https://scholars.lib.ntu.edu.tw/handle/123456789/551230
標題: | A randomized, open-label, Phase III clinical trial of nivolumab vs. therapy of investigator's choice in recurrent squamous cell carcinoma of the head and neck: A subanalysis of Asian patients versus the global population in checkmate 141 | 作者: | Kiyota N. Hasegawa Y. Takahashi S. Yokota T. Yen C.-J. Iwae S. Shimizu Y. RUEY-LONG HONG Goto M. Kang J.-H. Sum Kenneth Li W. Ferris R.L. Gillison M. Namba Y. Monga M. Lynch M. Tahara M. |
關鍵字: | Asian; Nivolumab; Programmed death-1; Squamous cell carcinoma of the head and neck | 公開日期: | 2017 | 出版社: | Elsevier Ltd | 卷: | 73 | 起(迄)頁: | 138-146 | 來源出版物: | Oral Oncology | 摘要: | Objectives To assess efficacy and safety of nivolumab versus investigator's choice of therapy (IC) in Asian patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Materials and methods Thirty-four patients from Japan, Taiwan, Hong Kong, and Korea received nivolumab 3 mg/kg (n = 23) every 2 weeks or IC (n = 11), as part of a global trial (n = 361), until intolerable toxicity or disease progression. The primary endpoint was overall survival (OS). Results Median OS was 9.5 months (95% confidence interval [CI] 9.1–NR) with nivolumab and 6.2 months (95% CI 2.6–NR) with IC. Seven (30.4%) patients receiving nivolumab and six (54.5%) receiving IC died. The hazard ratio (HR) for risk of death (nivolumab vs. IC) was 0.50 (95% CI 0.17–1.48). Median progression-free survival was 1.9 months (95% CI 1.6–7.5) with nivolumab and 1.8 months (95% CI 0.4–6.1) with IC (HR 0.57 [95% CI 0.25–1.33]). Objective response rates (complete + partial responses) were 26.1% (6/23 patients; 95% CI 10.2–48.4) for nivolumab and 0% (0/11 patients; 95% CI 0.0–28.5) for IC. Sixteen (69.6%) nivolumab-treated patients and 10 (90.9%) patients receiving IC had a treatment-related adverse event, most commonly decreased appetite (21.7%), pruritus, rash, and fatigue (17.4% each) with nivolumab, and nausea, stomatitis, and decreased appetite (27.3% each) with IC. Conclusion Nivolumab demonstrated a survival advantage compared with conventional treatments in Asian patients with platinum-refractory recurrent or metastatic SCCHN, and was well tolerated. Clinical trial registration NCT02105636. ? 2017 The Authors |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85029597650&doi=10.1016%2fj.oraloncology.2017.07.023&partnerID=40&md5=a7529a4f56324db9f61d3ed9de7f7488 https://scholars.lib.ntu.edu.tw/handle/123456789/551230 |
ISSN: | 1368-8375 | DOI: | 10.1016/j.oraloncology.2017.07.023 | SDG/關鍵字: | cetuximab; docetaxel; methotrexate; nivolumab; programmed death 1 ligand 1; antineoplastic agent; monoclonal antibody; nivolumab; adult; adverse event; aged; anemia; Article; Asian; asthenia; cancer combination chemotherapy; cancer growth; cancer recurrence; cancer survival; cancer therapy; clinical article; clinical assessment; clinical decision making; controlled study; decreased appetite; diarrhea; disease course; drug dose increase; drug efficacy; drug safety; drug tolerability; drug withdrawal; endocrine disease; fatigue; female; gastrointestinal disease; gastrointestinal symptom; head and neck squamous cell carcinoma; Hong Kong; human; hypersensitivity; investigator choice of therapy; Japan; kidney disease; Korea; liver disease; lung disease; malaise; male; mucosa inflammation; multicenter study; nausea; overall survival; patient risk; patient-reported outcome; phase 3 clinical trial; population; priority journal; progression free survival; pruritus; randomized controlled trial; rash; risk assessment; risk factor; skin disease; stomatitis; Taiwan; treatment duration; treatment response; very elderly; Asia; clinical trial; ethnology; head and neck tumor; squamous cell carcinoma; tumor recurrence; Antibodies, Monoclonal; Antineoplastic Agents; Asia; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Humans; Neoplasm Recurrence, Local |
顯示於: | 腫瘤醫學研究所 |
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