and 99 patients with chromophobe RCC (median age, 51 years).
• The primary outcome was recurrence-free survival, and the secondary outcome was overall survival. The median follow-up was 76 months.

TAKEAWAY:

• In the papillary RCC subgroup, the 5-year recurrence-free survival was lower among patients receiving everolimus vs placebo (62% vs 70%), but this difference was not significant (hazard ratio [HR], 1.19; 95% CI, 0.61-2.33; P = .61).
• In the chromophobe RCC subgroup, the 5-year recurrence-free survival was similar between the two groups — 79% for everolimus vs 77% for placebo (HR, 0.89; 95% CI, 0.37-2.13; P = .79).
• Everolimus was also not associated with a significant overall survival benefit in patients with papillary RCC (HR, 1.47; 95% CI, 0.67-3.24; P = .34) or chromophobe RCC (HR, 0.93; 95% CI, 0.33-2.65; P = .89). In the papillary RCC subgroup, 5-year overall survival rates were slightly lower in the everolimus group than in the placebo group (76% vs 82%); however, in the chromophobe RCC subgroup, the rates were the same for both arms (89%).
• Patients treated with everolimus reported an increased incidence of grade 3 or higher adverse events, compared with those treated with placebo (48% vs 9%). No treatment-related deaths were reported, but a significant number of patients — 54% with papillary RCC and 51% with chromophobe RCC — discontinued treatment early because of adverse events.

IN PRACTICE:

This secondary analysis “found that patients with papillary or chromophobe RCC did not benefit from treatment with everolimus in the adjuvant setting,” the authors wrote. “Our study highlights an area of unmet need in the kidney cancer field. It thus serves to provide a foundational background for future randomized clinical trials to address specific subgroups of RCC for risk mitigation strategies in the adjuvant setting.”

SOURCE:

The study was led by Shuchi Gulati, MD, MSc, University of California Davis Comprehensive Cancer Center, Sacramento, and was published online on August 6, 2024, in JAMA Network Open, along with an accompanying editorial.

LIMITATIONS:

The subgroup analyses were underpowered to detect a significant difference. Additionally, the study lacked a central pathology review to confirm non–clear cell histologies.

DISCLOSURES:

The study was supported by awards from the National Institutes of Health, National Cancer Institute, and National Clinical Trials Network. Several authors reported receiving grants or personal fees from various sources outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

• SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
• In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
• A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
• The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

• At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
• Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
• Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
• Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

• SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
• In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
• A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
• The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

• At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
• Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
• Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
• Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

In patients with pulmonary oligometastases from colorectal cancer (CRC), both stereotactic body radiotherapy (SBRT) and surgery led to similar overall survival rates at 5 years. However, those who received surgery had significantly better progression-free and disease-free survival rates, as well as a longer time to intrathoracic progression.
 

METHODOLOGY:

• SBRT has been shown to provide effective local control and improve short-term survival for patients with pulmonary oligometastases from CRC and has become an alternative for these patients who are ineligible or reluctant to undergo surgery. It’s unclear, however, whether SBRT should be prioritized over surgery in patients with CRC pulmonary metastases, largely because of a lack of prospective data.
• In the current analysis, researchers compared outcomes among 335 patients (median age, 61 years) with lung metastases from CRC who underwent surgery or SBRT, using data from the Peking University Cancer Hospital and Institute between March 2011 and September 2022.
• A total of 251 patients were included in the final analysis after propensity score matching, 173 (68.9%) underwent surgery and 78 (31.1%) received SBRT. The median follow-up was 61.6 months in the surgery group and 54.4 months in the SBRT group.
• The study outcomes were freedom from intrathoracic progression, progression-free survival, and overall survival.

