Olaparib in combination with pegylated liposomal doxorubicin for platinum-resistant ovarian cancer regardless of BRCA status : a GEICO phase II trial (ROLANDO study)
Perez-Fidalgo, J.A. (Hospital Clínic Universitari (València))
Cortés, A. (Hospital Universitario Ramón y Cajal)
Guerra, E. (Hospital Universitario Ramón y Cajal)
García García, Yolanda (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Iglesias, M. (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Bohn Sarmiento, U. (Hospital Universitario de Gran Canaria Doctor Negrín)
Calvo García, E. (Hospital Universitario Virgen del Rocío)
Manso Sánchez, L. (Hospital Universitario 12 de Octubre)
Santaballa, A. (Hospital Universitari i Politècnic La Fe de Valencia)
Oaknin, Ana (Hospital Universitari Vall d'Hebron)
Redondo, A. (Hospital Universitario La Paz (Madrid))
Rubio, M.J. (Hospital Universitario Reina Sofia)
González-Martín, A. (Clínica Universidad de Navarra, Madrid)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	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 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/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/m 2 (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/m 2 is better tolerated in the combination.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	BRCA wild-type ; Olaparib ; PARP inhibitor ; Pegylated liposomal doxorubicin ; Platinum-resistant recurrent ovarian cancer
Publicat a:	ESMO open, Vol. 6 (july 2021) , ISSN 2059-7029

DOI: 10.1016/j.esmoop.2021.100212
PMID: 34329939

9 p, 582.7 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d’Investigació i Innovació Parc Taulí (I3PT)
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