Lung cancer among postmenopausal women treated with estrogen alone in the women's health initiative randomized trial

Rowan T. Chlebowski, Garnet L. Anderson, Joann E. Manson, Ann G. Schwartz, Heather Wakelee, Margery Gass, Rebecca J. Rodabough, Karen Johnson, Jean Wactawski-Wende, Jane Morley Kotchen, Judith K. Ockene, Mary Jo O'Sullivan, F. Allan Hubbell, Jason W. Chien, Chu Chen, Marcia L. Stefanick

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Abstract

Background In the Women's Health Initiative (WHI) randomized controlled trial, use of estrogen plus progestin increased lung cancer mortality. We conducted post hoc analyses in the WHI trial evaluating estrogen alone to determine whether use of conjugated equine estrogen without progestin had a similar adverse influence on lung cancer. Methods The WHI study is a randomized, double-blind, placebo-controlled trial conducted in 40 centers in the United States. A total of 10739 postmenopausal women aged 50-79 years who had a previous hysterectomy were randomly assigned to receive a once-daily 0.625-mg tablet of conjugated equine estrogen (n = 5310) or matching placebo (n = 5429). Incidence and mortality rates for all lung cancers, small cell lung cancers, and non-small cell lung cancers in the two randomization groups were compared by use of hazard ratios (HRs) and 95% confidence intervals (CIs) that were estimated from Cox proportional hazards regression analyses. Analyses were by intention to treat, and all statistical tests were two-sided. Results After a mean of 7.9 years (standard deviation = 1.8 years) of follow-up, 61 women in the hormone therapy group were diagnosed with lung cancer compared with 54 in the placebo group (incidence of lung cancer per year = 0.15% vs 0.13%, respectively; HR of incidence = 1.17, 95% CI = 0.81 to 1.69, P =. 39). Non-small cell lung cancers were of comparable number, stage, and grade in both groups. Deaths from lung cancer did not differ between the two groups (34 vs 33 deaths in estrogen and placebo groups, respectively; HR of death = 1.07, 95% CI = 0.66 to 1.72, P =. 79).ConclusionUnlike use of estrogen plus progestin, which increased deaths from lung cancer, use of conjugated equine estrogen alone did not increase incidence or death from lung cancer.

Original languageEnglish (US)
Pages (from-to)1413-1421
Number of pages9
JournalJournal of the National Cancer Institute
Volume102
Issue number18
DOIs
StatePublished - Sep 22 2010

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Women's Health
Lung Neoplasms
Estrogens
Conjugated (USP) Estrogens
Progestins
Placebos
Incidence
Confidence Intervals
Non-Small Cell Lung Carcinoma
Intention to Treat Analysis
Mortality
Small Cell Lung Carcinoma
Group Psychotherapy
Random Allocation
Hysterectomy
Tablets
Randomized Controlled Trials
Regression Analysis
Hormones

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Chlebowski, R. T., Anderson, G. L., Manson, J. E., Schwartz, A. G., Wakelee, H., Gass, M., ... Stefanick, M. L. (2010). Lung cancer among postmenopausal women treated with estrogen alone in the women's health initiative randomized trial. Journal of the National Cancer Institute, 102(18), 1413-1421. https://doi.org/10.1093/jnci/djq285

Lung cancer among postmenopausal women treated with estrogen alone in the women's health initiative randomized trial. / Chlebowski, Rowan T.; Anderson, Garnet L.; Manson, Joann E.; Schwartz, Ann G.; Wakelee, Heather; Gass, Margery; Rodabough, Rebecca J.; Johnson, Karen; Wactawski-Wende, Jean; Kotchen, Jane Morley; Ockene, Judith K.; O'Sullivan, Mary Jo; Hubbell, F. Allan; Chien, Jason W.; Chen, Chu; Stefanick, Marcia L.

In: Journal of the National Cancer Institute, Vol. 102, No. 18, 22.09.2010, p. 1413-1421.

