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      Final Analysis of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230

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          Abstract

          Premature menopause is a serious long-term side effect of chemotherapy. We evaluated long-term pregnancy and disease-related outcomes for patients in S0230/POEMS, a study in premenopausal women with stage I-IIIA estrogen receptor-negative, progesterone receptor-negative breast cancer to be treated with cyclophosphamide-containing chemotherapy. Women were randomly assigned to standard chemotherapy with or without goserelin, a gonadotropin-releasing hormone agonist, and were stratified by age and chemotherapy regimen. All statistical tests were two-sided. Of 257 patients, 218 were eligible and evaluable (105 in the chemotherapy + goserelin arm and 113 in the chemotherapy arm). More patients in the chemotherapy + goserelin arm reported at least one pregnancy vs the chemotherapy arm (5-year cumulative incidence = 23.1%, 95% confidence interval [CI] = 15.3% to 31.9%; and 12.2%, 95% CI = 6.8% to 19.2%, respectively; odds ratio = 2.34; 95% CI = 1.07 to 5.11; P = .03). Randomization to goserelin + chemotherapy was associated with a nonstatistically significant improvement in disease-free survival (hazard ratio [HR] = 0.55; 95% CI = 0.27 to 1.10; P = .09) and overall survival (HR = 0.45; 95% CI = 0.19 to 1.04; P = .06). In this long-term analysis of POEMS/S0230, we found continued evidence that patients randomly assigned to receive goserelin + chemotherapy were not only more likely to avoid premature menopause, but were also more likely to become pregnant without adverse effect on disease-related outcomes.

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          Author and article information

          Journal
          JNCI: Journal of the National Cancer Institute
          Oxford University Press (OUP)
          0027-8874
          1460-2105
          October 27 2018
          October 27 2018
          Affiliations
          [1 ]Cleveland Clinic Foundation, Cleveland, OH
          [2 ]SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA
          [3 ]Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia
          [4 ]Breast Cancer Trials Australia and New Zealand (BCT-ANZ), Newcastle, Australia
          [5 ]International Breast Cancer Study Group (IBCSG), Bern, Switzerland
          [6 ]University of Sydney, Sydney, NSW, Australia
          [7 ]National Institute of Oncology, Budapest, Hungary
          [8 ]Auckland Regional Cancer and Blood Service, Auckland, New Zealand
          [9 ]Fox Chase Cancer Center, Philadelphia, PA
          [10 ]Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru
          [11 ]Oncosalud AUNA, Lima, Peru
          [12 ]Dana Farber Cancer Institute, Boston, MA
          [13 ]Wichita NCORP, Wichita, KS
          [14 ]Louisiana State University Health Sciences Center, New Orleans, LA
          [15 ]Seattle Cancer Care Alliance, and University of Washington, Seattle, WA
          [16 ]Calvary Mater Hospital, Newcastle, Australia
          [17 ]The Angeles Clinic and Research Institute, Santa Monica, CA
          [18 ]University of Kansas Cancer Center, Kansas City, KS
          [19 ]Division of Cancer Prevention, National Cancer Institute, Bethesda, MD
          [20 ]University of California at Irvine Chao Family Comprehensive Cancer Center, Orange, CA
          [21 ]IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA
          [22 ]MD Anderson Cancer Center, Houston, TX
          [23 ]Loyola University Medical Center, Cardinal Bernardin Cancer Center, Maywood, IL
          Article
          10.1093/jnci/djy185
          6657277
          30371800
          c0f68907-d40a-47e3-b6a4-af3ec127618a
          © 2018

          https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model

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