Progression-free survival by investigator versus blinded independent central review in newly diagnosed patients with high-grade serous ovarian cancer: Analysis of the VELIA/GOG-3005 trial.

Gynecologic Oncology
Carol AghajanianRobert L Coleman

Abstract

In the phase 3 VELIA/GOG-3005 trial, veliparib added to carboplatin-paclitaxel and continued as maintenance improved progression-free survival (PFS) compared to carboplatin-paclitaxel alone in patients with newly diagnosed ovarian carcinoma. Primary analysis of PFS was by investigator (INV) assessment, with a supplemental analysis of PFS by blinded independent central review (BICR). Patients received veliparib or placebo with carboplatin-paclitaxel (6 cycles) and as maintenance (30 additional cycles). The primary analysis compared PFS in the veliparib-throughout arm to the carboplatin-paclitaxel only arm in the BRCA mutation (BRCAm), homologous recombination deficiency (HRD), and intention-to-treat (ITT) populations. Exploratory analyses of PFS in BRCA wildtype (BRCAwt), homologous recombination proficient (HRP), and HRD + BRCAwt populations were also performed. PFS per BICR and overall concordance rates between INV and BICR assessments were analyzed. Hazard ratios for PFS by INV and BICR were consistent in each of the primary analysis and exploratory populations. In the ITT population, median PFS per INV was 23.5 months in the veliparib-throughout arm versus 17.3 months in the control arm (hazard ratio [HR] 0.683, 95% confiden...Continue Reading

References

Mar 25, 2011·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·O AmitH U Burger
Apr 26, 2016·Current Radiology Reports·Rosemarie ForstnerTeresa Margarida Cunha
Oct 9, 2016·The New England Journal of Medicine·Mansoor R MirzaUNKNOWN ENGOT-OV16/NOVA Investigators
Sep 29, 2019·The New England Journal of Medicine·Antonio González-MartínUNKNOWN PRIMA/ENGOT-OV26/GOG-3012 Investigators
Sep 29, 2019·The New England Journal of Medicine·Robert L ColemanMichael A Bookman
Jan 29, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A StoneA Sabin

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