Journal Article
. 2015 Mar; 372(10):923-32.
doi: 10.1056/NEJMoa1413204.

Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy

Halle C F Moore 1 Joseph M Unger  Kelly-Anne Phillips  Frances Boyle  Erika 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  Frank L Meyskens  Richard D Gelber  Gabriel N Hortobagyi  Kathy S Albain  POEMS/S0230 Investigators  
Affiliations
  • PMID: 25738668
  •     21 References
  •     104 citations

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.).

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Nikita M Shah, Dana M Scott, +4 authors, Jacqueline S Jeruss.
Ann Surg Oncol, 2019 Jan 27; 26(5). PMID: 30680478    Free PMC article.
Adjuvant gonadotropin-releasing hormone analogues for the prevention of chemotherapy-induced premature ovarian failure in premenopausal women.
Hengxi Chen, Li Xiao, +2 authors, Wei Huang.
Cochrane Database Syst Rev, 2019 Mar 04; 3. PMID: 30827035    Free PMC article.
Systematic Review.
Fertility preservation in patients with BRCA mutation.
Suleiman Ghunaim, Ghina Ghazeeri, Dalia Khalife, Hatem A Azim.
Ecancermedicalscience, 2020 May 19; 14. PMID: 32419845    Free PMC article.
Review.
The Effect of Systemic Chemotherapy on Ovarian Function: A Prospective Clinical Trial.
Filiz Çelebi, Çetin Ordu, +8 authors, Vahit Özmen.
Eur J Breast Health, 2020 Jul 14; 16(3). PMID: 32656517    Free PMC article.
The impact of menstruation persistence or recovery after chemotherapy on survival in young patients with hormone receptor negative breast cancer.
Mark van Barele, Bernadette A M Heemskerk-Gerritsen, +3 authors, Agnes Jager.
Breast, 2020 Jun 05; 52. PMID: 32497987    Free PMC article.
Adjuvant chemotherapy-associated lipid changes in breast cancer patients: A real-word retrospective analysis.
Tao He, Chengshi Wang, +9 authors, Jie Chen.
Medicine (Baltimore), 2020 Sep 03; 99(33). PMID: 32871996    Free PMC article.
[Anti-Müllerian hormone as a new marker of the ovarian reserve function preservation by goserelin during (neo)adjuvant chemotherapy for young breast cancer patients].
S Y Wang, S Wang.
Beijing Da Xue Xue Bao Yi Xue Ban, 2019 Jun 19; 51(3). PMID: 31209428    Free PMC article.
Ovarian Function and Fertility Preservation in Breast Cancer: Should Gonadotropin-Releasing Hormone Agonist be administered to All Premenopausal Patients Receiving Chemotherapy?
Matteo Lambertini, François Richard, +2 authors, Cynthia Villarreal-Garza.
Clin Med Insights Reprod Health, 2019 Mar 20; 13. PMID: 30886529    Free PMC article.
Review.
Durable Response of Androgen Receptor-Positive Male Breast Cancer to Goserelin.
Hamdy Abdel Azim, Loay Kassem, +3 authors, Nermine Shawky Kamal.
J Breast Cancer, 2019 Apr 04; 22(1). PMID: 30941241    Free PMC article.
Protective effect of gonadotropin-releasing hormone agonist against chemotherapy-induced ovarian dysfunction: A meta-analysis.
Fei Zheng, Bin Zhu, +4 authors, Yingqian Wang.
Oncol Lett, 2019 Jun 13; 17(6). PMID: 31186748    Free PMC article.
Gonadotropin-releasing hormone agonists during chemotherapy for ovarian function and fertility preservation for patients with early-stage breast cancer.
Hikmat Abdel-Razeq.
Cancer Manag Res, 2019 Jun 14; 11. PMID: 31190993    Free PMC article.
Review.
Potential Mechanisms of Ovarian Protection with Gonadotropin-Releasing Hormone Agonist in Breast Cancer Patients: A Review.
Francesca Poggio, Matteo Lambertini, +8 authors, Lucia Del Mastro.
Clin Med Insights Reprod Health, 2019 Aug 09; 13. PMID: 31391786    Free PMC article.
Review.
GnRHa for Ovarian Protection and the Association between AMH and Ovarian Function during Adjuvant Chemotherapy for Breast Cancer.
