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Introduction <p>Niraparib was approved in the EU in 2017 as maintenance treatment for platinum-sensitive, recurrent ovarian cancer, and in 2020 as first-line maintenance after response to platinum-based chemotherapy. Results from a prospective, noninterventional, single-arm, postauthorization safety study characterizing the risk of developing myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) and other second primary malignancies (SPMs) in patients treated with niraparib in routine clinical practice are reported.</p> Methods <p>Adult patients with epithelial ovarian cancer from Germany, Italy, the Netherlands, and Spain who received niraparib maintenance were enrolled. Patients were followed from niraparib initiation (index date) to the earliest of study completion at 5&#xa0;years’ follow-up, study discontinuation, death, or final database lock (July 11, 2024). Incidence of MDS/AML, and other SPMs were reported, and treatment-emergent adverse events were summarized. Analyses were stratified by niraparib maintenance treatment line.</p> Results <p>Overall, 745 patients (181 first-line maintenance; 564 recurrent) were enrolled and included in this analysis (median age, 65 years; stage III/IV at diagnosis, 89.5%; high-grade serous ovarian cancer at enrollment, 98.7%). Among patients tested for <i>BRCA</i> (<i>n</i> = 585), 14.7% had <i>BRCA</i>-mutated status. Median (Q1, Q3) niraparib treatment duration was 11.0 (5.1, 20.0) and 10.4 (4.8, 22.9) months in first-line maintenance and recurrent cohorts, respectively. Nine patients (1.2%) experienced 11 MDS/AML events, with an incidence rate of 0.51 (95% confidence interval [CI] 0.23–0.97) per 100 patient-years. Six patients (0.8%) experienced seven SPMs, with an incidence rate of 0.34 (95% CI 0.12–0.74) per 100 patient-years. All events occurred in the recurrent cohort, except one SPM event in the first-line cohort.</p> Conclusion <p>Results were consistent with the known niraparib safety profile. For all safety outcomes, observed event rates were consistent with those reported in the label and in niraparib clinical trials. No new safety signals were observed.</p> Trial Registration <p>ENCEPP registration number, EUPAS29407.</p>

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Real-World Risk of Myelodysplastic Syndrome/Acute Myeloid Leukemia and Other Second Primary Malignancies in Patients with Epithelial Ovarian Cancer Treated with Niraparib Maintenance Therapy: Results from a Postauthorization Safety Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月20日

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  • Maurice J. D. L. van der Vorst,
  • Constanza Maximiano Alonso,
  • Tirza Areli Calderón Boyle,
  • Jeanne M. Schilder,
  • Izabela A. Malinowska,
  • Guilan Ye,
  • Judith R. Kroep,
  • Juan Manuel Mañé Martínez,
  • Judi Kuplast,
  • Jessica Perhanidis,
  • Celeste Evans,
  • Amanda K. Golembesky,
  • Giulia Tasca,
  • Stefan Kommoss

摘要

Introduction

Niraparib was approved in the EU in 2017 as maintenance treatment for platinum-sensitive, recurrent ovarian cancer, and in 2020 as first-line maintenance after response to platinum-based chemotherapy. Results from a prospective, noninterventional, single-arm, postauthorization safety study characterizing the risk of developing myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) and other second primary malignancies (SPMs) in patients treated with niraparib in routine clinical practice are reported.

Methods

Adult patients with epithelial ovarian cancer from Germany, Italy, the Netherlands, and Spain who received niraparib maintenance were enrolled. Patients were followed from niraparib initiation (index date) to the earliest of study completion at 5 years’ follow-up, study discontinuation, death, or final database lock (July 11, 2024). Incidence of MDS/AML, and other SPMs were reported, and treatment-emergent adverse events were summarized. Analyses were stratified by niraparib maintenance treatment line.

Results

Overall, 745 patients (181 first-line maintenance; 564 recurrent) were enrolled and included in this analysis (median age, 65 years; stage III/IV at diagnosis, 89.5%; high-grade serous ovarian cancer at enrollment, 98.7%). Among patients tested for BRCA (n = 585), 14.7% had BRCA-mutated status. Median (Q1, Q3) niraparib treatment duration was 11.0 (5.1, 20.0) and 10.4 (4.8, 22.9) months in first-line maintenance and recurrent cohorts, respectively. Nine patients (1.2%) experienced 11 MDS/AML events, with an incidence rate of 0.51 (95% confidence interval [CI] 0.23–0.97) per 100 patient-years. Six patients (0.8%) experienced seven SPMs, with an incidence rate of 0.34 (95% CI 0.12–0.74) per 100 patient-years. All events occurred in the recurrent cohort, except one SPM event in the first-line cohort.

Conclusion

Results were consistent with the known niraparib safety profile. For all safety outcomes, observed event rates were consistent with those reported in the label and in niraparib clinical trials. No new safety signals were observed.

Trial Registration

ENCEPP registration number, EUPAS29407.