Can Better Diet Improve Survival in Black Women With Ovarian Cancer?

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Tue, 10/29/2024 - 09:36

 

TOPLINE:

Better prediagnosis dietary quality is linked to improved survival in Black women with high-grade serous ovarian cancer (HGSOC). No significant survival association was found among the full study sample, which included women with multiple types of epithelial ovarian cancer (EOC).

METHODOLOGY:

  • Researchers conducted a prospective cohort study among 483 self-identified Black women aged 20-79 years newly diagnosed with histologically confirmed EOC between December 2010 and December 2015.
  • The study aimed to examine associations between dietary patterns and survival among Black women diagnosed with EOC using data from the African American Cancer Epidemiology Study.
  • Dietary patterns were assessed using the Healthy Eating Index–2020 (HEI-2020) and Alternative Healthy Eating Index–2010 (AHEI-2010), based on dietary intake in the year prior to diagnosis collected via the validated Block 2005 Food Frequency Questionnaire (FFQ). Participant characteristics were summarized across quartiles of HEI-2020 and AHEI-2010 scores.
  • The researchers obtained and summarized clinical characteristics, including tumor characteristics, first-line treatment regimen, debulking status, residual disease, and cancer antigen 125 levels, from medical records.
  • The main outcome measure was overall survival, with hazard ratios (HRs) and 95% CIs estimated from multivariable Cox models for the association between adherence to dietary recommendations and overall mortality. Follow-up was conducted until October 2022, with data analyzed from March 2023 to June 2024.

TAKEAWAY:

  • No significant association was found between dietary patterns and overall mortality among women with EOC.
  • Among women with HGSOC, the most lethal histotype of EOC, better adherence to the HEI-2020 was associated with decreased mortality in later quartiles vs the first quartile (HR, 0.63; 95% CI, 0.44-0.92).
  • Similar results were observed with the AHEI-2010 among women with HGSOC for the second (HR, 0.62; 95% CI, 0.43-0.89) and fourth (HR, 0.67; 95% CI, 0.45-0.98) quartiles vs the first quartile.
  • Women with moderate and high prediagnosis dietary quality had significantly lower mortality rates from HGSOC than those with the lowest prediagnosis dietary quality.

IN PRACTICE:

“Our findings suggest that prediagnosis dietary patterns (ie, the combination of foods and nutrients) are more important than individual components for ovarian cancer survival as shown by comparing results of dietary patterns with individual components,” the authors of the study wrote.

SOURCE:

This study was led by Tsion A. Armidie, MPH, Rollins School of Public Health, Emory University in Atlanta, Georgia. It was published online on October 18 in JAMA Network Open.

LIMITATIONS:

This study’s limitations included the potential for residual confounding, despite accounting for a wide array of covariates. The median time between diagnosis and FFQ completion was 5.8 months, which may have introduced measurement errors in dietary recall. Additionally, the study did not collect postdiagnostic dietary information, which could have provided further insights into the association between diet and survival.

DISCLOSURES:

This study was supported by grants from the National Cancer Institute. One coauthor reported receiving personal fees from Pfizer outside the submitted work. One coauthor reported receiving grants from the US Department of Defense during the conduct of the study and Bristol-Myers Squibb and Karyopharm outside the submitted work. One coauthor reported receiving personal fees from Ashcraft and Gerel outside the submitted work. One coauthor reported receiving personal fees from Epidemiologic Research & Methods outside the submitted work. Additional disclosures are noted in the original article.

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

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TOPLINE:

Better prediagnosis dietary quality is linked to improved survival in Black women with high-grade serous ovarian cancer (HGSOC). No significant survival association was found among the full study sample, which included women with multiple types of epithelial ovarian cancer (EOC).

METHODOLOGY:

  • Researchers conducted a prospective cohort study among 483 self-identified Black women aged 20-79 years newly diagnosed with histologically confirmed EOC between December 2010 and December 2015.
  • The study aimed to examine associations between dietary patterns and survival among Black women diagnosed with EOC using data from the African American Cancer Epidemiology Study.
  • Dietary patterns were assessed using the Healthy Eating Index–2020 (HEI-2020) and Alternative Healthy Eating Index–2010 (AHEI-2010), based on dietary intake in the year prior to diagnosis collected via the validated Block 2005 Food Frequency Questionnaire (FFQ). Participant characteristics were summarized across quartiles of HEI-2020 and AHEI-2010 scores.
  • The researchers obtained and summarized clinical characteristics, including tumor characteristics, first-line treatment regimen, debulking status, residual disease, and cancer antigen 125 levels, from medical records.
  • The main outcome measure was overall survival, with hazard ratios (HRs) and 95% CIs estimated from multivariable Cox models for the association between adherence to dietary recommendations and overall mortality. Follow-up was conducted until October 2022, with data analyzed from March 2023 to June 2024.

TAKEAWAY:

  • No significant association was found between dietary patterns and overall mortality among women with EOC.
  • Among women with HGSOC, the most lethal histotype of EOC, better adherence to the HEI-2020 was associated with decreased mortality in later quartiles vs the first quartile (HR, 0.63; 95% CI, 0.44-0.92).
  • Similar results were observed with the AHEI-2010 among women with HGSOC for the second (HR, 0.62; 95% CI, 0.43-0.89) and fourth (HR, 0.67; 95% CI, 0.45-0.98) quartiles vs the first quartile.
  • Women with moderate and high prediagnosis dietary quality had significantly lower mortality rates from HGSOC than those with the lowest prediagnosis dietary quality.

IN PRACTICE:

“Our findings suggest that prediagnosis dietary patterns (ie, the combination of foods and nutrients) are more important than individual components for ovarian cancer survival as shown by comparing results of dietary patterns with individual components,” the authors of the study wrote.

SOURCE:

This study was led by Tsion A. Armidie, MPH, Rollins School of Public Health, Emory University in Atlanta, Georgia. It was published online on October 18 in JAMA Network Open.

LIMITATIONS:

This study’s limitations included the potential for residual confounding, despite accounting for a wide array of covariates. The median time between diagnosis and FFQ completion was 5.8 months, which may have introduced measurement errors in dietary recall. Additionally, the study did not collect postdiagnostic dietary information, which could have provided further insights into the association between diet and survival.

DISCLOSURES:

This study was supported by grants from the National Cancer Institute. One coauthor reported receiving personal fees from Pfizer outside the submitted work. One coauthor reported receiving grants from the US Department of Defense during the conduct of the study and Bristol-Myers Squibb and Karyopharm outside the submitted work. One coauthor reported receiving personal fees from Ashcraft and Gerel outside the submitted work. One coauthor reported receiving personal fees from Epidemiologic Research & Methods outside the submitted work. Additional disclosures are noted in the original article.

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

 

TOPLINE:

Better prediagnosis dietary quality is linked to improved survival in Black women with high-grade serous ovarian cancer (HGSOC). No significant survival association was found among the full study sample, which included women with multiple types of epithelial ovarian cancer (EOC).

METHODOLOGY:

  • Researchers conducted a prospective cohort study among 483 self-identified Black women aged 20-79 years newly diagnosed with histologically confirmed EOC between December 2010 and December 2015.
  • The study aimed to examine associations between dietary patterns and survival among Black women diagnosed with EOC using data from the African American Cancer Epidemiology Study.
  • Dietary patterns were assessed using the Healthy Eating Index–2020 (HEI-2020) and Alternative Healthy Eating Index–2010 (AHEI-2010), based on dietary intake in the year prior to diagnosis collected via the validated Block 2005 Food Frequency Questionnaire (FFQ). Participant characteristics were summarized across quartiles of HEI-2020 and AHEI-2010 scores.
  • The researchers obtained and summarized clinical characteristics, including tumor characteristics, first-line treatment regimen, debulking status, residual disease, and cancer antigen 125 levels, from medical records.
  • The main outcome measure was overall survival, with hazard ratios (HRs) and 95% CIs estimated from multivariable Cox models for the association between adherence to dietary recommendations and overall mortality. Follow-up was conducted until October 2022, with data analyzed from March 2023 to June 2024.