TAKEAWAY:

• At 5 years, rates of freedom from intrathoracic progression were more than twofold higher in the surgery group than in the SBRT group (53% vs 23.4%; hazard ratio [HR], 0.46; P < .001). Progression-free survival rates were also more than twofold higher in the surgery group vs the SBRT group (43.8% vs 18.5%; HR, 0.47; P < .001), respectively. In the SBRT group, a higher percentage of patients had a disease-free interval of less than 12 months compared with the surgery group, with rates of 48.7% and 32.9%, respectively (P = 0.025). 
• Overall survival, however, was not significantly different between the two groups at 5 years (72.5% in the surgery group vs 63.7% in the SBRT group; P = .260). The number of pulmonary metastases (HR, 1.87; 95% CI, 1.11-3.14, P = .019 and tumor size (HR, 1.03; 95% CI, 1.00-1.05, P = .023) were significant prognostic factors for overall survival.
• Local recurrence was more prevalent after SBRT (33.3%) than surgery (16.9%), while new intrathoracic tumors occurred more frequently after surgery than SBRT (71.8% vs 43.1%). Repeated local treatments were common among patients with intrathoracic progression, which might have contributed to favorable survival outcomes in both groups.
• Both treatments were well-tolerated with no treatment-related mortality or grade ≥ 3 toxicities. In the surgery group, 14 patients experienced complications, including atrial fibrillation (n = 4) and prolonged air leaks (n = 7). In the SBRT group, radiation pneumonitis was the most common adverse event (n = 21).

IN PRACTICE:

SBRT yielded overall survival benefits similar to surgery despite a “higher likelihood of prior extrapulmonary metastases, a shorter disease-free interval, and a greater number of metastatic lesions,” the authors wrote. Still, SBRT should be regarded as an “effective alternative in cases in which surgical intervention is either unviable or declined by the patient,” the authors concluded.
 

SOURCE:

The study was co-led by Yaqi Wang and Xin Dong, Peking University Cancer Hospital & Institute, Beijing, China, and was published online in the International Journal of Radiation Oncology, Biology, Physics.
 

LIMITATIONS:

This single-center retrospective study had an inherent selection bias. The lack of balanced sample sizes of the surgery and SBRT groups might have affected the robustness of the statistical analyses. Detailed data on adverse events were not available.
 

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China, Beijing Natural Science Foundation, and Beijing Municipal Administration of Hospital’s Ascent Plan. The authors did not declare any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Aspirin provides greater protection against colorectal cancer (CRC) in people with unhealthy lifestyles, particularly smokers with higher body weight, new data suggest. 

METHODOLOGY:

• Aspirin is an established agent for CRC prevention. Whether individuals with more lifestyle risk factors might derive greater benefit from aspirin remains unclear.
• Researchers analyzed regular aspirin use (defined as taking two or more standard 325-mg tablets per week) using long-term follow-up data from 63,957 women in the Nurses’ Health Study and 43,698 men in the Health Professionals Follow-Up Study.
• They calculated a healthy lifestyle score for each participant based on body mass index (BMI), alcohol intake, physical activity, diet, and smoking, with higher scores corresponding to healthier lifestyles.
• Outcomes included multivariable-adjusted 10-year cumulative incidence of CRC, the absolute risk reduction (ARR) with aspirin use, and number needed to treat associated with regular aspirin use by lifestyle score.

TAKEAWAY:

• During more than 3 million person-years of follow-up, 2544 new cases of CRC were documented.
• The 10-year cumulative incidence of CRC was 1.98% among regular aspirin users compared with 2.95% among nonusers, corresponding to an ARR of 0.97%.
• The ARR associated with aspirin use was greatest among individuals with the unhealthiest lifestyle scores and progressively decreased with healthier lifestyle scores (P < .001 for additive interaction).
• Those with the unhealthiest lifestyle scores (0-1) had a 10-year ARR of 1.28% from aspirin use, whereas those with the healthiest lifestyle scores (4-5) had an ARR of 0.11%.
• The number needed to treat with aspirin for 10 years to prevent one CRC case was 78 for those with the unhealthiest lifestyles, compared with 909 for those with the healthiest lifestyles.
• Among the individual components of the healthy lifestyle score, higher BMI and smoking correlated with greater reductions in CRC risk from aspirin use.

IN PRACTICE:

“These results support the use of lifestyle risk factors to identify individuals who may have a more favorable risk-benefit profile for cancer prevention with aspirin,” the authors wrote. 

