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Clinical Trial
. 2005 Oct 17;93(8):884-9.
doi: 10.1038/sj.bjc.6602804.

Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in advanced head and neck cancer

M Tsukuda  1 , A Kida, M Fujii, N Kono, T Yoshihara, Y Hasegawa, M Sugita; Chemotherapy Study Group of Head and Neck Cancer
Affiliations
Clinical Trial

Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in advanced head and neck cancer

M Tsukuda et al. Br J Cancer. .

Abstract

The purpose of this study was to determine the feasible adjuvant therapy administration schedule of S-1 for locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients receiving definitive treatments were randomly assigned to either arm A (51 cases) receiving oral S-1 of 2-week administration followed by 1-week rest for 6 months, or arm B receiving S-1 of 4-week administration followed by 2-week rest for 6 months. Planned treatment was given in 40% of patients in arm A and 29% in arm B. The cumulative rates of the relative total administration dose of S-1 at 100% were 54.9% (95% CI: 40.1-69.7%) in arm A and 34.3% (95% CI: 21.1-47.4%) in arm B, respectively (P=0.054). Adverse events were recorded in 41 patients (82.0%) in arm A and 48 patients (94.1%) in arm B (P=0.060). The incidences of diarrhoea (10 vs 28%; P<0.05) and skin toxicities (18 vs 37%; P<0.05) were significantly higher in arm B. One-year disease-free survival was similar in both arms: arm A 81.2% (95% CI: 70.0-92.4%); arm B 77.0% (95% CI: 65.0-89.0%). The schedule of 2-week administration followed by 1-week rest seems to be more feasible for oral 6-month administration of S-1 in adjuvant chemotherapy of locoregionally advanced SCCHN.

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Figures

Figure 1
Figure 1
Cumulative rate of total administration days of S-1 in each arm by Kaplan–Meier method; total administration days of S-1 within a 112-day administration period were 69.4% (95% CI: 56.0–82.9%) in arm A and 54.4% (95% CI: 40.6–68.1%) in arm B, respectively.
Figure 2
Figure 2
Cumulative rate of relative total administration dose of S-1 in each arm by Kaplan–Meier method; relative total administration dose of S-1 at 100% were 54.9% (95% CI: 40.1–69.7%) in arm A and 34.3% (95% CI: 21.1–47.4%) in arm B (P<0.1), respectively.
Figure 3
Figure 3
Disease-free survival rate in each arm; 1-year disease-free survival rates were 81.2% (95% CI: 70.0–92.4%) in arm A and 77.0% (95% CI: 65.0–89.0%) in arm B, respectively.
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