title: Randomized phase III trial of adjuvant chemotherapy with S-1 after curative treatment in patients with squamous-cell carcinoma of the head and neck (ACTS-HNC).
abstract: BACKGROUND
  We conducted a phase III study to evaluate S-1 as compared with UFT as control in patients after curative therapy for stage III, IVA, or IVB squamous-cell carcinoma of the head and neck (SCCHN).
  
  
  METHODS
  Patients were randomly assigned to the UFT group (300 or 400 mg day-1 for 1 year) or the S-1 group (80, 100, or 120 mg day-1 for 1 year). The primary end point was disease-free survival (DFS). Secondary end points were relapse-free survival, overall survival (OS), and safety.
  
  
  RESULTS
  A total of 526 patients were enrolled, and 505 were eligible for analysis. The 3-year DFS rate was 60.0% in the UFT group and 64.1% in the S-1 group (HR, 0.87; 95%CI, 0.66-1.16; p = 0.34). The 3-year OS rate was 75.8% and 82.9%, respectively (HR, 0.64; 95% CI, 0.44-0.94; p = 0.022). Among grade 3 or higher adverse events, the incidences of leukopenia (5.2%), neutropenia (3.6%), thrombocytopenia (2.0%), and mucositis/stomatitis (2.4%) were significantly higher in the S-1 group.
  
  
  CONCLUSIONS
  Although DFS did not differ significantly between the groups, OS was significantly better in the S-1 group than in the UFT group. S-1 is considered a treatment option after curative therapy for stage III, IVA, IVB SCCHN.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00336947 http://clinicaltrials.gov/show/NCT00336947.
authors: Department of Otolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, Hachioji, Japan.
authors: Kiyoaki
authors: K
authors: Tsukahara
authors: Department Head and Neck Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors: Akira
authors: A
authors: Kubota
authors: Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
authors: Yasuhisa
authors: Y
authors: Hasegawa
authors: Department of Otolaryngology, Yokohama Rosai Hospital, Yokohama, Japan.
authors: Hideki
authors: H
authors: Takemura
authors: Department of Otolaryngology, Hyogo College of Medicine, Nishinomiya, Japan.
authors: Tomonori
authors: T
authors: Terada
authors: Department of Otorhinolaryngology, and Head and Neck Surgery, Yokohama City University, School of Medicine, Yokohama, Japan.
authors: Takahide
authors: T
authors: Taguchi
authors: Department of Head and Neck Surgery, Kusatsu General Hospital, Kusatsu, Japan.
authors: Kunihiko
authors: K
authors: Nagahara
authors: Department of Otolaryngology, Head and Neck Surgery, National Hospital Organization Fukuyama Medical Center, Fukuyama, Japan.
authors: Hiroaki
authors: H
authors: Nakatani
authors: Department of Otolaryngology, Head and Neck Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors: Kunitoshi
authors: K
authors: Yoshino
authors: Department of Head and Neck Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
authors: Yuichiro
authors: Y
authors: Higaki
authors: Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.
authors: Shigemichi
authors: S
authors: Iwae
authors: Department of Head and Neck Surgery, Saitama Cancer Center, Saitama, Japan.
authors: Takeshi
authors: T
authors: Beppu
authors: Department of Otolaryngology, Kagoshima City Hospital, Kagoshima, Japan.
authors: Yutaka
authors: Y
authors: Hanamure
authors: Department of Otolaryngology, Akasaka Surge Clinic, Fukuoka, Japan.
authors: Kichinobu
authors: K
authors: Tomita
authors: Department of Otolaryngology, Head and Neck Surgery, Kyorin University School of Medicine, Mitaka, Japan.
authors: Naoyuki
authors: N
authors: Kohno
authors: Division of Head and Neck Surgery, Cancer Institute Hospital, Tokyo, Japan.
authors: Kazuyoshi
authors: K
authors: Kawabata
authors: Translational Research Informatics Center, Kobe, Japan.
authors: Masanori
authors: M
authors: Fukushima
authors: Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Japan.
authors: Satoshi
authors: S
authors: Teramukai
authors: Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
authors: Masato
authors: M
authors: Fujii
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D000077195:Squamous Cell Carcinoma of Head and Neck; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid