Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in advanced head and neck cancer
2005

Feasibility Study of S-1 for Chemotherapy in Head and Neck Cancer

Sample size: 102 publication Evidence: moderate

Author Information

Author(s): Tsukuda M, Kida A, Fujii M, Kono N, Yoshihara T, Hasegawa Y, Sugita M

Primary Institution: Yokohama City University Graduate School of Medicine

Hypothesis

The study aims to determine the feasible adjuvant therapy administration schedule of S-1 for locoregionally advanced squamous cell carcinoma of the head and neck.

Conclusion

The 2-week administration followed by a 1-week rest of S-1 is more feasible and tolerable compared to the 4-week administration followed by a 2-week rest.

Supporting Evidence

  • 40% of patients in arm A followed the planned schedule compared to 29% in arm B.
  • The cumulative rate of total administration days was 69.4% in arm A and 54.4% in arm B.
  • Adverse events were recorded in 82.0% of arm A and 94.1% of arm B patients.
  • Diarrhoea and skin toxicities were significantly higher in arm B.

Takeaway

This study tested two ways to give a cancer medicine called S-1 to patients with head and neck cancer, and found that one way was easier for patients to handle.

Methodology

Patients were randomly assigned to two different schedules of S-1 administration and monitored for feasibility and adverse events.

Limitations

The study had a relatively short follow-up period and did not assess long-term outcomes.

Participant Demographics

Patients aged 20-74 with stage III or IV SCCHN, primarily male (approximately 88% in arm A and 94.1% in arm B).

Statistical Information

P-Value

0.054

Confidence Interval

95% CI: 40.1–69.7%

Statistical Significance

p=0.054

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602804

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