The predictive and prognostic value of sex in early-stage colon cancer

A pooled analysis of 33,345 patients from the ACCENT database

Winson Y. Cheung, Qian Shi, Michael O'Connell, James Cassidy, Charles Blanke, David J. Kerr, Jeff Meyers, Eric Van Cutsem, Steven R. Alberts, Greg Yothers, Daniel J. Sargent

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Purpose: To compare long-term outcomes between men and women in a large cohort of clinical trial participants with early-stage colon cancer, specifically by examining whether the prognostic effect of sex varies based on age, stage of disease, and type of adjuvant therapy received. Methods: A pooled analysis of individual patient data from 33,345 patients with colon cancer enrolled in 24 phase III studies of various adjuvant systemic therapies was conducted. Chemotherapy consisted of (1) fluorouracil (5-FU), (2) 5-FU variations, (3) 5-FU plus oxaliplatin, (4) 5-FU plus irinotecan, or (5) oral fluoropyrimidine-based regimens. The primary endpoint was disease-free survival; secondary endpoints included overall survival and time to recurrence. Stratified Cox models were used to assess the effect of sex on outcomes. Multivariate models were used to assess adjusted effects and to explore the interaction among sex and other factors. Results: A total of 18,244 (55%) men and 15,101 (45%) women were included. In the entire cohort, the median age was 61 years; 91% (24,868) were white; 31% (10,347) and 69% (22,964) had stage I/II and III disease, respectively. Overall, men had inferior prognoses when compared with women for time to recurrence (hazard ratio [HR] 1.05 [95% CI, 1.01-1.09]) and other endpoints after adjusting for age, stage, and treatment. Sex was not a predictive factor of treatment efficacy (P for interaction between sex and treatment when adjusting for age and stage were.40,.67, and.77 for disease-free survival, overall survival, and time to recurrence, respectively). In exploratory analyses, worse outcomes in men were more prominent in the older patients when adjusting for stage and treatment (HR 1.08 in age ≤ 65 years vs. HR 1.18 in age > 65 years; interaction P =.016 for disease-free survival). The stage of disease and type of adjuvant regimen did not modify the prognostic value of sex. Conclusions: Sex is a modest independent prognostic marker for patients with early-stage colon cancer, particularly in older patients.

Original languageEnglish (US)
Pages (from-to)179-187
Number of pages9
JournalClinical Colorectal Cancer
Volume12
Issue number3
DOIs
StatePublished - Sep 2013
Externally publishedYes

Fingerprint

Colonic Neoplasms
Fluorouracil
Databases
Disease-Free Survival
oxaliplatin
irinotecan
Recurrence
Therapeutics
Sex Factors
Survival
Proportional Hazards Models
Clinical Trials
Drug Therapy

Keywords

  • Colon cancer
  • Outcomes
  • Sex
  • Survival

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

The predictive and prognostic value of sex in early-stage colon cancer : A pooled analysis of 33,345 patients from the ACCENT database. / Cheung, Winson Y.; Shi, Qian; O'Connell, Michael; Cassidy, James; Blanke, Charles; Kerr, David J.; Meyers, Jeff; Van Cutsem, Eric; Alberts, Steven R.; Yothers, Greg; Sargent, Daniel J.

In: Clinical Colorectal Cancer, Vol. 12, No. 3, 09.2013, p. 179-187.

Research output: Contribution to journalArticle

Cheung, WY, Shi, Q, O'Connell, M, Cassidy, J, Blanke, C, Kerr, DJ, Meyers, J, Van Cutsem, E, Alberts, SR, Yothers, G & Sargent, DJ 2013, 'The predictive and prognostic value of sex in early-stage colon cancer: A pooled analysis of 33,345 patients from the ACCENT database', Clinical Colorectal Cancer, vol. 12, no. 3, pp. 179-187. https://doi.org/10.1016/j.clcc.2013.04.004
Cheung, Winson Y. ; Shi, Qian ; O'Connell, Michael ; Cassidy, James ; Blanke, Charles ; Kerr, David J. ; Meyers, Jeff ; Van Cutsem, Eric ; Alberts, Steven R. ; Yothers, Greg ; Sargent, Daniel J. / The predictive and prognostic value of sex in early-stage colon cancer : A pooled analysis of 33,345 patients from the ACCENT database. In: Clinical Colorectal Cancer. 2013 ; Vol. 12, No. 3. pp. 179-187.
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abstract = "Purpose: To compare long-term outcomes between men and women in a large cohort of clinical trial participants with early-stage colon cancer, specifically by examining whether the prognostic effect of sex varies based on age, stage of disease, and type of adjuvant therapy received. Methods: A pooled analysis of individual patient data from 33,345 patients with colon cancer enrolled in 24 phase III studies of various adjuvant systemic therapies was conducted. Chemotherapy consisted of (1) fluorouracil (5-FU), (2) 5-FU variations, (3) 5-FU plus oxaliplatin, (4) 5-FU plus irinotecan, or (5) oral fluoropyrimidine-based regimens. The primary endpoint was disease-free survival; secondary endpoints included overall survival and time to recurrence. Stratified Cox models were used to assess the effect of sex on outcomes. Multivariate models were used to assess adjusted effects and to explore the interaction among sex and other factors. Results: A total of 18,244 (55{\%}) men and 15,101 (45{\%}) women were included. In the entire cohort, the median age was 61 years; 91{\%} (24,868) were white; 31{\%} (10,347) and 69{\%} (22,964) had stage I/II and III disease, respectively. Overall, men had inferior prognoses when compared with women for time to recurrence (hazard ratio [HR] 1.05 [95{\%} CI, 1.01-1.09]) and other endpoints after adjusting for age, stage, and treatment. Sex was not a predictive factor of treatment efficacy (P for interaction between sex and treatment when adjusting for age and stage were.40,.67, and.77 for disease-free survival, overall survival, and time to recurrence, respectively). In exploratory analyses, worse outcomes in men were more prominent in the older patients when adjusting for stage and treatment (HR 1.08 in age ≤ 65 years vs. HR 1.18 in age > 65 years; interaction P =.016 for disease-free survival). The stage of disease and type of adjuvant regimen did not modify the prognostic value of sex. Conclusions: Sex is a modest independent prognostic marker for patients with early-stage colon cancer, particularly in older patients.",
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AU - Shi, Qian