SOURCE:

The study, with first author Daniel R. Sikavi, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study population consisted of health professionals who were predominantly White, which may limit generalizability of the findings. Lifestyle factors and aspirin use were self-reported, which may introduce measurement errors. The study did not systematically assess adverse outcomes potentially due to aspirin use or the presence of a known hereditary cancer syndrome. 

DISCLOSURES:

The study had no commercial funding. The authors had no relevant conflicts of interest.

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

TOPLINE:

Aspirin provides greater protection against colorectal cancer (CRC) in people with unhealthy lifestyles, particularly smokers with higher body weight, new data suggest. 

METHODOLOGY:

• Aspirin is an established agent for CRC prevention. Whether individuals with more lifestyle risk factors might derive greater benefit from aspirin remains unclear.
• Researchers analyzed regular aspirin use (defined as taking two or more standard 325-mg tablets per week) using long-term follow-up data from 63,957 women in the Nurses’ Health Study and 43,698 men in the Health Professionals Follow-Up Study.
• They calculated a healthy lifestyle score for each participant based on body mass index (BMI), alcohol intake, physical activity, diet, and smoking, with higher scores corresponding to healthier lifestyles.
• Outcomes included multivariable-adjusted 10-year cumulative incidence of CRC, the absolute risk reduction (ARR) with aspirin use, and number needed to treat associated with regular aspirin use by lifestyle score.

TAKEAWAY:

• During more than 3 million person-years of follow-up, 2544 new cases of CRC were documented.
• The 10-year cumulative incidence of CRC was 1.98% among regular aspirin users compared with 2.95% among nonusers, corresponding to an ARR of 0.97%.
• The ARR associated with aspirin use was greatest among individuals with the unhealthiest lifestyle scores and progressively decreased with healthier lifestyle scores (P < .001 for additive interaction).
• Those with the unhealthiest lifestyle scores (0-1) had a 10-year ARR of 1.28% from aspirin use, whereas those with the healthiest lifestyle scores (4-5) had an ARR of 0.11%.
• The number needed to treat with aspirin for 10 years to prevent one CRC case was 78 for those with the unhealthiest lifestyles, compared with 909 for those with the healthiest lifestyles.
• Among the individual components of the healthy lifestyle score, higher BMI and smoking correlated with greater reductions in CRC risk from aspirin use.

IN PRACTICE:

“These results support the use of lifestyle risk factors to identify individuals who may have a more favorable risk-benefit profile for cancer prevention with aspirin,” the authors wrote. 

SOURCE:

The study, with first author Daniel R. Sikavi, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study population consisted of health professionals who were predominantly White, which may limit generalizability of the findings. Lifestyle factors and aspirin use were self-reported, which may introduce measurement errors. The study did not systematically assess adverse outcomes potentially due to aspirin use or the presence of a known hereditary cancer syndrome. 

DISCLOSURES:

The study had no commercial funding. The authors had no relevant conflicts of interest.

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

TOPLINE:

Aspirin provides greater protection against colorectal cancer (CRC) in people with unhealthy lifestyles, particularly smokers with higher body weight, new data suggest. 

METHODOLOGY:

• Aspirin is an established agent for CRC prevention. Whether individuals with more lifestyle risk factors might derive greater benefit from aspirin remains unclear.
• Researchers analyzed regular aspirin use (defined as taking two or more standard 325-mg tablets per week) using long-term follow-up data from 63,957 women in the Nurses’ Health Study and 43,698 men in the Health Professionals Follow-Up Study.
• They calculated a healthy lifestyle score for each participant based on body mass index (BMI), alcohol intake, physical activity, diet, and smoking, with higher scores corresponding to healthier lifestyles.
• Outcomes included multivariable-adjusted 10-year cumulative incidence of CRC, the absolute risk reduction (ARR) with aspirin use, and number needed to treat associated with regular aspirin use by lifestyle score.

