2026-04-13T01:37:23Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/120532024-11-01T01:14:24Zcom_2072_378070com_2072_378040col_2072_378092

Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial Graybill, Whitney S. McCormick, Colleen VALABREGA, Giorgio Pothuri, Bhavana OAKNIN, ANA Sanchez-Heras, Ana Beatriz Institut Català de la Salut [Valabrega G] AO Ordine Mauriziano Torino and Department of Oncology, University of Torino, Torino, Italy. [Pothuri B] GOG Foundation and Departments of Obstetrics/Gynecology and Medicine, Division of Gynecologic Oncology, Laura & Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA. [Oaknin A] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Graybill WS] Medical University of South Carolina, Charleston, SC, USA. [Sánchez AB] Unit of Genetic Counseling in Cancer and Gynecologic Oncology, Hospital General Universitario de Elche, Elche, Spain. [McCormick C] Legacy Medical Group Gynecologic Oncology, Portland, OR, USA Vall d'Hebron Barcelona Hospital Campus Avaluació de resultats (Assistència sanitària) Ovaris - Càncer - Tractament Inhibidors enzimàtics - Ús terapèutic ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Ovarian Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Poly(ADP-ribose) Polymerase Inhibitors Other subheadings::Other subheadings::/therapeutic use TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias ováricas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de poli(ADP-ribosa) polimerasas Otros calificadores::Otros calificadores::/uso terapéutico Niraparib; Ovarian cancer; PARP inhibitor Niraparib; Cáncer de ovario; Inhibidor de PARP Niraparib; Càncer d'ovari; Inhibidor de PARP Objective To evaluate the impact of age on the efficacy and safety of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer with a complete/partial response to first-line platinum-based chemotherapy. Methods Post hoc analysis of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016). Patients in the intent-to-treat population were categorized according to age at baseline (<65 years vs ≥65 years), and progression-free survival (PFS), safety, and health-related quality of life (HRQOL) were evaluated for each age subgroup (clinical cutoff date, May 17, 2019). Safety findings were also evaluated according to a fixed starting dose (FSD) or an individualized starting dose (ISD). Results Of 733 randomized patients, 289 (39.4%) were ≥65 years (190 niraparib, 99 placebo) at baseline. Median PFS (niraparib vs placebo) and hazard ratios (95% CI) were similar in patients aged <65 years (13.9 vs 8.2 months; HR, 0.61 [0.47–0.81]) and ≥65 years (13.7 vs 8.1 months; HR, 0.53 [0.39–0.74]). The incidences of any-grade and grade ≥3 treatment-emergent adverse events (TEAEs) were similar across age subgroups; in the niraparib arm, TEAEs leading to dose discontinuation occurred in 7.8% of patients <65 years and 18.4% of patients ≥65 years. ISD use lowered the incidence of grade ≥3 thrombocytopenia events in niraparib-treated patients compared with the FSD (<65 years: 42.8% vs 18.0%; ≥65 years 57.0% vs 26.1%). HRQOL was comparable across age subgroups. Conclusion Niraparib efficacy, safety, and HRQOL were generally comparable across age subgroups, although patients ≥65 years had a higher rate of discontinuations due to TEAEs. ISD use reduced grade ≥3 thrombocytopenia events regardless of age. This study (NCT02655016) was funded by GSK. 2024-10-11T10:52:11Z 2024-10-11T10:52:11Z 2024-08 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Valabrega G, Pothuri B, Oaknin A, Graybill WS, Sánchez AB, McCormick C, et al. Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 Aug;187:128–38. 0090-8258 https://hdl.handle.net/11351/12053 10.1016/j.ygyno.2024.03.009 38833992 001252237600001 http://hdl.handle.net/11351/12053 eng Gynecologic Oncology;187 https://doi.org/10.1016/j.ygyno.2024.03.009 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia