PT  - JOURNAL ARTICLE
AU  - A. Pace
AU  - D. Giannarelli
AU  - E. Galiè
AU  - A. Savarese
AU  - S. Carpano
AU  - M. Della Giulia
AU  - A. Pozzi
AU  - A. Silvani
AU  - P. Gaviani
AU  - V. Scaioli
AU  - B. Jandolo
AU  - L. Bove
AU  - F. Cognetti
TI  - Vitamin E neuroprotection for cisplatin neuropathy
AID  - 10.1212/WNL.0b013e3181d5279e
DP  - 2010 Mar 02
TA  - Neurology
PG  - 762--766
VI  - 74
IP  - 9
4099  - http://n.neurology.org/content/74/9/762.short
4100  - http://n.neurology.org/content/74/9/762.full
SO  - Neurology2010 Mar 02; 74
AB  - 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/m2. 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 (α-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). TNS=Total Neuropathy Score.