ABSTRACT
Objective TO evaluate the efficacy and safety of three adjuvant chemotherapy regimens after curative resection for stage III colorectal cancer,and present clinical evidence for proper choice.Methods 256 cases with stage Ⅲ colorectal cancer randomized to receive de Gramont,modified FOLFOX4(mFOLFOX4) and XELOX regimens.3-year disease-free survival(DFS) and overall survival(OS) were compared within the three groups and subgroups.Therapeutic adverse events were recorded and analyzed with Kaplan-Meier.Results Compared with de Gramont regimen,mFOLFOX4 and XELOX had superior efficacy.The two former could significantly improve 3-year DFS(79.7% vs.66.2%,P=0.015;81.5% vs.66.2%,P=0.004) and medium survival time(40.2 mon vs.37.8 mon,P=0.024;41.4 mon vs.37.8 mon,P=0.014).Meanwhile they could respectively decrease the ratio of recurrence risk 18%(P=0.024) and 21%(P=0.003).The relative benefit of mFOLFOX4 versus XELOX didn't differ for 3-year DFS [hazard ratio(HR): 0.84,95% confidence interval(CI): 0.79～1.12,P=0.13] and OS(HR: 0.87,95%CI: 0.84~1.06,P=0.54).In advanced analysis of DFS in subgroup,XELOX had better trend of survival advantage.mFOLFOX4 had higher adverse events within these regimens,especially in grade 3 or 4 neutropenia and peripheral neurologic adverse events.Conclusion XELOX maintains its efficacy and safety ratio in advanced colorectal cancer.Patients have good tolerance and compliance.The regiment is deserved to be applied in clinic.