Pal, Sumanta K., Rosenberg, Jonathan E., Hoffman-Censits, Jean H., Berger, Raanan, Quinn, David I., Galsky, Matthew D., Wolf, Juergen, Dittrich, Christian, Keam, Bhumsuk, Delord, Jean-Pierre, Schellens, Jan H. M., Gravis, Gwenaelle, Medioni, Jacques, Maroto, Pablo, Sriuranpong, Virote, Charoentum, Chaiyut, Burris, Howard A., Grunwald, Viktor, Petrylak, Daniel, Vaishampayan, Ulka ORCID: 0000-0001-5800-4571, Gez, Eliahu, De Giorgi, Ugo, Lee, Jae-Lyun, Voortman, Jens, Gupta, Sumati, Sharma, Sunil, Mortazavi, Amir, Vaughn, David J., Isaacs, Randi, Parker, Katie, Chen, Xueying, Yu, Kun, Porter, Dale, Porta, Diana Graus and Bajorin, Dean F. (2018). Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations. Cancer Discov., 8 (7). S. 812 - 822. PHILADELPHIA: AMER ASSOC CANCER RESEARCH. ISSN 2159-8290

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Abstract

BGJ398, a potent and selective pan-FGFR antagonist, was prospectively evaluated in patients with metastatic urothelial carcinoma bearing a diverse array of FGFR3 alterations. Patients (N = 67) who were unable to receive platinum chemotherapy were enrolled. The majority (70.1%) had received two or more prior antineoplastic therapies. BGJ398 was administered orally at 125 mg/day on a 3 weeks on, 1 week off schedule until unacceptable toxicity or progression. The primary endpoint was the response rate. Among 87 patients treated, an overall response rate of 25.4% was observed and an additional 38.8% of patients had disease stabilization, translating to a disease control rate of 64.2%. The most common treatment-emergent toxicities were hyperphosphatemia, elevated creatinine, fatigue, constipation, and decreased appetite. Further examination of BGJ398 in this disease setting is warranted. SIGNIFICANCE: BJG398 is active in patients with alterations in FGFR3, resulting in both reductions in tumor volume and stabilization of disease. (C) 2018 AACR.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Pal, Sumanta K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosenberg, Jonathan E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoffman-Censits, Jean H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berger, RaananUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Quinn, David I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Galsky, Matthew D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dittrich, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Keam, BhumsukUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delord, Jean-PierreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schellens, Jan H. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gravis, GwenaelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Medioni, JacquesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maroto, PabloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sriuranpong, ViroteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Charoentum, ChaiyutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burris, Howard A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grunwald, ViktorUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Petrylak, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vaishampayan, UlkaUNSPECIFIEDorcid.org/0000-0001-5800-4571UNSPECIFIED
Gez, EliahuUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Giorgi, UgoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lee, Jae-LyunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Voortman, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gupta, SumatiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sharma, SunilUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mortazavi, AmirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vaughn, David J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Isaacs, RandiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Parker, KatieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chen, XueyingUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yu, KunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Porter, DaleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Porta, Diana GrausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bajorin, Dean F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-180261
DOI: 10.1158/2159-8290.CD-18-0229
Journal or Publication Title: Cancer Discov.
Volume: 8
Number: 7
Page Range: S. 812 - 822
Date: 2018
Publisher: AMER ASSOC CANCER RESEARCH
Place of Publication: PHILADELPHIA
ISSN: 2159-8290
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CISPLATIN-INELIGIBLE PATIENTS; ACQUIRED-RESISTANCE; GENETIC ALTERATIONS; BLADDER-CANCER; SINGLE-ARM; MULTICENTER; PEMBROLIZUMAB; NVP-BGJ398; MUTATIONSMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/18026

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