Ying Zhong, Yan Lin, +11 authors, Qiang Sun.
J Cancer, 2019 Aug 16; 10(18). PMID: 31413747    Free PMC article.
Fertility Preservation Using GnRH Agonists: Rationale, Possible Mechanisms, and Explanation of Controversy.
Zeev Blumenfeld.
Clin Med Insights Reprod Health, 2019 Sep 07; 13. PMID: 31488958    Free PMC article.
Review.
Does Use of Neoadjuvant Chemotherapy Affect the Decision to Pursue Fertility Preservation Options in Young Women with Breast Cancer?
Angelena Crown, Shirin Muhsen, +4 authors, Mary L Gemignani.
Ann Surg Oncol, 2020 Aug 09; 27(12). PMID: 32767225    Free PMC article.
Fertility preservation for female cancer patients.
Miyuki Harada, Yutaka Osuga.
Int J Clin Oncol, 2018 Mar 05; 24(1). PMID: 29502284
Review.
Contrast-enhanced ultrasound for ovary assessment in a murine model: preliminary findings on the protective role of a gonadotropin-releasing hormone analogue from chemotherapy-induced ovarian damage.
Massimo Venturini, Alice Bergamini, +11 authors, Antonio Esposito.
Eur Radiol Exp, 2018 Dec 20; 2(1). PMID: 30564987    Free PMC article.
Interdisciplinary Screening, Diagnosis, Therapy and Follow-up of Breast Cancer. Guideline of the DGGG and the DKG (S3-Level, AWMF Registry Number 032/045OL, December 2017) - Part 2 with Recommendations for the Therapy of Primary, Recurrent and Advanced Breast Cancer.
Achim Wöckel, Jasmin Festl, +94 authors, Stephanie Stangl.
Geburtshilfe Frauenheilkd, 2018 Dec 26; 78(11). PMID: 30581198    Free PMC article.
FERTILITY PRESERVATION IN YOUNG WOMEN WITH EARLY-STAGE BREAST CANCER.
Petra Vuković, Miro Kasum, +5 authors, Ermin Čehić.
Acta Clin Croat, 2019 Aug 01; 58(1). PMID: 31363337    Free PMC article.
Review.
Chemotherapy Associated Ovarian Failure.
Davide Mauri, Ioanna Gazouli, +7 authors, Eleftherios Kampletsas.
Front Endocrinol (Lausanne), 2020 Dec 29; 11. PMID: 33363515    Free PMC article.
Review.
The Effects of Negative Elements in Environment and Cancer on Female Reproductive System.
Jiangxue Qu, Yuehan Li, Shujie Liao, Jie Yan.
Adv Exp Med Biol, 2021 Feb 02; 1300. PMID: 33523439
Fertility preservation in endocrine responsive breast cancer: data and prejudices.
Barbara Buonomoa, Fedro A Peccatorib.
Ecancermedicalscience, 2021 Feb 13; 14. PMID: 33574902    Free PMC article.
Review.
Iron-crosslinked Rososome with robust stability and high drug loading for synergistic cancer therapy.
Xiangdong Xue, Marina Ricci, +5 authors, Yuanpei Li.
J Control Release, 2020 Oct 12; 329. PMID: 33039481    Free PMC article.
Severe ovarian hyperstimulation syndrome associated with long-acting GnRH agonist in oncofertility patients.
Jacob Christ, Christopher N Herndon, Bo Yu.
J Assist Reprod Genet, 2021 Jan 21; 38(3). PMID: 33471229    Free PMC article.
The role of gonadotropin-releasing hormone agonists in female fertility preservation.
Jae Hoon Lee, Young Sik Choi.
Clin Exp Reprod Med, 2021 Mar 02; 48(1). PMID: 33648041    Free PMC article.
Survey of professionals on breast cancer, fertility preservation and pregnancy in Argentina.
Alejandra García, Gabriela Candás, +11 authors, Juan Luis Uriburu.
Ecancermedicalscience, 2021 Mar 30; 15. PMID: 33777176    Free PMC article.
Fertility Preservation in Female Pediatric Patients With Cancer: A Clinical and Regulatory Issue.
Serena Brancati, Lucia Gozzo, +3 authors, Filippo Drago.
Front Oncol, 2021 Apr 03; 11. PMID: 33796467    Free PMC article.
Review.
Oncofertility care in young women and the outcomes of pregnancy over the last 5 years.
Sayuri Takahashi, Akihito Horie, +8 authors, Masaki Mandai.
Future Sci OA, 2021 Apr 06; 7(4). PMID: 33815825    Free PMC article.