Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma
2008

S-1 and Docetaxel for Metastatic Gastric Cancer

Sample size: 82 publication 10 minutes Evidence: moderate

Author Information

Author(s): Park S R, Kim H K, Kim C G, Choi I J, Lee J S, Lee J H, Ryu K W, Kim Y-W, Bae J-M, Kim N K

Primary Institution: National Cancer Center, Republic of Korea

Hypothesis

To determine the maximum tolerated dose and evaluate the efficacy and toxicity of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma.

Conclusion

S-1 combined with weekly docetaxel is active in metastatic gastric carcinoma with moderate toxicities.

Supporting Evidence

  • The overall response rate was 66.7%.
  • The median time to progression was 6.5 months.
  • The median overall survival was 13.7 months.
  • Neutropenia was the most common grade 3/4 toxicity at 29.4%.
  • One treatment-related death occurred due to pneumonitis.

Takeaway

This study tested a new cancer treatment for stomach cancer and found it works well but can cause some side effects.

Methodology

Patients received S-1 orally and docetaxel intravenously in a phased trial to determine dosage and effectiveness.

Potential Biases

Potential biases may arise from the single-institution study design and patient selection criteria.

Limitations

The study had a limited sample size and was conducted in a specific patient population.

Participant Demographics

The study included 30 patients in phase I and 52 in phase II, with a median age of 50 years in phase I and 53 years in phase II.

Statistical Information

P-Value

0.0366

Confidence Interval

95% CI: 53.8–79.6%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604312

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