14033 Background: Based on the results of our phase I study on a combination of S-1 (tegafur, oxonic acid, and CDHP) and weekly paclitaxel (PTX) for advanced or recurrent gastric cancer (ARGC) (Ueda et al, ASCO 2004), we conducted a multi-center phase II study to prospectively evaluate efficacy, QOL, and toxicity of S-1 plus weekly PTX in patients with ARGC. METHODS Eligibility included patients with histologically-proven ARGC, 20-80 years old, having a ECOG performance status (PS) of 0-2 and adequate organ functions, and having received no prior chemotherapy except postoperative adjuvant therapies without taxanes. S-1 was given orally at a dose of 80 mg/m2/day for 14 consecutive days (days 1-14) followed by a 2-week rest. PTX was administered weekly as a 1-hour intravenous infusion on days 1, 8, and 15. This treatment was repeated every 4-weeks as one cycle. RESULTS Fifty-four patients with measurable lesions (RECIST) were enrolled between Feb. 2004 and Nov. 2005. Histologically, a half of the patients had differentiated type and the other patients had undifferentiated type adenocarcinoma. The median age was 61 (range, 38-78). Three-fourths were male patients. The PS was 0/1/2 in 47/6/1 patients respectively. Thirty nine were primary cases and 15 were recurrent cases after gastrectomy. Treatment was terminated in two patients for toxicities and in one patient for refusal during the first cycle; thus compliance of 94.4%. A total of 254 cycles were administered (median 4.7, range 2-14), and 45 patients were assessable efficacy and toxicity until Dec. 2005. In these 45 assessable patients, 2 CRs and 27 PRs were obtained, resulting in an overall response rate of 64.4%. Twelve pts (26.7%) had stable disease, and 4 pts (8.9%) progressed. The tumor control rate was 91.1%. CONCLUSIONS The combination of S-1 and weekly PTX is highly active for ARGC, and can be given safely with good tolerance and convenience profile. It is a candidate for the standard regimen and expected to contribute to better prognosis and QOL in ARGC patients. No significant financial relationships to disclose.