Vitamin E neuroprotection for cisplatin neuropathy A randomized, placebo-controlled trial

被引:142
作者
Pace, A. [1 ]
Giannarelli, D. [2 ]
Galie, E.
Savarese, A. [3 ]
Carpano, S. [3 ]
Della Giulia, M. [3 ]
Pozzi, A. [3 ]
Silvani, A. [4 ]
Gaviani, P. [4 ]
Scaioli, V. [4 ]
Jandolo, B.
Bove, L.
Cognetti, F. [3 ]
机构
[1] Regina Elena Inst Canc Res, Serv Neurol, Dept Neurosci, I-00144 Rome, Italy
[2] Regina Elena Inst Canc Res, Stat Unit, I-00144 Rome, Italy
[3] Regina Elena Inst Canc Res, Dept Oncol, I-00144 Rome, Italy
[4] Ist Neurol C Besta, Milan, Italy
关键词
CHEMOTHERAPY; NEUROTOXICITY; SUPPLEMENTATION; TOXICITY;
D O I
10.1212/WNL.0b013e3181d5279e
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Objective: The clinical use of cisplatin chemotherapy is limited by severe peripheral neurotoxicity reported in up to 90% of patients receiving a cumulative dose higher than 300 mg/m(2). The present study evaluates the neuroprotective effect of antioxidant supplementation (vitamin E) in patients treated with cisplatin chemotherapy. Methods: A total of 108 patients treated with cisplatin chemotherapy were randomly assigned to receive vitamin E supplementation (alpha-tocopherol 400 mg/day) or placebo. Treatment was started orally before chemotherapy and continued for 3 months after the suspension of cisplatin. Results: Of 108 randomized patients, 68 received at least one clinical and neurophysiologic examination after cisplatin CT; 41 patients received a cumulative dose of cisplatin higher than 300 mg/m2 and were eligible for statistical analysis: 17 in the vitamin E group (group 1) and 24 in the placebo group (group 2). The incidence of neurotoxicity was significantly lower in group 1 (5.9%) than in group 2 (41.7%) (p < 0.01). The severity of neurotoxicity, measured with a validated neurotoxicity score (Total Neuropathy Score [TNS]), was significantly lower in patients receiving vitamin E than those receiving placebo (mean TNS 1.4 vs 4.1; p < 0.01). Conclusions: This phase III study confirms the neuroprotective role of vitamin E against cisplatin peripheral neurotoxicity. Vitamin E supplementation should be adopted in patients receiving cisplatin-based chemotherapy. Classification of evidence: This study provides Class II evidence that vitamin E supplementation significantly reduces the relative risk of developing signs or symptoms of neurotoxicity (relative risk = 0.14) (95% confidence interval = 0.02-1.00, p < 0.05). Neurology (R) 2010; 74: 762-766
引用
收藏
页码:762 / 766
页数:5
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