Retrospective Evaluation of the Efficacy and Safety of Niraparib Maintenance; Real World Data on Turkish Early-Access Program
Kadriye Bir Yucel1, Alper Topal2, Ozan Yazici1, Nuri karadurmus2, Mukremin Uysal3, Nuriye Ozdemir1, Ismail Ersoz2, Osman Sutcuoglu1, Funda Yilmaz41Department of Medical Oncology, Gazi University, Ankara, Türkiye, 2Department of Medical Oncology, Gülhane Training and Research Hospital, Ankara, Türkiye, 3Department of Medical Oncology, Medstar Antalya Hospital, Antalya, Türkiye, 4Department of Medical Oncology, Abdurrahman Yurtaslan Oncology Hospital, Ankra,Türkiye
Objectives: The treatment of epithelial ovarian cancer has been revolutionized by the development of poly ADP-ribose polymerase (PARP) inhibitors which offer maintenance therapy options that extend progression-free survival (PFS). Methods: Patients from sixteen institutions in Turkey who had International Federation of Gynecology and Obstetrics stage III or IV epithelial ovarian cancer and complete or partial response to at least four cycles of platinum-based che motherapy were included in this retrospective study regardless of BRCA status and recurrence disease. Results: A total of 67 patients were evaluated. The median age was 58. The median follow-up was 17.5 months. Median PFS was 8.3 months in BRCAwt and 10.9 months in BRCAmut group (p=0.033). There was no significant difference in mPFS between primary and recurrent patients (10.2 vs. 9.4 months, p=0.328). The most common grade 3/4 adverse events were anemia (32.8%), thrombocytopenia (16.4%), and neutropenia (16.4%). Conclusion: The Turkish EAP's real-world data supports the efficacy and tolerability of niraparib in routine clinical prac tice and complements findings from randomized phase III trials. Keywords: BRCA, maintenance, niraparib, ovarian cancer, toxicity
Cite This Article
Bir Yucel K, Topal A, Yazici O, karadurmus N, Uysal M, Ozdemir N, Ersoz I, Sutcuoglu O, Yilmaz F. Retrospective Evaluation of the Efficacy and Safety of Niraparib Maintenance; Real World Data on Turkish Early-Access Program. EJMI. 2024; 8(3): 205-211
Corresponding Author: Kadriye Bir Yucel