Docetaxel in combination for advanced gastric cancer.

Docetaxel is considered to be active in untreated and previously treated patients with gastric carcinoma. In a multinational phase II trial (TAX 325), 158 untreated patients with advanced gastric cancer (99% without prior chemotherapy) were randomized to receive, every 3 weeks, either docetaxel 85 mg/m2 plus cisplatin 75 mg/m2 (TC) or docetaxel 75 mg/m2 plus cisplatin 75 mg/m2, plus a 5-day continuous infusion of 750 mg/m2 5-fluorouracil (FU; TCF). By intent-to-treat analysis, patients receiving TCF had a significantly higher response rate and longer time to progression. Overall survival in the two arms was not significantly different. Toxicity (particularly gastrointestinal toxicity) was greater with the TCF combination than in the TC arm, and there was a greater need for dose reduction. However, adverse events in both arms were manageable and there were no deaths associated with either regimen. Following these findings, a phase III trial comparing a control arm of cisplatin plus 5-FU against an experimental arm consisting of the TAX 325 phase II docetaxel/cisplatin/5-FU regimen is now in progress.