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GIST Rates Rise, With Black Patients Facing Higher Mortality
TOPLINE:
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:
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:
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.
Adjuvant Everolimus Offers No Survival Benefit in Non–Clear Cell RCC
TOPLINE:
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:
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:
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.
SBRT vs Surgery in CRC Lung Metastases: Which Is Better?
TOPLINE:
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:
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:
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.
Cancer Cases, Deaths in Men Predicted to Surge by 2050
TOPLINE:
— with substantial disparities in cancer cases and deaths by age and region of the world, a recent analysis found.
METHODOLOGY:
- Overall, men have higher cancer incidence and mortality rates, which can be largely attributed to a higher prevalence of modifiable risk factors such as smoking, alcohol consumption, and occupational carcinogens, as well as the underuse of cancer prevention, screening, and treatment services.
- To assess the burden of cancer in men of different ages and from different regions of the world, researchers analyzed data from the 2022 Global Cancer Observatory (GLOBOCAN), which provides national-level estimates for cancer cases and deaths.
- Study outcomes included the incidence, mortality, and prevalence of cancer among men in 2022, along with projections for 2050. Estimates were stratified by several factors, including age; region; and Human Development Index (HDI), a composite score for health, education, and standard of living.
- Researchers also calculated mortality-to-incidence ratios (MIRs) for various cancer types, where higher values indicate worse survival.
TAKEAWAY:
- The researchers reported an estimated 10.3 million cancer cases and 5.4 million deaths globally in 2022, with almost two thirds of cases and deaths occurring in men aged 65 years or older.
- By 2050, cancer cases and deaths were projected to increase by 84.3% (to 19 million) and 93.2% (to 10.5 million), respectively. The increase from 2022 to 2050 was more than twofold higher for older men and countries with low and medium HDI.
- In 2022, the estimated global cancer MIR among men was nearly 55%, with variations by cancer types, age, and HDI. The MIR was lowest for thyroid cancer (7.6%) and highest for pancreatic cancer (90.9%); among World Health Organization regions, Africa had the highest MIR (72.6%), while the Americas had the lowest MIR (39.1%); countries with the lowest HDI had the highest MIR (73.5% vs 41.1% for very high HDI).
- Lung cancer was the leading cause for cases and deaths in 2022 and was projected to remain the leading cause in 2050.
IN PRACTICE:
“Disparities in cancer incidence and mortality among men were observed across age groups, countries/territories, and HDI in 2022, with these disparities projected to widen further by 2050,” according to the authors, who called for efforts to “reduce disparities in cancer burden and ensure equity in cancer prevention and care for men across the globe.”
SOURCE:
The study, led by Habtamu Mellie Bizuayehu, PhD, School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, Australia, was published online in Cancer.
LIMITATIONS:
The findings may be influenced by the quality of GLOBOCAN data. Interpretation should be cautious as MIR may not fully reflect cancer outcome inequalities. The study did not include other measures of cancer burden, such as years of life lost or years lived with disability, which were unavailable from the data source.
DISCLOSURES:
The authors did not disclose any funding information. The authors declared no 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 first appeared on Medscape.com.
TOPLINE:
— with substantial disparities in cancer cases and deaths by age and region of the world, a recent analysis found.
METHODOLOGY:
- Overall, men have higher cancer incidence and mortality rates, which can be largely attributed to a higher prevalence of modifiable risk factors such as smoking, alcohol consumption, and occupational carcinogens, as well as the underuse of cancer prevention, screening, and treatment services.
- To assess the burden of cancer in men of different ages and from different regions of the world, researchers analyzed data from the 2022 Global Cancer Observatory (GLOBOCAN), which provides national-level estimates for cancer cases and deaths.
- Study outcomes included the incidence, mortality, and prevalence of cancer among men in 2022, along with projections for 2050. Estimates were stratified by several factors, including age; region; and Human Development Index (HDI), a composite score for health, education, and standard of living.
- Researchers also calculated mortality-to-incidence ratios (MIRs) for various cancer types, where higher values indicate worse survival.
TAKEAWAY:
- The researchers reported an estimated 10.3 million cancer cases and 5.4 million deaths globally in 2022, with almost two thirds of cases and deaths occurring in men aged 65 years or older.
- By 2050, cancer cases and deaths were projected to increase by 84.3% (to 19 million) and 93.2% (to 10.5 million), respectively. The increase from 2022 to 2050 was more than twofold higher for older men and countries with low and medium HDI.
- In 2022, the estimated global cancer MIR among men was nearly 55%, with variations by cancer types, age, and HDI. The MIR was lowest for thyroid cancer (7.6%) and highest for pancreatic cancer (90.9%); among World Health Organization regions, Africa had the highest MIR (72.6%), while the Americas had the lowest MIR (39.1%); countries with the lowest HDI had the highest MIR (73.5% vs 41.1% for very high HDI).
- Lung cancer was the leading cause for cases and deaths in 2022 and was projected to remain the leading cause in 2050.
IN PRACTICE:
“Disparities in cancer incidence and mortality among men were observed across age groups, countries/territories, and HDI in 2022, with these disparities projected to widen further by 2050,” according to the authors, who called for efforts to “reduce disparities in cancer burden and ensure equity in cancer prevention and care for men across the globe.”
