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 Field | Value | Language |
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dc.contributor.author | Kim, Youjin | - |
dc.contributor.author | Lee, Su Jin | - |
dc.contributor.author | Lee, Ji Yun | - |
dc.contributor.author | Lee, Se-Hoon | - |
dc.contributor.author | Sun, Jong-Mu | - |
dc.contributor.author | Park, Keunchil | - |
dc.contributor.author | An, Ho Jung | - |
dc.contributor.author | Cho, Jae Yong | - |
dc.contributor.author | Kang, Eun Joo | - |
dc.contributor.author | Lee, Ha-Young | - |
dc.contributor.author | Kim, Jinsoo | - |
dc.contributor.author | Keam, Bhumsuk | - |
dc.contributor.author | Kim, Hye Ryun | - |
dc.contributor.author | Lee, Kyoung Eun | - |
dc.contributor.author | Choi, Moon Young | - |
dc.contributor.author | Lee, Ki Hyeong | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.date.accessioned | 2021-09-03T05:13:10Z | - |
dc.date.available | 2021-09-03T05:13:10Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-06-01 | - |
dc.identifier.issn | 0008-543X | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/83179 | - |
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 PDGFR alpha and PDGFR beta). 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. (C) 2017 American Cancer Society. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.subject | ADENOID CYSTIC CARCINOMA | - |
dc.subject | GROWTH-FACTOR RECEPTOR | - |
dc.subject | C-KIT | - |
dc.subject | SYSTEMIC THERAPY | - |
dc.subject | II TRIAL | - |
dc.subject | EXPRESSION | - |
dc.subject | TUMORS | - |
dc.subject | MANAGEMENT | - |
dc.subject | INHIBITOR | - |
dc.subject | MUTATIONS | - |
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.contributor.affiliatedAuthor | Kang, Eun Joo | - |
dc.identifier.doi | 10.1002/cncr.30537 | - |
dc.identifier.scopusid | 2-s2.0-85010203076 | - |
dc.identifier.wosid | 000401841700013 | - |
dc.identifier.bibliographicCitation | CANCER, v.123, no.11, pp.1958 - 1964 | - |
dc.relation.isPartOf | CANCER | - |
dc.citation.title | CANCER | - |
dc.citation.volume | 123 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 1958 | - |
dc.citation.endPage | 1964 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | ADENOID CYSTIC CARCINOMA | - |
dc.subject.keywordPlus | GROWTH-FACTOR RECEPTOR | - |
dc.subject.keywordPlus | C-KIT | - |
dc.subject.keywordPlus | SYSTEMIC THERAPY | - |
dc.subject.keywordPlus | II TRIAL | - |
dc.subject.keywordPlus | EXPRESSION | - |
dc.subject.keywordPlus | TUMORS | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | MUTATIONS | - |
dc.subject.keywordAuthor | nintedanib | - |
dc.subject.keywordAuthor | salivary gland cancer | - |
dc.subject.keywordAuthor | vascular endothelial growth factor receptor (VEGFR) | - |
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