Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma
- Authors
- Loriot, Yohann; Matsubara, Nobuaki; Park, Se Hoon; Huddart, Robert A.; Burgess, Earle F.; Houede, Nadine; Banek, Severine; Guadalupi, Valentina; Ku, Ja Hyeon; Valderrama, Begona P.; Tran, Ben; Triantos, Spyros; Kean, Yin; Akapame, Sydney; Deprince, Kris; Mukhopadhyay, Sutapa; Stone, Nicole L.; Siefker-Radtke, Arlene O.
- Issue Date
- 21-Oct-2023
- Publisher
- MASSACHUSETTS MEDICAL SOC
- Citation
- NEW ENGLAND JOURNAL OF MEDICINE, v.389, no.21, pp 1961 - 1971
- Pages
- 11
- Indexed
- SCIE
SCOPUS
- Journal Title
- NEW ENGLAND JOURNAL OF MEDICINE
- Volume
- 389
- Number
- 21
- Start Page
- 1961
- End Page
- 1971
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/109893
- DOI
- 10.1056/NEJMoa2308849
- ISSN
- 0028-4793
1533-4406
- Abstract
- Background Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti-programmed cell death protein 1 [PD-1] or anti-programmed death ligand 1 [PD-L1] agents) are unclear.Methods We conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti-PD-1 or anti-PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator's choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.Results A total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P=0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).Conclusions Erdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti-PD-1 or anti-PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.)
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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