Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged ≥65 years from the PAOLA-1/ENGOT-ov25 trial
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.
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BibTeX
@article{sabatier2026efficacy,
title = {{Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged ≥65 years from the PAOLA-1/ENGOT-ov25 trial}},
author = {Renaud Sabatier and Frédérique Rousseau and Florence Joly and Claire Cropet and Coline Montégut and Johanna Frindte and Saverio Cinieri and Eva Guerra Alía and Stephan Polterauer and Hiroyuki Yoshida and Ignace Vergote and Nicoletta Colombo and Sakari Hietanen and Rémi Largillier and Ulrich Canzler and Alain Gratet and Frederik Marmé and Laure Favier and Eric Pujade-Lauraine and Isabelle Ray-Coquard},
journal = {European Journal of Cancer},
year = {2026},
month = sep,
doi = {10.1016/j.ejca.2022.11.029},
url = {https://hal.science/hal-05744028v1},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged ≥65 years from the PAOLA-1/ENGOT-ov25 trial
AU - Renaud Sabatier
AU - Frédérique Rousseau
AU - Florence Joly
AU - Claire Cropet
AU - Coline Montégut
AU - Johanna Frindte
AU - Saverio Cinieri
AU - Eva Guerra Alía
AU - Stephan Polterauer
AU - Hiroyuki Yoshida
AU - Ignace Vergote
AU - Nicoletta Colombo
AU - Sakari Hietanen
AU - Rémi Largillier
AU - Ulrich Canzler
AU - Alain Gratet
AU - Frederik Marmé
AU - Laure Favier
AU - Eric Pujade-Lauraine
AU - Isabelle Ray-Coquard
PY - 2026
DA - 2026/09/09
JO - European Journal of Cancer
DO - 10.1016/j.ejca.2022.11.029
UR - https://hal.science/hal-05744028v1
AB - 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.
SN - 0959-8049
ER -