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

Giorgio Valabrega*, Bhavana Pothuri, Ana Oaknin, Whitney S. Graybill, Ana Beatriz Sánchez, Colleen McCormick, Jean François Baurain, Anna V. Tinker, Hannelore Denys, Roisin E. O'Cearbhaill, Sakari Hietanen, Richard G. Moore, Anja Ør Knudsen, Thibault de La Motte Rouge, Florian Heitz, Tally Levy, Whitney York, Divya Gupta, Bradley J. Monk, Antonio González-Martín

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)128-138
Number of pages11
JournalGynecologic Oncology
Volume187
DOIs
StatePublished - Aug 2024

Funding

FundersFunder number
GlaxoSmithKline

    Keywords

    • Age
    • Maintenance
    • Niraparib
    • Ovarian cancer
    • PARP inhibitor

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