SOURCE:
The study, led by Habtamu Mellie Bizuayehu, PhD, School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, Australia, was published online in Cancer.
LIMITATIONS:
The findings may be influenced by the quality of GLOBOCAN data. Interpretation should be cautious as MIR may not fully reflect cancer outcome inequalities. The study did not include other measures of cancer burden, such as years of life lost or years lived with disability, which were unavailable from the data source.
DISCLOSURES:
The authors did not disclose any funding information. The authors declared no 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 first appeared on Medscape.com.
TOPLINE:
— with substantial disparities in cancer cases and deaths by age and region of the world, a recent analysis found.
METHODOLOGY:
- Overall, men have higher cancer incidence and mortality rates, which can be largely attributed to a higher prevalence of modifiable risk factors such as smoking, alcohol consumption, and occupational carcinogens, as well as the underuse of cancer prevention, screening, and treatment services.
- To assess the burden of cancer in men of different ages and from different regions of the world, researchers analyzed data from the 2022 Global Cancer Observatory (GLOBOCAN), which provides national-level estimates for cancer cases and deaths.
- Study outcomes included the incidence, mortality, and prevalence of cancer among men in 2022, along with projections for 2050. Estimates were stratified by several factors, including age; region; and Human Development Index (HDI), a composite score for health, education, and standard of living.
- Researchers also calculated mortality-to-incidence ratios (MIRs) for various cancer types, where higher values indicate worse survival.
TAKEAWAY:
- The researchers reported an estimated 10.3 million cancer cases and 5.4 million deaths globally in 2022, with almost two thirds of cases and deaths occurring in men aged 65 years or older.
- By 2050, cancer cases and deaths were projected to increase by 84.3% (to 19 million) and 93.2% (to 10.5 million), respectively. The increase from 2022 to 2050 was more than twofold higher for older men and countries with low and medium HDI.
- In 2022, the estimated global cancer MIR among men was nearly 55%, with variations by cancer types, age, and HDI. The MIR was lowest for thyroid cancer (7.6%) and highest for pancreatic cancer (90.9%); among World Health Organization regions, Africa had the highest MIR (72.6%), while the Americas had the lowest MIR (39.1%); countries with the lowest HDI had the highest MIR (73.5% vs 41.1% for very high HDI).
- Lung cancer was the leading cause for cases and deaths in 2022 and was projected to remain the leading cause in 2050.
IN PRACTICE:
“Disparities in cancer incidence and mortality among men were observed across age groups, countries/territories, and HDI in 2022, with these disparities projected to widen further by 2050,” according to the authors, who called for efforts to “reduce disparities in cancer burden and ensure equity in cancer prevention and care for men across the globe.”
SOURCE:
The study, led by Habtamu Mellie Bizuayehu, PhD, School of Public Health, Faculty of Medicine, The University of Queensland, Brisbane, Australia, was published online in Cancer.
LIMITATIONS:
The findings may be influenced by the quality of GLOBOCAN data. Interpretation should be cautious as MIR may not fully reflect cancer outcome inequalities. The study did not include other measures of cancer burden, such as years of life lost or years lived with disability, which were unavailable from the data source.
DISCLOSURES:
The authors did not disclose any funding information. The authors declared no 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 first appeared on Medscape.com.
High-Dose Psilocybin Shows Promising Results for Depression
TOPLINE:
, a new meta-analysis suggests.
METHODOLOGY:
- Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
- The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
- Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
- The primary outcome was a change in depressive symptoms from baseline.
TAKEAWAY:
- Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
- High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
- High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
- No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.
IN PRACTICE:
“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.
SOURCE:
The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ.
LIMITATIONS:
The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.
DISCLOSURES:
The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available 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:
, a new meta-analysis suggests.
METHODOLOGY:
- Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
- The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
- Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
- The primary outcome was a change in depressive symptoms from baseline.
TAKEAWAY:
- Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
- High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
- High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
- No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.
IN PRACTICE:
“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.
SOURCE:
The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ.
LIMITATIONS:
The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.
DISCLOSURES:
The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available 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:
, a new meta-analysis suggests.
METHODOLOGY:
- Researchers conducted a network meta-analysis to evaluate the comparative effectiveness of oral monotherapy with psychedelics versus escitalopram in patients with clinically diagnosed depression.
- The meta-analysis included 811 participants (mean age, 42.49 years; 54.2% women) with clinically diagnosed depression across 15 psychedelic trials and 1968 participants (mean age, 39.35 years; 62.5% women) across five escitalopram trials.
- Trials evaluated oral monotherapy with psychedelics (psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine [MDMA], and ayahuasca), fixed-dose escitalopram (up to 20 mg/d) versus placebo, and psychedelic versus escitalopram monotherapy.
- The primary outcome was a change in depressive symptoms from baseline.
TAKEAWAY:
- Placebo responses in antidepressant trials (mean difference, 3.79; 95% CI, 0.77-6.80) and extremely low-dose psilocybin (mean difference, 3.96; 95% CI, 0.61-7.17) were better than those in psychedelic trials.
- High-dose psilocybin (20 mg or more) performed better than placebo in the antidepressant trials (mean difference, > 3). However, when comparing high-dose psilocybin with the placebo used in antidepressant trials, the effect size was smaller. The standardized mean difference dropped from 0.88 to 0.31, indicating that the effect of high-dose psilocybin was similar to that of current antidepressants.
