Sistema de Salut de Catalunya
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
2024-10-11T10:52:11Z
2024-10-11T10:52:11Z
2024-08
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.
Article
Published version
English
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
Elsevier
Gynecologic Oncology;187
https://doi.org/10.1016/j.ygyno.2024.03.009
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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