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  • Efficacy and safety of an oral combination therapy of niraparib and etoposide in platinum resistant/refractory ovarian cancer: a single arm, prospective, phase II study

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Efficacy and safety of an oral combination therapy of niraparib and etoposide in platinum resistant/refractory ovarian cancer: a single arm, prospective, phase II study
  1. Huimei Zhou1,2,
  2. Qian Liu1,2,
  3. Depu Zhang3,
  4. Qingshui Li3,
  5. Dongyan Cao1,2,
  6. Ninghai Cheng1,2,
  7. Xirun Wan1,2,
  8. Ying Zhang1,2,
  9. Fengzhi Feng1,2,
  10. Yang Xiang1,2 and
  11. Jiaxin Yang1,2
    1. 1 Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
    2. 2 National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, China
    3. 3 Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China
    1. Correspondence to Dr Jiaxin Yang; jiaxin_yang{at}sina.com

    Abstract

    Objective Non-platinum chemotherapy is used in platinum resistant/refractory ovarian cancer patients but offers limited efficacy, especially in those who develop platinum resistance after ≤2 lines of platinum based chemotherapy. This phase II study aimed to evaluate the efficacy and safety of oral niraparib plus etoposide in platinum resistant/refractory ovarian cancer.

    Methods Platinum resistant/refractory ovarian cancer patients after ≤2 lines of platinum based chemotherapy, histologically confirmed as non-mucinous epithelial ovarian cancer, regardless of biomarker status, were eligible. Patients received niraparib with a starting dose of 200 mg/100 mg alternate once a day, and oral etoposide of 50 mg once a day, on days 1–20 of 30 days per cycle for a maximum of 6–8 cycles, followed by niraparib until disease progression or intolerable toxicity. The primary endpoint was investigator assessed progression free survival.

    Results 29 patients were enrolled from 22 May 2020 to 3 February 2023; 26 patients were included in the efficacy analysis set as per protocol. Median progression free survival was 4.2 months (95% confidence interval (CI) 3.9 to 4.4). Overall response rate was 26.9% (95% CI 8.7 to 45.2). Disease control rate was 57.7% (95% CI 37.3 to 78.0). Overall response rate in patients with a BRCA mutation and homologous recombination deficiency was 50% and 41.7%, respectively. Median progression free survival in patients with primary platinum resistance was 4.5 months (95% CI 3.6 to 5.3). 29 patients were included in the safety analysis set, and 8 (28%) patients experienced treatment related adverse events of grade ≥3. There was no treatment related discontinuation.

    Conclusions Niraparib combined with etoposide showed evidence of antitumor activity in platinum resistant/refractory ovarian cancer after ≤2 lines of platinum based chemotherapy, particularly in patients with a BRCA mutation, homologous recombination deficiency, or primary platinum resistance. This once-a-day oral combination was a convenient option.

    Trial registration number NCT04217798

    • Ovarian Cancer

    Data availability statement

    Data are available upon reasonable request. The data and/or analyzed in the current study are available from the corresponding author upon reasonable request.

    https://doi.org/10.1136/ijgc-2024-005386

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      Data availability statement

      Data are available upon reasonable request. The data and/or analyzed in the current study are available from the corresponding author upon reasonable request.

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      Footnotes

      • Contributors HZ: conceptualization, data curation, formal analysis, investigation, methodology, project administration, resources, software, supervision, validation, visualization, roles/writing—original draft, and writing—review and editing. QL: data curation, formal analysis, project administration, resources, software, visualization, roles/writing—original draft, and writing—review and editing. DZ, QL, DC, NC, XW, YZ, FF, and YX: data curation, formal analysis, and resources. JY:

        guarantor, conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, resources, supervision, validation, and writing—review and editing.

      • Funding This study was partly sponsored by Zai Lab (Shanghai). The sponsor was not involved in the design, data collection, statistical analysis, interpretation of the data, manuscript writing, or the decision to submit for publication.

      • Competing interests None declared.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.