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Safety of Tepotinib in Patients With MET Exon 14 Skipping NSCLC and Recommendations for Management
R. Veillon, H. Sakai, X. Le, E. Felip, AB. Cortot, EF. Smit, K. Park, F. Griesinger, C. Britschgi, YL. Wu, B. Melosky, S. Baijal, GC. Jr, M. Sedova, K. Berghoff, G. Otto, PK. Paik
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, práce podpořená grantem
- MeSH
- edém chemicky indukované farmakoterapie MeSH
- exony genetika MeSH
- hypoalbuminemie farmakoterapie MeSH
- inhibitory proteinkinas * škodlivé účinky MeSH
- klinické zkoušky, fáze II jako téma MeSH
- kreatinin terapeutické užití MeSH
- lidé MeSH
- mutace MeSH
- nádory plic * farmakoterapie genetika MeSH
- nauzea chemicky indukované MeSH
- nemalobuněčný karcinom plic * farmakoterapie genetika MeSH
- piperidiny škodlivé účinky MeSH
- pleurální výpotek MeSH
- průjem MeSH
- pyridaziny škodlivé účinky MeSH
- pyrimidiny škodlivé účinky MeSH
- senioři MeSH
- zvracení chemicky indukované MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
INTRODUCTION: The MET inhibitor tepotinib demonstrated durable clinical activity in patients with advanced MET exon 14 (METex14) skipping NSCLC. We report detailed analyses of adverse events of clinical interest (AECIs) in VISION, including edema, a class effect of MET inhibitors. PATIENTS AND METHODS: Incidence, management, and time to first onset/resolution were analyzed for all-cause AECIs, according to composite categories (edema, hypoalbuminemia, creatinine increase, and ALT/AST increase) or individual preferred terms (pleural effusion, nausea, diarrhea, and vomiting), for patients with METex14 skipping NSCLC in the phase II VISION trial. RESULTS: Of 255 patients analyzed (median age: 72 years), edema, the most common AECI, was reported in 69.8% (grade 3, 9.4%; grade 4, 0%). Median time to first edema onset was 7.9 weeks (range: 0.1-58.3). Edema was manageable with supportive measures, dose reduction (18.8%), and/or treatment interruption (23.1%), and rarely prompted discontinuation (4.3%). Other AECIs were also manageable and predominantly mild/moderate: hypoalbuminemia, 23.9% (grade 3, 5.5%); pleural effusion, 13.3% (grade ≥ 3, 5.1%); creatinine increase, 25.9% (grade 3, 0.4%); nausea, 26.7% (grade 3, 0.8%), diarrhea, 26.3% (grade 3, 0.4%), vomiting 12.9% (grade 3, 1.2%), and ALT/AST increase, 12.2% (grade ≥ 3, 3.1%). GI AEs typically occurred early and resolved in the first weeks. CONCLUSION: Tepotinib was well tolerated in the largest trial of a MET inhibitor in METex14 skipping NSCLC. The most frequent AEs were largely mild/moderate and manageable with supportive measures and/or dose reduction/interruption, and caused few withdrawals in this elderly population.
CHU Bordeaux Service des Maladies Respiratoires Bordeaux France
Cytel Czech Republic s r o Prague Czech Republic
Department of Clinical Oncology Hospital Sírio Libanês São Paulo Brazil
Department of Medicine Weill Cornell Medical College New York NY
Department of Oncology Vall d'Hebron Institute of Oncology Barcelona Spain
Department of Thoracic Oncology Saitama Cancer Center Saitama Japan
Global Clinical Development the healthcare business of Merck KGaA Darmstadt Germany
Global Patient Safety the healthcare business of Merck KGaA Darmstadt Germany
Medical Oncology The University of British Columbia Vancouver Canada
Netherlands Cancer Institute Amsterdam The Netherlands
Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Republic of Korea
Thoracic Oncology Service Memorial Sloan Kettering Cancer Center New York NY
University Hospitals Birmingham NHS Foundation Trust Birmingham UK
Citace poskytuje Crossref.org
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