TAKEAWAY:

• During more than 3 million person-years of follow-up, 2544 new cases of CRC were documented.
• The 10-year cumulative incidence of CRC was 1.98% among regular aspirin users compared with 2.95% among nonusers, corresponding to an ARR of 0.97%.
• The ARR associated with aspirin use was greatest among individuals with the unhealthiest lifestyle scores and progressively decreased with healthier lifestyle scores (P < .001 for additive interaction).
• Those with the unhealthiest lifestyle scores (0-1) had a 10-year ARR of 1.28% from aspirin use, whereas those with the healthiest lifestyle scores (4-5) had an ARR of 0.11%.
• The number needed to treat with aspirin for 10 years to prevent one CRC case was 78 for those with the unhealthiest lifestyles, compared with 909 for those with the healthiest lifestyles.
• Among the individual components of the healthy lifestyle score, higher BMI and smoking correlated with greater reductions in CRC risk from aspirin use.

IN PRACTICE:

“These results support the use of lifestyle risk factors to identify individuals who may have a more favorable risk-benefit profile for cancer prevention with aspirin,” the authors wrote. 

SOURCE:

The study, with first author Daniel R. Sikavi, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study population consisted of health professionals who were predominantly White, which may limit generalizability of the findings. Lifestyle factors and aspirin use were self-reported, which may introduce measurement errors. The study did not systematically assess adverse outcomes potentially due to aspirin use or the presence of a known hereditary cancer syndrome. 

DISCLOSURES:

The study had no commercial funding. The authors had no relevant conflicts of interest.

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

TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

• A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
• In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
• Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
• A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

• Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
• The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
• Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
• Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

• A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
• In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
• Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
• A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

• Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
• The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
• Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
• Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

• A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
• In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
• Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
• A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

• Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
• The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
• Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
• Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

Prior exposure to conventional irinotecan does not affect survival in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are subsequently treated with the liposomal formulation nanoliposomal irinotecan (nal‐IRI), according to a meta-analysis of real-world studies.

“The selection of later lines of chemotherapy regimens should be based on the differential safety profile, patient status, the cost of treatment, and health‐related quality of life,” reported lead author Amol Gupta, MD, from the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital in Baltimore.

The findings, published in Cancer on July 10, 2024, are “noteworthy with respect to calling attention to this important situation and the role of a new drug in the PDAC pharmacologic armamentarium,” Vincent J. Picozzi, MD from the Division of Hematology‐Oncology, Virginia Mason Medical Center, Seattle, wrote in an accompanying editorial.

Treatment of PDAC remains a challenge, the authors noted, as most diagnoses occur at a metastatic or locally advanced stage at which treatments provide only modest benefits and significant toxicities.

The introduction of the first‐line FOLFIRINOX regimen (fluorouracil [5‐FU], leucovorin [LV], irinotecan [IRI], and oxaliplatin) and gemcitabine plus nanoparticle albumin‐bound (nab)‐paclitaxel “has improved the survival of patients with advanced PDAC and increased the number of patients eligible for subsequent therapies” beyond the first-line setting, according to the authors. But survival benefits with FOLFIRINOX and gemcitabine‐based therapy remain poor, with median overall survival (OS) of 6 and 7.6 months, respectively, they noted.
 

Timing Liposomal Irinotecan

The liposomal formulation of IRI has resulted in improved pharmacokinetics and decreased toxicity, but use of this new formulation in later lines of therapy is sometimes limited by concerns that prior exposure to conventional IRI in FOLFIRINOX might produce cross-resistance and reduce the benefit of nal-IRI, the authors explained.

To examine this question, the researchers included eight retrospective chart reviews published up until April 2023 that included a total of 1368 patients who were treated with nal-IRI for locally advanced or metastatic PDAC (five studies) or locally advanced or metastatic PDAC (three studies). Patients ranged in age from 57.8 to 65 years, with the proportion of male patients ranging from 45.7% to 68.6%. The sample sizes of the studies ranged from 29 to 675 patients, with a follow-up range of 6-12.9 months.

Between 84.5% and 100% of patients had received two or more prior lines of therapy, with prior IRI exposure ranging from 20.9% to 100%. In total, 499 patients had prior IRI exposure, mostly in the first-line setting. When reported, most patients gave the reason for IRI discontinuation as disease progression.

