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  3. 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

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

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Autores de FISABIO

Autores ajenos a FISABIO

  • Valabrega G
  • Pothuri B
  • Oaknin A
  • Graybill WS
  • McCormick C
  • Baurain JF
  • Tinker AV
  • Denys H
  • O'Cearbhaill RE
  • Hietanen S
  • Moore RG
  • Knudsen AØ
  • de La Motte Rouge T
  • Heitz F
  • Levy T
  • York W
  • Gupta D
  • Monk BJ
  • González-Martín A

Grupos de Investigación

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. (c) 2024 Published by Elsevier Inc.

Datos de la publicación

ISSN/ISSNe:
0090-8258, 1095-6859

GYNECOLOGIC ONCOLOGY  Elsevier Inc.

Tipo:
Article
Páginas:
128-138
PubMed:
38833992

Citas Recibidas en Web of Science: 4

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Keywords

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

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