Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy

Halle C F Moore, Joseph M. Unger, Kelly Anne Phillips, Frances Boyle, E. Hitre, David Porter, Prudence A. Francis, Lori J. Goldstein, Henry L. Gomez, Carlos S. Vallejos, Ann H. Partridge, Shaker R. Dakhil, Agustin A. Garcia, Julie Gralow, Janine M. Lombard, John F. Forbes, Silvana Martino, William E. Barlow, Carol J. Fabian, Lori Minasian & 4 others Frank L. Meyskens, Richard D. Gelber, Gabriel N. Hortobagyi, Kathy S. Albain

Research output: Contribution to journalArticle

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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, 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.

Original languageEnglish
Pages (from-to)923-932
Number of pages10
JournalNew England Journal of Medicine
Volume372
Issue number10
DOIs
Publication statusPublished - Mar 5 2015

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Goserelin
Adjuvant Chemotherapy
Breast Neoplasms
Drug Therapy
Pregnancy Outcome
Gonadotropin-Releasing Hormone
Disease-Free Survival
Menstruation
Poisons
Age Factors
Follicle Stimulating Hormone
Menopause
Fertility
Logistic Models
Odds Ratio
Hormones
Confidence Intervals
Pregnancy
Survival

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Moore, H. C. F., Unger, J. M., Phillips, K. A., Boyle, F., Hitre, E., Porter, D., ... Albain, K. S. (2015). Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. New England Journal of Medicine, 372(10), 923-932. https://doi.org/10.1056/NEJMoa1413204

Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. / Moore, Halle C F; Unger, Joseph M.; Phillips, Kelly Anne; Boyle, Frances; Hitre, E.; Porter, David; Francis, Prudence A.; Goldstein, Lori J.; Gomez, Henry L.; Vallejos, Carlos S.; 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; Meyskens, Frank L.; Gelber, Richard D.; Hortobagyi, Gabriel N.; Albain, Kathy S.

In: New England Journal of Medicine, Vol. 372, No. 10, 05.03.2015, p. 923-932.

Research output: Contribution to journalArticle

Moore, HCF, Unger, JM, Phillips, KA, Boyle, F, Hitre, E, Porter, D, Francis, PA, Goldstein, LJ, Gomez, 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, Hortobagyi, GN & Albain, KS 2015, 'Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy', New England Journal of Medicine, vol. 372, no. 10, pp. 923-932. https://doi.org/10.1056/NEJMoa1413204
Moore, Halle C F ; Unger, Joseph M. ; Phillips, Kelly Anne ; Boyle, Frances ; Hitre, E. ; Porter, David ; Francis, Prudence A. ; Goldstein, Lori J. ; Gomez, Henry L. ; Vallejos, Carlos S. ; 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 ; Meyskens, Frank L. ; Gelber, Richard D. ; Hortobagyi, Gabriel N. ; Albain, Kathy S. / Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. In: New England Journal of Medicine. 2015 ; Vol. 372, No. 10. pp. 923-932.
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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, 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.",
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T1 - Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy

AU - Moore, Halle C F

AU - Unger, Joseph M.

AU - Phillips, Kelly Anne

AU - Boyle, Frances

AU - Hitre, E.

AU - Porter, David

AU - Francis, Prudence A.

AU - Goldstein, Lori J.

AU - Gomez, Henry L.

AU - Vallejos, Carlos S.

AU - Partridge, Ann H.

AU - Dakhil, Shaker R.

AU - Garcia, Agustin A.

AU - Gralow, Julie

AU - Lombard, Janine M.

AU - Forbes, John F.

AU - Martino, Silvana

AU - Barlow, William E.

AU - Fabian, Carol J.

AU - Minasian, Lori

AU - Meyskens, Frank L.

AU - Gelber, Richard D.

AU - Hortobagyi, Gabriel N.

AU - Albain, Kathy S.

PY - 2015/3/5

Y1 - 2015/3/5

N2 - 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.

AB - 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.

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