Summary
Del Mastro L, Boni L, Michelotti A, et al. Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: a randomized trial. JAMA 2011;306:269-276. Level of evidence: I.
Does temporary ovarian suppression by the gonadotropin-releasing hormone (GnRH) analogue triptorelin during chemotherapy lessen the incidence of early menopause in young patients with breast cancer undergoing adjuvant or neoadjuvant chemotherapy? This parallel, randomized, open-label, phase 3 superiority trial—PROMISE-GIM6 study (Prevention of Menopause Induced by Chemotherapy: A Study in Early Breast Cancer Patients–Gruppo Italiano Mammella 6)—was conducted at 16 sites in Italy. The 281 participating premenopausal women had stage I through III breast cancer and were candidates for adjuvant or neoadjuvant chemotherapy.
Patients were randomly allocated to chemotherapy alone or combined with triptorelin (administered intramuscularly at 3.75 mg at least 1 wk before the start of chemotherapy and every 4 wk during chemotherapy). The clinical and tumor characteristics of both groups were similar. At 12 months after treatment, the early menopause rate was 25.9% in the chemotherapy-alone group and 8.9% in the chemotherapy plus triptorelin group, an absolute difference of −17% (95% CI, −26% to −7.9%; P < 0.001). The odds ratio for treatment-related early menopause was 0.28 (95% CI, 0.14-0.59; P < 0.001). Researchers concluded that the use of triptorelin-induced temporary ovarian suppression during chemotherapy reduced occurrence of chemotherapy-induced early menopause in premenopausal patients with early-stage breast cancer.