Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1–3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with<i>FGFR3</i>Alterations
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- Sumanta K. Pal
- 1City of Hope, Duarte, California.
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- Jonathan E. Rosenberg
- 2Memorial Sloan Kettering Cancer Center, New York, New York.
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- Jean H. Hoffman-Censits
- 3Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania.
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- Raanan Berger
- 4The Chaim Sheba Medical Center, Ramat Gan, Israel.
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- David I. Quinn
- 5USC Norris Cancer Center, Los Angeles, California.
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- Matthew D. Galsky
- 6The Mount Sinai Hospital, New York, New York.
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- Juergen Wolf
- 7Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany.
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- Christian Dittrich
- 8Applied Cancer Research-Institution for Translational Research Vienna (ACR-ITR VIEnna), Kaiser-Franz-Josef-Spital, Vienna, Austria.
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- Bhumsuk Keam
- 9Seoul National University Hospital, Seoul, South Korea.
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- Jean-Pierre Delord
- 10IUCT Oncopole, Toulouse, France.
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- Jan H.M. Schellens
- 11The Netherlands Cancer Institute, Amsterdam, the Netherlands.
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- Gwenaelle Gravis
- 12Institut Paoli Calmettes, Marseilles, France.
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- Jacques Medioni
- 13Hôpital Européen Georges Pompidou, Paris, France.
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- Pablo Maroto
- 14Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
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- Virote Sriuranpong
- 15Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
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- Chaiyut Charoentum
- 16Maharaj Nakorn Chiangmai Hospital, Chiang Mai, Thailand.
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- Howard A. Burris
- 17Sarah Cannon Research Institute, Nashville, Tennessee.
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- Viktor Grünwald
- 18Medical School Hannover, Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover, Germany.
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- Daniel Petrylak
- 19Yale School of Medicine, New Haven, Connecticut.
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- Ulka Vaishampayan
- 20Wayne State University/Karmanos Cancer Institute, Detroit, Michigan.
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- Eliahu Gez
- 21Tel-Aviv Sourasky Medical Center (Ichilov), Tel Aviv, Israel.
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- Ugo De Giorgi
- 22Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
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- Jae-Lyun Lee
- 23Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
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- Jens Voortman
- 24VU University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands.
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- Sumati Gupta
- 25Huntsman Cancer Institute (University of Utah), Salt Lake City, Utah.
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- Sunil Sharma
- 25Huntsman Cancer Institute (University of Utah), Salt Lake City, Utah.
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- Amir Mortazavi
- 26The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
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- David J. Vaughn
- 27Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania.
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- Randi Isaacs
- 28Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
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- Katie Parker
- 28Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
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- Xueying Chen
- 28Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
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- Kun Yu
- 29Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.
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- Dale Porter
- 29Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.
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- Diana Graus Porta
- 30Novartis Pharma AG, Basel, Switzerland.
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- Dean F. Bajorin
- 2Memorial Sloan Kettering Cancer Center, New York, New York.
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説明
<jats:title>Abstract</jats:title><jats:p>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 67 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.</jats:p><jats:p>Significance: BJG398 is active in patients with alterations in FGFR3, resulting in both reductions in tumor volume and stabilization of disease. Our data highlight putative mechanisms of resistance to the agent, which may be useful in following disease status. Cancer Discov; 8(7); 812–21. ©2018 AACR.</jats:p><jats:p>This article is highlighted in the In This Issue feature, p. 781</jats:p>
収録刊行物
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- Cancer Discovery
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Cancer Discovery 8 (7), 812-821, 2018-07-01
American Association for Cancer Research (AACR)