AU - O'Connell, Michael

AU - Cassidy, James

AU - Blanke, Charles

AU - Kerr, David J.

AU - Meyers, Jeff

AU - Van Cutsem, Eric

AU - Alberts, Steven R.

AU - Yothers, Greg

AU - Sargent, Daniel J.

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Y1 - 2013/9

N2 - Purpose: To compare long-term outcomes between men and women in a large cohort of clinical trial participants with early-stage colon cancer, specifically by examining whether the prognostic effect of sex varies based on age, stage of disease, and type of adjuvant therapy received. Methods: A pooled analysis of individual patient data from 33,345 patients with colon cancer enrolled in 24 phase III studies of various adjuvant systemic therapies was conducted. Chemotherapy consisted of (1) fluorouracil (5-FU), (2) 5-FU variations, (3) 5-FU plus oxaliplatin, (4) 5-FU plus irinotecan, or (5) oral fluoropyrimidine-based regimens. The primary endpoint was disease-free survival; secondary endpoints included overall survival and time to recurrence. Stratified Cox models were used to assess the effect of sex on outcomes. Multivariate models were used to assess adjusted effects and to explore the interaction among sex and other factors. Results: A total of 18,244 (55%) men and 15,101 (45%) women were included. In the entire cohort, the median age was 61 years; 91% (24,868) were white; 31% (10,347) and 69% (22,964) had stage I/II and III disease, respectively. Overall, men had inferior prognoses when compared with women for time to recurrence (hazard ratio [HR] 1.05 [95% CI, 1.01-1.09]) and other endpoints after adjusting for age, stage, and treatment. Sex was not a predictive factor of treatment efficacy (P for interaction between sex and treatment when adjusting for age and stage were.40,.67, and.77 for disease-free survival, overall survival, and time to recurrence, respectively). In exploratory analyses, worse outcomes in men were more prominent in the older patients when adjusting for stage and treatment (HR 1.08 in age ≤ 65 years vs. HR 1.18 in age > 65 years; interaction P =.016 for disease-free survival). The stage of disease and type of adjuvant regimen did not modify the prognostic value of sex. Conclusions: Sex is a modest independent prognostic marker for patients with early-stage colon cancer, particularly in older patients.

AB - Purpose: To compare long-term outcomes between men and women in a large cohort of clinical trial participants with early-stage colon cancer, specifically by examining whether the prognostic effect of sex varies based on age, stage of disease, and type of adjuvant therapy received. Methods: A pooled analysis of individual patient data from 33,345 patients with colon cancer enrolled in 24 phase III studies of various adjuvant systemic therapies was conducted. Chemotherapy consisted of (1) fluorouracil (5-FU), (2) 5-FU variations, (3) 5-FU plus oxaliplatin, (4) 5-FU plus irinotecan, or (5) oral fluoropyrimidine-based regimens. The primary endpoint was disease-free survival; secondary endpoints included overall survival and time to recurrence. Stratified Cox models were used to assess the effect of sex on outcomes. Multivariate models were used to assess adjusted effects and to explore the interaction among sex and other factors. Results: A total of 18,244 (55%) men and 15,101 (45%) women were included. In the entire cohort, the median age was 61 years; 91% (24,868) were white; 31% (10,347) and 69% (22,964) had stage I/II and III disease, respectively. Overall, men had inferior prognoses when compared with women for time to recurrence (hazard ratio [HR] 1.05 [95% CI, 1.01-1.09]) and other endpoints after adjusting for age, stage, and treatment. Sex was not a predictive factor of treatment efficacy (P for interaction between sex and treatment when adjusting for age and stage were.40,.67, and.77 for disease-free survival, overall survival, and time to recurrence, respectively). In exploratory analyses, worse outcomes in men were more prominent in the older patients when adjusting for stage and treatment (HR 1.08 in age ≤ 65 years vs. HR 1.18 in age > 65 years; interaction P =.016 for disease-free survival). The stage of disease and type of adjuvant regimen did not modify the prognostic value of sex. Conclusions: Sex is a modest independent prognostic marker for patients with early-stage colon cancer, particularly in older patients.

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