Cited 11 times in
A Phase II Study of Nivolumab plus Gemcitabine in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (KCSG HN17-11)
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 홍민희 | - |
dc.date.accessioned | 2023-03-21T07:24:51Z | - |
dc.date.available | 2023-03-21T07:24:51Z | - |
dc.date.issued | 2022-10 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193358 | - |
dc.description.abstract | Purpose: Although programmed death 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors are promising agents for recurrent or metastatic nasopharyngeal carcinoma (NPC), PD-1/PD-L1 inhibitor monotherapy has shown modest efficacy. This study evaluated the efficacy and safety of nivolumab plus gemcitabine in patients with NPC who failed prior platinum-based chemotherapy. Patients and methods: This is a phase II, multicenter, open-label, single-arm study. Patients with recurrent or metastatic NPC received nivolumab 3 mg/kg and gemcitabine 1,250 mg/m2 every 2 weeks until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), overall survival (OS), and safety. To identify potential biomarkers, whole-exome sequencing, whole-transcriptome sequencing, and immune phenotype analysis based on Lunit SCOPE IO, an artificial intelligence-powered spatial tumor-infiltrating lymphocyte analyzer, were performed. Results: Thirty-six patients were enrolled between June 2018 and June 2019. The ORR was 36.1% and disease control rate was 97.2%. With median follow-up of 22.0 months, median PFS was 13.8 months [95% confidence interval (CI), 8.6-16.8 months]. Median OS was not reached, and OS rate at 6 months was 97.0% (95% CI, 80.4%-99.6%). The grade ≥3 treatment-related adverse events were hypertension (2.8%) and anemia (2.8%). In multivariate analysis of mutation of chromatin modifier gene, tumor mutational burden (≥ 2.1 mut/Mb), and somatic copy-number alteration (SCNA) level, the group with high SCNA (> 3 points; HR, 7.0; 95% CI, 1.3-37.9; P = 0.02) had independently associated with poor PFS. Immune phenotype analysis showed that tumors with high proportion of immune-excluded immune phenotype was significantly correlated with poor PFS (HR, 4.4; 95% CI, 1.2-16.2; P = 0.018). Conclusions: Nivolumab plus gemcitabine showed promising efficacy with favorable toxicity profiles in patients with advanced NPC in whom platinum-based combination chemotherapy failed. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | American Association for Cancer Research | - |
dc.relation.isPartOf | CLINICAL CANCER RESEARCH | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Artificial Intelligence | - |
dc.subject.MESH | B7-H1 Antigen / analysis | - |
dc.subject.MESH | B7-H1 Antigen / genetics | - |
dc.subject.MESH | Chromatin | - |
dc.subject.MESH | Deoxycytidine / analogs & derivatives | - |
dc.subject.MESH | Gemcitabine | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immune Checkpoint Inhibitors | - |
dc.subject.MESH | Nasopharyngeal Carcinoma / drug therapy | - |
dc.subject.MESH | Nasopharyngeal Carcinoma / etiology | - |
dc.subject.MESH | Nasopharyngeal Neoplasms* / drug therapy | - |
dc.subject.MESH | Nasopharyngeal Neoplasms* / genetics | - |
dc.subject.MESH | Nivolumab* / therapeutic use | - |
dc.subject.MESH | Programmed Cell Death 1 Receptor / therapeutic use | - |
dc.title | A Phase II Study of Nivolumab plus Gemcitabine in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (KCSG HN17-11) | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Hyun Ae Jung | - |
dc.contributor.googleauthor | Keon-Uk Park | - |
dc.contributor.googleauthor | Sanghee Cho | - |
dc.contributor.googleauthor | Jinyeong Lim | - |
dc.contributor.googleauthor | Keun-Wook Lee | - |
dc.contributor.googleauthor | Min Hee Hong | - |
dc.contributor.googleauthor | Tak Yun | - |
dc.contributor.googleauthor | Ho Jung An | - |
dc.contributor.googleauthor | Woong-Yang Park | - |
dc.contributor.googleauthor | Sergio Pereira | - |
dc.contributor.googleauthor | Chan-Young Ock | - |
dc.contributor.googleauthor | Bhumsuk Keam | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-22-1238 | - |
dc.contributor.localId | A04393 | - |
dc.relation.journalcode | J00564 | - |
dc.identifier.pmid | 35819451 | - |
dc.identifier.url | https://aacrjournals.org/clincancerres/article/28/19/4240/709307/A-Phase-II-Study-of-Nivolumab-plus-Gemcitabine-in | - |
dc.contributor.alternativeName | Hong, Min Hee | - |
dc.contributor.affiliatedAuthor | 홍민희 | - |
dc.citation.volume | 28 | - |
dc.citation.number | 19 | - |
dc.citation.startPage | 4240 | - |
dc.citation.endPage | 4247 | - |
dc.identifier.bibliographicCitation | CLINICAL CANCER RESEARCH, Vol.28(19) : 4240-4247, 2022-10 | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.