TAKEAWAY:

  • No significant association was found between dietary patterns and overall mortality among women with EOC.
  • Among women with HGSOC, the most lethal histotype of EOC, better adherence to the HEI-2020 was associated with decreased mortality in later quartiles vs the first quartile (HR, 0.63; 95% CI, 0.44-0.92).
  • Similar results were observed with the AHEI-2010 among women with HGSOC for the second (HR, 0.62; 95% CI, 0.43-0.89) and fourth (HR, 0.67; 95% CI, 0.45-0.98) quartiles vs the first quartile.
  • Women with moderate and high prediagnosis dietary quality had significantly lower mortality rates from HGSOC than those with the lowest prediagnosis dietary quality.

IN PRACTICE:

“Our findings suggest that prediagnosis dietary patterns (ie, the combination of foods and nutrients) are more important than individual components for ovarian cancer survival as shown by comparing results of dietary patterns with individual components,” the authors of the study wrote.

SOURCE:

This study was led by Tsion A. Armidie, MPH, Rollins School of Public Health, Emory University in Atlanta, Georgia. It was published online on October 18 in JAMA Network Open.

LIMITATIONS:

This study’s limitations included the potential for residual confounding, despite accounting for a wide array of covariates. The median time between diagnosis and FFQ completion was 5.8 months, which may have introduced measurement errors in dietary recall. Additionally, the study did not collect postdiagnostic dietary information, which could have provided further insights into the association between diet and survival.

DISCLOSURES:

This study was supported by grants from the National Cancer Institute. One coauthor reported receiving personal fees from Pfizer outside the submitted work. One coauthor reported receiving grants from the US Department of Defense during the conduct of the study and Bristol-Myers Squibb and Karyopharm outside the submitted work. One coauthor reported receiving personal fees from Ashcraft and Gerel outside the submitted work. One coauthor reported receiving personal fees from Epidemiologic Research & Methods outside the submitted work. Additional disclosures are noted in the original article.

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

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Are Three Cycles of Chemotherapy as Effective as Six for Retinoblastoma?

Article Type
Changed
Mon, 10/28/2024 - 15:47

 

TOPLINE:

Compared with six cycles, three cycles of chemotherapy for high-risk retinoblastoma showed noninferior 5-year disease-free survival (DFS). The three-cycle regimen also resulted in fewer adverse events and lower costs.

METHODOLOGY:

  • The introduction of chemotherapy has increased survival rates for patients with retinoblastoma, but the optimal number of postoperative adjuvant cycles remains unclear due to scant randomized clinical trial data for high-risk patients.
  • In the new trial, participants at two premier eye centers in China were randomly assigned to receive either three (n = 94) or six (n = 93) cycles of carboplatin, etoposide, and vincristine (CEV) chemotherapy after enucleation.
  • The primary endpoint was 5-year DFS, and the secondary endpoints were overall survival, safety, economic burden, and quality of life.
  • Patients were followed up every 3 months for the first 2 years and then every 6 months thereafter, with a median follow-up of 79 months.
  • Adverse events were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

TAKEAWAY:

  • The 5-year DFS rates were 90.4% and 89.2% for the three- and six-cycle groups, respectively, meeting the noninferiority criterion (P = .003).
  • The six-cycle group experienced a higher frequency of adverse events, including neutropenia, anemia, and nausea, than the three-cycle group.
  • The quality-of-life scores were higher in the three-cycle group, particularly in physical, emotional, and social functioning parameters.
  • The total, direct, and indirect costs were significantly lower in the three-cycle group than in the six-cycle group.

IN PRACTICE:

“A three-cycle CEV regimen demonstrated noninferiority, compared with a six-cycle approach, and was and proved to be an efficacious adjuvant chemotherapy regimen for individuals diagnosed with pathologically high-risk retinoblastoma,” the authors of the study wrote.

In an accompanying editorial, Ning Li, MD, and colleagues wrote that the findings “could lead to changes in clinical practice, reducing treatment burden and costs without compromising patient outcomes.”
 

SOURCE:

This study was led by Huijing Ye, MD, PhD, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University in Guangzhou, China. Both the study and editorial were published online in JAMA.

LIMITATIONS: 

The open-label design of the study might introduce bias, although an independent, blinded committee evaluated the clinical outcomes. The 12% noninferiority margin was notably substantial, considering the rarity of retinoblastoma and the wide range of survival rates. The criteria for adjuvant therapy, especially regarding choroidal invasion, were debatable and required further follow-up to clarify the prognosis related to various pathologic features.

DISCLOSURES:

This study was supported by the Sun Yat-Sen University Clinical Research 5010 Program and the Shanghai Committee of Science and Technology. No relevant conflict of interest was disclosed by the authors of the paper or the editorial.

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.

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TOPLINE:

Compared with six cycles, three cycles of chemotherapy for high-risk retinoblastoma showed noninferior 5-year disease-free survival (DFS). The three-cycle regimen also resulted in fewer adverse events and lower costs.

METHODOLOGY:

  • The introduction of chemotherapy has increased survival rates for patients with retinoblastoma, but the optimal number of postoperative adjuvant cycles remains unclear due to scant randomized clinical trial data for high-risk patients.
  • In the new trial, participants at two premier eye centers in China were randomly assigned to receive either three (n = 94) or six (n = 93) cycles of carboplatin, etoposide, and vincristine (CEV) chemotherapy after enucleation.
  • The primary endpoint was 5-year DFS, and the secondary endpoints were overall survival, safety, economic burden, and quality of life.
  • Patients were followed up every 3 months for the first 2 years and then every 6 months thereafter, with a median follow-up of 79 months.
  • Adverse events were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

TAKEAWAY:

  • The 5-year DFS rates were 90.4% and 89.2% for the three- and six-cycle groups, respectively, meeting the noninferiority criterion (P = .003).
  • The six-cycle group experienced a higher frequency of adverse events, including neutropenia, anemia, and nausea, than the three-cycle group.
  • The quality-of-life scores were higher in the three-cycle group, particularly in physical, emotional, and social functioning parameters.
  • The total, direct, and indirect costs were significantly lower in the three-cycle group than in the six-cycle group.

IN PRACTICE:

“A three-cycle CEV regimen demonstrated noninferiority, compared with a six-cycle approach, and was and proved to be an efficacious adjuvant chemotherapy regimen for individuals diagnosed with pathologically high-risk retinoblastoma,” the authors of the study wrote.

In an accompanying editorial, Ning Li, MD, and colleagues wrote that the findings “could lead to changes in clinical practice, reducing treatment burden and costs without compromising patient outcomes.”
 

SOURCE:

This study was led by Huijing Ye, MD, PhD, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University in Guangzhou, China. Both the study and editorial were published online in JAMA.

LIMITATIONS: 

The open-label design of the study might introduce bias, although an independent, blinded committee evaluated the clinical outcomes. The 12% noninferiority margin was notably substantial, considering the rarity of retinoblastoma and the wide range of survival rates. The criteria for adjuvant therapy, especially regarding choroidal invasion, were debatable and required further follow-up to clarify the prognosis related to various pathologic features.

