Ovarian suppression with triptorelin during chemotherapy for early-stage breast cancer significantly increased the chances that women would recover their long-term ovarian function, according to a multicenter phase III open-label study published online Dec. 22 in JAMA.
The treatment and control groups had similarly low pregnancy rates at 5 years, with no significant overall difference in disease-free survival, reported Dr. Matteo Lambertini of Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy, and his associates.
Cryopreserving embryos or oocytes remains the main way to protect fertility in young women with breast cancer. Clinicians have debated whether to use luteinizing hormone–releasing hormone analogues because of scarce data showing efficacy and concerns about compromising disease-free survival, the investigators noted. They randomized 281 premenopausal women with stage I-III hormone receptor–positive or hormone receptor–negative breast cancer to receive chemotherapy alone or with 3.75 mg triptorelin, given intramuscularly at least 1 week before and every 4 weeks during cancer treatment. The median age of patients was 39 years, the range was 24-45 years (JAMA 2015 Dec. 22;314:2632-40).
Nearly 73% of the triptorelin group and 64% of controls resumed menstruating within 5 years of completing chemotherapy, for an age-adjusted hazard ratio of 1.48 (95% CI, 1.12 to 1.95; P = .006). Cumulative 5-year pregnancy rates were 2.1% for the triptorelin group and 1.6% for controls (aHR, 2.4; 95% CI, 0.62 to 9.22; P = .2). About 81% of triptorelin patients and 84% of controls remained disease free at 5 years (HR, 1.17; 95% CI, 0.72 to 1.92; P = .52). The increase in risk among triptorelin patients was generally limited to those with hormone receptor–negative disease (5-year DFS, 62% and 76%), the investigators said.
When combined with recent findings from the POEMS study, the results show that temporary ovarian suppression before and during chemotherapy is an option for preserving ovarian function in premenopausal women with early-stage breast cancer, they concluded.
Istituto Nazionale per la Ricerca sul Cancro and the Associazione Italiana per la Ricerca sul Cancro funded the study. Dr. Lambertini reported no relevant disclosures. Two coauthors reported receiving research funding and honoraria from Amgen, GlaxoSmithKline, and Eisai. The senior author reported financial relationships with Takeda and with Ipsen, which supplied the triptorelin used in the study