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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Authors: 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
Format: article
Status:Published version
Publication Date:2024
Country:España
Institution:Universidad de Barcelona
Repository:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/224894
Online Access:https://hdl.handle.net/2445/224894
Access Level:Open access
Keyword:Quimioteràpia del càncer
Metàstasi
Càncer d'ovari
Cancer chemotherapy
Metastasis
Ovarian cancer
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repository_id_str
spelling Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 studyGraybill, Whitney S.Pardo Búrdalo, BeatrizO’Malley, David M.Vergote, IgnaceMonk, Bradley J.Auranen, AnnikaCopeland, Larry J.Sabbatini, RobertoHerzog, Thomas J. Follana, PhilippePothuri, BhavanaIoana Braicu, ElenaMccormick, ColleenYubero, AlfonsoMoore, Richard G.Vuylsteke, PeterRaaschou Jensen, NicolineYork, WhitneyHartman, JohnGonzález-Martin, Antonio Stockman, LizQuimioteràpia del càncerMetàstasiCàncer d'ovariCancer chemotherapyMetastasisOvarian cancerObjective 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.Elsevier BV2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/224894Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1136/ijgc-2024-005356International Journal of Gynecological Cancer, 2024, vol. 34, num. 7, 1041-1050https://doi.org/10.1136/ijgc-2024-005356cc-by-nc (c) IGCS and ESGO, 2024https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2248942026-05-27T06:46:51Z
dc.title.none.fl_str_mv Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
title Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
spellingShingle Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
Graybill, Whitney S.
Quimioteràpia del càncer
Metàstasi
Càncer d'ovari
Cancer chemotherapy
Metastasis
Ovarian cancer
title_short Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
title_full Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
title_fullStr Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
title_full_unstemmed Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
title_sort Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study
dc.creator.none.fl_str_mv 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
author Graybill, Whitney S.
author_facet 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
author_role author
author2 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
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Quimioteràpia del càncer
Metàstasi
Càncer d'ovari
Cancer chemotherapy
Metastasis
Ovarian cancer
topic Quimioteràpia del càncer
Metàstasi
Càncer d'ovari
Cancer chemotherapy
Metastasis
Ovarian cancer
description 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.
publishDate 2024
dc.date.none.fl_str_mv 2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/224894
url https://hdl.handle.net/2445/224894
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1136/ijgc-2024-005356
International Journal of Gynecological Cancer, 2024, vol. 34, num. 7, 1041-1050
https://doi.org/10.1136/ijgc-2024-005356
dc.rights.none.fl_str_mv cc-by-nc (c) IGCS and ESGO, 2024
https://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by-nc (c) IGCS and ESGO, 2024
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier BV
publisher.none.fl_str_mv Elsevier BV
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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