Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study

Objective To identify characteristics associated with long-term progression-free survival (>= 2 years) in patients with advanced ovarian cancer treated with niraparib first-line maintenance therapy in the phase III PRIMA/ENGOT-OV26/GOG-3012 study. Methods In this post hoc analysis of PRIMA, patie...

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Detalhes bibliográficos
Autores: Graybill, Whitney S., Pardo Búrdalo, Beatriz, O’Malley, David M., Vergote, Ignace, Monk, Bradley J., Auranen, Annika, Copeland, Larry J., Sabbatini, Roberto, Herzog, Thomas J., Follana, Philippe, Pothuri, Bhavana, Ioana Braicu, Elena, Mccormick, Colleen, Yubero, Alfonso, Moore, Richard G., Vuylsteke, Peter, Raaschou Jensen, Nicoline, York, Whitney, Hartman, John, González-Martin, Antonio, Stockman, Liz
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Recursos:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/224894
Acesso em linha:https://hdl.handle.net/2445/224894
Access Level:acceso abierto
Palavra-chave:Quimioteràpia del càncer
Metàstasi
Càncer d'ovari
Cancer chemotherapy
Metastasis
Ovarian cancer
Descrição
Resumo:Objective To identify characteristics associated with long-term progression-free survival (>= 2 years) in patients with advanced ovarian cancer treated with niraparib first-line maintenance therapy in the phase III PRIMA/ENGOT-OV26/GOG-3012 study. Methods In this post hoc analysis of PRIMA, patients randomized to niraparib were grouped based on investigator-assessed progression-free survival (progressive disease/censoring <2 years or >= 2 years after randomization). Variables assessed for predictive value were Eastern Cooperative Oncology Group performance status, International Federation of Gynecology and Obstetrics (FIGO) stage at diagnosis, clinical response to platinum-based chemotherapy, number of prior chemotherapy cycles, primary tumor location, body mass index, categorical age, debulking surgery type, number of baseline target lesions, number of baseline non-target lesions, BRCA/homologous recombination-deficiency status, residual disease status, and duration from end of chemotherapy to randomization. Logistic regression modeling using backward elimination (significance level=0.15) identified covariates associated with long-term progression-free survival (clinical cut-off date November 17, 2021). Results Of 487 patients randomized to niraparib, 152 (31%) had progressive disease/censoring >= 2 years after randomization. Multivariable logistic regression modeling using backward elimination identified BRCA1/2 mutation/homologous recombination deficiency status (p<0.0001), FIGO stage (p=0.041), primary tumor location (p=0.095), and number of baseline non-target lesions (p=0.0001) to be associated with long-term progression-free survival. Patients significantly more likely to achieve progression-free survival of >= 2 years in the final model were those with BRCA1- and BRCA2-mutated/homologous recombination-deficient tumors or BRCA wild-type/not determined/homologous recombination-deficient tumors (vs BRCA wild-type/homologous recombination-proficient/not determined tumors), FIGO stage III (vs IV), and 0 or 1 baseline non-target lesions (vs >= 2 baseline non-target lesions). Conclusions The hypothesis-generating results of this analysis suggest that BRCA1/2 mutation/homologous recombination-deficiency status, FIGO stage, and number of baseline non-target lesions may predict progression-free survival of >= 2 years in patients with advanced ovarian cancer receiving niraparib first-line maintenance therapy. Trial registration number NCT02655016.

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