Medical Oncology

, 30:667 | Cite as

Effect of leuprolide acetate on ovarian function after cyclophosphamide–doxorubicin-based chemotherapy in premenopausal patients with breast cancer: results from a phase II randomized trial

  • Guiping SongEmail author
  • Hui Gao
  • Zhixiang Yuan
Original Paper


Previous studies provided inconclusive evidence for the effectiveness of gonadotropin-releasing hormone analogue on ovarian function protection against chemotherapy-induced genotoxicity in premenopausal patients. This study was designed to examine the efficacy of leuprolide acetate on ovarian function preservation in patients with breast cancer. A total of 220 patients were recruited in this prospective clinical trial and were assigned randomly to receive cyclophosphamide–doxorubicin-based chemotherapy only or chemotherapy plus leuprolide acetate. Resumption of menses or premenopausal levels of both follicle-stimulating hormone (FSH) and estradiol (E 2) within 12 months after the end of chemotherapy were considered as effective ovarian preservation. A total of 183 patients were considered evaluable (94 in chemotherapy-only group and 89 in chemotherapy plus leuprolide acetate group). At the end of follow-up, 27 patients in chemotherapy group and 15 in chemotherapy plus leuprolide acetate group resumed menses; seven patients in chemotherapy group and 14 in chemotherapy plus leuprolide acetate group restored premenopausal levels of FSH and E 2. The median time to resume menses was 9.2 months for patients in chemotherapy plus leuprolide acetate group and was not reached in chemotherapy-only group. In addition, our results demonstrated that age and chemotherapy doses made no significant difference in the occurrence of premature menopause. The leuprolide acetate treatment simultaneously with cyclophosphamide–doxorubicin-based chemotherapy reduced the risk of developing premature menopause in premenopausal patients with breast cancer.


Leuprolide acetate Ovarian function Chemotherapy 


Conflict of interest



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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.Department of PharmacyJiangyin Hospital Affiliated to Nanjing University of Traditional Chinese MedicineJiangyinChina
  2. 2.Medical College, Qingdao UniversityQingdaoChina
  3. 3.Sichuan Academy of Chinese Medicine SciencesChengduChina

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