- High-dose psilocybin was associated with a greater response than escitalopram at 10 mg (4.66; 95% CI, 1.36-7.74) and 20 mg (4.69; 95% CI, 1.64-7.54).
- No interventions were associated with an increased risk for all-cause discontinuation or severe adverse events.
IN PRACTICE:
“Taken together, our study findings suggest that among psychedelic treatments, high-dose psilocybin is more likely to reach the minimal important difference for depressive symptoms in studies with adequate blinding design, while the effect size of psilocybin was similar to that of current antidepressant drugs, showing a mean standardized mean difference of 0.3,” the authors wrote.
SOURCE:
The study was led by Tien-Wei Hsu, MD, I-Shou University and Kaohsiung Medical University, Kaohsiung City, Taiwan. It was published online in The BMJ.
LIMITATIONS:
The study did not assess long-term effects of the interventions. Participants in the MDMA trials were primarily diagnosed with posttraumatic stress disorder, which may not be representative of the general population with depressive symptoms. Moreover, the sample size of the psychedelic trials was small. Using extremely low-dose psychedelics as a reference group may have eliminated some pharmacologic effects as these doses cannot be considered a placebo.
DISCLOSURES:
The study was supported by grants from the National Science and Technology Council. The authors declared no financial relationships with any organizations outside the submitted work in the past 3 years. Full disclosures are available 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.
TYK2 Inhibitor Effective for Psoriasis in Phase 2 Study
TOPLINE:
METHODOLOGY:
- Researchers performed a phase 2b, randomized, double-blind trial to assess the efficacy, safety, and tolerability of different doses of zasocitinib in adults with moderate to severe psoriasis (mean age, 47 years; 32% women) at 47 centers in the United States and eight centers in Canada. Most (83%) were White, 7% were Black, and 8% were Asian.
- A total of 287 patients were randomly assigned to receive one of the four oral doses of zasocitinib (2 mg, 5 mg, 15 mg, or 30 mg, once daily) or a matched placebo for 12 weeks, followed by a 4-week safety monitoring period.
- The primary outcome was the proportion of patients achieving a ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) from baseline at week 12.
TAKEAWAY:
- At week 12, PASI 75 was achieved by 18%, 44%, 68%, and 67% of patients receiving zasocitinib at doses of 2 mg, 5 mg, 15 mg, and 30 mg, respectively, vs 6% of patients receiving placebo.
- PASI 90 was achieved in 8%, 21%, 45%, and 46% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, and in no patients in the placebo group.
- At week 12, 10%, 27%, 49%, and 52% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, had no or mild disease (a score of 0 or 1) according to the Physician Global Assessment tool vs 4% in the placebo group.
- Treatment-emergent adverse events occurred in 53%-62% of patients in the zasocitinib groups compared with 44% in the placebo group. The most common were COVID-19, acne/acneiform dermatitis, and diarrhea. There were no reports of major adverse cardiovascular events, thromboembolic events, or opportunistic infections.
IN PRACTICE:
“Zasocitinib, an advanced, potent, and highly selective oral TYK2 inhibitor bioengineered to optimize target coverage and functional selectivity, achieved biologic-level efficacy with complete skin clearance observed after only a 12-week treatment period in up to one third of patients, with a low incidence of known tolerability issues and absence of serious toxic effects that are characteristic of [Janus kinase] 1-3 inhibition,” the authors wrote.
SOURCE:
The study was led by April W. Armstrong, MD, MPH, University of California, Los Angeles, and was published online on August 21, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was limited by a relatively small sample size and a short duration. In addition, the inclusion of predominantly White patients may limit the generalizability of findings to a diverse population.
DISCLOSURES:
The study was funded by Nimbus Discovery, which includes Nimbus Therapeutics and Nimbus Lakshmi. Dr. Armstrong’s disclosures included receiving grants and/or personal fees from various pharmaceutical companies, including Nimbus Therapeutics and Nimbus. Three authors were employees of and reported holding equity, stocks, or shares in Nimbus. Several authors had disclosures related to pharmaceutical companies, including Nimbus.
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:
METHODOLOGY:
- Researchers performed a phase 2b, randomized, double-blind trial to assess the efficacy, safety, and tolerability of different doses of zasocitinib in adults with moderate to severe psoriasis (mean age, 47 years; 32% women) at 47 centers in the United States and eight centers in Canada. Most (83%) were White, 7% were Black, and 8% were Asian.
- A total of 287 patients were randomly assigned to receive one of the four oral doses of zasocitinib (2 mg, 5 mg, 15 mg, or 30 mg, once daily) or a matched placebo for 12 weeks, followed by a 4-week safety monitoring period.
- The primary outcome was the proportion of patients achieving a ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) from baseline at week 12.
TAKEAWAY:
- At week 12, PASI 75 was achieved by 18%, 44%, 68%, and 67% of patients receiving zasocitinib at doses of 2 mg, 5 mg, 15 mg, and 30 mg, respectively, vs 6% of patients receiving placebo.
- PASI 90 was achieved in 8%, 21%, 45%, and 46% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, and in no patients in the placebo group.
- At week 12, 10%, 27%, 49%, and 52% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, had no or mild disease (a score of 0 or 1) according to the Physician Global Assessment tool vs 4% in the placebo group.
