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Effects of niraparib dose reduction on short-term outcomes in ovarian cancer patients
  1. Matteo Bruno1,
  2. Adriana Ionelia Apostol1,
  3. Serena Maria Boccia1,
  4. Carolina Maria Sassu1,
  5. Sara Lardino1,
  6. Camilla Culcasi1,
  7. Domenica Lorusso1,2,
  8. Giovanni Scambia1,2,
  9. Anna Fagotti1,2 and
  10. Claudia Marchetti1,2
    1. 1Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
    2. 2Dipartimento Scienze della Vita e Sanità Pubblica, Università Cattolica del Sacro Cuore, Rome, Italy
    1. Correspondence to Professor Anna Fagotti, Dipartimento Scienze della Salute della Donna e del Bambino, Policlinico Universitario Agostino Gemelli, Rome, Italy; anna.fagotti{at}


    Objectives Despite the individualized starting dose for maintenance therapy in ovarian cancer, the niraparib dose reduction rate remains high. The aim of this study was to evaluate the impact of niraparib dose reduction on progression-free survival in newly diagnosed primary advanced ovarian cancer and recurrent ovarian cancer patients. We also aimed to compare the reduction rates and the safety of niraparib on primary and relapse groups, and identify which factors may predict dose reduction.

    Methods Patients with primary or recurrent ovarian cancer in maintenance who received niraparib between 2019 and 2022 were retrospectively evaluated. Niraparib dosing was based on individualized starting dose of 300 or 200 mg/day. The impact of niraparib dose reductions was focused on patients treated with 200 or 100 mg in both groups. Reduction rates, adverse events and predictive factors of reduction were assessed in each study group. The primary endpoint was progression-free survival in primary and relapse groups; the secondary endpoints were the reduction rates, the safety and tolerability of niraparib in both groups.

    Results Of 215 patients identified, 124 (57.7%) primary and 91 (42.3%) recurrent ovarian cancer patients were included. The majority of patients started niraparib at 200 mg/day (92.7% primary and 80.2% relapse group); dose reductions from 300 or 200 mg/day to 200 or 100 mg/day occurred more frequently within cycles 1–3 (67% primary and 45% relapse group, p=0.001). Grade≥3 adverse events were lower in the relapse group (54.8% primary and 35.1% relapse, p=0.001). In both groups, dose modifications over the treatment did not significantly impair median progression-free survival. Univariate and multivariate analysis demonstrated that weight and platinum-doublets were possible risk factors for dose reduction.

    Conclusions Niraparib dose reduction occurs in almost half of patients within cycles 1–3, although it is significantly more common in the first-line setting. Survival outcomes seem not to be impaired by dose reduction.

    • Ovarian Cancer
    • Gynecology
    • Carcinoma, Ovarian Epithelial
    • Medical Oncology

    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    • X @annafagottimd

    • MB and AIA contributed equally.

    • Presented at The abstract of this article was presented in the Mini-oral Session on Ovarian Cancer during the European Society of Gynaecological Oncology (ESGO) Congress held in Istanbul, Turkey, September 28 to October 1, 2023.

    • Contributors MB, CM, AIA: conceptualization, data curation, methodology, formal analysis, writing original draft. SMB, CMS: data collection, investigation, methodology. MB, CM: methodology, formal and statistical analysis. AIA, SL, CC: data collection, data curation. GS, AF, DL: investigation, validation, supervision. All authors discussed the results; reviewed and revised the manuscript, and approved the final version of the manuscript. CM: guarantor for the overall content.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests CM is on the consultant/advisory board for Clovis, Pharmamar, GSK, AstraZeneca, and MSD, and received travel accommodation from Pharmamar and Roche. AF reports commercial interests with AstraZeneca, MSD, Johnson & Johnson, and Pharmamar. GS reports research support from MSD and honoraria from Clovis Oncology, and is a consultant for GSK, Tesaro, and Johnson & Johnson. DL is on the consultant/advisory board for Clovis Oncology, Pharmamar, GSK, AstraZeneca, MSD, Genmab, Immunogen, Seagen, Novartis, Oncoinvest, Concept, and Sutro; she reports research support from Clovis Oncology, GSK, MSD, Pharmamar, Genmab, Immunogen, Incyte, Roche, Seagen, and Novartis, and received travel accommodation from AstraZeneca, Clovis Oncology, and GSK.

    • 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.