| Popis: |
Background Oxaliplatin as part of XELOX regimen has a more favorable toxicity profile than cisplatin for patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy, a cumulative, dose-related toxicity. Thus, capecitabine maintenance regimen might achieve maximum treatment effect while reducing cumulative neurotoxicity of oxaliplatin. The aim of this study was to compare survivals of AGC patients between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Methods Sixty-three patients treated with six cycles of XELOX for AGC in six hospitals of the Catholic University of Korea were randomized 1:1 to capecitabine maintenance or observation. The primary end point was PFS (PFS) analyzed using a two-sided log-rank test stratified at 5% significance level. Results Between 2015 and 2020, 32 and 31 patients were randomized to maintenance and observation groups, respectively. After randomization, the median number of cycles for maintenance capecitabine was 6. PFS was significantly higher for the maintenance group (6.3 months vs. 4.1 months, P = 0.010). OS (OS) was not significantly different between the two groups (18.2 months vs. 16.5 months, P = 0.624). Toxicity such as hand-foot syndrome was reported in some cases of the maintenance group. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (HR: 0.472, 95% CI: 0.250-0.890, P = 0.020). Conclusions After six cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS than observation and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS. |