- Treatment-emergent adverse events occurred in 53%-62% of patients in the zasocitinib groups compared with 44% in the placebo group. The most common were COVID-19, acne/acneiform dermatitis, and diarrhea. There were no reports of major adverse cardiovascular events, thromboembolic events, or opportunistic infections.
IN PRACTICE:
“Zasocitinib, an advanced, potent, and highly selective oral TYK2 inhibitor bioengineered to optimize target coverage and functional selectivity, achieved biologic-level efficacy with complete skin clearance observed after only a 12-week treatment period in up to one third of patients, with a low incidence of known tolerability issues and absence of serious toxic effects that are characteristic of [Janus kinase] 1-3 inhibition,” the authors wrote.
SOURCE:
The study was led by April W. Armstrong, MD, MPH, University of California, Los Angeles, and was published online on August 21, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was limited by a relatively small sample size and a short duration. In addition, the inclusion of predominantly White patients may limit the generalizability of findings to a diverse population.
DISCLOSURES:
The study was funded by Nimbus Discovery, which includes Nimbus Therapeutics and Nimbus Lakshmi. Dr. Armstrong’s disclosures included receiving grants and/or personal fees from various pharmaceutical companies, including Nimbus Therapeutics and Nimbus. Three authors were employees of and reported holding equity, stocks, or shares in Nimbus. Several authors had disclosures related to pharmaceutical companies, including Nimbus.
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:
METHODOLOGY:
- Researchers performed a phase 2b, randomized, double-blind trial to assess the efficacy, safety, and tolerability of different doses of zasocitinib in adults with moderate to severe psoriasis (mean age, 47 years; 32% women) at 47 centers in the United States and eight centers in Canada. Most (83%) were White, 7% were Black, and 8% were Asian.
- A total of 287 patients were randomly assigned to receive one of the four oral doses of zasocitinib (2 mg, 5 mg, 15 mg, or 30 mg, once daily) or a matched placebo for 12 weeks, followed by a 4-week safety monitoring period.
- The primary outcome was the proportion of patients achieving a ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) from baseline at week 12.
TAKEAWAY:
- At week 12, PASI 75 was achieved by 18%, 44%, 68%, and 67% of patients receiving zasocitinib at doses of 2 mg, 5 mg, 15 mg, and 30 mg, respectively, vs 6% of patients receiving placebo.
- PASI 90 was achieved in 8%, 21%, 45%, and 46% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, and in no patients in the placebo group.
- At week 12, 10%, 27%, 49%, and 52% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, had no or mild disease (a score of 0 or 1) according to the Physician Global Assessment tool vs 4% in the placebo group.
- Treatment-emergent adverse events occurred in 53%-62% of patients in the zasocitinib groups compared with 44% in the placebo group. The most common were COVID-19, acne/acneiform dermatitis, and diarrhea. There were no reports of major adverse cardiovascular events, thromboembolic events, or opportunistic infections.
IN PRACTICE:
“Zasocitinib, an advanced, potent, and highly selective oral TYK2 inhibitor bioengineered to optimize target coverage and functional selectivity, achieved biologic-level efficacy with complete skin clearance observed after only a 12-week treatment period in up to one third of patients, with a low incidence of known tolerability issues and absence of serious toxic effects that are characteristic of [Janus kinase] 1-3 inhibition,” the authors wrote.
SOURCE:
The study was led by April W. Armstrong, MD, MPH, University of California, Los Angeles, and was published online on August 21, 2024, in JAMA Dermatology.
LIMITATIONS:
The study was limited by a relatively small sample size and a short duration. In addition, the inclusion of predominantly White patients may limit the generalizability of findings to a diverse population.
DISCLOSURES:
The study was funded by Nimbus Discovery, which includes Nimbus Therapeutics and Nimbus Lakshmi. Dr. Armstrong’s disclosures included receiving grants and/or personal fees from various pharmaceutical companies, including Nimbus Therapeutics and Nimbus. Three authors were employees of and reported holding equity, stocks, or shares in Nimbus. Several authors had disclosures related to pharmaceutical companies, including Nimbus.
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.
Hearing Loss, Neuropathy Cut Survival in Older Adults
TOPLINE:
METHODOLOGY:
- Researchers analyzed 793 older adults recruited from primary care practices participating in the OKLAHOMA Studies in 1999.
- Participants completed a questionnaire and underwent a physical examination; timed gait assessments (50 ft); and tests for peripheral nerve function, balance, and hearing.
- Hearing thresholds were tested at 20, 25, and 40 dB, respectively, and at sound frequencies of 500, 1000, 2000, and 4000 Hz.
- Researchers tracked mortality data over 22 years.
TAKEAWAY:
- Overall, 83% participants experienced hearing loss. Regular use of hearing aids was low, reported in 19% and 55% of those with moderate and severe hearing loss, respectively.
- Hearing loss was linked to impaired balance (P = .0014), slower walking (P = .0024), and reduced survival time (P = .0001). Moderate to severe hearing loss was strongly associated with reduced survival time (odds ratio, 1.36; P = .001), independent of the use of hearing aids.
