A multicenter phase II study of sequential paclitaxel and S-1 (TXL/S-1) as postoperative adjuvant chemotherapy for gastric cancer (GC)

Publisher Website
Google Scholar
Abstract
4067 Background: Of patients who undergo R0 resection for GC with serosal invasion (T3–4), more than half recur mainly in the peritoneum (and eventually need palliative chemotherapy). So far compliance of early postoperative chemotherapy was low and it has failed to suppress peritoneal relapse. Since TXL and S1 exhibited efficacy for diffuse type and peritoneal tumors in the phase II studies, we have investigated the safety and feasibility of TXL/S1 as sequential adjuvant chemotherapy following radical resection of T3–4 gastric cancer. Methods: Eligibility criteria included histologically proven GC; sT3–4; sN0–2; M0 (except peritoneal cytology); post D2–3 gastrectomy and R0–1; ECOG PS 0–1; and 20–80 years old. On postoperative day 14 to 56, patients received 3 courses of weekly TXL (80mg/m2 on day 1, 8 for the 1st course and on day 1, 8, 15 for the 2nd and 3rd courses, repeated every 3 or 4 weeks) followed by 4 courses of S1 (80mg/m2 daily for 2 weeks, repeated every 3 weeks). The primary endpoints were % of patients who completed all 7 courses (compliance) and incidence of severe toxicities and the secondary endpoints were survival and toxicities. Primary analysis was to see whether the lower 95% confidence limit of compliance was greater than 69% and sample size of 50 was calculated. Results: 50 patients were accrued from May 2003 to March 2004. The median age was 63 (range 33–74); male/female: 34/16; pT2/T3/T4: 2/41/4; f-stage2/3a/3b/4: 11/13/16/7. In 4 patients treatment was terminated for toxicities, in 2 for refusal, and in one for recurrence; thus compliance of 87.9% (95%CI:81–98%) was achieved. Grade 4 hematological toxicities in 2% and grade 3 non-hematological toxicities in 4% of the patients were observed. The analysis for survival will be performed in 2007. Conclusions: Sequential chemotherapy with TXL/S1 was safe and well tolerated as a postoperative adjuvant treatment for patients with T3 tumors. Its survival benefit will be assessed in a large phase III study (the SAMIT trial). No significant financial relationships to disclose.

This publication has 0 references indexed in Scilit: