Docetaxel and S-1 Combination Chemotherapy Show Encouraging Activity in Advanced Gastric Cancer

Strategic Insights -

Scientists at Catholic University have reported promising results from a Phase I dose escalation study of docetaxel with a fixed dose of S-1 in combination chemotherapy for advanced gastric cancer. The study aimed to estimate the maximum-tolerated dose (MTD) of docetaxel and determine the recommended dose (RD) for further studies. The trial enrolled 13 patients with histologically proven gastric carcinoma and involved administering intravenous docetaxel at increasing doses, alongside a fixed dose of oral S-1.

Key Takeaways:

  • The maximum-tolerated dose (MTD) of docetaxel was determined to be 60 mg/m2, with docetaxel 50 mg/m2 declared as the recommended dose (RD) for further studies.
  • Nine out of 13 enrolled patients responded to treatment, resulting in an overall objective response rate of 69.2% (95% CI, 44.1-94.3%).
  • The median time to progression was 8.38 months (range 1.44-8.51), and the overall survival duration was 9.9 months (range 0.62-11.57).
  • Neutropenia was the most common grade 3/4 toxicity of docetaxel plus S-1, but was deemed tolerable and manageable.
  • This regimen showed encouraging activity and a manageable safety profile in advanced gastric carcinoma.

Statistics:

  • 69.2% overall objective response rate (95% CI, 44.1-94.3%).
  • Median time to progression: 8.38 months (range 1.44-8.51).
  • Overall survival duration: 9.9 months (range 0.62-11.57).
  • Number of patents enrolled: 13.

Sources:

  • Kim Y, Lee S, Lee SH, et al. Phase I dose escalation study of docetaxel with a fixed dose of S-1 in combination chemotherapy for advanced gastric cancer. Cancer Chemotherapy and Pharmacology, 2009;63(2):253-260.
  • Clinical Trials Week. Docetaxel and S-1 Combination Therapy Shows Promise in Advanced Gastric Cancer. NewsRx.com, 2009.