氨磷汀预防消化道肿瘤草酸铂化疗引起的神经毒性

背景与目的:草酸铂广泛用于消化道肿瘤的化疗,突出的神经毒性限制了剂量和疗效的提高.本研究旨在评价氨磷汀对草酸铂神经毒性的防治效果.方法:92例FOLFOX 4方案化疗的结直肠癌、胃癌患者,随机进人氨磷汀组(草酸铂前静脉注射氨磷汀500 mg/m2,n=46)或对照组(草酸铂前静脉注射还原性谷胱甘肽1500 mg/m2,n=46).每化疗2周期详细评价神经毒性.结果:氨磷汀组Ⅰ～Ⅱ度和Ⅲ～Ⅳ度神经毒性发生率与对照组相比,分别为10.9%:73.9%(P＜0.001)和2.2%:19.6%(P=0.007),均显著降低.氨汀组因化疗毒性的方案改变明显少于对照组(4.3%:23.9%,P=0.007).化疗近期有效率氨磷汀组与对照组差异无显著性(44.4%:38.5%,P=0.659).结论:氨磷汀对含草酸铂方案化疗的神经毒性有明显防治作用.不降低化疗疗效.

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.