Nejvíce citovaný článek - PubMed ID 22624135
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.
- Klíčová slova
- Adverse event, Edema, MET inhibitor, Nausea, Non–small cell lung cancer,
- 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
- Názvy látek
- inhibitory proteinkinas * MeSH
- kreatinin MeSH
- piperidiny MeSH
- pyridaziny MeSH
- pyrimidiny MeSH
- tepotinib MeSH Prohlížeč