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A phase II study of poziotinib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
DC Field | Value | Language |
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dc.contributor.author | 김혜련 | - |
dc.contributor.author | 안병철 | - |
dc.contributor.author | 이지현 | - |
dc.contributor.author | 임선민 | - |
dc.contributor.author | 조병철 | - |
dc.contributor.author | 홍민희 | - |
dc.contributor.author | 허성구 | - |
dc.date.accessioned | 2021-12-28T17:02:52Z | - |
dc.date.available | 2021-12-28T17:02:52Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/186910 | - |
dc.description.abstract | Background: In phase I studies, poziotinib has shown meaningful efficacy against various types of cancers. This phase 2 study aimed to investigate the efficacy and safety of poziotinib in recurrent and/or metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Methods: Overall, 49 patients were enrolled (median age, 62 years; age range, 21-78 years). Patients received a median of two prior treatments including chemotherapy and others and received 12 mg poziotinib orally once daily as part of a 28-day cycle. The primary endpoint was objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS) and overall survival (OS). Targeted capture sequencing was performed using available tissues to identify translational biomarkers related to clinical response. Results: ORR was 22.4%, median PFS was 4.0 months (95% confidence interval [CI], 1.8-6.2 months), and median OS was 7.6 months (95% CI, 4.4-10.8 months). The most common treatment-related adverse events were acneiform rash (85%) and mucositis (77%). A grade 3 or higher adverse event was acneiform rash (3%). Targeted capture sequencing was performed in 30 tissue samples. TP53 and PIK3CA were the most frequently mutated genes (43%), followed by CCND1 (33%) and EGFR (30%). Mutations in ERBB2, ERBB3, and ERBB4, which are HER family genes, were observed in 17%, 13%, and 10% samples, respectively. There was no difference in the frequency of somatic mutations in the HER family genes between the clinically benefitted and non-benefitted groups. Conclusion: Compared to other pan-HER inhibitors, poziotinib showed clinically meaningful efficacy in heavily treated R/M-HNSCC. Clinical trial registration number: NCT02216916. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | John Wiley & Sons Ltd. | - |
dc.relation.isPartOf | CANCER MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | A phase II study of poziotinib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Ji Hyun Lee | - |
dc.contributor.googleauthor | Seong Gu Heo | - |
dc.contributor.googleauthor | Beung-Chul Ahn | - |
dc.contributor.googleauthor | Min Hee Hong | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Sun Min Lim | - |
dc.contributor.googleauthor | Hye Ryun Kim | - |
dc.identifier.doi | 10.1002/cam4.4231 | - |
dc.contributor.localId | A01166 | - |
dc.contributor.localId | A05556 | - |
dc.contributor.localId | A06101 | - |
dc.contributor.localId | A03369 | - |
dc.contributor.localId | A03822 | - |
dc.contributor.localId | A04393 | - |
dc.relation.journalcode | J00449 | - |
dc.identifier.eissn | 2045-7634 | - |
dc.identifier.pmid | 34528763 | - |
dc.subject.keyword | biomarker | - |
dc.subject.keyword | head and neck cancer | - |
dc.subject.keyword | poziotinib | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | 김혜련 | - |
dc.contributor.affiliatedAuthor | 안병철 | - |
dc.contributor.affiliatedAuthor | 이지현 | - |
dc.contributor.affiliatedAuthor | 임선민 | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.contributor.affiliatedAuthor | 홍민희 | - |
dc.citation.volume | 10 | - |
dc.citation.number | 20 | - |
dc.citation.startPage | 7012 | - |
dc.citation.endPage | 7020 | - |
dc.identifier.bibliographicCitation | CANCER MEDICINE, Vol.10(20) : 7012-7020, 2021-07 | - |
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