PLoS ONE (Jan 2015)

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).

  • Kiyoaki Tsukahara,
  • Akira Kubota,
  • Yasuhisa Hasegawa,
  • Hideki Takemura,
  • Tomonori Terada,
  • Takahide Taguchi,
  • Kunihiko Nagahara,
  • Hiroaki Nakatani,
  • Kunitoshi Yoshino,
  • Yuichiro Higaki,
  • Shigemichi Iwae,
  • Takeshi Beppu,
  • Yutaka Hanamure,
  • Kichinobu Tomita,
  • Naoyuki Kohno,
  • Kazuyoshi Kawabata,
  • Masanori Fukushima,
  • Satoshi Teramukai,
  • Masato Fujii,
  • ACTS-HNC group

DOI
https://doi.org/10.1371/journal.pone.0116965
Journal volume & issue
Vol. 10, no. 2
p. e0116965

Abstract

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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). PATIENTS AND 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. TRIAL REGISTRATION:ClinicalTrials.gov NCT00336947 http://clinicaltrials.gov/show/NCT00336947.