WEDNESDAY, Aug. 15, 2018 (HealthDay News) — Single-agent talazoparib provides significant benefit over standard chemotherapy for patients with advanced breast cancer and germline BRCA1/2 mutation, according to a study published online Aug. 15 in the New England Journal of Medicine.
Jennifer K. Litton, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted a randomized phase 3 trial involving patients with advanced breast cancer and a germline BRCA1/2 mutation. Participants were randomized to receive talazoparib (287 patients) or standard single-agent therapy of the physician’s choice (144 patients).
The researchers found that, compared with the standard therapy group, the talazoparib group had significantly longer median progression-free survival (8.6 versus 5.6 months; hazard ratio for disease progression or death, 0.54; 95 percent confidence interval, 0.41 to 0.71; P < 0.001). For death, the interim median hazard ratio was 0.76 (95 percent confidence interval, 0.55 to 1.06; P = 0.11). The talazoparib group had a higher objective response rate than the standard-therapy group (62.6 versus 27.2 percent; odds ratio, 5.0; 95 percent confidence interval, 2.9 to 8.8; P < 0.001). Overall, 55 and 38 percent of patients who received talazoparib and standard therapy, respectively, had hematologic grade 3 to 4 events. Outcomes reported by patients favored talazoparib, with significant overall improvements and significant delays noted in the time to clinically meaningful deterioration according to the global health status-quality-of-life and breast symptoms scales.
“Talazoparib resulted in a significantly longer progression-free survival than standard-of-care chemotherapy,” the authors write.
The study was funded by the Pfizer company Medivation, which manufactures talazoparib.
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