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 Journal Article
| Authors: | Valabrega, G.; Pothuri, B.; Oaknin, A.; Graybill, W. S.; Sánchez, A. B.; McCormick, C.; Baurain, J. F.; Tinker, A. V.; Denys, H.; O'Cearbhaill, R. E.; Hietanen, S.; Moore, R. G.; Knudsen, A. Ø; de La Motte Rouge, T.; Heitz, F.; Levy, T.; York, W.; Gupta, D.; Monk, B. J.; González-Martín, A. |
| Article Title: | 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 |
| Abstract: | 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. © 2024 |
| Keywords: | adult; treatment response; aged; major clinical study; constipation; fatigue; neutropenia; advanced cancer; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; hypertension; side effect; follow up; ovarian cancer; homologous recombination; progression free survival; quality of life; antineoplastic metal complex; multiple cycle treatment; neutrophil count; ovary cancer; anemia; nausea; thrombocytopenia; incidence; hemoglobin; hemoglobin blood level; brca1 protein; brca2 protein; retrospective study; age; abdominal pain; asthenia; dizziness; dyspnea; febrile neutropenia; drug fatality; insomnia; myelodysplastic syndrome; minimal residual disease; sepsis; headache; neoadjuvant chemotherapy; drug exposure; platelet count; hematocrit; maintenance; post hoc analysis; randomized controlled trial (topic); erythrocyte count; decreased appetite; phase 3 clinical trial (topic); functional assessment of cancer therapy; patient-reported outcome; parp inhibitor; international federation of gynecology and obstetrics; first-line treatment; maintenance chemotherapy; macrocytic anemia; niraparib; intention to treat analysis; human; female; article; treatment interruption; ecog performance status; elevated blood pressure; european organization for research and treatment of cancer quality of life questionnaire core 30; european quality of life 5 dimensions 5 level questionnaire |
| Journal Title: | Gynecologic Oncology |
| Volume: | 187 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2024-08-01 |
| Start Page: | 128 |
| End Page: | 138 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2024.03.009 |
| PUBMED: | 38833992 |
| PROVIDER: | scopus |
| PMCID: | PMC12124154 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledge in the PDF -- Source: Scopus |