DISCLOSURES:

This study was supported by the Sun Yat-Sen University Clinical Research 5010 Program and the Shanghai Committee of Science and Technology. No relevant conflict of interest was disclosed by the authors of the paper or the editorial.

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:

Compared with six cycles, three cycles of chemotherapy for high-risk retinoblastoma showed noninferior 5-year disease-free survival (DFS). The three-cycle regimen also resulted in fewer adverse events and lower costs.

METHODOLOGY:

  • The introduction of chemotherapy has increased survival rates for patients with retinoblastoma, but the optimal number of postoperative adjuvant cycles remains unclear due to scant randomized clinical trial data for high-risk patients.
  • In the new trial, participants at two premier eye centers in China were randomly assigned to receive either three (n = 94) or six (n = 93) cycles of carboplatin, etoposide, and vincristine (CEV) chemotherapy after enucleation.
  • The primary endpoint was 5-year DFS, and the secondary endpoints were overall survival, safety, economic burden, and quality of life.
  • Patients were followed up every 3 months for the first 2 years and then every 6 months thereafter, with a median follow-up of 79 months.
  • Adverse events were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

TAKEAWAY:

  • The 5-year DFS rates were 90.4% and 89.2% for the three- and six-cycle groups, respectively, meeting the noninferiority criterion (P = .003).
  • The six-cycle group experienced a higher frequency of adverse events, including neutropenia, anemia, and nausea, than the three-cycle group.
  • The quality-of-life scores were higher in the three-cycle group, particularly in physical, emotional, and social functioning parameters.
  • The total, direct, and indirect costs were significantly lower in the three-cycle group than in the six-cycle group.

IN PRACTICE:

“A three-cycle CEV regimen demonstrated noninferiority, compared with a six-cycle approach, and was and proved to be an efficacious adjuvant chemotherapy regimen for individuals diagnosed with pathologically high-risk retinoblastoma,” the authors of the study wrote.

In an accompanying editorial, Ning Li, MD, and colleagues wrote that the findings “could lead to changes in clinical practice, reducing treatment burden and costs without compromising patient outcomes.”
 

SOURCE:

This study was led by Huijing Ye, MD, PhD, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University in Guangzhou, China. Both the study and editorial were published online in JAMA.

LIMITATIONS: 

The open-label design of the study might introduce bias, although an independent, blinded committee evaluated the clinical outcomes. The 12% noninferiority margin was notably substantial, considering the rarity of retinoblastoma and the wide range of survival rates. The criteria for adjuvant therapy, especially regarding choroidal invasion, were debatable and required further follow-up to clarify the prognosis related to various pathologic features.

DISCLOSURES:

This study was supported by the Sun Yat-Sen University Clinical Research 5010 Program and the Shanghai Committee of Science and Technology. No relevant conflict of interest was disclosed by the authors of the paper or the editorial.

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.

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Can Belzutifan Improve Outcomes in Advanced RCC?

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Changed
Fri, 08/23/2024 - 11:09

 

TOPLINE: 

Belzutifan demonstrated a significant benefit over everolimus in progression-free survival and objective response rates in advanced renal cell carcinoma. At 18 months, 24% of participants on belzutifan were alive and progression free, compared with 8.3% on everolimus.
 

METHODOLOGY:

  • The phase 3, multicenter, open-label, randomized, active-controlled LITESPARK-005 trial was conducted at 147 sites in six regions.
  • The trial aimed to compare the efficacy and safety of belzutifan with everolimus in 746 participants with advanced clear cell renal cell carcinoma who had disease progression after receiving immune checkpoint and antiangiogenic therapies. 
  • Patients were randomly assigned to receive either 120 mg of belzutifan or 10 mg of everolimus orally once daily and were followed for a median of 18.4 months at the first interim analysis and of 25.7 months at the second interim analysis.
  • The dual primary endpoints were progression-free survival and overall survival, with the key secondary endpoint having been a confirmed objective response, defined as a complete or partial response.
  • Dose modifications were allowed to manage adverse events, with belzutifan doses reduced to 80 mg and then to 40 mg daily if needed.

TAKEAWAY:

  • Belzutifan showed a significant benefit over everolimus in progression-free survival, with 24% of participants on belzutifan alive and progression free at 18 months, compared with 8.3% on everolimus (P = .002).
  • The objective response rate was significantly higher in the belzutifan group (21.9%) compared with the everolimus group (3.5%) (P < .001).
  • The median overall survival was 21.4 months for belzutifan and 18.1 months for everolimus, with a hazard ratio for death of 0.88 (95% CI, 0.73-1.07; P = .20).
  • Grade 3 or higher adverse events occurred in 61.8% of participants in the belzutifan group and in 62.5% in the everolimus group, with adverse events leading to treatment discontinuation in 5.9% and 14.7% of participants, respectively.

IN PRACTICE:

“The LITESPARK-005 trial introduced [hypoxia-Inducible factor 2 alpha] inhibition as an active therapeutic mechanism and established belzutifan as a treatment option in patients with advanced renal-cell carcinoma after both immune checkpoint and antiangiogenic therapies,” the authors wrote.
 

SOURCE:

Corresponding author Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, was one of four authors who contributed equally to the article, which was published on August 21 in The New England Journal of Medicine.
 

LIMITATIONS: 

The study’s limitations include the open-label design, which may introduce bias. The trial did not include a placebo group, and the follow-up period may not be sufficient to capture long-term outcomes. In addition, the study population was heavily pretreated, which may limit the generalizability of the findings to broader patient populations.
 

DISCLOSURES:

Dr. Choueiri disclosed receiving consultancy fees from Merck, the sponsor of the study, and other pharmaceutical companies. Additional disclosures are noted in the original article.

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

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TOPLINE: 

Belzutifan demonstrated a significant benefit over everolimus in progression-free survival and objective response rates in advanced renal cell carcinoma. At 18 months, 24% of participants on belzutifan were alive and progression free, compared with 8.3% on everolimus.
 

METHODOLOGY:

  • The phase 3, multicenter, open-label, randomized, active-controlled LITESPARK-005 trial was conducted at 147 sites in six regions.
  • The trial aimed to compare the efficacy and safety of belzutifan with everolimus in 746 participants with advanced clear cell renal cell carcinoma who had disease progression after receiving immune checkpoint and antiangiogenic therapies. 
  • Patients were randomly assigned to receive either 120 mg of belzutifan or 10 mg of everolimus orally once daily and were followed for a median of 18.4 months at the first interim analysis and of 25.7 months at the second interim analysis.
  • The dual primary endpoints were progression-free survival and overall survival, with the key secondary endpoint having been a confirmed objective response, defined as a complete or partial response.
  • Dose modifications were allowed to manage adverse events, with belzutifan doses reduced to 80 mg and then to 40 mg daily if needed.

TAKEAWAY:

  • Belzutifan showed a significant benefit over everolimus in progression-free survival, with 24% of participants on belzutifan alive and progression free at 18 months, compared with 8.3% on everolimus (P = .002).
  • The objective response rate was significantly higher in the belzutifan group (21.9%) compared with the everolimus group (3.5%) (P < .001).
  • The median overall survival was 21.4 months for belzutifan and 18.1 months for everolimus, with a hazard ratio for death of 0.88 (95% CI, 0.73-1.07; P = .20).
  • Grade 3 or higher adverse events occurred in 61.8% of participants in the belzutifan group and in 62.5% in the everolimus group, with adverse events leading to treatment discontinuation in 5.9% and 14.7% of participants, respectively.

