[Prophylactic effect of amifostine on oxaliplatin-related neurotoxicity in patients with digestive tract tumors].

BACKGROUND & OBJECTIVE Oxaliplatin, an active agent used widely in treating digestive tract tumors, displays a frequent dose-limiting neurotoxicity. This study was to assess the clinical efficacy of amifostine in preventing neurotoxicity induced by oxaliplatin. METHODS A total of 92 patients with colorectal cancer or gastric cancer were enrolled, and randomly assigned to receive amifostine (500 mg/m2)(amifostine group, 46 patients) or glutamine (1500 mg/m2) (control group, 46 patients) just before oxaliplatin infusion. All patients received FOLFOX4 regimen. Neurological toxicity and efficacy of chemotherapy were assessed. RESULTS The occurrence rates of grade I-II and grade III-IV peripheral neurotoxicity after chemotherapy were significantly lower in amifostine group than in control group (10.9% vs. 73.9%, P < 0.001; 2.2% vs. 19.6%, P = 0.007). The frequency of regimen change because of chemotherapy-related neurotoxicity was significantly lower in amifostine group than in control group (4.3% vs. 23.9%,P = 0.007). The overall response rates of evaluable patients were 44.4% in amifostine group and 38.5% in control group (P = 0.66). CONCLUSION Amifostine could significantly reduce the occurrence and severity of peripheral neurotoxicity caused by oxaliplatin in the patients with digestive tract tumors, but not affect response to chemotherapy.