Abstract
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/m2 oral S-1 from days 1–14. The starting docetaxel dose was 45 mg/m2 and this was escalated to a maximum of 70 mg/m2. In phase II, response rate, progression-free survival (PFS), overall survival (OS), and safety were assessed. Results: The recommended doses were 50 mg/m2 docetaxel (day 1) and 80 mg/m2 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/m2 docetaxel plus 80 mg/m2 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.
Highlights
Previous clinical trials confirmed that docetaxel alone displays good anticancer effects when used to treat non-small cell lung cancer
Patients were enrolled in this study if they met the following eligibility criteria: cytologically or histologically confirmed diagnosis of incurable, previously treated non-small cell lung cancer; no previous use of docetaxel or uracil plus tegafur (UFT); age between 20–75 years; performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale; an estimated life expectancy of >12 weeks; adequate bone marrow function; adequate hepatic function (bilirubin level ≤1.5 mg/dL and a serum ratio of aspartate amino transferase to alanine amino transferase (AST/ALT) ≤2.5 × UNL); adequate renal function; a measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0; and provision of written informed consent
Based on large-scale randomized controlled trials that compared 75 mg/m2 docetaxel to optimal supportive care or other anticancer drugs, docetaxel monotherapy is considered to be a standard treatment for advanced non-small cell lung cancer in second-line settings [1,3]
Summary
Previous clinical trials confirmed that docetaxel alone displays good anticancer effects when used to treat non-small cell lung cancer. In a previous phase II study, monotherapy with S-1 produced a significant response in previously treated non-small cell lung cancer [6]. To improve the response rate in previously-treated patients with advanced non-small cell lung cancer, we conducted a phase I/II clinical study of docetaxel plus S-1. In this regimen, docetaxel was administered on day 1 while S-1 was administered on days 1 to 14, according to the potential schedule dependency previously reported by Kano et al [8]. The primary objectives were to determine the maximum-tolerated dose (MTD) and the recommended dose for this regimen in a phase I study and confirm its efficacy and safety in the phase II study
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