The phase 3 POLO study was conducted to determine whether PARP inhibitor, olaparib, as maintenance therapy can extend the PFS of metastatic pancreatic cancer patients who harbored a germline BRCA mutation and disease had not progressed during first-line platinum-based chemotherapy. Of the 3315 patients who underwent screening, 247 (7.45%) had a germline BRCA mutation and 154 patients further underwent randomization (92 for olaparib; 62 for placebo). Median PFS was 7.4 months in the olaparib group and 3.8 months in the placebo group (HR=0.53, 95% CI 0.35-0.82, p=0.004). Median overall survival (interim analysis) was 18.9 and 18.1 months in the olaparib and placebo group, respectively (HR=0.91, 95% CI 0.56-1.46, p=0.68). This results suggested that olaparib maintenance therapy after the first-line platinum-based chemotherapy can significantly extend the PFS of metastatic pancreatic cancer patients who had a germline BRCA mutation.
N Engl J Med. 2019 Jun 2. [Epub ahead of print]