Olaparib in combination with pegylated liposomal doxorubicin for platinum-resistant ovarian cancer regardless of BRCA status: a GEICO phase II trial (ROLANDO study)

Fecha de publicación: 01/08/2021 Fecha Ahead of Print: 27/07/2021

Autores de IIS La Fe

Ana Santaballa Bertrán

Autor

Participantes ajenos a IIS La Fe

Perez-Fidalgo, JA
Cortes, A
Guerra, E
Garcia, Y
Iglesias, M
Sarmiento, UB
Garcia, EC
Sanchez, LM
Oaknin, A
Redondo, A
Rubio, MJ
Gonzalez-Martin, A

Abstract

Background: There 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 and methods: 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) thorn intravenous pegylated liposomal doxorubicin (PLD) 40 mg/m(2) (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. Results: 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%). Conclusions: The PLDeolaparib combination has shown significant activity in PROC regardless of BRCA status. PLD at 30 mg/m2 is better tolerated in the combination.

Datos de la publicación

ISSN/ISSNe:: 2059-7029, 2059-7029
Tipo:: Article
Páginas:: 100212-100212
DOI:: 10.1016/j.esmoop.2021.100212
PubMed:: 34329939
Factor de Impacto:: 1,524 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Keywords

platinum-resistant recurrent ovarian cancer; PARP inhibitor; olaparib; pegylated liposomal doxorubicin; BRCA wild-type

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