Safety of everolimus for women over age 65 with advanced breast cancer (BC): 12.5-month follow-up of BOLERO-2

Autor: Tibor Csoszi, Shaker R. Dakhil, Michael Gnant, Tarek Sahmoud, Hugues Bourgeois, José Baselga, Hope S. Rugo, Howard A. Burris, Shinzaburo Noguchi, Karen Osborne, Martine Piccart-Gebhart, Antonio González-Martín, Pabak Mukhopadhyay, Gabriel N. Hortobagyi, Tanya Taran, Daniel Y.C. Heng, Mario Campone, Kathleen I. Pritchard, Vichien Srimuninnimit, Puttisak Puttawibul
Rok vydání: 2012
Předmět:
Zdroj: Journal of Clinical Oncology. 30:104-104
ISSN: 1527-7755
0732-183X
Popis: 104 Background: Postmenopausal women with estrogen-receptor–positive (ER+) BC who relapse/progress on a nonsteroidal aromatase inhibitor (NSAI) are usually treated with the steroidal AI exemestane (EXE), but there is no currently approved treatment for this indication. The BOLERO-2 trial showed that adding everolimus (EVE), an oral inhibitor of mammalian target of rapamycin (mTOR), to EXE significantly improved clinical benefit beyond that of EXE alone (Hortobagyi et al, SABCS 2011, Abstract S3-7). As many women with advanced BC are elderly, the tolerability profile of EVE + EXE in this population is of interest. Methods: BOLERO-2 is a phase III, randomized trial comparing EVE (10 mg once daily) vs placebo (PBO), both plus EXE (25 mg once daily), in postmenopausal women with advanced ER+ BC progressing or recurring after NSAIs. Safety data with a focus on elderly patients are reported at 12.5 months’ median follow-up. Results: Baseline disease characteristics, age, and prior cancer therapy were well balanced between treatment arms (N = 724). At 12.5 months’ median follow-up, the addition of EVE to EXE significantly improved progression-free survival in patients
Databáze: OpenAIRE