Across all patients, the pooled progression-free survival (PFS) and OS were 2.02 months and 4.26 months, respectively, with comparable outcomes in patients with prior IRI exposure compared with those without: PFS (hazard ratio [HR], 1.17; 95% CI, 0.94-1.47; P = .17) and OS (HR, 1.16; 95% CI, 0.95-1.42; P = .16), respectively. This held true regardless of whether patients had experienced progressive disease on conventional IRI. Specifically, the PFS and OS of patients who discontinued conventional IRI because of progressive disease were comparable (HR, 1.50 and HR, 1.70) with those of patients who did not have progressive disease.

The authors reported there was substantial variation in predictors of nal-IRI outcomes among the studies examined. One study reported a numerical but not statistically significant better PFS and OS associated with longer IRI exposure and a higher cumulative dose of prior IRI. Two studies suggested worse PFS and OS associated with later treatment lines of nal-IRI, although adjusted HR did not reflect this. Sequence of treatment was a significant predictor of outcome, as were surgery and metastatic disease, bone and liver metastases, serum albumin < 40 g/L, a neutrophil‐to-lymphocyte ratio > 5, and an elevated baseline carbohydrate antigen 19‐9 level.

“There are several reasons to consider why nal‐IRI may be effective after standard IRI has failed to be so,” said Dr. Picozzi, suggesting pharmacokinetics or an improved tumor tissue/normal tissue exposure ratio as possible explanations. “However, as the authors point out, the results from this pooled, retrospective review could also simply be the result of methodological bias (eg, selection bias) or patient selection,” he added.

“Perhaps the best way of considering the results of the analysis (remembering that the median PFS was essentially the same as the first restaging visit) is that nal‐IRI may be just another in a list of suboptimal treatment options in this situation, he wrote. “If its inherent activity is very low in third‐line treatment (like all other agents to date), the use and response to prior standard IRI may be largely irrelevant.”

Consequently, he concurs with the authors that the selection of third-line treatment options and beyond for advanced APDAC should not be influenced by prior IRI exposure.
 

First-Line Liposomal Irinotecan Approved

In February, the US Food and Drug Administration (FDA) approved nal-IRI (Onivyde) as part of a new first-line regimen for first-line metastatic PDAC. In the new regimen (NALIRIFOX), nal-IRI is substituted for the conventional IRI found in FOLFIRINOX, boosting the cost more than 15-fold from around $500-$7800 per cycle.

The FDA approval was based on the results of the NAPOLI-3 study, which did not compare outcomes of NALIRIFOX with FOLFIRINOX, but rather, compared first-line nal-IRI with the combination of nab‐paclitaxel and gemcitabine. The study showed longer OS (HR, 0.83; 95% CI, 0.70-0.99; P = .04) and PFS (HR, 0.69; 95% CI, 0.58-0.83; P < .001), with first-line nal-IRI.

The absence of a head-to-head comparison has some oncologists debating whether the new regimen is a potential new standard first-line treatment or whether the cost outweighs the potential benefits.

One study author reported grants/contracts from AbbVie, Bristol Myers Squibb, Curegenix, Medivir, Merck, and Nouscom; personal/consulting fees from Bayer, Catenion, G1 Therapeutics, Janssen Pharmaceuticals, Merck, Merus, Nouscom, Regeneron, Sirtex Medical Inc., Tango Therapeutics, and Tavotek Biotherapeutics; and support for other professional activities from Bristol Myers Squibb and Merck outside the submitted work. Another study author reported personal/consulting fees from Astellas Pharma, AstraZeneca, IDEAYA Biosciences, Merck, Merus, Moderna, RenovoRx, Seattle Genetics, and TriSalus Life Sciences outside the submitted work. The remaining authors and Picozzi disclosed no conflicts of interest.
 

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

Prior exposure to conventional irinotecan does not affect survival in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are subsequently treated with the liposomal formulation nanoliposomal irinotecan (nal‐IRI), according to a meta-analysis of real-world studies.

“The selection of later lines of chemotherapy regimens should be based on the differential safety profile, patient status, the cost of treatment, and health‐related quality of life,” reported lead author Amol Gupta, MD, from the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital in Baltimore.

