Abstract
e18041 Background: S-1, a novel oral fluorouracil derivative, is active against NSCLC. Previous studies investigating a combination of S-1 plus DTX showed promising efficacy but clinically problematic emesis. We conducted a phase I study to find the maximum tolerated doses (MTD) of bi-weekly administered DTX with oral S-1 for one week, and a phase II study to evaluate the efficacy and toxicity. Methods: Previously treated pts with NSCLC were included. Other eligibility criteria were performance status of 0-1, measurable lesions, age < 75 years, and adequate organic functions were eligible. Pts received S-1 on days 1-7 and DTX on day 1 of each 14-day cycle. Results: Doses of S-1/DTX (mg/m2) in the phase I study portion were escalated as follows: 80/30, 80/35, and 80/40. In the phase I, MTD among 13 patients were S-1 80 mg/m2 with DTX 40 mg/m2. The dose limiting toxicity (DLT) was febrile neutropenia. The recommended doses for the phase II study were S-1 80mg/m2 and DTX 35 mg/m2. A total of 34 pts from 5 institutions were enrolled from Oct. 2009 to Nov .2010. The overall responses were CR 0; PR 9; SD 12; PD 10 and NE 3, resulting in a response rate of 26.5% (95% confidence interval [CI], 11.6-41.3%). The overall disease control rate was 61.8% (95% CI, 45.4-78.1%). Hematologic grade 3/4 toxicities were neutropenia (29.4%), febrile neutropenia (2.9%) and thrombocytopenia (2.9%). In non-haematologic toxicities, 4 patients with grade 2 interstitial pneumonitis were observed. Nine patients experienced grade 1 nausea only for short durations, and there were no grade 2 nausea. There was no emesis in 18 patients (52.9%). Conclusions: The combination of one week S-1 with biweekly DTX is an active regimen with low-emesis for previously treated NSCLC.
Published Version
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