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
Journal
Oral Oncology
Journal Volume
73
Pages
138-146
Date Issued
2017
Author(s)
Kiyota N.
Hasegawa Y.
Takahashi S.
Yokota T.
Yen C.-J.
Iwae S.
Shimizu Y.
Goto M.
Kang J.-H.
Sum Kenneth Li W.
Ferris R.L.
Gillison M.
Namba Y.
Monga M.
Lynch M.
Tahara M.
Abstract
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
Subjects
Asian; Nivolumab; Programmed death-1; Squamous cell carcinoma of the head and neck
SDGs
Other Subjects
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
Publisher
Elsevier Ltd
Type
journal article