IN PRACTICE:

“The LITESPARK-005 trial introduced [hypoxia-Inducible factor 2 alpha] inhibition as an active therapeutic mechanism and established belzutifan as a treatment option in patients with advanced renal-cell carcinoma after both immune checkpoint and antiangiogenic therapies,” the authors wrote.
 

SOURCE:

Corresponding author Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, was one of four authors who contributed equally to the article, which was published on August 21 in The New England Journal of Medicine.
 

LIMITATIONS: 

The study’s limitations include the open-label design, which may introduce bias. The trial did not include a placebo group, and the follow-up period may not be sufficient to capture long-term outcomes. In addition, the study population was heavily pretreated, which may limit the generalizability of the findings to broader patient populations.
 

DISCLOSURES:

Dr. Choueiri disclosed receiving consultancy fees from Merck, the sponsor of the study, and other pharmaceutical companies. Additional disclosures are noted in the original article.

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

 

TOPLINE: 

Belzutifan demonstrated a significant benefit over everolimus in progression-free survival and objective response rates in advanced renal cell carcinoma. At 18 months, 24% of participants on belzutifan were alive and progression free, compared with 8.3% on everolimus.
 

METHODOLOGY:

  • The phase 3, multicenter, open-label, randomized, active-controlled LITESPARK-005 trial was conducted at 147 sites in six regions.
  • The trial aimed to compare the efficacy and safety of belzutifan with everolimus in 746 participants with advanced clear cell renal cell carcinoma who had disease progression after receiving immune checkpoint and antiangiogenic therapies. 
  • Patients were randomly assigned to receive either 120 mg of belzutifan or 10 mg of everolimus orally once daily and were followed for a median of 18.4 months at the first interim analysis and of 25.7 months at the second interim analysis.
  • The dual primary endpoints were progression-free survival and overall survival, with the key secondary endpoint having been a confirmed objective response, defined as a complete or partial response.
  • Dose modifications were allowed to manage adverse events, with belzutifan doses reduced to 80 mg and then to 40 mg daily if needed.

TAKEAWAY:

  • Belzutifan showed a significant benefit over everolimus in progression-free survival, with 24% of participants on belzutifan alive and progression free at 18 months, compared with 8.3% on everolimus (P = .002).
  • The objective response rate was significantly higher in the belzutifan group (21.9%) compared with the everolimus group (3.5%) (P < .001).
  • The median overall survival was 21.4 months for belzutifan and 18.1 months for everolimus, with a hazard ratio for death of 0.88 (95% CI, 0.73-1.07; P = .20).
  • Grade 3 or higher adverse events occurred in 61.8% of participants in the belzutifan group and in 62.5% in the everolimus group, with adverse events leading to treatment discontinuation in 5.9% and 14.7% of participants, respectively.

IN PRACTICE:

“The LITESPARK-005 trial introduced [hypoxia-Inducible factor 2 alpha] inhibition as an active therapeutic mechanism and established belzutifan as a treatment option in patients with advanced renal-cell carcinoma after both immune checkpoint and antiangiogenic therapies,” the authors wrote.
 

SOURCE:

Corresponding author Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, was one of four authors who contributed equally to the article, which was published on August 21 in The New England Journal of Medicine.
 

LIMITATIONS: 

The study’s limitations include the open-label design, which may introduce bias. The trial did not include a placebo group, and the follow-up period may not be sufficient to capture long-term outcomes. In addition, the study population was heavily pretreated, which may limit the generalizability of the findings to broader patient populations.
 

DISCLOSURES:

Dr. Choueiri disclosed receiving consultancy fees from Merck, the sponsor of the study, and other pharmaceutical companies. Additional disclosures are noted in the original article.

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

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Breast Cancer Index Predicts Benefit of Ovarian Function Suppression in Premenopausal Women

Article Type
Changed
Fri, 08/16/2024 - 12:17

 

TOPLINE: 

The Breast Cancer Index (BCI) can predict which premenopausal women with hormone receptor–positive breast cancer benefit from ovarian function suppression (OFS) therapy. Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.

METHODOLOGY:

  • Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
  • Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
  • BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
  • The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
  • Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.

TAKEAWAY:

  • According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
  • Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
  • In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
  • BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.

IN PRACTICE:

“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.

SOURCE:

The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.

LIMITATIONS: 

The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.

DISCLOSURES:

Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.

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

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TOPLINE: 

The Breast Cancer Index (BCI) can predict which premenopausal women with hormone receptor–positive breast cancer benefit from ovarian function suppression (OFS) therapy. Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.

METHODOLOGY:

  • Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
  • Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
  • BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
  • The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
  • Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.

TAKEAWAY:

  • According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
  • Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
  • In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
  • BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.

IN PRACTICE:

“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.

SOURCE:

The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.

LIMITATIONS: 

The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.

DISCLOSURES:

Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.

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

 

TOPLINE: 

The Breast Cancer Index (BCI) can predict which premenopausal women with hormone receptor–positive breast cancer benefit from ovarian function suppression (OFS) therapy. Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.

METHODOLOGY:

  • Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
  • Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
  • BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
  • The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
  • Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.

TAKEAWAY:

  • According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
  • Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
  • In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
  • BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.

IN PRACTICE:

“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.

SOURCE:

The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.

LIMITATIONS: 

The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.

DISCLOSURES:

Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.

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

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Pure Mucinous Breast Cancer Shows Better Survival Rates Than Other Subtypes

Article Type
Changed
Mon, 08/26/2024 - 11:23

 

TOPLINE:

Patients with pure mucinous breast cancer (PMBC) show superior recurrence-free interval (RFI), recurrence-free survival (RFS), and overall survival (OS), compared with patients with invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC). Patients with PMBC had a 5-year RFI of 96.1%, RFS of 94.9%, and OS of 98.1%.

METHODOLOGY:

  • Researchers analyzed data from 23,102 women diagnosed with hormone receptor–positive HER2-negative stage I-III breast cancer, including 20,684 with IDC, 1475 with ILC, and 943 with PMBC.
  • The multicenter cohort study included patients who underwent primary breast surgery at six academic institutions in Singapore, Taiwan, Korea, and Japan between January 2000 and December 2015.
  • Current National Comprehensive Cancer Network Clinical Practice Guidelines “recommend consideration of adjuvant chemotherapy only for node-positive tumors,” whereas adjuvant endocrine therapy is recommended for estrogen receptor–positive and/or progesterone receptor–positive, node-positive tumors or tumors ≥ 3 cm. Previous studies have reported no significant association between adjuvant chemotherapy and breast cancer–specific survival or OS in patients with early-stage mucinous breast carcinoma.
  • The study aimed to compare the recurrence and survival outcomes of PMBC against IDC and ILC, identify clinicopathologic prognostic factors of PMBC, and explore the association of adjuvant systemic therapy with outcomes across subgroups of PMBC.
  • Extracted information included patient demographics, tumor characteristics, treatment administered, and staging according to the AJCC TNM classifications.

TAKEAWAY:

  • Patients with PMBC had better RFI (hazard ratio [HR], 0.59; 95% CI, 0.43-0.80), RFS (HR, 0.70; 95% CI, 0.56-0.89), and OS (HR, 0.71; 95% CI, 0.53-0.96) than patients with IDC in multivariable Cox regression analyses.
  • Fewer than half (48.7%) of the recurrences in patients with PMBC were distant, which was a lower rate than for patients with IDC (67.3%) and ILC (80.6%).
  • Significant prognostic factors for RFI in PMBC included positive lymph node(s) (HR, 2.42; 95% CI, 1.08-5.40), radiotherapy (HR, 0.44; 95% CI, 0.23-0.85), and endocrine therapy (HR, 0.25; 95% CI, 0.09-0.70).
  • No differential chemotherapy associations with outcomes were detected across PMBC subgroups by nodal stage, tumor size, and age.

