Perez-Fidalgo, J ACortés, AGuerra, EGarcía, YIglesias, MBohn Sarmiento, UCalvo García, EManso Sánchez, LSantaballa, AOaknin, ARedondo, ARubio, M JGonzález-Martín, A2025-01-072025-01-072021-07-27https://hdl.handle.net/10668/25902There is limited evidence for the benefit of olaparib in platinum-resistant ovarian cancer (PROC) patients with BRCA wild-type tumors. This study investigated whether this combination of a DNA-damaging chemotherapy plus olaparib is effective in PROC regardless BRCA status. Patients with high-grade serous or endometrioid ovarian carcinoma and one previous PROC recurrence were enrolled regardless of BRCA status. Patients with ≤4 previous lines (up to 5 in BRCA-mut) with at least one previous platinum-sensitive relapse were included; primary PROC was allowed only in case of BRCA-mut. Patients initially received six cycles of olaparib 300 mg b.i.d. (biduum) + intravenous pegylated liposomal doxorubicin (PLD) 40 mg/m2 (PLD40) every 28 days, followed by maintenance with olaparib 300 mg b.i.d. until progression or toxicity. The PLD dose was reduced to 30 mg/m2 (PLD30) due to toxicity. The primary endpoint was progression-free survival (PFS) at 6 months (6m-PFS) by RECIST version 1.1. A proportion of 40% 6m-PFS or more was considered of clinical interest. From 2017 to 2020, 31 PROC patients were included. BRCA mutations were present in 16%. The median of previous lines was 2 (range 1-5). The overall disease control rate was 77% (partial response rate of 29% and stable disease rate of 48%). After a median follow-up of 10 months, the 6m-PFS and median PFS were 47% and 5.8 months, respectively. Grade ≥3 treatment-related adverse events occurred in 74% of patients, with neutropenia/anemia being the most frequent. With PLD30 serious AEs were less frequent than with PLD40 (21% versus 47%, respectively); moreover, PLD30 was associated with less PLD delays (32% versus 38%) and reductions (16% versus 22%). The PLD-olaparib combination has shown significant activity in PROC regardless of BRCA status. PLD at 30 mg/m2 is better tolerated in the combination.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/BRCA wild-typePARP inhibitorolaparibpegylated liposomal doxorubicinplatinum-resistant recurrent ovarian cancerAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDoxorubicinFemaleHumansNeoplasm Recurrence, LocalOvarian NeoplasmsPhthalazinesPiperazinesPolyethylene GlycolsOlaparib in combination with pegylated liposomal doxorubicin for platinum-resistant ovarian cancer regardless of BRCA status: a GEICO phase II trial (ROLANDO study).research article34329939open access10.1016/j.esmoop.2021.1002122059-7029PMC8446804https://europepmc.org/articles/pmc8446804?pdf=renderhttps://pmc.ncbi.nlm.nih.gov/articles/PMC8446804/pdf