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Comparison of survival outcomes and safety between early and late initiation of niraparib maintenance in newly diagnosed advanced epithelial ovarian cancer
  1. Se Ik Kim1,
  2. Ji Hyun Kim2,
  3. Eun Young Park3,
  4. Eun Taeg Kim4,
  5. Eunjin Choi1,
  6. Jae-Weon Kim1,
  7. Sang-Yoon Park2 and
  8. Myong Cheol Lim2
    1. 1Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Jongno-gu, Korea (the Republic of)
    2. 2Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea (the Republic of)
    3. 3Biostatistics Collaboration Team, Research Core Center, National Cancer Center, Goyang, Korea (the Republic of)
    4. 4Department of Obstetrics and Gynecology, Kosin University College of Medicine, Busan, Korea (the Republic of)
    1. Correspondence to Dr Myong Cheol Lim; gynlim{at}gmail.com

    Abstract

    Objective This multicenter retrospective cohort study aimed to compare survival outcomes and adverse events between early and late initiation of niraparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer.

    Methods We included patients with stage III–IV ovarian cancer who showed a complete or partial response to frontline platinum-based chemotherapy and received niraparib maintenance therapy between October 2019 and December 2022. The primary endpoint was the HR for progression-free survival based on the median initiation interval, which was defined as the duration between the completion of chemotherapy and commencement of maintenance therapy. The secondary endpoint was the comparison of progression-free survival at another time point that determined the interval that maximized the difference between the survival curves of the two groups using the Contal and O’Quigley method.

    Results This analysis included 146 patients who received niraparib maintenance therapy. The median age was 58 years (IQR 50–63.3). The median initiation interval was 8.4 (IQR 5.7–8.9) weeks. After adjusting for prognostic factors for progression-free survival identified through multivariable analysis, early initiation (≤8 weeks) of niraparib was associated with significantly better progression-free survival (HR=0.57; 95% CI 0.33 to 0.99; p=0.047). Furthermore, the initiation interval that maximized the difference in progression-free survival was 6 weeks. Multivariable analysis revealed that early initiation (≤6 weeks) of niraparib significantly increased progression-free survival (HR=0.37; 95% CI 0.18 to 0.76; p=0.007). The rate of treatment discontinuation due to treatment-emergent adverse events was higher (12.5% versus. 2.8%; p=0.036) in patients receiving niraparib within 6 weeks than those treated later, with no significant effect in those initiating treatment within 8 weeks.

    Conclusion Early initiation of niraparib maintenance therapy within 8 weeks of chemotherapy completion improved progression-free survival, with further benefits observed with treatment within 6 weeks in patients with newly diagnosed advanced ovarian cancer.

    • Ovarian Cancer

    Data availability statement

    Data are available upon reasonable request. In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

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    Data availability statement

    Data are available upon reasonable request. In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

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    Footnotes

    • SIK and JHK are joint first authors.

    • SIK and JHK contributed equally.

    • Contributors Guarantor for overall content: MCL. Concept and design: SIK, JHK, MCL Acquisition, analysis, or interpretation of data: SIK, JHK, EYP, ETK, J-WK, EC, S-YP, MCL. Drafting of the manuscript: SIK, JHK, ETK. Critical revision of the manuscript for important intellectual content: SIK, JHK, S-YP, MCL. Statistical analysis: SIK, JHK, EYP, ETK. Administrative, technical, or material support: SIK, JHK, EYP, ETK, J-WK, EC, S-YP, MCL. Supervision: J-WK, S-YP, MCL.

    • Funding This research was supported by a grant from the Korean Cancer Survivors Healthcare R&D Project through the National Cancer Center, funded by the Ministry of Health & Welfare, Republic of Korea (grant number: RS-2023-CC140196). The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript 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.