دورية أكاديمية
FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1 / 3 mRNA Expression.
| العنوان: | FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1 / 3 mRNA Expression. |
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| المؤلفون: | Sternberg, Cora N., Petrylak, Daniel P., Bellmunt, Joaquim, Nishiyama, Hiroyuki, Necchi, Andrea, Gurney, Howard, Lee, Jae-Lyun, Van Der Heijden, Michiel S., Rosenbaum, Eli, Penel, Nicolas, Pang, See-Tong, Li, Jian-Ri, García Del Muro, Xavier, Joly, Florence, Pápai, Zsuzsanna, Bao, Weichao, Ellinghaus, Peter, Lu, Chengxing, Sierecki, Mitchell, Coppieters, Sabine, Nakajima, Keiko, Ishida, Tatiane Cristine, Quinn, David I. |
| المساهمون: | Université de Lille, CHU Lille, Sandra and Edward Meyer Cancer Center New-York, Yale University New Haven, Harvard Medical School Boston HMS, IMIM-Hospital del Mar, Université de Tsukuba = University of Tsukuba, Universita Vita Salute San Raffaele = Vita-Salute San Raffaele University Milan, Italie UniSR, Macquarie University, University of Ulsan, Netherlands Cancer Institute NKI, METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, Service d'oncologie médicale (CHRU Lille), Chang Gung Memorial Hospital Taipei CGMH, Tunghai University Taichung, University of Barcelona, Service de recherche clinique Centre François Baclesse, National Institute of Oncology Budapest, Hungary, Bayer HealthCare Pharmaceuticals Inc Whippany, Bayer Pharma AG Berlin, School of Medicine Los Angeles |
| سنة النشر: | 2023 |
| المجموعة: | LillOA (Lille Open Archive - Université de Lille) |
| الوصف: | PURPOSE Rogaratinib, an oral pan-fibroblast growth factor receptor (FGFR1-4) inhibitor, showed promising phase I efficacy and safety in patients with advanced urothelial carcinoma (UC) with FGFR1-3 mRNA overexpression. We assessed rogaratinib efficacy and safety versus chemotherapy in patients with FGFR mRNA-positive advanced/metastatic UC previously treated with platinum chemotherapy. METHODS FORT-1 (ClinicalTrials.gov identifier: NCT03410693) was a phase II/III, randomized, open-label trial. Patients with FGFR1/3 mRNA-positive locally advanced or metastatic UC with ≥ 1 prior platinum-containing regimen were randomly assigned (1:1) to rogaratinib (800 mg orally twice daily, 3-week cycles; n = 87) or chemotherapy (docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 intravenously once every 3 weeks; n = 88). The primary end point was overall survival, with objective response rate (ORR) analysis planned following phase II accrual. Because of comparable efficacy between treatments, enrollment was stopped before progression to phase III; a full interim analysis of phase II was completed. RESULTS ORRs were 20.7% (rogaratinib, 18/87; 95% CI, 12.7 to 30.7) and 19.3% (chemotherapy, 17/88; 95% CI, 11.7 to 29.1). Median overall survival was 8.3 months (95% CI, 6.5 to not estimable) and 9.8 months (95% CI, 6.8 to not estimable; hazard ratio, 1.11; 95% CI, 0.71 to 1.72; P = .67). Grade 3/4 events occurred in 37 (43.0%)/4 (4.7%) patients and 32 (39.0%)/15 (18.3%), respectively. No rogaratinib-related deaths occurred. Exploratory analysis of patients with FGFR3 DNA alterations showed ORRs of 52.4% (11/21; 95% CI, 29.8 to 74.3) for rogaratinib and 26.7% (4/15; 95% CI, 7.8 to 55.1) for chemotherapy. CONCLUSION To our knowledge, these are the first data to compare FGFR-directed therapy with chemotherapy in patients with FGFR-altered UC, showing comparable efficacy and manageable safety. Exploratory testing suggested FGFR3 DNA alterations in association with FGFR1/3 mRNA overexpression may be better predictors of ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/octet-stream; application/rdf+xml; charset=utf-8; application/pdf |
| اللغة: | English |
| تدمد: | 36240478 |
| العلاقة: | Journal of Clinical Oncology; J Clin Oncol; http://hdl.handle.net/20.500.12210/89966Test |
| الإتاحة: | https://doi.org/20.500.12210/89966Test https://hdl.handle.net/20.500.12210/89966Test |
| حقوق: | Attribution-NonCommercial-NoDerivs 3.0 United States ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.4A746EB7 |
| قاعدة البيانات: | BASE |
| تدمد: | 36240478 |
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