CHICAGO—Use of sequential paclitaxel followed by oral fluorinated pyrimidines (FU) results in a trend for better disease-free survival (DFS), the primary endpoint, in patients with locally advanced gastric cancer, results from the SAMIT study reported at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.
In addition, while comparison between the FUs showed that tegafur/uracil (UFT) was inferior to S-1, sequential paclitaxel/S-1 was safe and effective for locally advanced gastric cancer in an adjuvant setting, said Kazuhiro Yoshida, MD, PhD, of the Department of Surgical Oncology at Gifu University School of Medicine, Gifu, Japan.
Although adjuvant chemotherapy with UFT was once a standard treatment in Japan, it has been surpassed by S-1 based on results from a large randomized trial; however, UFT and S-1 have not been compared in clinical trials.
The phase 3 randomized SAMIT trial randomly assigned patients to UFT 267 mg/m2/day (arm A), S-1 80 mg/m2/day (arm B), weekly paclitaxel 80 mg/m2 followed by UFT (arm C), or paclitaxel followed by S-1 (arm D).
Between August 2004 and October 2007, 1,495 patients from 232 centers were randomly assigned to one of the four treatment arms. Median follow-up was 1,875 days and 728 events occurred. Mean age was 64 years; 86% had a performance status of 0; 68% of tumors were 8 cm or greater, and 85% were clinically node-positive.
Grade 3-4 hematologic adverse events (AEs) were primarily neutropenia and leucopenia; nonhematologic AEs included fatigue, anorexia, nausea/vomiting, diarrhea, and elevated AST and ALT. There were no treatment-related deaths.
The difference in 3-year DFS between sequential arms C and D (54.0%) and single-agent arms A and B (57.2%) was not statistically significant (hazard ratio [HR], 0.92; 95% CI: 0.80-1.07; P=0.273). For UFT-based versus S-1-based therapy, the HR for the non-inferiority of UFT was 1.23 (95% CI: 1.07-1.43; P=0.151) and the HR for the superiority of S-1 was 0.81 (P=0.0057).