IN PRACTICE:

“This international multicenter cohort study on PMBC evaluated one of the largest contemporary real-world datasets for clinical prognostic factors, which also includes valuable data on relapse events, associations of adjuvant systemic therapy, and a comparison with the SEER database,” wrote the authors of the study. “In our cohort, as anticipated, PMBC showed superior RFI, RFS, and OS compared with IDC and ILC, which both had comparatively similar survival outcomes.”

SOURCE:

Corresponding author, Yoon-Sim Yap, MBBS, PhD, of the National Cancer Centre Singapore in Singapore, designed the study. The paper was published online on May 14 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The retrospective nature over a long period and lack of a central pathology review in this study are among its limitations. The high extent of missing values for tumor grade in PMBC in the multicenter cohort could impact the identified prognostic factors. The study’s findings may not be generalizable to all populations due to the specific geographic locations of the participating institutions.

DISCLOSURES:

Study author Yeon Hee Park, MD, PhD, disclosed serving on a data safety monitoring board and on an advisory board for AstraZeneca, Pfizer, Roche, Menarini, Novartis, and Daiichi Sankyo and serving as a consultant for AstraZeneca, Pfizer, Eli Lilly and Company, Gilead Sciences, Merck, Eisai, Roche, Daiichi Sankyo, Menarini, Everest Pharmaceuticals, and Novartis. Additional disclosures are noted in the original article.

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

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TOPLINE:

Patients with pure mucinous breast cancer (PMBC) show superior recurrence-free interval (RFI), recurrence-free survival (RFS), and overall survival (OS), compared with patients with invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC). Patients with PMBC had a 5-year RFI of 96.1%, RFS of 94.9%, and OS of 98.1%.

METHODOLOGY:

  • Researchers analyzed data from 23,102 women diagnosed with hormone receptor–positive HER2-negative stage I-III breast cancer, including 20,684 with IDC, 1475 with ILC, and 943 with PMBC.
  • The multicenter cohort study included patients who underwent primary breast surgery at six academic institutions in Singapore, Taiwan, Korea, and Japan between January 2000 and December 2015.
  • Current National Comprehensive Cancer Network Clinical Practice Guidelines “recommend consideration of adjuvant chemotherapy only for node-positive tumors,” whereas adjuvant endocrine therapy is recommended for estrogen receptor–positive and/or progesterone receptor–positive, node-positive tumors or tumors ≥ 3 cm. Previous studies have reported no significant association between adjuvant chemotherapy and breast cancer–specific survival or OS in patients with early-stage mucinous breast carcinoma.
  • The study aimed to compare the recurrence and survival outcomes of PMBC against IDC and ILC, identify clinicopathologic prognostic factors of PMBC, and explore the association of adjuvant systemic therapy with outcomes across subgroups of PMBC.
  • Extracted information included patient demographics, tumor characteristics, treatment administered, and staging according to the AJCC TNM classifications.

TAKEAWAY:

  • Patients with PMBC had better RFI (hazard ratio [HR], 0.59; 95% CI, 0.43-0.80), RFS (HR, 0.70; 95% CI, 0.56-0.89), and OS (HR, 0.71; 95% CI, 0.53-0.96) than patients with IDC in multivariable Cox regression analyses.
  • Fewer than half (48.7%) of the recurrences in patients with PMBC were distant, which was a lower rate than for patients with IDC (67.3%) and ILC (80.6%).
  • Significant prognostic factors for RFI in PMBC included positive lymph node(s) (HR, 2.42; 95% CI, 1.08-5.40), radiotherapy (HR, 0.44; 95% CI, 0.23-0.85), and endocrine therapy (HR, 0.25; 95% CI, 0.09-0.70).
  • No differential chemotherapy associations with outcomes were detected across PMBC subgroups by nodal stage, tumor size, and age.

IN PRACTICE:

“This international multicenter cohort study on PMBC evaluated one of the largest contemporary real-world datasets for clinical prognostic factors, which also includes valuable data on relapse events, associations of adjuvant systemic therapy, and a comparison with the SEER database,” wrote the authors of the study. “In our cohort, as anticipated, PMBC showed superior RFI, RFS, and OS compared with IDC and ILC, which both had comparatively similar survival outcomes.”

SOURCE:

Corresponding author, Yoon-Sim Yap, MBBS, PhD, of the National Cancer Centre Singapore in Singapore, designed the study. The paper was published online on May 14 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The retrospective nature over a long period and lack of a central pathology review in this study are among its limitations. The high extent of missing values for tumor grade in PMBC in the multicenter cohort could impact the identified prognostic factors. The study’s findings may not be generalizable to all populations due to the specific geographic locations of the participating institutions.

DISCLOSURES:

Study author Yeon Hee Park, MD, PhD, disclosed serving on a data safety monitoring board and on an advisory board for AstraZeneca, Pfizer, Roche, Menarini, Novartis, and Daiichi Sankyo and serving as a consultant for AstraZeneca, Pfizer, Eli Lilly and Company, Gilead Sciences, Merck, Eisai, Roche, Daiichi Sankyo, Menarini, Everest Pharmaceuticals, and Novartis. Additional disclosures are noted in the original article.

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

 

TOPLINE:

Patients with pure mucinous breast cancer (PMBC) show superior recurrence-free interval (RFI), recurrence-free survival (RFS), and overall survival (OS), compared with patients with invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC). Patients with PMBC had a 5-year RFI of 96.1%, RFS of 94.9%, and OS of 98.1%.

METHODOLOGY:

  • Researchers analyzed data from 23,102 women diagnosed with hormone receptor–positive HER2-negative stage I-III breast cancer, including 20,684 with IDC, 1475 with ILC, and 943 with PMBC.
  • The multicenter cohort study included patients who underwent primary breast surgery at six academic institutions in Singapore, Taiwan, Korea, and Japan between January 2000 and December 2015.
  • Current National Comprehensive Cancer Network Clinical Practice Guidelines “recommend consideration of adjuvant chemotherapy only for node-positive tumors,” whereas adjuvant endocrine therapy is recommended for estrogen receptor–positive and/or progesterone receptor–positive, node-positive tumors or tumors ≥ 3 cm. Previous studies have reported no significant association between adjuvant chemotherapy and breast cancer–specific survival or OS in patients with early-stage mucinous breast carcinoma.
  • The study aimed to compare the recurrence and survival outcomes of PMBC against IDC and ILC, identify clinicopathologic prognostic factors of PMBC, and explore the association of adjuvant systemic therapy with outcomes across subgroups of PMBC.
  • Extracted information included patient demographics, tumor characteristics, treatment administered, and staging according to the AJCC TNM classifications.

TAKEAWAY:

  • Patients with PMBC had better RFI (hazard ratio [HR], 0.59; 95% CI, 0.43-0.80), RFS (HR, 0.70; 95% CI, 0.56-0.89), and OS (HR, 0.71; 95% CI, 0.53-0.96) than patients with IDC in multivariable Cox regression analyses.
  • Fewer than half (48.7%) of the recurrences in patients with PMBC were distant, which was a lower rate than for patients with IDC (67.3%) and ILC (80.6%).
  • Significant prognostic factors for RFI in PMBC included positive lymph node(s) (HR, 2.42; 95% CI, 1.08-5.40), radiotherapy (HR, 0.44; 95% CI, 0.23-0.85), and endocrine therapy (HR, 0.25; 95% CI, 0.09-0.70).
  • No differential chemotherapy associations with outcomes were detected across PMBC subgroups by nodal stage, tumor size, and age.

