Phase I/II Study of Docetaxel and S-1 in Previously-Treated Patients with Advanced Non-Small Cell Lung Cancer: LOGIK0408.

Background: As docetaxel plus S-1 may be feasible for cancer treatment, we conducted a phase I/II trial to determine the recommended docetaxel dose and the fixed S-1 dose (phase I), as well as confirm the regimen's efficacy and safety (phase II) for previously-treated patients with advanced non-small cell lung cancer.

Methods: Patients ≤75 years with performance status ≤1 and adequate organ function were treated at three-week intervals with docetaxel on day 1 and 80 mg/m oral S-1 from days 1-14. The starting docetaxel dose was 45 mg/m and this was escalated to a maximum of 70 mg/m. In phase II, response rate, progression-free survival (PFS), overall survival (OS), and safety were assessed.

Results: The recommended doses were 50 mg/m docetaxel (day 1) and 80 mg/m S-1 (days 1-14). Grades 3 and 4 leukocytopenia and neutropenia occurred in 44% and 67% of patients, respectively. Nonhematologic toxicities were generally mild. Overall response to chemotherapy was 7.7% (95% confidence interval (CI), 1.6-20.9%), and median PFS and OS were 18.0 weeks (95% CI; 11.3-22.9 weeks) and 53.0 weeks, respectively.

Conclusion: Fifty mg/m docetaxel plus 80 mg/m oral S-1 had a lower response rate than anticipated; however, the survival data were encouraging. A further investigation is warranted to select the optimal patient population.