dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Veillon, Remi |
dc.contributor.author | Sakai, Hiroshi |
dc.contributor.author | Felip Font, Enriqueta |
dc.contributor.author | Cortot, Alexis |
dc.contributor.author | Le, Xiuning |
dc.contributor.author | Smit, Egbert |
dc.date.accessioned | 2022-09-09T07:16:34Z |
dc.date.available | 2022-09-09T07:16:34Z |
dc.date.issued | 2022-06 |
dc.identifier.citation | Veillon R, Sakai H, Le X, Felip E, Cortot AB, Smit EF, et al. Safety of Tepotinib in Patients With MET Exon 14 Skipping NSCLC and Recommendations for Management. Clin Lung Cancer. 2022 Jun;23(4):320–32. |
dc.identifier.issn | 1525-7304 |
dc.identifier.uri | https://hdl.handle.net/11351/8083 |
dc.description | Edema; Nausea; Non-small cell lung cancer |
dc.description.abstract | 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. |
dc.language.iso | eng |
dc.publisher | Elsevier |
dc.relation.ispartofseries | Clinical Lung Cancer;23(4) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Pulmons - Càncer - Tractament |
dc.subject | Avaluació de resultats (Assistència sanitària) |
dc.subject.mesh | Carcinoma, Non-Small-Cell Lung |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Treatment Outcome |
dc.title | Safety of Tepotinib in Patients With MET Exon 14 Skipping NSCLC and Recommendations for Management |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1016/j.cllc.2022.03.002 |
dc.subject.decs | carcinoma de pulmón de células no pequeñas |
dc.subject.decs | /farmacoterapia |
dc.subject.decs | resultado del tratamiento |
dc.relation.publishversion | https://doi.org/10.1016/j.cllc.2022.03.002 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Veillon R] CHU Bordeaux, Service des Maladies Respiratoires, Bordeaux, France. [Sakai H] Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan. [Le X] Department of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. [Felip E] Department of Oncology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Cortot AB] Univ. Lille, CHU Lille, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 – UMR-S 1277 - Canther, Lille, France. [Smit EF] Netherlands Cancer Institute, Amsterdam, The Netherlands |
dc.identifier.pmid | 35466070 |
dc.identifier.wos | 000810868000011 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |