Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 이경은 | * |
dc.date.accessioned | 2017-02-15T08:02:08Z | - |
dc.date.available | 2017-02-15T08:02:08Z | - |
dc.date.issued | 2017 | * |
dc.identifier.issn | 0008-543X | * |
dc.identifier.other | OAK-20105 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/234534 | - |
dc.description.abstract | BACKGROUND: Salivary gland cancers (SGCs) are uncommon and account for less than 5% of all head and neck cancers, but they are histologically heterogeneous. No specific therapy, including targeted agents, has consistently improved clinical outcomes in recurrent/metastatic SGC. Recent studies suggest that vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) play important roles in SGC. Nintedanib is a potent small-molecule, triple-receptor tyrosine kinase inhibitor (VEGFR1, VEGFR2, and VEGFR3; fibroblast growth factor receptor 1 [FGFR1], FGFR2, and FGFR3; and PDGFRα and PDGFRß). This study sought to determine the antitumor activity of nintedanib in patients with recurrent or metastatic SGC. METHODS: This open-label, multicenter, phase 2, single-arm study was conducted at 11 hospitals in South Korea. Patients with pathologically confirmed recurrent and/or metastatic SGC for whom at least 1 line of systemic chemotherapy had failed were enrolled. Nintedanib was given orally at 200 mg twice a day until disease progression or unacceptable toxicity. The primary endpoint was the response rate. The secondary endpoints were progression-free survival, overall survival, toxicity, and the disease-control rate. The Simon 2-stage minimax design was used. RESULTS: The median age of the patients was 54 years, 60% were female, and 95% had an Eastern Cooperative Oncology Group performance status of 0 or 1. The majority of the patients had adenoid cystic carcinoma (65%), and 40% received at least 2 prior rounds of chemotherapy. After 20 patients were enrolled, the study was stopped because no responders were observed at stage I. There were no partial responses, but the disease-control rate was 75% (15 of 20). The median duration of stable disease was 8.2 months (range, 1.76-12.36 months). At the time of the data cutoff, with a median follow-up of 9.5 months, the median overall survival had not been reached, and the progression-free survival rate at 6 months was 60% (95% confidence interval, 0.34-0.79). Grade 3 adverse events included liver enzyme elevation (25%) and nausea/vomiting (5%). Four patients who required a dose reduction because of a grade 3 liver enzyme elevation showed no further grade 3 events. CONCLUSIONS: Single-agent nintedanib did not yield a partial response but did achieve a 75% disease-control rate with long-term stabilization in SGC patients. Because of the high rate and long duration of disease control with a good safety profile, further investigation is warranted. Cancer 2017;123:1958–1964. © 2017 American Cancer Society. © 2017 American Cancer Society | * |
dc.language | English | * |
dc.publisher | John Wiley and Sons Inc. | * |
dc.subject | nintedanib | * |
dc.subject | salivary gland cancer | * |
dc.subject | vascular endothelial growth factor receptor (VEGFR) | * |
dc.title | Clinical trial of nintedanib in patients with recurrent or metastatic salivary gland cancer of the head and neck: A multicenter phase 2 study (Korean Cancer Study Group HN14-01) | * |
dc.type | Article | * |
dc.relation.issue | 11 | * |
dc.relation.volume | 123 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 1958 | * |
dc.relation.lastpage | 1964 | * |
dc.relation.journaltitle | Cancer | * |
dc.identifier.doi | 10.1002/cncr.30537 | * |
dc.identifier.wosid | WOS:000401841700013 | * |
dc.identifier.scopusid | 2-s2.0-85010203076 | * |
dc.author.google | Kim Y. | * |
dc.author.google | Lee S.J. | * |
dc.author.google | Lee J.Y. | * |
dc.author.google | Lee S.-H. | * |
dc.author.google | Sun J.-M. | * |
dc.author.google | Park K. | * |
dc.author.google | An H.J. | * |
dc.author.google | Cho J.Y. | * |
dc.author.google | Kang E.J. | * |
dc.author.google | Lee H.-Y. | * |
dc.author.google | Kim J. | * |
dc.author.google | Keam B. | * |
dc.author.google | Kim H.R. | * |
dc.author.google | Lee K.E. | * |
dc.author.google | Choi M.Y. | * |
dc.author.google | Lee K.H. | * |
dc.author.google | Ahn M.-J. | * |
dc.contributor.scopusid | 이경은(7501517217;58364338700) | * |
dc.date.modifydate | 20240123091958 | * |