Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial
Journal of Clinical Oncology Jun 12, 2019
Kindler HL, et al. - In POLO—the first phase 3, international, randomized, double-blind, placebo-controlled trial to validate a biomarker-driven treatment in pancreatic cancer (PC) —researchers examined the efficacy of maintenance treatment with a PARP inhibitor in PC. The study sample consisted of patients with a germline BRCA1 and/or BRCA2 mutations (gBRCAms) and pancreatic adenocarcinoma who had received 16 or more weeks of first-line PBC for metastatic disease without progression. Of 3,315 patients screened, 2,487 had gBRCAms. A total of 154 patients were randomized to 3:2 to maintenance olaparib (O) tablets (300 mg twice daily; n=92) or placebo (P; n=62). Among these patients, 151 (O, n=90; P, n=61) were treated. Progression-free survival (PFS) by blinded independent central review (modified RECIST 1.1) was considered the primary endpoint. In mPC pts with a gBRCAm who had not progressed on PBC, a statistically significant and clinically meaningful improvement in PFS was achieved with maintenance olaparib. A safety profile consistent with the already recognized profile for olaparib was supported in this study.
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