IN PRACTICE:

“This international multicenter cohort study on PMBC evaluated one of the largest contemporary real-world datasets for clinical prognostic factors, which also includes valuable data on relapse events, associations of adjuvant systemic therapy, and a comparison with the SEER database,” wrote the authors of the study. “In our cohort, as anticipated, PMBC showed superior RFI, RFS, and OS compared with IDC and ILC, which both had comparatively similar survival outcomes.”

SOURCE:

Corresponding author, Yoon-Sim Yap, MBBS, PhD, of the National Cancer Centre Singapore in Singapore, designed the study. The paper was published online on May 14 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The retrospective nature over a long period and lack of a central pathology review in this study are among its limitations. The high extent of missing values for tumor grade in PMBC in the multicenter cohort could impact the identified prognostic factors. The study’s findings may not be generalizable to all populations due to the specific geographic locations of the participating institutions.

DISCLOSURES:

Study author Yeon Hee Park, MD, PhD, disclosed serving on a data safety monitoring board and on an advisory board for AstraZeneca, Pfizer, Roche, Menarini, Novartis, and Daiichi Sankyo and serving as a consultant for AstraZeneca, Pfizer, Eli Lilly and Company, Gilead Sciences, Merck, Eisai, Roche, Daiichi Sankyo, Menarini, Everest Pharmaceuticals, and Novartis. Additional disclosures are noted in the original article.

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

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Can Addressing Depression Reduce Chemo Toxicity in Older Adults?

Article Type
Changed
Wed, 08/14/2024 - 02:05

 

TOPLINE:

Elevated depression symptoms are linked to an increased risk for severe chemotherapy toxicity in older adults with cancer. This risk is mitigated by geriatric assessment (GA)-driven interventions.

METHODOLOGY:

  • Researchers conducted a secondary analysis of a randomized controlled trial to evaluate whether greater reductions in grade 3 chemotherapy-related toxicities occurred with geriatric assessment-driven interventions vs standard care.
  • A total of 605 patients aged 65 years and older with any stage of solid malignancy were included, with 402 randomized to the intervention arm and 203 to the standard-of-care arm.
  • Mental health was assessed using the Mental Health Inventory 13, and chemotherapy toxicity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
  • Patients in the intervention arm received recommendations from a multidisciplinary team based on their baseline GA, while those in the standard-of-care arm received only the baseline assessment results.
  • The study was conducted at City of Hope National Medical Center in Duarte, California, and patients were followed throughout treatment or for up to 6 months from starting chemotherapy.

TAKEAWAY:

  • According to the authors, patients with depression had increased chemotherapy toxicity in the standard-of-care arm (70.7% vs 54.3%; P = .02) but not in the GA-driven intervention arm (54.3% vs 48.5%; P = .27).
  • The association between depression and chemotherapy toxicity was also seen after adjustment for the Cancer and Aging Research Group toxicity score (odds ratio, [OR], 1.98; 95% CI, 1.07-3.65) and for demographic, disease, and treatment factors (OR, 2.00; 95% CI, 1.03-3.85).
  • No significant association was found between anxiety and chemotherapy toxicity in either the standard-of-care arm (univariate OR, 1.07; 95% CI, 0.61-1.88) or the GA-driven intervention arm (univariate OR, 1.15; 95% CI, 0.78-1.71).
  • The authors stated that depression was associated with increased odds of hematologic-only toxicities (OR, 2.50; 95% CI, 1.13-5.56) in the standard-of-care arm.
  • An analysis of a small subgroup found associations between elevated anxiety symptoms and increased risk for hematologic and nonhematologic chemotherapy toxicities.

IN PRACTICE:

“The current study showed that elevated depression symptoms are associated with increased risk of severe chemotherapy toxicities in older adults with cancer. This risk was mitigated in those in the GA intervention arm, which suggests that addressing elevated depression symptoms may lower the risk of toxicities,” the authors wrote. “Overall, elevated anxiety symptoms were not associated with risk for severe chemotherapy toxicity.”

SOURCE:

Reena V. Jayani, MD, MSCI, of Vanderbilt University Medical Center in Nashville, Tennessee, was the first and corresponding author for this paper. This study was published online August 4, 2024, in Cancer

LIMITATIONS:

The thresholds for depression and anxiety used in the Mental Health Inventory 13 were based on an English-speaking population, which may not be fully applicable to Chinese- and Spanish-speaking patients included in the study. Depression and anxiety were not evaluated by a mental health professional or with a structured interview to assess formal diagnostic criteria. Psychiatric medication used at the time of baseline GA was not included in the analysis. The study is a secondary analysis of a randomized controlled trial, and it is not known which components of the interventions affected mental health.

DISCLOSURES:

This research project was supported by the UniHealth Foundation, the City of Hope Center for Cancer and Aging, and the National Institutes of Health. One coauthor disclosed receiving institutional research funding from AstraZeneca and Brooklyn ImmunoTherapeutics and consulting for multiple pharmaceutical companies, including AbbVie, Adagene, and Bayer HealthCare Pharmaceuticals. William Dale, MD, PhD, of City of Hope National Medical Center, served as senior author and a principal investigator. Additional disclosures are noted in the original article.

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

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Topics
Sections

 

TOPLINE:

Elevated depression symptoms are linked to an increased risk for severe chemotherapy toxicity in older adults with cancer. This risk is mitigated by geriatric assessment (GA)-driven interventions.

METHODOLOGY:

  • Researchers conducted a secondary analysis of a randomized controlled trial to evaluate whether greater reductions in grade 3 chemotherapy-related toxicities occurred with geriatric assessment-driven interventions vs standard care.
  • A total of 605 patients aged 65 years and older with any stage of solid malignancy were included, with 402 randomized to the intervention arm and 203 to the standard-of-care arm.
  • Mental health was assessed using the Mental Health Inventory 13, and chemotherapy toxicity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
  • Patients in the intervention arm received recommendations from a multidisciplinary team based on their baseline GA, while those in the standard-of-care arm received only the baseline assessment results.
  • The study was conducted at City of Hope National Medical Center in Duarte, California, and patients were followed throughout treatment or for up to 6 months from starting chemotherapy.

TAKEAWAY:

  • According to the authors, patients with depression had increased chemotherapy toxicity in the standard-of-care arm (70.7% vs 54.3%; P = .02) but not in the GA-driven intervention arm (54.3% vs 48.5%; P = .27).
  • The association between depression and chemotherapy toxicity was also seen after adjustment for the Cancer and Aging Research Group toxicity score (odds ratio, [OR], 1.98; 95% CI, 1.07-3.65) and for demographic, disease, and treatment factors (OR, 2.00; 95% CI, 1.03-3.85).
  • No significant association was found between anxiety and chemotherapy toxicity in either the standard-of-care arm (univariate OR, 1.07; 95% CI, 0.61-1.88) or the GA-driven intervention arm (univariate OR, 1.15; 95% CI, 0.78-1.71).
  • The authors stated that depression was associated with increased odds of hematologic-only toxicities (OR, 2.50; 95% CI, 1.13-5.56) in the standard-of-care arm.
  • An analysis of a small subgroup found associations between elevated anxiety symptoms and increased risk for hematologic and nonhematologic chemotherapy toxicities.

IN PRACTICE:

“The current study showed that elevated depression symptoms are associated with increased risk of severe chemotherapy toxicities in older adults with cancer. This risk was mitigated in those in the GA intervention arm, which suggests that addressing elevated depression symptoms may lower the risk of toxicities,” the authors wrote. “Overall, elevated anxiety symptoms were not associated with risk for severe chemotherapy toxicity.”

