Journal Article

Safety and quality of life with maintenance olaparib plus bevacizumab in older patients with ovarian cancer: subgroup analysis of PAOLA‑1/ENGOT-ov25

Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN) ; Université Claude Bernard Lyon 1 (UCBL) ; Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Vergote, Ignace, Falandry, Claire, Schauer, Christian, Moubarak, Malak, Rousseau, Frédérique, Cinieri, Saverio, Fujiwara, Hiroyuki, Joly, Florence, Research on Healthcare Performance (RESHAPE - Inserm U1290 - UCBL1) ; Université Claude Bernard Lyon 1 (UCBL) ; Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Parma, Gabriella, Cropet, Claire, Marmé, Frederik, Pujade-Lauraine, Eric, Guerra-Alía, Eva, Canzler, Ulrich, Anota, Amélie, Centre de Recherche en Cancérologie de Marseille (CRCM) ; Aix Marseille Université (AMU)-Institut Paoli-Calmettes (IPC) ; Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nati

2025

Overview

Abstract Background In PAOLA-1/ENGOT-ov25, the addition of olaparib to bevacizumab maintenance improved overall survival in patients with newly diagnosed advanced ovarian cancer. We describe the safety profile and quality of life (QoL) of this combination in older patients in PAOLA-1. Methods Safety (CTCAE v4.03) and QoL (EORTC QoL Questionnaires Core 30 and Ovarian 28) data were collected. We compared safety by age (≥70 vs <70 years) in the olaparib-containing arm. QoL by treatment arm was assessed in older patients. Geriatric features, including Geriatric Vulnerability Score (GVS), were also gathered. Results Of 806 patients randomized, 142 were ≥70 years old (olaparib-containing arm: n = 104; placebo arm: n = 38). Older patients treated with olaparib exhibited a similar safety profile to younger patients, except for higher rates of all grades of lymphopenia and grade ≥3 hypertension (31.7% vs 21.6%, P =.032 and 26.9% vs 16.7%, P =.019, respectively). No hematological malignancy was reported. Two years after randomization, mean Global Health Status and cognitive functioning seemed better with olaparib than bevacizumab alone (adjusted mean difference: +4.47 points [95% CI, −0.49 to 9.42] and +4.82 [−0.57 to 10.21], respectively), and other QoL items were similar between arms. In the olaparib-containing arm, older patients with baseline GVS ≥ 1 (n = 48) exhibited increased toxicity and poorer QoL than those with GVS of 0 (n = 34). Conclusion Among older patients in PAOLA-1, olaparib plus bevacizumab had a manageable safety profile and no adverse impact on QoL. Additional data are required to confirm these results in more vulnerable patients. (ClinicalTrials.gov Identifier: NCT02477644).

• Publisher: Oxford University Press,CCSD
• Subject: Aged / Aged patients / Aged, 80 and over / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Bevacizumab - administration & dosage / Bevacizumab - adverse effects / Bevacizumab - pharmacology / Bevacizumab - therapeutic use / Chemotherapy, Combination / Drug therapy / Female / Geriatrics / Gynecologic Oncology / Humans / Life Sciences / Middle Aged / Ovarian cancer / Ovarian Neoplasms - drug therapy / Ovarian Neoplasms - pathology / Patient outcomes / Phthalazines - administration & dosage / Phthalazines - adverse effects / Phthalazines - pharmacology / Phthalazines - therapeutic use / Piperazines - administration & dosage / Piperazines - adverse effects / Piperazines - pharmacology / Piperazines - therapeutic use / Quality of Life / Santé publique et épidémiologie