- Title
- Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy
- Creator
- Moore, Halle C. F.; Unger, Joseph M.; Partridge, Ann H.; Dakhil, Shaker R.; Garcia, Agustin A.; Gralow, Julie; Lombard, Janine M.; Forbes, John F.; Martino, Silvana; Barlow, William E.; Fabian, Carol J.; Minasian, Lori; Phillips, Kelly-Anne; Meyskens, Frank L.; Gelber, Richard D.; Hortobagyi, Gabriel N.; Albain, Kathy S.; Boyle, Frances; Hitre, Erika; Porter, David; Francis, Prudence A.; Goldstein, Lori J.; Gomez, Henry L.; Vallejos, Carlos S.
- Relation
- New England Journal of Medicine Vol. 372, Issue 10, p. 923-932
- Publisher Link
- http://dx.doi.org/10.1056/NEJMoa1413204
- Publisher
- Massachusetts Medical Society
- Resource Type
- journal article
- Date
- 2015
- Description
- 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, 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.
- Subject
- breast cancer; chemotherapy; ovarian failure; gonadotropin-releasing hormone (GnRH)
- Identifier
- http://hdl.handle.net/1959.13/1336256
- Identifier
- uon:27579
- Identifier
- ISSN:0028-4793
- Rights
- From New England Journal of Medicine, Moore HCF, Under JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomex HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL, Gelber RD, Hartobagyi GN, Albain KS, Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy, Volume No. 372, Page No. 923-932. © 2015 Massachusetts Medical Society. Reprinted with permission.
- Language
- eng
- Full Text
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