SOURCE:

Reena V. Jayani, MD, MSCI, of Vanderbilt University Medical Center in Nashville, Tennessee, was the first and corresponding author for this paper. This study was published online August 4, 2024, in Cancer

LIMITATIONS:

The thresholds for depression and anxiety used in the Mental Health Inventory 13 were based on an English-speaking population, which may not be fully applicable to Chinese- and Spanish-speaking patients included in the study. Depression and anxiety were not evaluated by a mental health professional or with a structured interview to assess formal diagnostic criteria. Psychiatric medication used at the time of baseline GA was not included in the analysis. The study is a secondary analysis of a randomized controlled trial, and it is not known which components of the interventions affected mental health.

DISCLOSURES:

This research project was supported by the UniHealth Foundation, the City of Hope Center for Cancer and Aging, and the National Institutes of Health. One coauthor disclosed receiving institutional research funding from AstraZeneca and Brooklyn ImmunoTherapeutics and consulting for multiple pharmaceutical companies, including AbbVie, Adagene, and Bayer HealthCare Pharmaceuticals. William Dale, MD, PhD, of City of Hope National Medical Center, served as senior author and a principal investigator. Additional disclosures are noted in the original article.

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

 

TOPLINE:

Elevated depression symptoms are linked to an increased risk for severe chemotherapy toxicity in older adults with cancer. This risk is mitigated by geriatric assessment (GA)-driven interventions.

METHODOLOGY:

  • Researchers conducted a secondary analysis of a randomized controlled trial to evaluate whether greater reductions in grade 3 chemotherapy-related toxicities occurred with geriatric assessment-driven interventions vs standard care.
  • A total of 605 patients aged 65 years and older with any stage of solid malignancy were included, with 402 randomized to the intervention arm and 203 to the standard-of-care arm.
  • Mental health was assessed using the Mental Health Inventory 13, and chemotherapy toxicity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
  • Patients in the intervention arm received recommendations from a multidisciplinary team based on their baseline GA, while those in the standard-of-care arm received only the baseline assessment results.
  • The study was conducted at City of Hope National Medical Center in Duarte, California, and patients were followed throughout treatment or for up to 6 months from starting chemotherapy.

TAKEAWAY:

  • According to the authors, patients with depression had increased chemotherapy toxicity in the standard-of-care arm (70.7% vs 54.3%; P = .02) but not in the GA-driven intervention arm (54.3% vs 48.5%; P = .27).
  • The association between depression and chemotherapy toxicity was also seen after adjustment for the Cancer and Aging Research Group toxicity score (odds ratio, [OR], 1.98; 95% CI, 1.07-3.65) and for demographic, disease, and treatment factors (OR, 2.00; 95% CI, 1.03-3.85).
  • No significant association was found between anxiety and chemotherapy toxicity in either the standard-of-care arm (univariate OR, 1.07; 95% CI, 0.61-1.88) or the GA-driven intervention arm (univariate OR, 1.15; 95% CI, 0.78-1.71).
  • The authors stated that depression was associated with increased odds of hematologic-only toxicities (OR, 2.50; 95% CI, 1.13-5.56) in the standard-of-care arm.
  • An analysis of a small subgroup found associations between elevated anxiety symptoms and increased risk for hematologic and nonhematologic chemotherapy toxicities.

IN PRACTICE:

“The current study showed that elevated depression symptoms are associated with increased risk of severe chemotherapy toxicities in older adults with cancer. This risk was mitigated in those in the GA intervention arm, which suggests that addressing elevated depression symptoms may lower the risk of toxicities,” the authors wrote. “Overall, elevated anxiety symptoms were not associated with risk for severe chemotherapy toxicity.”

SOURCE:

Reena V. Jayani, MD, MSCI, of Vanderbilt University Medical Center in Nashville, Tennessee, was the first and corresponding author for this paper. This study was published online August 4, 2024, in Cancer

LIMITATIONS:

The thresholds for depression and anxiety used in the Mental Health Inventory 13 were based on an English-speaking population, which may not be fully applicable to Chinese- and Spanish-speaking patients included in the study. Depression and anxiety were not evaluated by a mental health professional or with a structured interview to assess formal diagnostic criteria. Psychiatric medication used at the time of baseline GA was not included in the analysis. The study is a secondary analysis of a randomized controlled trial, and it is not known which components of the interventions affected mental health.

DISCLOSURES:

This research project was supported by the UniHealth Foundation, the City of Hope Center for Cancer and Aging, and the National Institutes of Health. One coauthor disclosed receiving institutional research funding from AstraZeneca and Brooklyn ImmunoTherapeutics and consulting for multiple pharmaceutical companies, including AbbVie, Adagene, and Bayer HealthCare Pharmaceuticals. William Dale, MD, PhD, of City of Hope National Medical Center, served as senior author and a principal investigator. Additional disclosures are noted in the original article.

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

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Metastasis-Directed Therapy Ups PFS in Pancreatic Cancer

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Wed, 08/07/2024 - 10:48

 

TOPLINE:

Adding metastasis-directed therapy (MDT) to systemic therapy improves progression-free survival (PFS) to 10.3 months vs 2.5 months with systemic therapy alone in patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).

METHODOLOGY:

  • Researchers conducted a phase 2 multicenter, randomized basket trial involving 41 patients with oligometastatic PDAC in the EXTEND trial.
  • Participants were randomly assigned 1:1 to receive MDT plus systemic therapy or systemic therapy alone.
  • MDT included definitive local therapy, with stereotactic ablative radiotherapy recommended when feasible. Members of the control group were allowed to receive MDT if their disease progressed.
  • The primary endpoint was PFS, measured from random assignment to radiologic progression, clinical progression, or death.
  • “Secondary endpoints included overall survival, time to next-line systemic therapy, time to local failure, time to new lesion formation, toxicity, and quality of life,” the authors said.

TAKEAWAY:

  • According to the authors, adding MDT to systemic therapy significantly improved PFS to 10.3 months vs 2.5 months with systemic therapy alone (P = .030).
  • The hazard ratio for PFS was 0.43 (95% CI, 0.20-0.94), indicating a substantial reduction in the risk for disease progression or death with MDT.
  • No grade 4 or 5 treatment-emergent adverse events were observed, suggesting that MDT is a safe addition to systemic therapy.
  • Longer PFS and overall survival were associated with activated systemic immunity after MDT, suggesting that “an activated systemic immune profile, supported by a diverse T-cell receptor repertoire, might promote immunosurveillance of distant microscopic disease.”

IN PRACTICE:

“No other PDAC-specific trials have been reported, and tumor-agnostic studies, such as SABR-COMET or the National Health Service single-arm registry study, have not published PDAC-specific outcomes. Thus, the EXTEND trial provides the strongest evidence to date in favor of the existence of an oligometastatic state in PDAC.”

SOURCE:

The study was led by Ethan B. Ludmir, MD, and Alexander D. Sherry, MD, both of the University of Texas MD Anderson Cancer Center, Houston. It was published online on August 5 in The Journal of Clinical Oncology.

LIMITATIONS:

The study’s broad enrollment criteria may have introduced heterogeneity in the patient population, potentially affecting the generalizability of the findings. The study was not powered to evaluate overall survival, and the small sample size may have limited the robustness of the results. Crossover and non–cancer-related deaths could have influenced the comparisons, and quality-of-life data were limited because of the COVID-19 pandemic. The definition of oligometastasis used in the trial may have oversimplified the complex spectrum of the disease.

