Naomi Kiyota1, Yasuhisa Hasegawa2, Shunji Takahashi3, Tomoya Yokota4, Chia-Jui Yen5, Shigemichi Iwae6, Yasushi Shimizu7, Ruey-Long Hong8, Masahiro Goto9, Jin-Hyoung Kang10, Wing Sum Kenneth Li11, Robert L Ferris12, Maura Gillison13, Yoshinobu Namba14, Manish Monga15, Mark Lynch16, Makoto Tahara17. 1. Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan; Kobe University Hospital Cancer Center, Kobe, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp. 2. Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. Electronic address: hasegawa@aichi-cc.jp. 3. Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: s.takahashi-chemotherapy@jfcr.or.jp. 4. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Shizuoka, Japan. Electronic address: t.yokota@scchr.jp. 5. National Cheng Kung University Hospital, Tainan, Taiwan. Electronic address: yencj@mail.ncku.edu.tw. 6. Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan. Electronic address: s.iwae@hp.pref.hyogo.jp. 7. Department of Medical Oncology, Hokkaido University Hospital, Sapporo, Japan. Electronic address: y-simz@med.hokudai.ac.jp. 8. National Taiwan University Hospital, Taipei, Taiwan. Electronic address: rlhong@ntu.edu.tw. 9. Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan. Electronic address: in2030@osaka-med.ac.jp. 10. The Catholic University Of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea. Electronic address: oncologykang@naver.com. 11. Queen Elizabeth Hospital, Hong Kong, China. Electronic address: lws466@ha.org.hk. 12. University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA, USA. Electronic address: ferrisrl@upmc.edu. 13. The Ohio State University, Columbus, OH, USA. Electronic address: maura.gillison@osumc.edu. 14. ONO Pharmaceutical Co., Ltd., Osaka, Japan. Electronic address: y.nanba@ono.co.jp. 15. Bristol-Myers Squibb, Princeton, NJ, USA. Electronic address: Manish.Monga@bms.com. 16. Bristol-Myers Squibb, Princeton, NJ, USA. Electronic address: Mark.Lynch@bms.com. 17. Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: matahara@east.ncc.go.jp.
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 3mg/kg (n=23) every 2weeks 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 9.5months (95% confidence interval [CI] 9.1-NR) with nivolumab and 6.2months (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 1.9months (95% CI 1.6-7.5) with nivolumab and 1.8months (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.
RCT Entities:
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 3mg/kg (n=23) every 2weeks 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 9.5months (95% confidence interval [CI] 9.1-NR) with nivolumab and 6.2months (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 1.9months (95% CI 1.6-7.5) with nivolumab and 1.8months (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.
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