1. Final Analysis of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230.
- Author
-
Moore, Halle CF, Unger, Joseph M, Phillips, Kelly-Anne, Boyle, Frances, Hitre, Erika, Moseley, Anna, Porter, David J, Francis, Prudence A, Goldstein, Lori J, Gomez, Henry L, Vallejos, Carlos S, Partridge, Ann H, Dakhil, Shaker R, Garcia, Agustin A, Gralow, Julie R, Lombard, Janine M, Forbes, John F, Martino, Silvana, Barlow, William E, Fabian, Carol J, Minasian, Lori M, Meyskens, Frank L, Gelber, Richard D, Hortobagyi, Gabriel N, and Albain, Kathy S
- Subjects
Cancer ,Aging ,Clinical Trials and Supportive Activities ,Breast Cancer ,Contraception/Reproduction ,Estrogen ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Reproductive health and childbirth ,Good Health and Well Being ,Adult ,Anthracyclines ,Antineoplastic Combined Chemotherapy Protocols ,Breast Neoplasms ,Cyclophosphamide ,Female ,Follow-Up Studies ,Goserelin ,Humans ,Menopause ,Premature ,Middle Aged ,Pregnancy ,Pregnancy Outcome ,Primary Ovarian Insufficiency ,Receptors ,Estrogen ,Survival Rate ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - 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.
- Published
- 2019