- Peripheral neuropathy was present in 32% participants. The condition also increased the risk for death over the study period (hazard ratio [HR], 1.32; P = .003). Participants with both hearing loss and peripheral neuropathy showed reduced balance and survival time compared with people with either condition alone (HR, 1.55; P < .0001).
IN PRACTICE:
“Like peripheral neuropathy, advanced-age hearing loss is associated with reduced life expectancy, probably mediated in part through an adverse impact on balance,” the authors wrote. “Greater appreciation for the serious impacts of hearing loss and peripheral neuropathy could lead to further efforts to understand their causes and improve prevention and treatment strategies.”
SOURCE:
The study was led by James W. Mold, MD, MPH, of the University of Oklahoma Health Sciences Center, Oklahoma City. It was published online in the Journal of the American Geriatrics Society.
LIMITATIONS:
The dataset was collected in 1999 and may not entirely represent the current cohorts of older primary care patients. The absence of soundproof rooms and the exclusion of some components of the standard audiometric evaluation may have affected low-frequency sound measurements. Furthermore, physical examination was a less accurate measure of peripheral neuropathy. Information on the duration or severity of predictors and causes of death was not available.
DISCLOSURES:
The study was funded by the Presbyterian Health Foundation. The authors did not disclose any competing interests.
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:
METHODOLOGY:
- Researchers analyzed 793 older adults recruited from primary care practices participating in the OKLAHOMA Studies in 1999.
- Participants completed a questionnaire and underwent a physical examination; timed gait assessments (50 ft); and tests for peripheral nerve function, balance, and hearing.
- Hearing thresholds were tested at 20, 25, and 40 dB, respectively, and at sound frequencies of 500, 1000, 2000, and 4000 Hz.
- Researchers tracked mortality data over 22 years.
TAKEAWAY:
- Overall, 83% participants experienced hearing loss. Regular use of hearing aids was low, reported in 19% and 55% of those with moderate and severe hearing loss, respectively.
- Hearing loss was linked to impaired balance (P = .0014), slower walking (P = .0024), and reduced survival time (P = .0001). Moderate to severe hearing loss was strongly associated with reduced survival time (odds ratio, 1.36; P = .001), independent of the use of hearing aids.
- Peripheral neuropathy was present in 32% participants. The condition also increased the risk for death over the study period (hazard ratio [HR], 1.32; P = .003). Participants with both hearing loss and peripheral neuropathy showed reduced balance and survival time compared with people with either condition alone (HR, 1.55; P < .0001).
IN PRACTICE:
“Like peripheral neuropathy, advanced-age hearing loss is associated with reduced life expectancy, probably mediated in part through an adverse impact on balance,” the authors wrote. “Greater appreciation for the serious impacts of hearing loss and peripheral neuropathy could lead to further efforts to understand their causes and improve prevention and treatment strategies.”
SOURCE:
The study was led by James W. Mold, MD, MPH, of the University of Oklahoma Health Sciences Center, Oklahoma City. It was published online in the Journal of the American Geriatrics Society.
LIMITATIONS:
The dataset was collected in 1999 and may not entirely represent the current cohorts of older primary care patients. The absence of soundproof rooms and the exclusion of some components of the standard audiometric evaluation may have affected low-frequency sound measurements. Furthermore, physical examination was a less accurate measure of peripheral neuropathy. Information on the duration or severity of predictors and causes of death was not available.
DISCLOSURES:
The study was funded by the Presbyterian Health Foundation. The authors did not disclose any competing interests.
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:
METHODOLOGY:
- Researchers analyzed 793 older adults recruited from primary care practices participating in the OKLAHOMA Studies in 1999.
- Participants completed a questionnaire and underwent a physical examination; timed gait assessments (50 ft); and tests for peripheral nerve function, balance, and hearing.
- Hearing thresholds were tested at 20, 25, and 40 dB, respectively, and at sound frequencies of 500, 1000, 2000, and 4000 Hz.
- Researchers tracked mortality data over 22 years.
TAKEAWAY:
- Overall, 83% participants experienced hearing loss. Regular use of hearing aids was low, reported in 19% and 55% of those with moderate and severe hearing loss, respectively.
- Hearing loss was linked to impaired balance (P = .0014), slower walking (P = .0024), and reduced survival time (P = .0001). Moderate to severe hearing loss was strongly associated with reduced survival time (odds ratio, 1.36; P = .001), independent of the use of hearing aids.
- Peripheral neuropathy was present in 32% participants. The condition also increased the risk for death over the study period (hazard ratio [HR], 1.32; P = .003). Participants with both hearing loss and peripheral neuropathy showed reduced balance and survival time compared with people with either condition alone (HR, 1.55; P < .0001).
IN PRACTICE:
“Like peripheral neuropathy, advanced-age hearing loss is associated with reduced life expectancy, probably mediated in part through an adverse impact on balance,” the authors wrote. “Greater appreciation for the serious impacts of hearing loss and peripheral neuropathy could lead to further efforts to understand their causes and improve prevention and treatment strategies.”
SOURCE:
The study was led by James W. Mold, MD, MPH, of the University of Oklahoma Health Sciences Center, Oklahoma City. It was published online in the Journal of the American Geriatrics Society.
LIMITATIONS:
The dataset was collected in 1999 and may not entirely represent the current cohorts of older primary care patients. The absence of soundproof rooms and the exclusion of some components of the standard audiometric evaluation may have affected low-frequency sound measurements. Furthermore, physical examination was a less accurate measure of peripheral neuropathy. Information on the duration or severity of predictors and causes of death was not available.
