The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase III clinical trial.
The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase III clinical trial.
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DOI：
10.1007/s00520-010-1018-3
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发表时间：
2011-11
影响因子：
3.1
通讯作者：
Loprinzi, Charles L.
中科院分区：
文献类型：
--
作者：
Kottschade, Lisa A.;Sloan, Jeff A.;Mazurczak, Miroslaw A.;Johnson, David B.;Murphy, Bronagh P.;Rowland, Kendrith M.;Smith, DeAnne A.;Berg, Alan R.;Stella, Philip J.;Loprinzi, Charles L.
化疗引起的周围神经病变（CIPN）仍然是许多癌症患者的实质性问题。根据有希望出现的试点数据，目前的研究评估了维生素E预防CIPN的使用。在接受神经毒性化疗的患者中进行了一项III期、随机、双盲、安慰剂对照研究，采用维生素E（400 mg）/安慰剂每日两次给药。主要终点是每个治疗组中2级+感觉神经病变（SN）毒性（CTCAE v 3.0）的发生率，通过卡方检验进行分析。计划的样本量为每组100例患者，以提供80%的把握度来检测2级+ SN毒性发生率的差异，从安慰剂组的25%到维生素E组的10%。2006年12月1日至2007年12月14日期间，共招募了207例患者，产生了189例可评价病例进行分析。细胞毒性药物包括紫杉烷类（109）、顺铂（8）、卡铂（2）、奥沙利铂（50）或联合用药（20）。两组之间2级+ SN的发生率无差异（34%-维生素E，29%-安慰剂; P=0.43）。治疗组间至神经病变发作时间（P=0.58）、因神经病变导致化疗剂量降低（P=0.21）或源自患者报告的神经病变症状评估的次要终点无显著差异。治疗总体耐受性良好。在接受神经毒性化疗的研究组患者中，维生素E似乎没有降低感觉神经病变的发生率。
Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a substantial problem for many cancer patients. Pursuant to promising appearing pilot data, the current study evaluated the use of vitamin E for the prevention of CIPN. A phase III, randomized, double-blind, placebo-controlled study was conducted in patients undergoing therapy with neurotoxic chemotherapy, utilizing twice daily dosing of vitamin E (400 mg)/placebo. The primary endpoint was the incidence of grade 2+ sensory neuropathy (SN) toxicity (CTCAE v 3.0) in each treatment arm, analyzed by chi-square testing. Planned sample size was 100 patients per arm to provide 80% power to detect a difference in incidence of grade 2+ SN toxicity from 25% in the placebo group to 10% in the vitamin E group. Two-hundred seven patients were enrolled between December 1, 2006 and December 14, 2007, producing 189 evaluable cases for analysis. Cytotoxic agents included taxanes (109), cisplatin (8), carboplatin (2), oxaliplatin (50), or combination (20). There was no difference in the incidence of grade 2+ SN between the two arms (34%—vitamin E, 29%—placebo; P=0.43). There were no significant differences between treatment arms for time to onset of neuropathy (P=0.58), for chemotherapy dose reductions due to neuropathy (P=0.21), or for secondary endpoints derived from patient-reported neuropathy symptom assessments. The treatment was well tolerated overall. Vitamin E did not appear to reduce the incidence of sensory neuropathy in the studied group of patients receiving neurotoxic chemotherapy.
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影响因子：
1.1
作者：
Sloan, J A;Dueck, A
通讯作者：
Dueck, A
影响因子：
11.5
作者：
Openshaw, H;Beamon, K;Somlo, G
通讯作者：
Somlo, G
影响因子：
45.3
作者：
CASCINU, S;CORDELLA, L;CATALANO, G
通讯作者：
CATALANO, G
影响因子：
4.7
作者：
Argyriou, Andreas A.;Chroni, Elisabeth;Kalofonos, Haralabos P.
通讯作者：
Kalofonos, Haralabos P.
影响因子：
6.2
作者：
Rao, Ravi D.;Michalak, John C.;Wong, Gilbert Y.
通讯作者：
Wong, Gilbert Y.