Randomized CLIO/BGOG-ov10 trial of olaparib monotherapy versus physician's choice chemotherapy in relapsed ovarian cancer.

Comparison of olaparib (OLA) monotherapy versus chemotherapy in patients with platinum-sensitive (PSOC) or platinum-resistant ovarian cancer (PROC). Patients with measurable disease and ≥ 1 prior line of chemotherapy (CT) were randomized 2:1 to OLA (300 mg tablets, BID) or physician's choice CT.: for PSOC: Carboplatin-Pegylated-Liposomal-Doxorubicin (PLD) or Carboplatin-Gemcitabine; for PROC: PLD, Topotecan, Paclitaxel or Gemcitabine. 160 patients (60 with PSOC and 100 with PROC) were randomized 2:1 to OLA (n = 107) or CT (n = 53). Baseline characteristics were similar between both arms. Overall objective response rate (ORR) for OLA and CT were similar (24.3% (26/107) and 28.3% (15/53), respectively). Clinical benefit rate (≥ 12 weeks) was similar with 54.2% (58/107) and 56.6% (30/53), respectively. In PSOC, ORR was 35.0% (14/40) and 65.0% (13/20) for OLA and CT (p = 0.053); in PROC, ORR was 17.9% (12/67) and 6.1% (2/33) for OLA and CT (p = 0.134). ORR in heavily pretreated PROC (>4 prior lines) was 22.9% (8/35) with OLA versus 0% (0/14) for CT. ORR of 35.7% (5/14) and 13.2% (7/53) was observed in BRCA-mutated and -wildtype PROC cases, respectively. Median PFS in PROC was not significantly different with 2.9 months (95% CI 2.8-5.1 in the OLA group versus 3.8 months (95% CI 3.0-6.4) in the CT group (hazard ratio [HR] 1.11 [95% CI 0.72-1.78]; log-rank p = 0.600). OLA monotherapy showed overall an equal response rate in relapsed ovarian cancer compared with CT. In PROC, ORR and TFST tended to be higher with OLA than with CT. In heavily pretreated patients (four lines or more) with PROC disease, OLA treatment seemed to be more effective than CT.

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Déclaration de conflit d'intérêts

Declaration of Competing Interest Dr. Lambrechts reports personal fees from Astra Zeneca (Advisory boards and speaker's fee), personal fees from MSD (Advisory boards), grants from Agilent Technologies (industry-sponsored grant), outside the submitted work. In addition, Dr. Lambrechts has a patent application pending. I. Vergote reports grants and other from Amgen (Europe) GmbH (2019), personal fees and other from AstraZeneca (2019–2022), other from Clovis Oncology Inc. (2019–2019), other from Carrick Therapeutics (2019), other from Deciphera Pharmaceuticals (2020−2021), personal fees from Elevar Therapeutics (2020), personal fees and other from F. Hoffmann-La Roche Ltd. (2019–2021), other from Genmab (2019–2021), personal fees and other from GSK (2019–2021), personal fees and other from Immunogen Inc. (2019–2022), personal fees from Jazzpharma (2021−2022), personal fees from Mersana (2020), other from Millennium Pharmaceuticals (2019), personal fees and other from MSD (2019–2022), personal fees and other from Novocure (2020−2022), personal fees from Octimet Oncology NV (2019), personal fees and other from Oncoinvent AS (2019–2022), personal fees and other from Sotio a.s. (2019–2022), personal fees from Verastem Oncology (2020), personal fees from Zentalis (2020), grants and other from Roche, other from Tesaro, personal fees from Agenus (2021), personal fees from Aksebio (2021), personal fees from Eisai (2021), personal fees from Karyopharm (2021), personal fees from Novartis (2021), personal fees from Seagen (2021), outside the submitted work. All other authors declared no conflicts of interest.