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| Verfasst von: | Javle, Milind [VerfasserIn]  |
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| | Lowery, Maeve [VerfasserIn] |
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| | Shroff, Rachna T. [VerfasserIn] |
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| | Weiss, Karl Heinz [VerfasserIn] |
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| | Springfeld, Christoph [VerfasserIn] |
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| | Borad, Mitesh J. [VerfasserIn] |
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| | Ramanathan, Ramesh K. [VerfasserIn] |
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| | Goyal, Lipika [VerfasserIn] |
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| | Sadeghi, Saeed [VerfasserIn] |
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| | Macarulla, Teresa [VerfasserIn] |
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| | El-Khoueiry, Anthony [VerfasserIn] |
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| | Kelley, Robin Kate [VerfasserIn] |
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| | Borbath, Ivan [VerfasserIn] |
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| | Choo, Su Pin [VerfasserIn] |
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| | Oh, Do-Youn [VerfasserIn] |
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| | Philip, Philip A. [VerfasserIn] |
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| | Chen, Li-Tzong [VerfasserIn] |
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| | Reungwetwattana, Thanyanan [VerfasserIn] |
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| | Van Cutsem, Eric [VerfasserIn] |
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| | Yeh, Kun-Huei [VerfasserIn] |
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| | Ciombor, Kristen [VerfasserIn] |
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| | Finn, Richard S. [VerfasserIn] |
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| | Patel, Anuradha [VerfasserIn] |
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| | Sen, Suman [VerfasserIn] |
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| | Porter, Dale [VerfasserIn] |
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| | Isaacs, Randi [VerfasserIn] |
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| | Zhu, Andrew X. [VerfasserIn] |
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| | Abou-Alfa, Ghassan K. [VerfasserIn] |
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| | Bekaii-Saab, Tanios [VerfasserIn] |
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| Titel: | Phase II study of BGJ398 in patients with FGFR-altered advanced cholangiocarcinoma |
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| Verf.angabe: | Milind Javle, Maeve Lowery, Rachna T. Shroff, Karl Heinz Weiss, Christoph Springfeld, Mitesh J. Borad, Ramesh K. Ramanathan, Lipika Goyal, Saeed Sadeghi, Teresa Macarulla, Anthony El-Khoueiry, Robin Kate Kelley, Ivan Borbath, Su Pin Choo, Do-Youn Oh, Philip A. Philip, Li-Tzong Chen, Thanyanan Reungwetwattana, Eric Van Cutsem, Kun-Huei Yeh, Kristen Ciombor, Richard S. Finn, Anuradha Patel, Suman Sen, Dale Porter, Randi Isaacs, Andrew X. Zhu, Ghassan K. Abou-Alfa, Tanios Bekaii-Saab |
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| E-Jahr: | 2017 |
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| Jahr: | November 28, 2017 |
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| Umfang: | 7 S. |
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| Fussnoten: | Gesehen am 02.03.2020 ; Das pdf umfasst 14 Seiten |
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| Titel Quelle: | Enthalten in: Journal of clinical oncology |
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| Ort Quelle: | Alexandria, Va. : American Society of Clinical Oncology, 1983 |
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| Jahr Quelle: | 2017 |
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| Band/Heft Quelle: | 36(2017), 3, Seite 276-282 |
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| ISSN Quelle: | 1527-7755 |
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| Abstract: | PurposeNo standard treatment exists for patients with cholangiocarcinoma for whom first-line gemcitabine-based therapy fails. Fibroblast growth factor receptor 2 (FGFR2) fusions/translocations are present in 13% to 17% of intrahepatic cholangiocarcinomas. BGJ398, an orally bioavailable, selective pan-FGFR kinase inhibitor, has shown preliminary clinical activity against tumors with FGFR alterations.MethodsA multicenter, open-label, phase II study (ClinicalTrials.gov identifier: NCT02150967) evaluated BGJ398 antitumor activity in patients age ≥ 18 years with advanced or metastatic cholangiocarcinoma containing FGFR2 fusions or other FGFR alterations whose disease had progressed while receiving prior therapy. Patients received BGJ398 125 mg once daily for 21 days, then 7 days off (28-day cycles). The primary end point was investigator-assessed overall response rate.ResultsSixty-one patients (35 women; median age, 57 years) with FGFR2 fusion (n = 48), mutation (n = 8), or amplification (n = 3) participated. At the prespecified data cutoff (June 30, 2016), 50 patients had discontinued treatment. All responsive tumors contained FGFR2 fusions. The overall response rate was 14.8% (18.8% FGFR2 fusions only), disease control rate was 75.4% (83.3% FGFR2 fusions only), and estimated median progression-free survival was 5.8 months (95% CI, 4.3 to 7.6 months). Adverse events included hyperphosphatemia (72.1% all grade), fatigue (36.1%), stomatitis (29.5%), and alopecia (26.2%). Grade 3 or 4 treatment-related adverse events occurred in 25 patients (41%) and included hyperphosphatemia (16.4%), stomatitis (6.6%), and palmar-plantar erythrodysesthesia (4.9%).ConclusionBGJ398 is a first-in-class FGFR kinase inhibitor with manageable toxicities that shows meaningful clinical activity against chemotherapy-refractory cholangiocarcinoma containing FGFR2 fusions. This promising antitumor activity supports continued development of BGJ398 in this highly selected patient population. |
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| DOI: | doi:10.1200/JCO.2017.75.5009 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext: https://doi.org/10.1200/JCO.2017.75.5009 |
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| | Verlag: https://ascopubs.org/doi/abs/10.1200/JCO.2017.75.5009 |
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| | DOI: https://doi.org/10.1200/JCO.2017.75.5009 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| K10plus-PPN: | 1691316903 |
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| Verknüpfungen: | → Zeitschrift |
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Phase II study of BGJ398 in patients with FGFR-altered advanced cholangiocarcinoma / Javle, Milind [VerfasserIn]; November 28, 2017 (Online-Ressource)