The findings, published in Cancer on July 10, 2024, are “noteworthy with respect to calling attention to this important situation and the role of a new drug in the PDAC pharmacologic armamentarium,” Vincent J. Picozzi, MD from the Division of Hematology‐Oncology, Virginia Mason Medical Center, Seattle, wrote in an accompanying editorial.

Treatment of PDAC remains a challenge, the authors noted, as most diagnoses occur at a metastatic or locally advanced stage at which treatments provide only modest benefits and significant toxicities.

The introduction of the first‐line FOLFIRINOX regimen (fluorouracil [5‐FU], leucovorin [LV], irinotecan [IRI], and oxaliplatin) and gemcitabine plus nanoparticle albumin‐bound (nab)‐paclitaxel “has improved the survival of patients with advanced PDAC and increased the number of patients eligible for subsequent therapies” beyond the first-line setting, according to the authors. But survival benefits with FOLFIRINOX and gemcitabine‐based therapy remain poor, with median overall survival (OS) of 6 and 7.6 months, respectively, they noted.
 

Timing Liposomal Irinotecan

The liposomal formulation of IRI has resulted in improved pharmacokinetics and decreased toxicity, but use of this new formulation in later lines of therapy is sometimes limited by concerns that prior exposure to conventional IRI in FOLFIRINOX might produce cross-resistance and reduce the benefit of nal-IRI, the authors explained.

To examine this question, the researchers included eight retrospective chart reviews published up until April 2023 that included a total of 1368 patients who were treated with nal-IRI for locally advanced or metastatic PDAC (five studies) or locally advanced or metastatic PDAC (three studies). Patients ranged in age from 57.8 to 65 years, with the proportion of male patients ranging from 45.7% to 68.6%. The sample sizes of the studies ranged from 29 to 675 patients, with a follow-up range of 6-12.9 months.

Between 84.5% and 100% of patients had received two or more prior lines of therapy, with prior IRI exposure ranging from 20.9% to 100%. In total, 499 patients had prior IRI exposure, mostly in the first-line setting. When reported, most patients gave the reason for IRI discontinuation as disease progression.

Across all patients, the pooled progression-free survival (PFS) and OS were 2.02 months and 4.26 months, respectively, with comparable outcomes in patients with prior IRI exposure compared with those without: PFS (hazard ratio [HR], 1.17; 95% CI, 0.94-1.47; P = .17) and OS (HR, 1.16; 95% CI, 0.95-1.42; P = .16), respectively. This held true regardless of whether patients had experienced progressive disease on conventional IRI. Specifically, the PFS and OS of patients who discontinued conventional IRI because of progressive disease were comparable (HR, 1.50 and HR, 1.70) with those of patients who did not have progressive disease.

The authors reported there was substantial variation in predictors of nal-IRI outcomes among the studies examined. One study reported a numerical but not statistically significant better PFS and OS associated with longer IRI exposure and a higher cumulative dose of prior IRI. Two studies suggested worse PFS and OS associated with later treatment lines of nal-IRI, although adjusted HR did not reflect this. Sequence of treatment was a significant predictor of outcome, as were surgery and metastatic disease, bone and liver metastases, serum albumin < 40 g/L, a neutrophil‐to-lymphocyte ratio > 5, and an elevated baseline carbohydrate antigen 19‐9 level.

“There are several reasons to consider why nal‐IRI may be effective after standard IRI has failed to be so,” said Dr. Picozzi, suggesting pharmacokinetics or an improved tumor tissue/normal tissue exposure ratio as possible explanations. “However, as the authors point out, the results from this pooled, retrospective review could also simply be the result of methodological bias (eg, selection bias) or patient selection,” he added.

“Perhaps the best way of considering the results of the analysis (remembering that the median PFS was essentially the same as the first restaging visit) is that nal‐IRI may be just another in a list of suboptimal treatment options in this situation, he wrote. “If its inherent activity is very low in third‐line treatment (like all other agents to date), the use and response to prior standard IRI may be largely irrelevant.”

