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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 | 김혜련 | - |
dc.contributor.author | 조재용 | - |
dc.date.accessioned | 2018-07-20T07:47:25Z | - |
dc.date.available | 2018-07-20T07:47:25Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0008-543X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/160524 | - |
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. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Wiley | - |
dc.relation.isPartOf | CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adenocarcinoma/drug therapy* | - |
dc.subject.MESH | Adenocarcinoma/secondary | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antineoplastic Agents/therapeutic use* | - |
dc.subject.MESH | Bone Neoplasms/drug therapy | - |
dc.subject.MESH | Bone Neoplasms/secondary | - |
dc.subject.MESH | Carcinoma, Adenoid Cystic/drug therapy* | - |
dc.subject.MESH | Carcinoma, Adenoid Cystic/secondary | - |
dc.subject.MESH | Carcinoma, Mucoepidermoid/drug therapy* | - |
dc.subject.MESH | Carcinoma, Mucoepidermoid/secondary | - |
dc.subject.MESH | Early Termination of Clinical Trials | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Head and Neck Neoplasms/drug therapy | - |
dc.subject.MESH | Head and Neck Neoplasms/pathology | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Indoles/therapeutic use* | - |
dc.subject.MESH | Liver Neoplasms/drug therapy | - |
dc.subject.MESH | Liver Neoplasms/secondary | - |
dc.subject.MESH | Lung Neoplasms/drug therapy* | - |
dc.subject.MESH | Lung Neoplasms/secondary | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Recurrence, Local/drug therapy* | - |
dc.subject.MESH | Neoplasm Recurrence, Local/pathology | - |
dc.subject.MESH | Palliative Care | - |
dc.subject.MESH | Pleural Neoplasms/drug therapy | - |
dc.subject.MESH | Pleural Neoplasms/secondary | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Salivary Gland Neoplasms/drug therapy* | - |
dc.subject.MESH | Salivary Gland Neoplasms/pathology | - |
dc.subject.MESH | Treatment Failure | - |
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.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Youjin Kim | - |
dc.contributor.googleauthor | Su Jin Lee | - |
dc.contributor.googleauthor | Ji Yun Lee | - |
dc.contributor.googleauthor | Se‐Hoon Lee | - |
dc.contributor.googleauthor | Jong‐Mu Sun | - |
dc.contributor.googleauthor | Keunchil Park | - |
dc.contributor.googleauthor | Ho Jung An | - |
dc.contributor.googleauthor | Jae Yong Cho | - |
dc.contributor.googleauthor | Eun Joo Kang | - |
dc.contributor.googleauthor | Ha‐Young Lee | - |
dc.contributor.googleauthor | Jinsoo Kim | - |
dc.contributor.googleauthor | Bhumsuk Keam | - |
dc.contributor.googleauthor | Hye Ryun Kim | - |
dc.contributor.googleauthor | Kyoung Eun Lee | - |
dc.contributor.googleauthor | Moon Young Choi | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Myung‐Ju Ahn | - |
dc.identifier.doi | 10.1002/cncr.30537 | - |
dc.contributor.localId | A01166 | - |
dc.contributor.localId | A03899 | - |
dc.relation.journalcode | J00434 | - |
dc.identifier.eissn | 1097-0142 | - |
dc.identifier.pmid | 28102887 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/abs/10.1002/cncr.30537 | - |
dc.subject.keyword | nintedanib | - |
dc.subject.keyword | salivary gland cancer | - |
dc.subject.keyword | vascular endothelial growth factor receptor (VEGFR) | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.alternativeName | Cho, Jae Yong | - |
dc.contributor.affiliatedAuthor | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | Cho, Jae Yong | - |
dc.citation.volume | 123 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 1958 | - |
dc.citation.endPage | 1964 | - |
dc.identifier.bibliographicCitation | CANCER, Vol.123(11) : 1958-1964, 2017 | - |
dc.identifier.rimsid | 44258 | - |
dc.type.rims | ART | - |
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