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

Tsukuda M, Kida A, Fujii M, Kono N, Yoshihara T, Hasegawa Y, Sugita M, Chemotherapy Study Group of Head and Neck Canc - Br. J. Cancer (2005)

Bottom Line: 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).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%).

View Article: PubMed Central - PubMed

Affiliation: Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine, Kanazawa-ku, Yokohama, Japan. mtsukuda@med.yokohama-cu.ac.jp

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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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.
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fig2: 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.

Mentions: In total, 40% of patients in arm A receive S-1 administration along the planned schedule and dose, while 29% in arm B did (not significant: NS) (Table 2). The rates of cases that discontinued S-1 administration due to adverse events were 22.0% in arm A and 29.4% in arm B, respectively (Table 2). The cumulative rates of total administration days of S-1 on day 112 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 (NS, P=0.147) (Figure 1). The mean of total administration days in each arm was almost identical (87.3 days vs 87.2 days) (Table 3). The cumulative rates of the relative total administration dose 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) (Figure 2). The mean of the relative total administration dose in each arm was similar (76.1 vs 75.7%) (Table 3).


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

Tsukuda M, Kida A, Fujii M, Kono N, Yoshihara T, Hasegawa Y, Sugita M, Chemotherapy Study Group of Head and Neck Canc - Br. J. Cancer (2005)

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.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2361656&req=5

fig2: 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.
Mentions: In total, 40% of patients in arm A receive S-1 administration along the planned schedule and dose, while 29% in arm B did (not significant: NS) (Table 2). The rates of cases that discontinued S-1 administration due to adverse events were 22.0% in arm A and 29.4% in arm B, respectively (Table 2). The cumulative rates of total administration days of S-1 on day 112 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 (NS, P=0.147) (Figure 1). The mean of total administration days in each arm was almost identical (87.3 days vs 87.2 days) (Table 3). The cumulative rates of the relative total administration dose 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) (Figure 2). The mean of the relative total administration dose in each arm was similar (76.1 vs 75.7%) (Table 3).

Bottom Line: 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).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%).

View Article: PubMed Central - PubMed

Affiliation: Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine, Kanazawa-ku, Yokohama, Japan. mtsukuda@med.yokohama-cu.ac.jp

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.

Show MeSH
Related in: MedlinePlus