title: Phase II trial of chemoradiotherapy with S-1 plus cisplatin for unresectable locally advanced head and neck cancer (JCOG0706).
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/m(2) /day and cisplatin at 20 mg/m(2) /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.
authors.affiliation: Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Tahara
authors.affiliation: Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Kiyota
authors.affiliation: Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: Japan Clinical Oncology Group Operations Office, National Cancer Center, Tokyo, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: Department of Head and Neck Surgery, Kashiwa, Japan.
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Hayashi
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Akimoto
authors.affiliation: Department of Head and Neck Surgery, Aichi Cancer Center, Nagoya, Japan.
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Hasegawa
authors.affiliation: Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.
authors.forename: Shigemichi
authors.initials: S
authors.lastname: Iwae
authors.affiliation: Department of Head and Neck Surgery, Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Nobuya
authors.initials: N
authors.lastname: Monden
authors.affiliation: Division of Head and Neck Surgery, Miyagi Cancer Center, Natori, Japan.
authors.forename: Kazuto
authors.initials: K
authors.lastname: Matsuura
authors.affiliation: Department of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Fujii
authors.affiliation: Division of Clinical Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Onozawa
authors.affiliation: Department of Otolaryngology, Hokkaido University Hospital, Sapporo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Homma
authors.affiliation: Department of Head and Neck Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kubota
authors.affiliation: Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.affiliation: Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Fujii
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D011446:Prospective Studies; D000077195:Squamous Cell Carcinoma of Head and Neck; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
keywords: Chemoradiotherapy; S-1; cisplatin; head and neck cancer; unresectable