https://scholars.lib.ntu.edu.tw/handle/123456789/557706
DC 欄位 | 值 | 語言 |
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dc.contributor.author | Paik P.K. | en_US |
dc.contributor.author | Felip E. | en_US |
dc.contributor.author | Veillon R. | en_US |
dc.contributor.author | Sakai H. | en_US |
dc.contributor.author | Cortot A.B. | en_US |
dc.contributor.author | Garassino M.C. | en_US |
dc.contributor.author | Mazieres J. | en_US |
dc.contributor.author | Viteri S. | en_US |
dc.contributor.author | Senellart H. | en_US |
dc.contributor.author | van Meerbeeck J. | en_US |
dc.contributor.author | Raskin J. | en_US |
dc.contributor.author | Reinmuth N. | en_US |
dc.contributor.author | Conte P. | en_US |
dc.contributor.author | Kowalski D. | en_US |
dc.contributor.author | Cho B.C. | en_US |
dc.contributor.author | Patel J.D. | en_US |
dc.contributor.author | Horn L. | en_US |
dc.contributor.author | Griesinger F. | en_US |
dc.contributor.author | Han J.-Y. | en_US |
dc.contributor.author | Kim Y.-C. | en_US |
dc.contributor.author | Chang G.-C. | en_US |
dc.contributor.author | Tsai C.-L. | en_US |
dc.contributor.author | CHIH-HSIN YANG | en_US |
dc.contributor.author | Chen Y.-M. | en_US |
dc.contributor.author | Smit E.F. | en_US |
dc.contributor.author | van der Wekken A.J. | en_US |
dc.contributor.author | Kato T. | en_US |
dc.contributor.author | Juraeva D. | en_US |
dc.contributor.author | Stroh C. | en_US |
dc.contributor.author | Bruns R. | en_US |
dc.contributor.author | Straub J. | en_US |
dc.contributor.author | Johne A. | en_US |
dc.contributor.author | Scheele J. | en_US |
dc.contributor.author | Heymach J.V. | en_US |
dc.contributor.author | Le X. | en_US |
dc.creator | Paik P.K.;Felip E.;Veillon R.;Sakai H.;Cortot A.B.;Garassino M.C.;Mazieres J.;Viteri S.;Senellart H.;Van Meerbeeck J.;Raskin J.;Reinmuth N.;Conte P.;Kowalski D.;Cho B.C.;Patel J.D.;Horn L.;Griesinger F.;Han J.-Y.;Kim Y.-C.;Chang G.-C.;Tsai C.-L.;Chih-Hsin Yang;Chen Y.-M.;Smit E.F.;Van Der Wekken A.J.;Kato T.;Juraeva D.;Stroh C.;Bruns R.;Straub J.;Johne A.;Scheele J.;Heymach J.V.;Le X. | - |
dc.date.accessioned | 2021-04-23T05:56:28Z | - |
dc.date.available | 2021-04-23T05:56:28Z | - |
dc.date.issued | 2020 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85089665538&doi=10.1056%2fNEJMoa2004407&partnerID=40&md5=8f37b0f296a3ca7e066a056ba0bb0b3b | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/557706 | - |
dc.description.abstract | BACKGROUND A splice-site mutation that results in a loss of transcription of exon 14 in the oncogenic driver MET occurs in 3 to 4% of patients with non-small-cell lung cancer (NSCLC). We evaluated the efficacy and safety of tepotinib, a highly selective MET inhibitor, in this patient population. METHODS In this open-label, phase 2 study, we administered tepotinib (at a dose of 500 mg) once daily in patients with advanced or metastatic NSCLC with a confirmed MET exon 14 skipping mutation. The primary end point was the objective response by independent review among patients who had undergone at least 9 months of follow-up. The response was also analyzed according to whether the presence of a MET exon 14 skipping mutation was detected on liquid biopsy or tissue biopsy. RESULTS As of January 1, 2020, a total of 152 patients had received tepotinib, and 99 patients had been followed for at least 9 months. The response rate by independent review was 46% (95% confidence interval [CI], 36 to 57), with a median duration of response of 11.1 months (95% CI, 7.2 to could not be estimated) in the combined-biopsy group. The response rate was 48% (95% CI, 36 to 61) among 66 patients in the liquid-biopsy group and 50% (95% CI, 37 to 63) among 60 patients in the tissue-biopsy group; 27 patients had positive results according to both methods. The investigator-assessed response rate was 56% (95% CI, 45 to 66) and was similar regardless of the previous therapy received for advanced or metastatic disease. Adverse events of grade 3 or higher that were considered by investigators to be related to tepotinib therapy were reported in 28% of the patients, including peripheral edema in 7%. Adverse events led to permanent discontinuation of tepotinib in 11% of the patients. A molecular response, as measured in circulating free DNA, was observed in 67% of the patients with matched liquid-biopsy samples at baseline and during treatment. CONCLUSIONS Among patients with advanced NSCLC with a confirmed MET exon 14 skipping mutation, the use of tepotinib was associated with a partial response in approximately half the patients. Peripheral edema was the main toxic effect of grade 3 or higher. (Funded by Merck [Darmstadt, Germany]; VISION ClinicalTrials.gov number, NCT02864992.). Copyright ? 2020 Massachusetts Medical Society. | - |
dc.publisher | Massachussetts Medical Society | - |
dc.relation.ispartof | New England Journal of Medicine | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | alanine aminotransferase; amylase; aspartate aminotransferase; creatinine; scatter factor receptor; tepotinib; triacylglycerol lipase; antineoplastic agent; piperidine derivative; protein kinase inhibitor; pyridazine derivative; pyrimidine derivative; scatter factor receptor; tepotinib; adult; advanced cancer; aged; alanine aminotransferase blood level; alopecia; amylase blood level; antineoplastic activity; Article; aspartate aminotransferase blood level; asthenia; cohort analysis; creatinine blood level; decreased appetite; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; dyspnea; exon skipping; fatigue; female; follow up; gene amplification; gene deletion; gene mutation; human; human tissue; hypoalbuminemia; liquid biopsy; major clinical study; male; median survival time; MET gene; metastasis; multicenter study; nausea; non small cell lung cancer; open study; overall survival; peripheral edema; phase 2 clinical trial; pleura effusion; priority journal; progression free survival; proto oncogene; quality of life; respiratory failure; side effect; treatment duration; treatment response; triacylglycerol lipase blood level; tumor biopsy; upper abdominal pain; vomiting; clinical trial; edema; exon; genetics; lung tumor; middle aged; mutation; non small cell lung cancer; very elderly; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Edema; Exons; Female; Humans; Lung Neoplasms; Male; Middle Aged; Mutation; Piperidines; Protein Kinase Inhibitors; Proto-Oncogene Proteins c-met; Pyridazines; Pyrimidines | - |
dc.title | Tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1056/NEJMoa2004407 | - |
dc.identifier.pmid | 32469185 | - |
dc.identifier.scopus | 2-s2.0-85089665538 | - |
dc.relation.pages | 931-943 | - |
dc.relation.journalvolume | 383 | - |
dc.relation.journalissue | 10 | - |
item.cerifentitytype | Publications | - |
item.fulltext | no fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.openairetype | journal article | - |
item.grantfulltext | none | - |
crisitem.author.dept | Oncology | - |
crisitem.author.dept | Cancer Administration and Coordination Center | - |
crisitem.author.dept | National Taiwan University Cancer Center (NTUCC) | - |
crisitem.author.orcid | 0000-0002-5586-5138 | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
顯示於: | 腫瘤醫學研究所 |
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