DISCLOSURES:
The study was funded by the Presbyterian Health Foundation. The authors did not disclose any competing interests.
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.
Liver Transplant Delays Progression in Colorectal Metastasis
TOPLINE:
METHODOLOGY:
- Research has shown promising results for well-selected patients with unresectable colorectal liver metastasis undergoing liver transplant; however, the absence of a suitable comparison group makes it difficult to evaluate the overall effectiveness of this treatment method.
- Researchers evaluated 33 patients with colorectal cancer and unresectable liver metastasis (mean age, 43.5 years; 52% women) who were eligible for liver transplants, according to validated selection criteria.
- Of these, 20 patients (61%) underwent a liver transplant, while 13 (39%) declined transplantation and received alternative therapy.
- Patients who received liver transplants did not undergo regular chemotherapy until recurrence, whereas those in the alternative therapy group continued systemic chemotherapy, with hepatic artery infusion pump placement (n = 5), liver resections (n = 6), and locoregional therapies (n = 6).
- The main outcomes of the study were overall survival and PFS.
TAKEAWAY:
- The median follow-up duration was 986 days in the liver transplant group and 657 days in the alternative therapy group.
- Patients who underwent liver transplant showed higher PFS rates at 1 year (90.0% vs 41.7%), 2 years (72.7% vs 10.4%), and 3 years (36.4% vs 10.4%). The PFS gains were statistically significant (P < .01).
- Overall survival was also higher in the transplant group — 100% vs 83.9% at 1 year, and 90.0% vs 73.4% at both 2 and 3 years. The differences, however, did not reach significance (P = .12).
- Liver transplant was associated with a lower recurrence rate (5% vs 23%), which also did not reach significance (P = .28) possibly because of the small patient population.
IN PRACTICE:
“This study represents the best available data for evaluating alternatives to [liver transplant],” the authors wrote, adding that the patients should be “referred for multidisciplinary evaluation to transplant oncology centers with strict criteria.”
SOURCE:
The study was led by Matthew M. Byrne, MD, Department of Surgery, University of Rochester Medical Center, Rochester, New York, and was published online in JAMA Surgery.
LIMITATIONS:
The patient population was small, making it difficult to interpret statistical significance. The inclusion of patients with financial and social support might limit generalizability. The survival was calculated from the date of transplant or dropout. Additionally, the study did not explore sex-based differences in treatment choice.
DISCLOSURES:
The authors did not disclose any funding information. One author reported holding shares with HistoSonics, not related to 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:
METHODOLOGY:
- Research has shown promising results for well-selected patients with unresectable colorectal liver metastasis undergoing liver transplant; however, the absence of a suitable comparison group makes it difficult to evaluate the overall effectiveness of this treatment method.
- Researchers evaluated 33 patients with colorectal cancer and unresectable liver metastasis (mean age, 43.5 years; 52% women) who were eligible for liver transplants, according to validated selection criteria.
- Of these, 20 patients (61%) underwent a liver transplant, while 13 (39%) declined transplantation and received alternative therapy.
- Patients who received liver transplants did not undergo regular chemotherapy until recurrence, whereas those in the alternative therapy group continued systemic chemotherapy, with hepatic artery infusion pump placement (n = 5), liver resections (n = 6), and locoregional therapies (n = 6).
- The main outcomes of the study were overall survival and PFS.
TAKEAWAY:
- The median follow-up duration was 986 days in the liver transplant group and 657 days in the alternative therapy group.
- Patients who underwent liver transplant showed higher PFS rates at 1 year (90.0% vs 41.7%), 2 years (72.7% vs 10.4%), and 3 years (36.4% vs 10.4%). The PFS gains were statistically significant (P < .01).
- Overall survival was also higher in the transplant group — 100% vs 83.9% at 1 year, and 90.0% vs 73.4% at both 2 and 3 years. The differences, however, did not reach significance (P = .12).
- Liver transplant was associated with a lower recurrence rate (5% vs 23%), which also did not reach significance (P = .28) possibly because of the small patient population.
IN PRACTICE:
“This study represents the best available data for evaluating alternatives to [liver transplant],” the authors wrote, adding that the patients should be “referred for multidisciplinary evaluation to transplant oncology centers with strict criteria.”
SOURCE:
The study was led by Matthew M. Byrne, MD, Department of Surgery, University of Rochester Medical Center, Rochester, New York, and was published online in JAMA Surgery.
LIMITATIONS:
The patient population was small, making it difficult to interpret statistical significance. The inclusion of patients with financial and social support might limit generalizability. The survival was calculated from the date of transplant or dropout. Additionally, the study did not explore sex-based differences in treatment choice.
DISCLOSURES:
The authors did not disclose any funding information. One author reported holding shares with HistoSonics, not related to 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:
METHODOLOGY:
- Research has shown promising results for well-selected patients with unresectable colorectal liver metastasis undergoing liver transplant; however, the absence of a suitable comparison group makes it difficult to evaluate the overall effectiveness of this treatment method.
- Researchers evaluated 33 patients with colorectal cancer and unresectable liver metastasis (mean age, 43.5 years; 52% women) who were eligible for liver transplants, according to validated selection criteria.
