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Clinical Trial
. 2025 Jul 4;30(7):oyae322.
doi: 10.1093/oncolo/oyae322.

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

Coline Montégut  1   2 , Claire Falandry  2   3 , Saverio Cinieri  4   5 , Claire Cropet  6 , Laure Montane  6 , Frédérique Rousseau  1   2 , Florence Joly  2   7 , Malak Moubarak  8 , Anna M Mosconi  5   9 , Eva M Guerra-Alía  10   11 , Christian Schauer  12   13 , Hiroyuki Fujiwara  14   15 , Ignace Vergote  16   17 , Gabriella Parma  18   19 , Gabriel Lindahl  20   21 , Amélie Anota  6 , Ulrich Canzler  22   23   24 , Frederik Marmé  24   25 , Eric Pujade-Lauraine  2   26 , Isabelle Ray-Coquard  2   7   27 , Renaud Sabatier  1   2
Affiliations
Clinical Trial

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

Coline Montégut et al. Oncologist. .

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).

Keywords: elderly; geriatric assessment; ovarian cancer; quality of life; safety.

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Conflict of interest statement

C.M.: reports no conflict of interest.

C.F.: has received advisory or consultancy honoraria from Leo Pharma, Pfizer, MSD Oncology, Teva, AstraZeneca, Baxter, Eisai, Janssen Oncology, Novartis, Chugai Pharma, and Astellas Pharma; and non-financial support from Janssen Oncology, Pierre Fabre, AstraZeneca, and Leo Pharma.

S.C.: reports no conflict of interest.

C.C.: reports no conflict of interest.

L.M.: reports no conflict of interest.

F.R.: reports advisory boards for Eisai, Novartis, and Viatris-Mylan.

F.J.: reports consulting fees from GSK (consulting for the European Medicines Agency); payment/honoraria (advisory board) from AstraZeneca, Merck Sharp & Dohme LLC (MSD), and Seagen; payment/honoraria (advisory board, lectures) from GSK and Clovis; and support for attending meetings and/or travel (symposium) from GSK, AstraZeneca, and MSD.

M.M.: reports no conflict of interest.

A.M.M.: reports no conflict of interest.

E.M.G.-A.: reports consulting fees from AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, and Roche; speaker bureau/expert testimony honorarium from AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, and Clovis Oncology; and travel support from Roche, GSK-Tesaro, and Baxter.

C.S.: reports no conflict of interest.

H.F.: reports no conflict of interest.

I.V.: reports consulting fees from Agenus, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F. Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazz Pharma, Karyopharm, Mersana, MSD, Novocure, Novartis, Oncoinvent, OncXerna, Sanofi, Regeneron, Seagen, Sotio, Verastem Oncology, and Zentalis; contracted research (via KULeuven) from Oncoinvent AS; corporate-sponsored research from Amgen and Roche; and accommodations and travel expenses from Karyopharm, Genmab, and Novocure.

G.P.: reports no conflict of interest.

G.L.: reports no conflict of interest.

A.A.: reports having received consulting fees and travel expenses from AstraZeneca, BMS, and Roche; travel expenses from Novartis and Pfizer; and consulting fees from Amgen.

U.C.: reports advisory fees from AstraZeneca; and speakers’ bureau fees from Lilly and AstraZeneca.

F.M.: reports honoraria from AGO Research GmbH (funding indirectly provided by AstraZeneca); and personal fees from Roche, AstraZeneca, Pfizer, Tesaro, Novartis, Amgen, PharmaMar, Genomic Health, CureVac, Eisai, Clovis Oncology, Janssen-Cilag, Gilead, GSK, MSD, Seagen, Myriad Genetics, and Pierre Fabre.

E.P.-L.: reports lecture fees, fees for serving on a speakers’ bureau, and travel support from AstraZeneca, GSK, Roche, and Tesaro; lecture fees from Clovis Oncology and Pfizer; expert testimony fees from AstraZeneca; support for attending meetings and/or travel from AstraZeneca and GSK; fees from AstraZeneca, Incyte, and Roche for participating on a data safety monitoring board or advisory board; and employment by ARCAGY Research.

I.R.-C.: reports honoraria (self) from AbbVie, Agenus, Advaxis, BMS, PharmaMar, Genmab, Pfizer, AstraZeneca, Roche, GSK, MSD, Deciphera, Mersena, Merck Sereno, Novartis, Amgen, Tesaro, and Clovis; honoraria (institution) from GSK, MSD, Roche, and BMS; advisory/consulting fees from AbbVie, Agenus, Advaxis, BMS, PharmaMar, Genmab, Pfizer, AstraZeneca, Roche/Genentech, GSK, MSD, Deciphera, Mersena, Merck Sereno, Novartis, Amgen, Tesaro, and Clovis; and travel support from Roche, AstraZeneca, and GSK.

R.S.: reports advisory board for Roche, GSK, and Novartis; and non-financial support (travel, accommodation, and meeting registration fees) from Pfizer, Roche, GSK, BMS, and AstraZeneca.

Figures

Figure 1.
Figure 1.
Study flow diagram. GVS, Geriatric Vulnerability Score; QoL, quality of life.
Figure 2.
Figure 2.
Least-squares mean change from baseline to month 24 of the functional (A) and symptomatic domain (B) EORTC QLQ-C30 scores and the functional (C) and symptomatic domain (D) EORTC QLQ-OV28 scores in older patients (≥70 years old). *Clinically significant difference, according to Musoro et al. CT, chemotherapy; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC QLQ-OV28, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Ovarian 28; GHS, Global Health Status; GI, gastrointestinal; LS, least-squares; QoL, quality of life.
Figure 3.
Figure 3.
Least-squares mean longitudinal change from baseline to month 24 of selected EORTC QLQ-C30 scores in older patients (≥70 years old) receiving olaparib according to GVS group. Results from fatigue and nausea and vomiting scores have been reversed on the graph so that a positive change will correspond with an improvement. *Clinically significant difference, according to Musoro et al. EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; GVS, Geriatric Vulnerability Score; LS, least-squares.
See this image and copyright information in PMC

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