Consequently, he concurs with the authors that the selection of third-line treatment options and beyond for advanced APDAC should not be influenced by prior IRI exposure.
 

First-Line Liposomal Irinotecan Approved

In February, the US Food and Drug Administration (FDA) approved nal-IRI (Onivyde) as part of a new first-line regimen for first-line metastatic PDAC. In the new regimen (NALIRIFOX), nal-IRI is substituted for the conventional IRI found in FOLFIRINOX, boosting the cost more than 15-fold from around $500-$7800 per cycle.

The FDA approval was based on the results of the NAPOLI-3 study, which did not compare outcomes of NALIRIFOX with FOLFIRINOX, but rather, compared first-line nal-IRI with the combination of nab‐paclitaxel and gemcitabine. The study showed longer OS (HR, 0.83; 95% CI, 0.70-0.99; P = .04) and PFS (HR, 0.69; 95% CI, 0.58-0.83; P < .001), with first-line nal-IRI.

The absence of a head-to-head comparison has some oncologists debating whether the new regimen is a potential new standard first-line treatment or whether the cost outweighs the potential benefits.

One study author reported grants/contracts from AbbVie, Bristol Myers Squibb, Curegenix, Medivir, Merck, and Nouscom; personal/consulting fees from Bayer, Catenion, G1 Therapeutics, Janssen Pharmaceuticals, Merck, Merus, Nouscom, Regeneron, Sirtex Medical Inc., Tango Therapeutics, and Tavotek Biotherapeutics; and support for other professional activities from Bristol Myers Squibb and Merck outside the submitted work. Another study author reported personal/consulting fees from Astellas Pharma, AstraZeneca, IDEAYA Biosciences, Merck, Merus, Moderna, RenovoRx, Seattle Genetics, and TriSalus Life Sciences outside the submitted work. The remaining authors and Picozzi disclosed no conflicts of interest.
 

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

Prior exposure to conventional irinotecan does not affect survival in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who are subsequently treated with the liposomal formulation nanoliposomal irinotecan (nal‐IRI), according to a meta-analysis of real-world studies.

“The selection of later lines of chemotherapy regimens should be based on the differential safety profile, patient status, the cost of treatment, and health‐related quality of life,” reported lead author Amol Gupta, MD, from the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital in Baltimore.

The findings, published in Cancer on July 10, 2024, are “noteworthy with respect to calling attention to this important situation and the role of a new drug in the PDAC pharmacologic armamentarium,” Vincent J. Picozzi, MD from the Division of Hematology‐Oncology, Virginia Mason Medical Center, Seattle, wrote in an accompanying editorial.

Treatment of PDAC remains a challenge, the authors noted, as most diagnoses occur at a metastatic or locally advanced stage at which treatments provide only modest benefits and significant toxicities.

The introduction of the first‐line FOLFIRINOX regimen (fluorouracil [5‐FU], leucovorin [LV], irinotecan [IRI], and oxaliplatin) and gemcitabine plus nanoparticle albumin‐bound (nab)‐paclitaxel “has improved the survival of patients with advanced PDAC and increased the number of patients eligible for subsequent therapies” beyond the first-line setting, according to the authors. But survival benefits with FOLFIRINOX and gemcitabine‐based therapy remain poor, with median overall survival (OS) of 6 and 7.6 months, respectively, they noted.
 

Timing Liposomal Irinotecan

The liposomal formulation of IRI has resulted in improved pharmacokinetics and decreased toxicity, but use of this new formulation in later lines of therapy is sometimes limited by concerns that prior exposure to conventional IRI in FOLFIRINOX might produce cross-resistance and reduce the benefit of nal-IRI, the authors explained.

To examine this question, the researchers included eight retrospective chart reviews published up until April 2023 that included a total of 1368 patients who were treated with nal-IRI for locally advanced or metastatic PDAC (five studies) or locally advanced or metastatic PDAC (three studies). Patients ranged in age from 57.8 to 65 years, with the proportion of male patients ranging from 45.7% to 68.6%. The sample sizes of the studies ranged from 29 to 675 patients, with a follow-up range of 6-12.9 months.