Research output: Contribution to journalArticle

Chlebowski, RT, Anderson, GL, Manson, JE, Schwartz, AG, Wakelee, H, Gass, M, Rodabough, RJ, Johnson, K, Wactawski-Wende, J, Kotchen, JM, Ockene, JK, O'Sullivan, MJ, Hubbell, FA, Chien, JW, Chen, C & Stefanick, ML 2010, 'Lung cancer among postmenopausal women treated with estrogen alone in the women's health initiative randomized trial', Journal of the National Cancer Institute, vol. 102, no. 18, pp. 1413-1421. https://doi.org/10.1093/jnci/djq285
Chlebowski, Rowan T. ; Anderson, Garnet L. ; Manson, Joann E. ; Schwartz, Ann G. ; Wakelee, Heather ; Gass, Margery ; Rodabough, Rebecca J. ; Johnson, Karen ; Wactawski-Wende, Jean ; Kotchen, Jane Morley ; Ockene, Judith K. ; O'Sullivan, Mary Jo ; Hubbell, F. Allan ; Chien, Jason W. ; Chen, Chu ; Stefanick, Marcia L. / Lung cancer among postmenopausal women treated with estrogen alone in the women's health initiative randomized trial. In: Journal of the National Cancer Institute. 2010 ; Vol. 102, No. 18. pp. 1413-1421.
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abstract = "Background In the Women's Health Initiative (WHI) randomized controlled trial, use of estrogen plus progestin increased lung cancer mortality. We conducted post hoc analyses in the WHI trial evaluating estrogen alone to determine whether use of conjugated equine estrogen without progestin had a similar adverse influence on lung cancer. Methods The WHI study is a randomized, double-blind, placebo-controlled trial conducted in 40 centers in the United States. A total of 10739 postmenopausal women aged 50-79 years who had a previous hysterectomy were randomly assigned to receive a once-daily 0.625-mg tablet of conjugated equine estrogen (n = 5310) or matching placebo (n = 5429). Incidence and mortality rates for all lung cancers, small cell lung cancers, and non-small cell lung cancers in the two randomization groups were compared by use of hazard ratios (HRs) and 95{\%} confidence intervals (CIs) that were estimated from Cox proportional hazards regression analyses. Analyses were by intention to treat, and all statistical tests were two-sided. Results After a mean of 7.9 years (standard deviation = 1.8 years) of follow-up, 61 women in the hormone therapy group were diagnosed with lung cancer compared with 54 in the placebo group (incidence of lung cancer per year = 0.15{\%} vs 0.13{\%}, respectively; HR of incidence = 1.17, 95{\%} CI = 0.81 to 1.69, P =. 39). Non-small cell lung cancers were of comparable number, stage, and grade in both groups. Deaths from lung cancer did not differ between the two groups (34 vs 33 deaths in estrogen and placebo groups, respectively; HR of death = 1.07, 95{\%} CI = 0.66 to 1.72, P =. 79).ConclusionUnlike use of estrogen plus progestin, which increased deaths from lung cancer, use of conjugated equine estrogen alone did not increase incidence or death from lung cancer.",
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AU - Chlebowski, Rowan T.

AU - Anderson, Garnet L.

AU - Manson, Joann E.

AU - Schwartz, Ann G.

AU - Wakelee, Heather

AU - Gass, Margery

AU - Rodabough, Rebecca J.

AU - Johnson, Karen

AU - Wactawski-Wende, Jean

AU - Kotchen, Jane Morley

AU - Ockene, Judith K.

AU - O'Sullivan, Mary Jo

AU - Hubbell, F. Allan

AU - Chien, Jason W.

AU - Chen, Chu

AU - Stefanick, Marcia L.

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N2 - Background In the Women's Health Initiative (WHI) randomized controlled trial, use of estrogen plus progestin increased lung cancer mortality. We conducted post hoc analyses in the WHI trial evaluating estrogen alone to determine whether use of conjugated equine estrogen without progestin had a similar adverse influence on lung cancer. Methods The WHI study is a randomized, double-blind, placebo-controlled trial conducted in 40 centers in the United States. A total of 10739 postmenopausal women aged 50-79 years who had a previous hysterectomy were randomly assigned to receive a once-daily 0.625-mg tablet of conjugated equine estrogen (n = 5310) or matching placebo (n = 5429). Incidence and mortality rates for all lung cancers, small cell lung cancers, and non-small cell lung cancers in the two randomization groups were compared by use of hazard ratios (HRs) and 95% confidence intervals (CIs) that were estimated from Cox proportional hazards regression analyses. Analyses were by intention to treat, and all statistical tests were two-sided. Results After a mean of 7.9 years (standard deviation = 1.8 years) of follow-up, 61 women in the hormone therapy group were diagnosed with lung cancer compared with 54 in the placebo group (incidence of lung cancer per year = 0.15% vs 0.13%, respectively; HR of incidence = 1.17, 95% CI = 0.81 to 1.69, P =. 39). Non-small cell lung cancers were of comparable number, stage, and grade in both groups. Deaths from lung cancer did not differ between the two groups (34 vs 33 deaths in estrogen and placebo groups, respectively; HR of death = 1.07, 95% CI = 0.66 to 1.72, P =. 79).ConclusionUnlike use of estrogen plus progestin, which increased deaths from lung cancer, use of conjugated equine estrogen alone did not increase incidence or death from lung cancer.

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