PARP Inhibitor Boosts Response Rates for BRCA+ Breast Cancer

Adding veliparib to a chemotherapy regimen increased response rates for patients with BRCA-positive breast cancer.
BY JASON M. BRODERICK @jasoncology
PUBLISHED: DECEMBER 07, 2016
There was a response rate of 77.8 percent when patients with advanced BRCA-positive breast cancer added the PARP inhibitor veliparib to carboplatin/paclitaxel chemotherapy, according to findings from the phase 2 BROCADE trial.

“The addition of veliparib to carboplatin/paclitaxel resulted in trends toward improved progression-free survival (PFS) and overall survival (OS) and a significant increase in the overall response rate (ORR),” lead study author Hyo Sook Han, M.D., associate member at Moffitt Cancer Center, said when presenting the results at the 2016 San Antonio Breast Cancer Symposium.

The phase 2 BROCADE study included 290 women with histologically or cytologically confirmed locally recurrent or metastatic breast cancer who harbored a deleterious BRCA1 or BRCA2 germline mutation. Patients were allowed to have received two or fewer prior lines of chemotherapy in the metastatic setting. Individuals with prior PARP inhibitor treatment or CNS metastases were ineligible.

The three-arm trial randomized patients in a 1-1-1 ratio to veliparib (120 mg twice daily on days one through seven) plus carboplatin (AUC 6)/paclitaxel (175 mg/m2) every three weeks (97 patients); the same chemotherapy regimen plus placebo (99 patients); or veliparib (40 mg twice daily on days one through seven) plus temozolomide (150-200 mg/meach day on days one through five) every four weeks (94 patients).

Han reported the findings for the first two arms at the press briefing. In the placebo arm, the median patient age was 46 years (range, 24-66). Regarding hormone receptor status, 43.4 percent of patients were ER/PgR-negative and 56.6 percent of patients were ER and/or PgR-positive.

HER2neu-negative status was reported for 92.9 percent of patients and 42.4 percent of patients had triple-negative disease. The ECOG performance status was 0-1 for 93.9 percent of patients. The number of prior treatments received across all settings was zero, one, two or more than two, for 23.2 percent, 42.4 percent, 25.3 percent, and 9.1 percent of patients.

In the veliparib arm, the median patient age was 44 years (range, 25-65). The hormone receptor status was ER/PgR-negative for 41.2 percent of patients and ER and/or PgR-positive for 58.8 percent of patients.

HER2neu-negative status was reported for 96.9 percent of patients and 41.2 percent of patients had triple-negative disease. The ECOG performance status was 0-1 for 94.8 percent of patients. The number of prior treatments received across all settings was zero, one, two or more than two, for 19.6 percent, 48.5 percent, 24.7 percent, and 7.2 percent of patients.

Tumor response was assessed in patients with measurable disease, which included 72 patients in the veliparib arm and 80 patients in the placebo arm. The overall response rate was 77.8 percent in the veliparib arm and 61.3 percent in the placebo group.



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