Between 84.5% and 100% of patients had received two or more prior lines of therapy, with prior IRI exposure ranging from 20.9% to 100%. In total, 499 patients had prior IRI exposure, mostly in the first-line setting. When reported, most patients gave the reason for IRI discontinuation as disease progression.

Across all patients, the pooled progression-free survival (PFS) and OS were 2.02 months and 4.26 months, respectively, with comparable outcomes in patients with prior IRI exposure compared with those without: PFS (hazard ratio [HR], 1.17; 95% CI, 0.94-1.47; P = .17) and OS (HR, 1.16; 95% CI, 0.95-1.42; P = .16), respectively. This held true regardless of whether patients had experienced progressive disease on conventional IRI. Specifically, the PFS and OS of patients who discontinued conventional IRI because of progressive disease were comparable (HR, 1.50 and HR, 1.70) with those of patients who did not have progressive disease.

The authors reported there was substantial variation in predictors of nal-IRI outcomes among the studies examined. One study reported a numerical but not statistically significant better PFS and OS associated with longer IRI exposure and a higher cumulative dose of prior IRI. Two studies suggested worse PFS and OS associated with later treatment lines of nal-IRI, although adjusted HR did not reflect this. Sequence of treatment was a significant predictor of outcome, as were surgery and metastatic disease, bone and liver metastases, serum albumin < 40 g/L, a neutrophil‐to-lymphocyte ratio > 5, and an elevated baseline carbohydrate antigen 19‐9 level.

“There are several reasons to consider why nal‐IRI may be effective after standard IRI has failed to be so,” said Dr. Picozzi, suggesting pharmacokinetics or an improved tumor tissue/normal tissue exposure ratio as possible explanations. “However, as the authors point out, the results from this pooled, retrospective review could also simply be the result of methodological bias (eg, selection bias) or patient selection,” he added.

“Perhaps the best way of considering the results of the analysis (remembering that the median PFS was essentially the same as the first restaging visit) is that nal‐IRI may be just another in a list of suboptimal treatment options in this situation, he wrote. “If its inherent activity is very low in third‐line treatment (like all other agents to date), the use and response to prior standard IRI may be largely irrelevant.”

Consequently, he concurs with the authors that the selection of third-line treatment options and beyond for advanced APDAC should not be influenced by prior IRI exposure.
 

First-Line Liposomal Irinotecan Approved

In February, the US Food and Drug Administration (FDA) approved nal-IRI (Onivyde) as part of a new first-line regimen for first-line metastatic PDAC. In the new regimen (NALIRIFOX), nal-IRI is substituted for the conventional IRI found in FOLFIRINOX, boosting the cost more than 15-fold from around $500-$7800 per cycle.

The FDA approval was based on the results of the NAPOLI-3 study, which did not compare outcomes of NALIRIFOX with FOLFIRINOX, but rather, compared first-line nal-IRI with the combination of nab‐paclitaxel and gemcitabine. The study showed longer OS (HR, 0.83; 95% CI, 0.70-0.99; P = .04) and PFS (HR, 0.69; 95% CI, 0.58-0.83; P < .001), with first-line nal-IRI.

The absence of a head-to-head comparison has some oncologists debating whether the new regimen is a potential new standard first-line treatment or whether the cost outweighs the potential benefits.

One study author reported grants/contracts from AbbVie, Bristol Myers Squibb, Curegenix, Medivir, Merck, and Nouscom; personal/consulting fees from Bayer, Catenion, G1 Therapeutics, Janssen Pharmaceuticals, Merck, Merus, Nouscom, Regeneron, Sirtex Medical Inc., Tango Therapeutics, and Tavotek Biotherapeutics; and support for other professional activities from Bristol Myers Squibb and Merck outside the submitted work. Another study author reported personal/consulting fees from Astellas Pharma, AstraZeneca, IDEAYA Biosciences, Merck, Merus, Moderna, RenovoRx, Seattle Genetics, and TriSalus Life Sciences outside the submitted work. The remaining authors and Picozzi disclosed no conflicts of interest.
 

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