Multicenter phase II study of weekly paclitaxel plus S-1 combination chemotherapy in patients with advanced gastric cancer

Abstract

Background: A multicenter phase II study was conducted to evaluate the efficacy and safety of a combination regimen of weekly paclitaxel plus S-1 in patients with advanced gastric cancer. Methods: Patients with previously untreated metastatic or recurrent gastric cancer received intravenous paclitaxel 50 mg/m2 on days 1, 8, and 15, plus oral S-1 40 mg/m2 b.i.d. on days 1 to 14 followed by 2 weeks off, in a 28-day cycle. Results: A total of 54 patients were registered. All of them had measurable disease and were determined to be eligible for the present study. Two complete responses and 23 partial responses were confirmed, giving an overall response rate of 46.3%. At a final follow up of 3 years, the median progressionfree survival and median overall survival were 6.0 and 14.3 months, respectively. Grade 3 neutropenia occurred in 14 patients, and grade 4 in 1 patient (total, 27.8%). The most serious nonhematological toxicity was diarrhea, where grade 3 occurred in 5 patients (9.3%). There were no treatmentrelated deaths. Conclusion: A combination of weekly paclitaxel plus S-1 was found to be well tolerated and effective in patients with advanced gastric cancer. Further investigation with comparative trials is needed for confirmation. © 2010 The International Gastric Cancer Association and The Japanese Gastric Cancer Association.