DISCLOSURES:

Dr. Ludmir disclosed employment with Alaunos Therapeutics and consulting for Xerient. Dr. Sherry reported employment with MD Anderson Cancer Center and honoraria from Sermo. One coauthor has an uncompensated relationship with Polaris Consulting. Another coauthor has stock ownership in BriaCell and a consulting or an advisory role with Regeneron. Additional disclosures are noted in the original article.

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

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TOPLINE:

Adding metastasis-directed therapy (MDT) to systemic therapy improves progression-free survival (PFS) to 10.3 months vs 2.5 months with systemic therapy alone in patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).

METHODOLOGY:

  • Researchers conducted a phase 2 multicenter, randomized basket trial involving 41 patients with oligometastatic PDAC in the EXTEND trial.
  • Participants were randomly assigned 1:1 to receive MDT plus systemic therapy or systemic therapy alone.
  • MDT included definitive local therapy, with stereotactic ablative radiotherapy recommended when feasible. Members of the control group were allowed to receive MDT if their disease progressed.
  • The primary endpoint was PFS, measured from random assignment to radiologic progression, clinical progression, or death.
  • “Secondary endpoints included overall survival, time to next-line systemic therapy, time to local failure, time to new lesion formation, toxicity, and quality of life,” the authors said.

TAKEAWAY:

  • According to the authors, adding MDT to systemic therapy significantly improved PFS to 10.3 months vs 2.5 months with systemic therapy alone (P = .030).
  • The hazard ratio for PFS was 0.43 (95% CI, 0.20-0.94), indicating a substantial reduction in the risk for disease progression or death with MDT.
  • No grade 4 or 5 treatment-emergent adverse events were observed, suggesting that MDT is a safe addition to systemic therapy.
  • Longer PFS and overall survival were associated with activated systemic immunity after MDT, suggesting that “an activated systemic immune profile, supported by a diverse T-cell receptor repertoire, might promote immunosurveillance of distant microscopic disease.”

IN PRACTICE:

“No other PDAC-specific trials have been reported, and tumor-agnostic studies, such as SABR-COMET or the National Health Service single-arm registry study, have not published PDAC-specific outcomes. Thus, the EXTEND trial provides the strongest evidence to date in favor of the existence of an oligometastatic state in PDAC.”

SOURCE:

The study was led by Ethan B. Ludmir, MD, and Alexander D. Sherry, MD, both of the University of Texas MD Anderson Cancer Center, Houston. It was published online on August 5 in The Journal of Clinical Oncology.

LIMITATIONS:

The study’s broad enrollment criteria may have introduced heterogeneity in the patient population, potentially affecting the generalizability of the findings. The study was not powered to evaluate overall survival, and the small sample size may have limited the robustness of the results. Crossover and non–cancer-related deaths could have influenced the comparisons, and quality-of-life data were limited because of the COVID-19 pandemic. The definition of oligometastasis used in the trial may have oversimplified the complex spectrum of the disease.

DISCLOSURES:

Dr. Ludmir disclosed employment with Alaunos Therapeutics and consulting for Xerient. Dr. Sherry reported employment with MD Anderson Cancer Center and honoraria from Sermo. One coauthor has an uncompensated relationship with Polaris Consulting. Another coauthor has stock ownership in BriaCell and a consulting or an advisory role with Regeneron. Additional disclosures are noted in the original article.

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

 

TOPLINE:

Adding metastasis-directed therapy (MDT) to systemic therapy improves progression-free survival (PFS) to 10.3 months vs 2.5 months with systemic therapy alone in patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).

METHODOLOGY:

  • Researchers conducted a phase 2 multicenter, randomized basket trial involving 41 patients with oligometastatic PDAC in the EXTEND trial.
  • Participants were randomly assigned 1:1 to receive MDT plus systemic therapy or systemic therapy alone.
  • MDT included definitive local therapy, with stereotactic ablative radiotherapy recommended when feasible. Members of the control group were allowed to receive MDT if their disease progressed.
  • The primary endpoint was PFS, measured from random assignment to radiologic progression, clinical progression, or death.
  • “Secondary endpoints included overall survival, time to next-line systemic therapy, time to local failure, time to new lesion formation, toxicity, and quality of life,” the authors said.

TAKEAWAY:

  • According to the authors, adding MDT to systemic therapy significantly improved PFS to 10.3 months vs 2.5 months with systemic therapy alone (P = .030).
  • The hazard ratio for PFS was 0.43 (95% CI, 0.20-0.94), indicating a substantial reduction in the risk for disease progression or death with MDT.
  • No grade 4 or 5 treatment-emergent adverse events were observed, suggesting that MDT is a safe addition to systemic therapy.
  • Longer PFS and overall survival were associated with activated systemic immunity after MDT, suggesting that “an activated systemic immune profile, supported by a diverse T-cell receptor repertoire, might promote immunosurveillance of distant microscopic disease.”

IN PRACTICE:

“No other PDAC-specific trials have been reported, and tumor-agnostic studies, such as SABR-COMET or the National Health Service single-arm registry study, have not published PDAC-specific outcomes. Thus, the EXTEND trial provides the strongest evidence to date in favor of the existence of an oligometastatic state in PDAC.”

SOURCE:

The study was led by Ethan B. Ludmir, MD, and Alexander D. Sherry, MD, both of the University of Texas MD Anderson Cancer Center, Houston. It was published online on August 5 in The Journal of Clinical Oncology.

LIMITATIONS:

The study’s broad enrollment criteria may have introduced heterogeneity in the patient population, potentially affecting the generalizability of the findings. The study was not powered to evaluate overall survival, and the small sample size may have limited the robustness of the results. Crossover and non–cancer-related deaths could have influenced the comparisons, and quality-of-life data were limited because of the COVID-19 pandemic. The definition of oligometastasis used in the trial may have oversimplified the complex spectrum of the disease.

DISCLOSURES:

Dr. Ludmir disclosed employment with Alaunos Therapeutics and consulting for Xerient. Dr. Sherry reported employment with MD Anderson Cancer Center and honoraria from Sermo. One coauthor has an uncompensated relationship with Polaris Consulting. Another coauthor has stock ownership in BriaCell and a consulting or an advisory role with Regeneron. Additional disclosures are noted in the original article.

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

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The Last 30 Days: How Oncologists’ Choices Affect End-of-Life Cancer Care

Article Type
Changed
Wed, 08/07/2024 - 04:48

 

TOPLINE:

Oncologists show significant variability in prescribing systemic cancer therapies in the last 30 days of life. Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.

METHODOLOGY:

  • Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
  • A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
  • Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
  • The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
  • Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.

TAKEAWAY:

  • Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
  • Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
  • Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
  • No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).

IN PRACTICE:

“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.

SOURCE:

The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.

LIMITATIONS:

The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.

DISCLOSURES:

The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.

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

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TOPLINE:

Oncologists show significant variability in prescribing systemic cancer therapies in the last 30 days of life. Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.

METHODOLOGY:

  • Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
  • A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
  • Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
  • The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
  • Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.

TAKEAWAY:

  • Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
  • Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
  • Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
  • No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).

IN PRACTICE:

“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.

SOURCE:

The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.

LIMITATIONS:

The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.

DISCLOSURES:

The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.

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

 

TOPLINE:

Oncologists show significant variability in prescribing systemic cancer therapies in the last 30 days of life. Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.

METHODOLOGY:

  • Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
  • A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
  • Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
  • The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
  • Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.

TAKEAWAY:

  • Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
  • Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
  • Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
  • No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).

IN PRACTICE:

“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.

SOURCE:

The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.

LIMITATIONS:

The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.

DISCLOSURES:

The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.

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

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