[Combination chemotherapy of TS-1 and docetaxel on advanced and recurrent gastric cancer]

In the present article, we have summarized the clinical trials on docetaxel and the phase I study of docetaxel and combination therapy. Patients with a performance status (PS) of 0 to 2 received docetaxel at the starting dose of 40 mg/m2 by iv infusion over 1 hour on day 1 and TS-1 at the full dose of 80 mg/m2 daily for two weeks every three weeks. Nine patients were treated with increasing dose levels of docetaxel as follows: (docetaxel/TS-1, mg/m2): 40/80 (level 1), 50/80 (level 2) and 60/80 (level 3), and all the cases were found to be assessable for drug safety, while 7 were assessable for response. The MTD was reached at the 50/80 mg/m2 dose level in three patients out of six, who experienced a dose limiting toxicity (DLT). On the other hand, partial response was achieved in 5 (71.4%) of the 7 patients with evaluable lesions. The drug combination showed a good safety profile, and the responses observed in the study suggest that the drug combination shows a high degree of efficacy in patients with advanced and or recurrent gastric cancer.