Estrogen plus progestin and colorectal cancer incidence and mortality

Michael S. Simon, Rowan T. Chlebowski, Jean Wactawski-Wende, Karen Johnson, Andrew Muskovitz, Ikuko Kato, Alicia Young, F. A. Hubbell, Ross L. Prentice

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Abstract

Purpose: During the intervention phase in the Women's Health Initiative (WHI) clinical trial, use of estrogen plus progestin reduced the colorectal cancer diagnosis rate, but the cancers were found at a substantially higher stage. To assess the clinical relevance of the findings, analyses of the influence of combined hormone therapy on colorectal cancer incidence and colorectal cancer mortality were conducted after extended follow-up. Patients and Methods: The WHI study was a randomized, double-blind, placebo-controlled clinical trial involving 16,608 postmenopausal women with an intact uterus who were randomly assigned to daily 0.625 mg conjugated equine estrogen plus 2.5 mg medroxyprogesterone acetate (n = 8,506) or matching placebo (n = 8,102). Colorectal cancer diagnosis rates and colorectal cancer mortality were assessed. Results: After a mean of 5.6 years (standard deviation [SD], 1.03 years) of intervention and 11.6 years (SD, 3.1 years) of total follow-up, fewer colorectal cancers were diagnosed in the combined hormone therapy group compared with the placebo group (diagnoses/year, 0.12% v 0.16%; hazard ratio [HR], 0.72; 95% CI, 0.56 to 0.94; P = .014). Bowel screening examinations were comparable between groups throughout. Cancers in the combined hormone therapy group more commonly had positive lymph nodes (50.5% v 28.6%; P < .001) and were at higher stage (regional or distant, 68.8% v 51.4%; P = .003). Although not statistically significant, there was a higher number of colorectal cancer deaths in the combined hormone therapy group (37 v 27 deaths; 0.04% v 0.03%; HR, 1.29; 95% CI, 0.78 to 2.11; P = .320). Conclusion: The findings, suggestive of diagnostic delay, do not support a clinically meaningful benefit for combined hormone therapy on colorectal cancer.

Original languageEnglish (US)
Pages (from-to)3983-3990
Number of pages8
JournalJournal of Clinical Oncology
Volume30
Issue number32
DOIs
StatePublished - Nov 10 2012

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Progestins
Colorectal Neoplasms
Estrogens
Mortality
Incidence
Hormones
Group Psychotherapy
Placebos
Women's Health
Conjugated (USP) Estrogens
Medroxyprogesterone Acetate
Controlled Clinical Trials
Uterus
Neoplasms
Lymph Nodes
Clinical Trials
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Simon, M. S., Chlebowski, R. T., Wactawski-Wende, J., Johnson, K., Muskovitz, A., Kato, I., ... Prentice, R. L. (2012). Estrogen plus progestin and colorectal cancer incidence and mortality. Journal of Clinical Oncology, 30(32), 3983-3990. https://doi.org/10.1200/JCO.2012.42.7732

Estrogen plus progestin and colorectal cancer incidence and mortality. / Simon, Michael S.; Chlebowski, Rowan T.; Wactawski-Wende, Jean; Johnson, Karen; Muskovitz, Andrew; Kato, Ikuko; Young, Alicia; Hubbell, F. A.; Prentice, Ross L.

In: Journal of Clinical Oncology, Vol. 30, No. 32, 10.11.2012, p. 3983-3990.

Research output: Contribution to journalArticle

Simon, MS, Chlebowski, RT, Wactawski-Wende, J, Johnson, K, Muskovitz, A, Kato, I, Young, A, Hubbell, FA & Prentice, RL 2012, 'Estrogen plus progestin and colorectal cancer incidence and mortality', Journal of Clinical Oncology, vol. 30, no. 32, pp. 3983-3990. https://doi.org/10.1200/JCO.2012.42.7732
Simon MS, Chlebowski RT, Wactawski-Wende J, Johnson K, Muskovitz A, Kato I et al. Estrogen plus progestin and colorectal cancer incidence and mortality. Journal of Clinical Oncology. 2012 Nov 10;30(32):3983-3990. https://doi.org/10.1200/JCO.2012.42.7732
Simon, Michael S. ; Chlebowski, Rowan T. ; Wactawski-Wende, Jean ; Johnson, Karen ; Muskovitz, Andrew ; Kato, Ikuko ; Young, Alicia ; Hubbell, F. A. ; Prentice, Ross L. / Estrogen plus progestin and colorectal cancer incidence and mortality. In: Journal of Clinical Oncology. 2012 ; Vol. 30, No. 32. pp. 3983-3990.
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abstract = "Purpose: During the intervention phase in the Women's Health Initiative (WHI) clinical trial, use of estrogen plus progestin reduced the colorectal cancer diagnosis rate, but the cancers were found at a substantially higher stage. To assess the clinical relevance of the findings, analyses of the influence of combined hormone therapy on colorectal cancer incidence and colorectal cancer mortality were conducted after extended follow-up. Patients and Methods: The WHI study was a randomized, double-blind, placebo-controlled clinical trial involving 16,608 postmenopausal women with an intact uterus who were randomly assigned to daily 0.625 mg conjugated equine estrogen plus 2.5 mg medroxyprogesterone acetate (n = 8,506) or matching placebo (n = 8,102). Colorectal cancer diagnosis rates and colorectal cancer mortality were assessed. Results: After a mean of 5.6 years (standard deviation [SD], 1.03 years) of intervention and 11.6 years (SD, 3.1 years) of total follow-up, fewer colorectal cancers were diagnosed in the combined hormone therapy group compared with the placebo group (diagnoses/year, 0.12{\%} v 0.16{\%}; hazard ratio [HR], 0.72; 95{\%} CI, 0.56 to 0.94; P = .014). Bowel screening examinations were comparable between groups throughout. Cancers in the combined hormone therapy group more commonly had positive lymph nodes (50.5{\%} v 28.6{\%}; P < .001) and were at higher stage (regional or distant, 68.8{\%} v 51.4{\%}; P = .003). Although not statistically significant, there was a higher number of colorectal cancer deaths in the combined hormone therapy group (37 v 27 deaths; 0.04{\%} v 0.03{\%}; HR, 1.29; 95{\%} CI, 0.78 to 2.11; P = .320). Conclusion: The findings, suggestive of diagnostic delay, do not support a clinically meaningful benefit for combined hormone therapy on colorectal cancer.",
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