- Of these, 20 patients (61%) underwent a liver transplant, while 13 (39%) declined transplantation and received alternative therapy.
- Patients who received liver transplants did not undergo regular chemotherapy until recurrence, whereas those in the alternative therapy group continued systemic chemotherapy, with hepatic artery infusion pump placement (n = 5), liver resections (n = 6), and locoregional therapies (n = 6).
- The main outcomes of the study were overall survival and PFS.
TAKEAWAY:
- The median follow-up duration was 986 days in the liver transplant group and 657 days in the alternative therapy group.
- Patients who underwent liver transplant showed higher PFS rates at 1 year (90.0% vs 41.7%), 2 years (72.7% vs 10.4%), and 3 years (36.4% vs 10.4%). The PFS gains were statistically significant (P < .01).
- Overall survival was also higher in the transplant group — 100% vs 83.9% at 1 year, and 90.0% vs 73.4% at both 2 and 3 years. The differences, however, did not reach significance (P = .12).
- Liver transplant was associated with a lower recurrence rate (5% vs 23%), which also did not reach significance (P = .28) possibly because of the small patient population.
IN PRACTICE:
“This study represents the best available data for evaluating alternatives to [liver transplant],” the authors wrote, adding that the patients should be “referred for multidisciplinary evaluation to transplant oncology centers with strict criteria.”
SOURCE:
The study was led by Matthew M. Byrne, MD, Department of Surgery, University of Rochester Medical Center, Rochester, New York, and was published online in JAMA Surgery.
LIMITATIONS:
The patient population was small, making it difficult to interpret statistical significance. The inclusion of patients with financial and social support might limit generalizability. The survival was calculated from the date of transplant or dropout. Additionally, the study did not explore sex-based differences in treatment choice.
DISCLOSURES:
The authors did not disclose any funding information. One author reported holding shares with HistoSonics, not related to 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.
Few Severe Toxicities After SBRT in Oligometastatic Cancer
TOPLINE:
according to a large real-world analysis.
METHODOLOGY:
- Advances in cancer imaging have helped identify more patients with oligometastatic disease. Although the standard treatment approach typically involves systemic therapy such as chemotherapy and immunotherapy, SBRT has increasingly become an option for these patients. However, the toxicities associated with SBRT remain less clear.
- OligoCare, a European, prospective, registry-based, single-arm observational study, aims to provide real-world outcomes among patients with oligometastatic cancer who received SBRT. In this analysis, the researchers evaluated early toxicities among 1468 patients with different primary cancers — non–small cell lung cancer (NSCLC; 19.7%), colorectal cancer (20%), breast cancer (15.5%), and prostate cancer (44.8%).
- The primary outcome was acute toxicities, including new malignancies and deaths, within 6 months of initiating SBRT.
- Overall, 527 (35.9%) patients received concomitant systemic treatment and 828 (56%) had de novo oligometastatic disease.
TAKEAWAY:
- Overall, though, only eight patients (0.5%) experienced acute SBRT-related toxicity of grade 3 and above within 6 months; two events, however, were fatal (pneumonitis and cerebral hemorrhage), and both occurred in patients with NSCLC.
- The other six grade 3 events included one instance of each of the following: empyema, pneumonia, radiation pneumonitis, radiation skin injury, decreased appetite, and bone pain. Two of these events occurred in patients with NSCLC, two in patients with breast cancer, one in patients with colorectal cancer, and one in patients with prostate cancer.
- New primary malignancies were reported in 13 (0.9%) patients, which included bladder cancer (n = 3), nonmelanoma skin cancer (n = 3), and leukemia (n = 1).
- Overall, 43 (2.9%) patients died within 6 months, most from their primary cancer (58.1%).
IN PRACTICE:
Low rates of early acute toxicities reported in this real-world study help confirm the safety of SBRT in the treatment of oligometastases, the authors concluded. However, “some anatomical sites might be associated with an increased risk of even severe or fatal toxicities.”
SOURCE:
The study, led by Filippo Alongi, Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center, Negrar di Valpolicella, Italy, and University of Brescia, also in Italy, was published online in Radiotherapy & Oncology .
LIMITATIONS:
Some limitations of the study include the nonrandomized design and potential variability in patient selection criteria, treatment doses, and schedules.
DISCLOSURES:
The study did not receive any funding support. Two authors declared receiving speaker or lecture honoraria or consultation fees from 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:
according to a large real-world analysis.
METHODOLOGY:
- Advances in cancer imaging have helped identify more patients with oligometastatic disease. Although the standard treatment approach typically involves systemic therapy such as chemotherapy and immunotherapy, SBRT has increasingly become an option for these patients. However, the toxicities associated with SBRT remain less clear.
- OligoCare, a European, prospective, registry-based, single-arm observational study, aims to provide real-world outcomes among patients with oligometastatic cancer who received SBRT. In this analysis, the researchers evaluated early toxicities among 1468 patients with different primary cancers — non–small cell lung cancer (NSCLC; 19.7%), colorectal cancer (20%), breast cancer (15.5%), and prostate cancer (44.8%).
- The primary outcome was acute toxicities, including new malignancies and deaths, within 6 months of initiating SBRT.
