Randomised phase II study comparing dose-escalated weekly paclitaxel vs standard-dose weekly paclitaxel for patients with previously treated advanced gastric cancer

Background: This randomised phase II trial compared dose-escalated weekly paclitaxel (wPTX) vs standard-dose wPTX for patients with previously treated advanced gastric cancer (AGC). Methods: Ninety patients were randomised to a standard dose of wPTX (80 mg m(-2)) or an escalated dose of wPTX (80-120 mg m(-2)) to assess the superiority of overall survival (OS) with a one-sided alpha error of 0.3 and a power of 0.8. Results: The median OS showed a trend towards longer survival in the dose-escalated arm (11.8 vs 9.6 months; hazard ratio (HR), 0.75; one-sided P = 0.12), although it was statistically not significant. The median progression-free survival (PFS) was significantly longer in the dose-escalated arm (4.3 vs 2.5 months, HR, 0.55; P = 0.017). Objective response rate was 30.3% with dose escalation and 17.1% with standard dose (P = 0.2). The frequency of all grades of neutropenia was significantly higher with dose escalation (88.7% vs 60.0%, P = 0.002); however, no significant difference was observed in the proportion of patients experiencing grade 3 or more (40.9% vs 31.1%, P = 0.34). Conclusion: Dose-escalated wPTX in patients with pretreated AGC met our predefined threshold of primary end point, OS (P < 0.3); however, it did not show a significantly longer OS. Progression-free survival was significantly better with dose escalation.