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 and Group Acts-Hnc

PLOS ONE, 2015, vol. 10, issue 2, 1-15

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). 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

Date: 2015
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DOI: 10.1371/journal.pone.0116965

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