- Overall, 527 (35.9%) patients received concomitant systemic treatment and 828 (56%) had de novo oligometastatic disease.
TAKEAWAY:
- Overall, though, only eight patients (0.5%) experienced acute SBRT-related toxicity of grade 3 and above within 6 months; two events, however, were fatal (pneumonitis and cerebral hemorrhage), and both occurred in patients with NSCLC.
- The other six grade 3 events included one instance of each of the following: empyema, pneumonia, radiation pneumonitis, radiation skin injury, decreased appetite, and bone pain. Two of these events occurred in patients with NSCLC, two in patients with breast cancer, one in patients with colorectal cancer, and one in patients with prostate cancer.
- New primary malignancies were reported in 13 (0.9%) patients, which included bladder cancer (n = 3), nonmelanoma skin cancer (n = 3), and leukemia (n = 1).
- Overall, 43 (2.9%) patients died within 6 months, most from their primary cancer (58.1%).
IN PRACTICE:
Low rates of early acute toxicities reported in this real-world study help confirm the safety of SBRT in the treatment of oligometastases, the authors concluded. However, “some anatomical sites might be associated with an increased risk of even severe or fatal toxicities.”
SOURCE:
The study, led by Filippo Alongi, Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center, Negrar di Valpolicella, Italy, and University of Brescia, also in Italy, was published online in Radiotherapy & Oncology .
LIMITATIONS:
Some limitations of the study include the nonrandomized design and potential variability in patient selection criteria, treatment doses, and schedules.
DISCLOSURES:
The study did not receive any funding support. Two authors declared receiving speaker or lecture honoraria or consultation fees from 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:
according to a large real-world analysis.
METHODOLOGY:
- Advances in cancer imaging have helped identify more patients with oligometastatic disease. Although the standard treatment approach typically involves systemic therapy such as chemotherapy and immunotherapy, SBRT has increasingly become an option for these patients. However, the toxicities associated with SBRT remain less clear.
- OligoCare, a European, prospective, registry-based, single-arm observational study, aims to provide real-world outcomes among patients with oligometastatic cancer who received SBRT. In this analysis, the researchers evaluated early toxicities among 1468 patients with different primary cancers — non–small cell lung cancer (NSCLC; 19.7%), colorectal cancer (20%), breast cancer (15.5%), and prostate cancer (44.8%).
- The primary outcome was acute toxicities, including new malignancies and deaths, within 6 months of initiating SBRT.
- Overall, 527 (35.9%) patients received concomitant systemic treatment and 828 (56%) had de novo oligometastatic disease.
TAKEAWAY:
- Overall, though, only eight patients (0.5%) experienced acute SBRT-related toxicity of grade 3 and above within 6 months; two events, however, were fatal (pneumonitis and cerebral hemorrhage), and both occurred in patients with NSCLC.
- The other six grade 3 events included one instance of each of the following: empyema, pneumonia, radiation pneumonitis, radiation skin injury, decreased appetite, and bone pain. Two of these events occurred in patients with NSCLC, two in patients with breast cancer, one in patients with colorectal cancer, and one in patients with prostate cancer.
- New primary malignancies were reported in 13 (0.9%) patients, which included bladder cancer (n = 3), nonmelanoma skin cancer (n = 3), and leukemia (n = 1).
- Overall, 43 (2.9%) patients died within 6 months, most from their primary cancer (58.1%).
IN PRACTICE:
Low rates of early acute toxicities reported in this real-world study help confirm the safety of SBRT in the treatment of oligometastases, the authors concluded. However, “some anatomical sites might be associated with an increased risk of even severe or fatal toxicities.”
SOURCE:
The study, led by Filippo Alongi, Advanced Radiation Oncology Department, IRCCS Sacro Cuore Don Calabria Hospital, Cancer Care Center, Negrar di Valpolicella, Italy, and University of Brescia, also in Italy, was published online in Radiotherapy & Oncology .
LIMITATIONS:
Some limitations of the study include the nonrandomized design and potential variability in patient selection criteria, treatment doses, and schedules.
DISCLOSURES:
The study did not receive any funding support. Two authors declared receiving speaker or lecture honoraria or consultation fees from 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.
Radiation Therapy Underused After Nipple-Sparing Mastectomy
TOPLINE:
METHODOLOGY:
- Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
- Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
- The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
- The team also compared overall survival outcomes in patients with positive margins and node involvement.
TAKEAWAY:
- Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
- Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
- Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
- In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).
IN PRACTICE:
The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.
SOURCE:
The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology.
LIMITATIONS:
Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes.
DISCLOSURES:
The study did not receive any funding support. The authors disclosed no 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 first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
- Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
- The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
- The team also compared overall survival outcomes in patients with positive margins and node involvement.
TAKEAWAY:
- Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
- Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
- Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
- In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).
IN PRACTICE:
The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.
SOURCE:
The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology.
LIMITATIONS:
Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes.
DISCLOSURES:
The study did not receive any funding support. The authors disclosed no 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 first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
- Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
- The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
- The team also compared overall survival outcomes in patients with positive margins and node involvement.
TAKEAWAY:
- Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
- Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
- Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
- In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).
IN PRACTICE:
The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.
SOURCE:
The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology.
LIMITATIONS:
Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes.
DISCLOSURES:
The study did not receive any funding support. The authors disclosed no 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 first appeared on Medscape.com.