[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.
Lu
Pei
P
Department of Oncology, The First Affiliated Hospital,Zhengzhou University, Zhengzhou, Henan, 450052, P. R. China.
Fan
Qing-Xia
QX
Wang
Liu-Xing
LX
Wang
Xin
X
Zong
Hong
H
Wang
Rui-Lin
RL
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