2022-RA-1134-ESGO First real-life data on niraparib maintenance in newly-diagnosed advanced ovarian cancer: a descriptive analysis of the Temporary Authorisation for Use (ATU) cohort. (20th October 2022)

• Record Type: Journal Article
• Authors: Rouge, Thibault de la Motte; Selle, Frédéric; Kfoury, Maria; Fumet, Jean-David; Frenel, Jean-Sébastien; Wasserman, Johanna; Largillier, Rémy; Fages, Anne; Jacquemin, Virginie; Mouaddin, Nadia El; Haddad, Leïla; Tessier, Christophe; Follana, Philppe; Berton, Dominique; Floquet, Anne; Prulhiere, Karine; Pautier, Patricia
• Is Part Of: International journal of gynecological cancer. Volume 32(2022)Supplement 2
• Page Start: A303
• Page End: A304
• Publication Date: 2022-10-20
• Subjects: Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2022-ESGO.647
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Introduction/Background: Niraparib is a PARP inhibitor approved in Europe as maintenance monotherapy in advanced ovarian cancer (aOC) after response to 1L platinum-based chemotherapy. PRIMA/ENGOT-ov26/GOG-3012 showed significant improvement in progression-free survival in aOC with niraparib versus placebo. An early access program (cohort [c]ATU) in France allowed real-world patients with newly-diagnosed aOC who had limited treatment options to receive 1L maintenance treatment with niraparib, when bevacizumab maintenance was not an option for BRCA wild-type patients. Methodology: Patients with newly-diagnosed aOC, including patients without residual disease (RD), were eligible if they had response following platinum-based chemotherapy, were not eligible for bevacizumab, and lacked a BRCA mutation. Niraparib was administered orally (200/300 mg/day) by baseline weight and platelet count. Results: From August 2020-March 2021, 67 oncologists from 55 hospitals completed evaluations for 82 patients with newly-diagnosed aOC; 73 met all eligibility criteria; 67 were exposed to niraparib. Baseline characteristics ( table 1 ) showed that of 48 patients with prior surgery, 36 had interval debulking and 12 upfront surgery; 94% (34/36) and 100% (12/12) had no RD, respectively. Mean niraparib dose at treatment initiation was 207.8 mg/day compared with 181.3 mg/day reported in PRIMA (Mirza, et al. J Clin Oncol;2020:38(15 suppl):6050). Niraparib was discontinued before the end of the ATU period in 8/67 patients (due to adverse events [AEs], n=4; disease progression, n=3; patient request, n=1). 86 treatment-related AEs occurred in 28/67 patients, most commonly thrombocytopenia (25% of patients [grade 3/4 in 7%]), nausea (10% [1%]), and abnormal haemoglobin (9% [0%]). Conclusion: In the first real-life data from patients without maintenance treatment options, no additional safety concerns were observed with niraparib at a comparable median dose versus PRIMA in an older population. The enrolment of 67 patients in 8 months highlights the need for access to treatments for patients with newly-diagnosed aOC in France.