Phase II trial of chemoradiotherapy with S‐1 plus cisplatin for unresectable locally advanced head and neck cancer (JCOG0706)

Cancer Science

Makoto Tahara⁸  Naomi Kiyota¹¹  Junki Mizusawa⁹  Kenichi Nakamura⁷  Ryuichi Hayashi¹³  Tetsuo Akimoto¹²  Yasuhisa Hasegawa¹  Shigemichi Iwae³  Nobuya Monden⁴  Kazuto Matsuura^8,14  Hirofumi Fujii^5,8  Yusuke Onozawa^8,10  Akira Homma^2,8  Akira Kubota^6,8  Haruhiko Fukuda⁹ 

[1] Department of Head and Neck Surgery, Aichi Cancer Center, Nagoya, Japan;Department of Otolaryngology, Hokkaido University Hospital, Sapporo, Japan;Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan;Department of Head and Neck Surgery, Shikoku Cancer Center, Matsuyama, Japan;Department of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan;Department of Head and Neck Surgery, Kanagawa Cancer Center, Yokohama, Japan;Japan Clinical Oncology Group Operations Office, National Cancer Center, Tokyo, Japan;Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan;Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan;Division of Clinical Oncology, Shizuoka Cancer Center, Shizuoka, Japan;Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan;Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan;Department of Head and Neck Surgery, Kashiwa, Japan;Division of Head and Neck Surgery, Miyagi Cancer Center, Natori, Japan

关键词: Chemoradiotherapy;    cisplatin;    head and neck cancer;    S‐1;    unresectable;   

DOI  :  10.1111/cas.12657

来源: Wiley

【 摘 要 】

Abstract

We conducted a phase II study to evaluate the efficacy and safety of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck. Chemotherapy consisted of S-1 twice daily on days 1–14 at 60 mg/m²/day and cisplatin at 20 mg/m²/day on days 8–11, repeated twice at a 5-week interval. Single daily radiation of 70 Gy in 35 fractions was given concurrently starting on day 1. For patients achieving an objective response after chemoradiotherapy, two additional cycles of chemotherapy were administered. Of the 45 enrolled patients, the percentage of clinical complete remission, the primary endpoint, was 64.4% (8 complete response, 21 good partial response) on central review. After a median follow-up of 3.52 years, 3-year local progression-free survival was 62.2%, with 3-year progression-free survival of 60.0%, 3-year overall survival of 64.4%, and 3-year time to treatment failure of 48.9%. Grade 3 or 4 toxicity included pharyngeal mucositis (46.7%), oral mucositis (44.4%), dysphagia (46.7%), anorexia (42.2%), radiation dermatitis (26.7%), neutropenia (26.7%), and febrile neutropenia (4.4%). No treatment-related deaths were observed. This combination showed promising efficacy with acceptable toxicities.

【 授权许可】

CC BY-NC-ND   
© 2015 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.

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