Long-term outcome results of the phase III PROMISE-GIM6 study evaluating the role of LHRH analog (LHRHa) during chemotherapy (CT) as a strategy to reduce ovarian failure in early breast cancer (BC) patients.

Survivorship and Health Policy
Session Type and Session Title: 
Oral Abstract Session A: Local/Regional Therapy, Survivorship, and Health Policy
General Poster Session A: Local/Regional Therapy, Survivorship, and Health Policy
Abstract Number: 
J Clin Oncol 32, 2014 (suppl 26; abstr 105)
Matteo Lambertini, Luca Boni, Andrea Michelotti, Teresa Gamucci, Nina Olmeo, Stefania Gori, Monica Giordano, Ornella Garrone, Alessia Levaggi, Francesca Poggio, Sara Giraudi, Claudia Bighin, Paolo Pronzato, Lucia Del Mastro; Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Genova, Italy; Clinical Trial Coordinating Center, AOU Careggi, Istituto Toscano Tumori (ITT), Firenze, Italy; U.O. Oncologia Medica, Pisa, Italy; Medical Oncology Unit, ASL Frosinone, Sora, Italy; Oncologia Medica ASL, Sassari, Italy; Oncologia Medica, Ospedale Sacro Cuore, Negrar, Italy; Santa Anna Hospital, Como, Italy; Medical Oncology, Santa Croce General Hospital, Cuneo, Italy; Department of Medical Oncology, IRCCS AOU San Martino – IST, Genova, Italy; IRCCS Azienda Ospedaliera Universitaria San Martino, Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy; Department of Medical Oncology, U.O. Sviluppo Terapie Innovative, IRCCS AOU San Martino-IST, Genova, Italy

Abstract Disclosures


Background: The PROMISE-GIM6 phase III randomized study showed that the use of triptorelin-induced temporary ovarian suppression during CT in premenopausal patients with early-stage BC reduced the occurrence of CT-induced early menopause (Del Mastro L, JAMA 2011). The 2013 ASCO and ESMO guidelines on fertility preservation in cancer patients consider this strategy still experimental due to the absence of data on long-term ovarian function and pregnancy rates, and some concerns exist on the safety of this procedure particularly for hormone-receptor positive BC patients. The present analysis reports long-term outcome results of the study. Methods: From October 2003 to January 2008, 281 premenopausal women with stage I through III BC who were candidates for adjuvant or neoadjuvant CT were randomized to receive CT alone or combined with triptorelin. The primary objective was to compare the incidence of CT-induced early menopause in patients treated with CT alone or combined with triptorelin. The present analysis considers data on recurrences, pregnancies and long-term ovarian function. Results: A total of 133 pts were enrolled in the CT alone arm and 148 in the CT + LHRHa arm; 82% and 79% of pts had hormone receptor positive-disease, respectively. The median follow-up at the time of the analysis was 7.3 years (interquartile range: 6.3-8.2 years). No differences in the 5-year disease-free survival (DFS) between treatment arms were observed (83.7% in CT alone arm vs 80.5% in CT plus LHRHa: HR=1.17; 95% CI 0.72-1.92, p=0.519). After the end of adjuvant treatments, 4 pregnancies (3.0%; incidence rate per 100 person-year=0.4) occurred in the CT-alone group and 8 pregnancies (5.4%; incidence rate per 100 person-year=0.8) occurred in the CT plus triptorelin group (CT + LHRHa arm vs CT alone: OR=1.84; 95% CI 0.54-6.27, p=0.39). Conclusions: The administration of LHRHa with CT was associated with the occurrence of more pregnancies; no differences in DFS were observed. The analysis on long-term ovarian function is still ongoing and will be presented at the meeting. Clinical trial information: NCT00311636.