Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer
2006

Docetaxel and S-1 for Advanced Gastric Cancer

Sample size: 50 publication Evidence: moderate

Author Information

Author(s): Yamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H, Komatsu Y, Kato T, Saitoh S, Akiya T, Munakata M, Miyata Y, Maeda Y, Takiuchi H, Nakano S, Esaki T, Kinjo F, Sakata Y

Primary Institution: Saitama Cancer Centre

Hypothesis

Docetaxel combined with S-1 would confer a clinically meaningful improvement in overall response rate and median survival, with a manageable safety profile.

Conclusion

The combination of docetaxel and S-1 is an active and well-tolerated regimen in patients with advanced gastric cancer.

Supporting Evidence

  • The overall response rate was 46%.
  • The median overall survival was estimated to be 14 months.
  • 67% of patients experienced grade 3/4 neutropenia.

Takeaway

Doctors tested a new medicine combination to help people with stomach cancer, and it worked pretty well without too many bad side effects.

Methodology

This was a multicentre, open-label, single-arm, phase I/II study conducted at 16 institutions in Japan.

Limitations

The median survival observed may be influenced by poststudy chemotherapy, which was administered to 78% of patients.

Participant Demographics

{"median_age":65,"age_range":"42-79","sex_distribution":{"male":31,"female":15},"prior_chemotherapy":{"received":16,"not_received":30}}

Statistical Information

Confidence Interval

{"overall_response_rate":"95% CI, 31–61%","median_overall_survival":"95% CI, 8.3–17.3"}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603196

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