Effect of Luteinizing Hormone-Releasing Hormone Agonist on Ovarian Function After Modern Adjuvant Breast Cancer Chemotherapy: The GBG 37 ZORO Study

Gerber, Bernd and von Minckwitz, Gunter and Stehle, Heinrich and Reimer, Toralf and Felberbaum, Ricardo and Maass, Nikolai and Fischer, Dorothea and Sommer, Harald L. and Conrad, Bettina and Ortmann, Olaf and Fehm, Tanja and Rezai, Mahdi and Mehta, Keyur and Loibl, Sibylle (2011) Effect of Luteinizing Hormone-Releasing Hormone Agonist on Ovarian Function After Modern Adjuvant Breast Cancer Chemotherapy: The GBG 37 ZORO Study. JOURNAL OF CLINICAL ONCOLOGY, 29 (17). pp. 2334-2341. ISSN 0732-183X, 1527-7755

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Abstract

Purpose Observational studies suggested that luteinizing hormone-releasing hormone agonists (LHRHa) might prevent premature ovarian failure resulting from adjuvant chemotherapy in premenopausal patients. We aimed to test the efficacy of ovarian function preservation with the LHRHa goserelin in patients with breast cancer. Patients and Methods In a prospective, randomized, open-label, controlled multicenter study, 60 patients younger than age 46 years with hormone-insensitive breast cancer were allocated to receive anthracycline/cyclophosphamide (with or without taxane) - based neoadjuvant chemotherapy with or without goserelin. The first goserelin injection was administered at least 2 weeks before the first chemotherapy cycle, continuing at 3.6 mg subcutaneously every 4 weeks until the end of the last cycle. The primary objective was the reappearance of normal ovarian function, defined as two consecutive menstrual periods within 21 to 35 days at 6 months after end of chemotherapy. Results Fifty-three patients (88.3%) experienced temporary amenorrhea (93.3% with v 83.3% without goserelin). No significant difference was observed regarding the reappearance of menstruation at 6 months after chemotherapy (70.0% with v 56.7% without goserelin; difference of 13.3%; 95% CI, -10.85 to 37.45; P = .284). All but one evaluable patient reported regular menses at 2 years after chemotherapy. Time to restoration of menstruation was 6.8 months (95% CI, 5.2 to 8.4) with goserelin and 6.1 months (95% CI, 5.3 to 6.8) without goserelin (P = .304). Chemotherapy resulted in a decreased ovarian reserve measured by inhibin B and anti-Mullerian hormone during follow-up, supporting the other findings. Conclusion Premenopausal patients with breast cancer receiving goserelin simultaneously with modern neoadjuvant chemotherapy did not experience statistically significantly less amenorrhea 6 months after end of chemotherapy compared with those receiving chemotherapy alone. J Clin Oncol 29: 2334- 2341. (C) 2011 by American Society of Clinical Oncology

Item Type: Article
Uncontrolled Keywords: PREMENOPAUSAL WOMEN; YOUNG-WOMEN; FERTILITY PRESERVATION; INDUCED AMENORRHEA; RANDOMIZED-TRIALS; GENE-EXPRESSION; RESERVE; PREVENTION; PROTECTION; GOSERELIN;
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie)
Depositing User: Dr. Gernot Deinzer
Date Deposited: 09 Jun 2020 09:11
Last Modified: 09 Jun 2020 09:11
URI: https://pred.uni-regensburg.de/id/eprint/20664

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