Long-term efficacy, tolerability and overall survival in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer treated with maintenance olaparib capsules following response to chemotherapy

Michael Friedlander*, Ursula Matulonis, Charlie Gourley, Andreas du Bois, Ignace Vergote, Gordon Rustin, Clare Scott, Werner Meier, Ronnie Shapira-Frommer, Tamar Safra, Daniela Matei, Vadim Shirinkin, Frédéric Selle, Anitra Fielding, Elizabeth S. Lowe, Emma L. McMurtry, Stuart Spencer, Philip Rowe, Helen Mann, David ParryJonathan Ledermann

*Corresponding author for this work

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

Background: In Study 19, maintenance monotherapy with olaparib significantly prolonged progression-free survival vs placebo in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer. Methods: Study 19 was a randomised, placebo-controlled, Phase II trial enrolling 265 patients who had received at least two platinum-based chemotherapy regimens and were in complete or partial response to their most recent regimen. Patients were randomised to olaparib (capsules; 400 mg bid) or placebo. We present long-term safety and final mature overall survival (OS; 79% maturity) data, from the last data cut-off (9 May 2016). Results: Thirty-two patients (24%) received maintenance olaparib for over 2 years; 15 (11%) did so for over 6 years. No new tolerability signals were identified with long-term treatment and adverse events were generally low grade. The incidence of discontinuations due to adverse events was low (6%). An apparent OS advantage was observed with olaparib vs placebo (hazard ratio 0.73, 95% confidence interval 0.55‒0.95, P = 0.02138) irrespective of BRCA1/2 mutation status, although the predefined threshold for statistical significance was not met. Conclusions: Study 19 showed a favourable final OS result irrespective of BRCA1/2 mutation status and unprecedented long-term benefit with maintenance olaparib for a subset of platinum-sensitive, recurrent ovarian cancer patients.

Original languageEnglish (US)
Pages (from-to)1075-1085
Number of pages11
JournalBritish Journal of Cancer
Volume119
Issue number9
DOIs
StatePublished - Oct 30 2018

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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