Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy Journal Article

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Authors: Moore, H. C.; Unger, J. M.; Phillips, K. A.; Boyle, F.; Hitre, E.; Porter, D.; Francis, P. A.; Goldstein, L. J.; Gomez, H. L.; Vallejos, C. S.; Partridge, A. H.; Dakhil, S. R.; Garcia, A. A.; Gralow, J; Lombard, J. M.; Forbes, J. F.; Martino, S.; Barlow, W. E.; Fabian, C. J.; Minasian, L.; Meyskens, F. L., Jr; Gelber, R. D.; Hortobagyi, G. N.; Albain, K. S.; POEMS/S0230 Investigators
Article Title: Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy
Abstract: BACKGROUND: Ovarian failure is a common toxic effect of chemotherapy. Studies of the use of gonadotropin-releasing hormone (GnRH) agonists to protect ovarian function have shown mixed results and lack data on pregnancy outcomes. METHODS: We randomly assigned 257 premenopausal women with operable hormone-receptor-negative breast cancer to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy-alone group). The primary study end point was the rate of ovarian failure at 2 years, with ovarian failure defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone (FSH) in the postmenopausal range. Rates were compared with the use of conditional logistic regression. Secondary end points included pregnancy outcomes and disease-free and overall survival. RESULTS: At baseline, 218 patients were eligible and could be evaluated. Among 135 with complete primary end-point data, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group (odds ratio, 0.30; 95% confidence interval [CI], 0.09 to 0.97; two-sided P=0.04). Owing to missing primary end-point data, sensitivity analyses were performed, and the results were consistent with the main findings. Missing data did not differ according to treatment group or according to the stratification factors of age and planned chemotherapy regimen. Among the 218 patients who could be evaluated, pregnancy occurred in more women in the goserelin group than in the chemotherapy-alone group (21% vs. 11%, P=0.03); women in the goserelin group also had improved disease-free survival (P=0.04) and overall survival (P=0.05). CONCLUSIONS: Although missing data weaken interpretation of the findings, administration of goserelin with chemotherapy appeared to protect against ovarian failure, reducing the risk of early menopause and improving prospects for fertility. (Funded by the National Cancer Institute and others; POEMS/S0230 ClinicalTrials.gov number, NCT00068601.).
Journal Title: The New England journal of medicine
Volume: 372
Issue: 10
ISSN: 1533-4406; 0028-4793
Publisher: Unknown  
Journal Place: United States
Date Published: 2015
Start Page: 923
End Page: 932
Language: eng
DOI/URL:

10.1056/NEJMoa1413204
Notes: ClinicalTrials.gov/NCT00068601; GR: 189954/PHS HHS/United States; GR: CA075362/CA/NCI NIH HHS/United States; GR: CA180801/CA/NCI NIH HHS/United States; GR: CA180820/CA/NCI NIH HHS/United States; GR: CA180821/CA/NCI NIH HHS/United States; GR: CA180830/CA/NCI NIH HHS/United States; GR: CA180858/CA/NCI NIH HHS/United States; GR: CA189808/CA/NCI NIH HHS/United States; GR: CA189822/CA/NCI NIH HHS/United States; GR: CA189858/CA/NCI NIH HHS/United States; GR: CA189872/CA/NCI NIH HHS/United States; GR: CA189953/CA/NCI NIH HHS/United States; GR: CA189957/CA/NCI NIH HHS/United States; GR: CA189972/CA/NCI NIH HHS/United States; GR: CA189974/CA/NCI NIH HHS/United States; GR: CA27525/CA/NCI NIH HHS/United States; GR: CA31946/CA/NCI NIH HHS/United States; JID: 0255562; 0F65R8P09N (Goserelin); 33515-09-2 (Gonadotropin-Releasing Hormone); ppublish
LUC Authors
  1. Kathy S. Albain
    34 Albain
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