Key clinical point: Final 12-year results from the PROMISE-GIM6 study reassures safety of concurrent administration of g onadotropin-releasing hormone agonist (GnRHa), triptorelin during chemotherapy in premenopausal women with early breast cancer (BC).
Major finding: The 12-year disease-free survival (65.7 % vs 69.2%; hazard ratio [HR], 1.16; P = .50 ), overall survival (81.2 % vs 81.3%; HR, 1.17; P = .58 ), and posttreatment pregnancy (9 vs 4 patients; HR, 2.14; P = .20) were not significantly different in GnRHa+chemotherapy vs chemotherapy-only groups.
Study details: PROMISE-GIM6, a phase 3 superiority trial included 281 premenopausal women with hormone receptor-positive or -negative early BC who were randomly assigned to receive GnRHa+chemotherapy or chemotherapy alone.
Disclosures: This study was funded by IRCCS Ospedale Policlinico San Martino and Associazione Italiana per la Ricerca sul Cancro and the Italian Ministry of Health. Some of the authors declared serving as a consultant and/or receiving speaker honoraria and travel accommodation from various pharmaceutical companies.
Source: Lambertini M et al. J Natl Cancer Inst. 2021 Nov 25. doi: 10.1093/jnci/djab213.