Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the paola-1/engot-ov25 trial

Keiichi Fujiwara, Hiroyuki Fujiwara, Hiroyuki Yoshida, Toyomi Satoh, Kan Yonemori, Shoji Nagao, Takashi Matsumoto, Hiroaki Kobayashi, Hughes Bourgeois, Philipp Harter, Anna Maria Mosconi, Isabel Palacio Vazquez, Alexander Reinthaller, Tomoko Fujita, Philip Rowe, Eric Pujade-Lauraine, Isabelle Ray-Coquard

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. Methods: PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). Results: Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11–1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16–2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. Conclusion: Results in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer.

Original languageEnglish
Article numbere82
JournalJournal of gynecologic oncology
Volume32
Issue number5
DOIs
Publication statusPublished - 2021
Externally publishedYes

Keywords

  • Bevacizumab
  • BRCA Mutation
  • Homologous Recombination Deficiency
  • Newly Diagnosed Advanced Ovarian Cancer
  • Olaparib
  • PAOLA-1

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynaecology

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