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


CONCLUSIONS
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.
Department of Oncology, The First Affiliated Hospital,Zhengzhou University, Zhengzhou, Henan, 450052, P. R. China.
Pei
P
Lu
Qing-Xia
QX
Fan
Liu-Xing
LX
Wang
Xin
X
Wang
Hong
H
Zong
Rui-Lin
RL
Wang
D004999:Amifostine / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D020258:Neurotoxicity Syndromes / Q000209:etiology / Q000517:prevention & control*; D009944:Organoplatinum Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D000077150:Oxaliplatin; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000473:pathology; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000473:pathology
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D004999:Amifostine