Abstract
Abstract Introduction: The BOLERO-2 trial demonstrated that combining the oral mammalian target of rapamycin (mTOR) inhibitor, EVE, with the steroidal aromatase inhibitor, EXE, more than doubled median progression-free survival (PFS) compared with placebo (PBO) plus EXE in postmenopausal women with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2−) breast cancer (BC) who relapsed or progressed following a nonsteroidal aromatase inhibitor (NSAI). Patients also achieved responses per Response Evaluation Criteria in Solid Tumors (RECIST) during treatment with EVE+EXE. Methods: The phase 3, double-blind, BOLERO-2 trial randomized postmenopausal women with HR+ BC progressing or recurring after NSAIs in a 2:1 manner to EVE 10 mg once daily plus EXE 25 mg once daily (EVE+EXE; n = 485) or placebo (PBO) plus EXE (PBO+EXE; n = 239). The primary endpoint was PFS by local assessment. Overall response rate (ORR; complete + partial response per investigator assessment based on RECIST 1.0) and duration of overall response were secondary endpoints. In addition, best percentage change from baseline in sum of longest diameters of target lesions was assessed. Results: At the time of final PFS analyses at 18 months’ median follow-up, ORR was significantly higher in the EVE+EXE arm compared with the PBO+EXE arm (12.6% vs 1.7%, respectively, by local assessment; P<.0001). Among patients with measurable disease at baseline, 71% in the EVE+EXE arm had a decrease in the sum of longest diameters of target lesions compared with baseline vs 30% in the PBO+EXE arm. Median duration of overall response was 10.5 months (95% confidence interval [CI]: 8.2, 21.9 months) for EVE+EXE and 6.9 months (95% CI: 4.2, 6.9 months) for PBO+EXE. Of note, only 4 patients in the PBO+EXE arm had an objective response to treatment. Conclusions: In addition to PFS, the combination of EVE plus EXE significantly improved ORR vs PBO+EXE in patients with HR+, HER2− advanced BC progressing during or after NSAI therapy. Furthermore, greater than two-thirds of patients treated with EVE+EXE experienced tumor shrinkage during treatment. These results further support the rationale for combining EVE with EXE to improve clinical outcomes in HR+, HER2− advanced BC progressing after NSAI therapy. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-16-17.
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