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Adding GnRH analogue to chemotherapy reduced early menopause in patients with breast cancer
Del Mastro L. JAMA. 2011;306:269-276.
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Temporarily suppressing ovarian function using the gonadotropin-releasing hormone analogue triptorelin reduced the rate of chemotherapy-induced early menopause among premenopausal women with breast cancer, according to researchers in Italy.
Chemotherapy is associated with at least a 40% incidence of long-term amenorrhea, with the most marked effect seen with regimens containing a high cumulative dose of cyclophosphamide, according to background data supplied in the study. Previous preclinical data from phase 2 studies have demonstrated that the use of a gonadotropin-releasing hormone (GnRH) analogue during chemotherapy reduced ovarian toxicity and protected the ovaries of 67% and 96% of women with breast cancer, respectively.
Prevention of Menopause Induced by Chemotherapy: A Study in Early Breast Cancer Patients–Gruppo Italiano Mammella 6 (PROMISE-GIM6) — a randomized, open-label, phase 3 superiority study — included 281 premenopausal women with stage I to stage III breast cancer enrolled at 16 sites in Italy between October 2003 and January 2008. All patients were eligible for adjuvant or neoadjuvant chemotherapy.
Patients were randomly assigned to chemotherapy alone (n=133) or chemotherapy plus 3.75 mg triptorelin (n=148) administered intramuscularly at least 1 week before chemotherapy, then every 4 weeks for the duration of chemotherapy. The primary endpoint was incidence of early menopause, defined as discontinuation of menstrual activity and postmenopausal levels of follicle-stimulating hormone and estradiol, 12 months after the last cycle of chemotherapy.
There was an absolute difference of –17% in the rate of early menopause (95% CI, –26 to –7.9) among those in the chemotherapy-alone group (rate of 25.9%) vs. the chemotherapy plus triptorelin group (rate of 8.9%). The median time to menses continuation was 6.7 months among women assigned to chemotherapy plus triptorelin, but menses resumption was not achieved among women in the chemotherapy-alone group. The OR for chemotherapy-related early menopause was 0.28 (95% CI, 0.14-0.59).
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