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

Journal of the National Cancer Institute Nov 01, 2018

Moore HCF, et al. - As premature menopause is a serious long-term side effect of chemotherapy, researchers evaluated 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) in terms of long-term pregnancy and disease-related outcomes. Evidence indicated avoidance of premature menopause as well as a higher likelihood of becoming pregnant in patients randomly assigned to receive goserelin + chemotherapy, without adverse effect on disease-related outcomes.

Methods

  • Standard chemotherapy with or without goserelin, a gonadotropin-releasing hormone agonist, was randomly assigned to the women.
  • Stratification of the women by age and chemotherapy regimen was done, as were two-sided statistical tests.

Results

  • Among 257 patients, evaluation was performed of 218 eligible patients (105 in the chemotherapy + goserelin arm and 113 in the chemotherapy arm).
  • At least one pregnancy was reported by more patients in the chemotherapy + goserelin arm 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).
  • 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) was evident in correlation to randomization to goserelin + chemotherapy.
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