1. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma
- Author
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Loriot, Yohann, Necchi, Andrea, Park, Se Hoon, Garcia-Donas, Jesus, Huddart, Robert, Burgess, Earle, Fleming, Mark, Rezazadeh, Arash, Mellado, Begoña, Varlamov, Sergey, Joshi, Monika, Duran, Ignacio, Tagawa, Scott, Zakharia, Yousef, Zhong, Bob, Stuyckens, Kim, Santiago-Walker, Ademi, De Porre, Peter, O’Hagan, Anne, Avadhani, Anjali, Siefker-Radtke, Arlene, Houédé, Nadine, Loriot, Y, Necchi, A, Park, Sh, Garcia-Donas, J, Huddart, R, Burgess, E, Fleming, M, Rezazadeh, A, Mellado, B, Varlamov, S, Joshi, M, Duran, I, Tagawa, St, Zakharia, Y, Zhong, B, Stuyckens, K, Santiago-Walker, A, De Porre, P, O'Hagan, A, Avadhani, A, Siefker-Radtke, Ao, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Fondazione IRCCS Istituto Nazionale dei Tumori, Samsung Medical Center Sungkyunkwan University School of Medicine, Institute Division of Hematology/Oncology, Centro Integral Oncologico Clara Campal, Academic Radiotherapy Unit, Institute of cancer research, The Levine Cancer Institute, Virginia Oncology Associates, University of Louisville, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Department of Scientific Information Analyses, Siberian Research Institute of Cheese-Making, Barnaul, Russia, Department of Veterinary and Biomedical Sciences, Penn State Cancer Institute, The Pennsylvania State University, 115 Henning Building, University Park, PA 16802, USA., Marqués de Valdecilla University Hospital [Santander], Weill Medical College of Cornell University [New York], Department of Pediatrics and Holden Comprehensive Cancer Center [Iowa City, USA], University of Iowa [Iowa City]-Carver College of Medicine, University of Iowa, Janssen Research & Development [Spring House, PA, USA], Janssen Pharmaceutica [Beerse], Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), and Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)
- Subjects
Adult ,Urologic Neoplasms ,Metastatic Urothelial Carcinoma ,Antineoplastic Agents ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,medicine.disease_cause ,03 medical and health sciences ,0302 clinical medicine ,Immune system ,Erdafitinib ,Quinoxalines ,Humans ,MESH: Quinoxalines / administration & dosage ,Receptors, Fibroblast Growth Factor / antagonists & inhibitors ,Receptors, Fibroblast Growth Factor / genetics ,Urologic Neoplasms / drug therapy ,Medicine ,030212 general & internal medicine ,Progression-free survival ,Neoplasm Metastasis ,Urothelium ,Receptor ,Protein Kinase Inhibitors ,Aged ,Aged, 80 and over ,Mutation ,MESH: Antineoplastic Agents / administration & dosage ,Protein Kinase Inhibitors / administration & dosage ,Pyrazoles / administration & dosage ,business.industry ,General Medicine ,Middle Aged ,Protein-Tyrosine Kinases ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,Receptors, Fibroblast Growth Factor ,Progression-Free Survival ,3. Good health ,Treatment Outcome ,Fibroblast growth factor receptor ,Cancer research ,Pyrazoles ,business - Abstract
Alterations in the gene encoding fibroblast growth factor receptor (In this open-label, phase 2 study, we enrolled patients who had locally advanced and unresectable or metastatic urothelial carcinoma with prespecifiedA total of 99 patients in the selected-regimen group received a median of five cycles of erdafitinib. Of these patients, 43% had received at least two previous courses of treatment, 79% had visceral metastases, and 53% had a creatinine clearance of less than 60 ml per minute. The rate of confirmed response to erdafitinib therapy was 40% (3% with a complete response and 37% with a partial response). Among the 22 patients who had undergone previous immunotherapy, the confirmed response rate was 59%. The median duration of progression-free survival was 5.5 months, and the median duration of overall survival was 13.8 months. Treatment-related adverse events of grade 3 or higher, which were managed mainly by dose adjustments, were reported in 46% of the patients; 13% of the patients discontinued treatment because of adverse events. There were no treatment-related deaths.The use of erdafitinib was associated with an objective tumor response in 40% of previously treated patients who had locally advanced and unresectable or metastatic urothelial carcinoma with
- Published
- 2019