Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy - A phase 3 randomized, double-blind, placebo-controlled trial, N01C3
Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy - A phase 3 randomized, double-blind, placebo-controlled trial, N01C3
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DOI：
10.1002/cncr.23482
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发表时间：
2008-06-15
期刊：
影响因子：
6.2
通讯作者：
Loprinzi, Charles L.
中科院分区：
文献类型：
--
作者：
Rao, Ravi D.;Flynn, Patrick J.;Loprinzi, Charles L.
背景拉莫三嗪是一种抗癫痫药物，据报道可有效减轻与各种病因相关的神经病症状。在此基础上，采用随机、双盲、安慰剂对照的多中心临床试验，评价拉莫三嗪对化疗所致周围神经病变（CIPN）疼痛及其他神经病变症状的疗效。症状性CIPN患者的症状评分为1）0-10数字评定量表（NRS）>3或2）东部肿瘤协作组（ECOG）神经病变量表（ENS）0-3>1，符合条件（两种量表中的数字越高，症状严重程度越高）。患者被随机分配接受拉莫三嗪（目标剂量为300 mg/天）或安慰剂治疗10周。每两周测量一次终点。共入组131例患者。两组基线匹配良好。在为期10周的试验期间，拉莫三嗪组和安慰剂组的平均疼痛评分（NRS）均下降，两组之间的变化无统计学显著差异（分别较基线降低0.3和0.5个单位; P = 0.56）。同样，治疗后ENS的降低无统计学差异（分别为0.4和0.3; P = .3）。其他主观症状量表的变化在两组之间也没有统计学差异。各组毒副反应轻微，相似。结果表明，拉莫三嗪是不能有效地缓解患者的神经病变症状，因为CIPN。
BACKGROUND. Lamotrigine, an antiepileptic agent, has been reported as being effective in reducing symptoms of neuropathy associated with various etiologies. Based on such data, a multicenter double-blind, placebo-controlled, randomized trial was conducted to evaluate the effect of lamotrigine on pain and other neuropathic symptoms due to chemotherapy-induced peripheral neuropathy (CIPN).METHODS. Patients with symptomatic CIPN with symptom scores of either 1) >3 on a 0-10 Numerical Rating Scale (NRS) or 2) >1 on the 0-3 the Eastern Cooperative Oncology Group (ECOG) neuropathy scale (ENS) were eligible (higher numbers corresponding to greater severity of symptoms in both scales). Patients were randomly assigned to receive lamotrigine (target dose of 300 mg/day) or placebo for 10 weeks. Endpoints were measured biweekly.RESULTS. In all, 131 patients were enrolled. Both groups were well matched at baseline. Over the 10-week period of the trial, the average pain scores (NRS) for the lamotrigine and placebo arms declined in both arms, with no statistically significant difference noted between the changes in the 2 groups (0.3 and 0.5 unit reduction from baseline, respectively; P = .56). Similarly, decreases in the ENS with therapy were not statistically different (0.4 and 0.3, respectively; P = .3). Changes in other subjective symptom scales were also not found to be statistically different between the 2 groups. Toxicities were mild and similar in each group.CONCLUSIONS. The results suggest that lamotrigine is not effective for relieving neuropathic symptoms in patients because of CIPN.