Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged ≥65 years from the PAOLA-1/ENGOT-ov25 trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Renaud Sabatier - , INSERM - Institut national de la santé et de la recherche médicale (Author)
  • Frédérique Rousseau - , INSERM - Institut national de la santé et de la recherche médicale (Author)
  • Florence Joly - , Centre Georges-François Leclerc (Author)
  • Claire Cropet - , Centre Léon Bérard (Author)
  • Coline Montégut - , INSERM - Institut national de la santé et de la recherche médicale (Author)
  • Johanna Frindte - , University of Duisburg-Essen (Author)
  • Saverio Cinieri - , and MITO (Author)
  • Eva M. Guerra Alía - , Hospital Ramon y Cajal (Author)
  • Stephan Polterauer - , Medical University of Vienna (Author)
  • Hiroyuki Yoshida - , Saitama Medical University (Author)
  • Ignace Vergote - , KU Leuven (Author)
  • Nicoletta Colombo - , University of Milan - Bicocca (Author)
  • Sakari Hietanen - , University of Turku (Author)
  • Rémi Largillier - , GINECO - Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (Author)
  • Ulrich Canzler - , Department of Gynecology and Obstetrics, National Center for Tumor Diseases (NCT) Dresden (Author)
  • Alain Gratet - , Clinique Pasteur Toulouse (Author)
  • Frederik Marmé - , Heidelberg University  (Author)
  • Laure Favier - , Centre Georges-François Leclerc (Author)
  • Eric Pujade-Lauraine - , GINECO - Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (Author)
  • Isabelle Ray-Coquard - , Universite Claude Bernard Lyon 1 (Author)

Abstract

Background: The phase III PAOLA-1/ENGOT-ov25 study (NCT02477644) showed that addition of olaparib to bevacizumab maintenance improved progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer. We evaluated maintenance olaparib plus bevacizumab in older patients in PAOLA-1. Methods: Baseline clinical and molecular data, and PFS, were compared between older (aged ≥65 years) and younger patients (<65 years). Factors associated with olaparib efficacy, and safety in age subgroups, were also assessed. Results: Of 806 randomised patients, 292 (36.2%) were ≥65 years. A lower proportion of older versus younger patients had an Eastern Cooperative Oncology Group performance status of 0 (61.0% versus 76.2%) and upfront surgery (42.0% versus 55.7%). Older patients were less likely to have a BRCA1/2 mutation (17.1% versus 36.7%) or homologous recombination deficiency-positive status (34.1% versus 55.7%). After median follow-up of 22.1 months, median PFS was 21.6 months with olaparib versus 16.6 months with placebo in the older population (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.41–0.75), comparable with the younger population (median 22.9 versus 16.9 months; HR 0.61, 95% CI 0.49–0.77). PFS benefits were observed in patients with a BRCA mutation or homologous recombination deficiency-positive tumours. Incidence of olaparib-related grade ≥3 adverse events in older patients was comparable with that of younger patients (36.8% versus 31.7%) although hypertension and anaemia were more common in older patients. No treatment-related deaths occurred in older patients receiving olaparib. Conclusion: Older patients enrolled in PAOLA-1 achieved similar PFS benefits compared with younger patients, with a similar safety profile.

Details

Original languageEnglish
Pages (from-to)42-52
Number of pages11
JournalEuropean journal of cancer
Volume181
Publication statusPublished - Mar 2023
Peer-reviewedYes

External IDs

PubMed 36634389

Keywords

Sustainable Development Goals

ASJC Scopus subject areas

Keywords

  • Elderly, Olaparib, Ovarian cancer, Safety, Survival, Humans, Ovarian Neoplasms/drug therapy, Piperazines/adverse effects, Bevacizumab/adverse effects, Neoplasm Recurrence, Local/drug therapy, Female, Aged, Phthalazines/adverse effects