Guo Ying, Jones Desiree, Palmer J Lynn, Forman Arthur, Dakhil Shaker R, Velasco Maria R, Weiss Matthias, Gilman Paul, Mills G M, Noga Stephen J, Eng Cathy, Overman Michael J, Fisch Michael J
The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 1414, Houston, TX, 77030, USA,
Support Care Cancer. 2014 May;22(5):1223-31. doi: 10.1007/s00520-013-2075-1. Epub 2013 Dec 22.
Chemotherapy-induced peripheral neuropathy is frequently a dose-limiting factor in cancer treatment and may cause pain and irreversible function loss in cancer survivors. We tested whether alpha-lipoic acid (ALA) could decrease the severity of peripheral neuropathy symptoms in patients undergoing platinum-based chemotherapy.
Cancer patients 18 years or older were randomly selected to receive either 600 mg ALA or a placebo three times a day orally for 24 weeks while receiving chemotherapy regimens including cisplatin or oxaliplatin. Neuropathy was measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale and the NCI Common Toxicity Criteria for Adverse Events neurotoxicity grades. Results from timed functional tests and the Brief Pain Inventory (BPI) were secondary endpoints.
Seventy of 243 (29 %) patients completed the study (24 weeks). Both the ALA and the placebo arms had a comparable drop-out rate. No statistically significant differences were found between the ALA and the placebo groups for FACT/GOG-Ntx scores, BPI scores, and patients' functional outcomes.
This strategy of oral ALA administration was ineffective at preventing neurotoxicity caused by oxaliplatin or cisplatin. High attrition rates due to poor patient compliance and manner of dosage administration in this trial demonstrated a lack of feasibility for this intervention. Future studies to explore ALA as a neuroprotective agent should take heed of the barriers confronted in this study.
化疗引起的周围神经病变常常是癌症治疗中的剂量限制因素，可能导致癌症幸存者出现疼痛和不可逆的功能丧失。我们测试了α-硫辛酸（ALA）是否能减轻接受铂类化疗患者的周围神经病变症状的严重程度。
随机选择18岁及以上的癌症患者，在接受包括顺铂或奥沙利铂的化疗方案期间，每天口服3次600mg ALA或安慰剂，持续24周。通过癌症治疗功能评估/妇科肿瘤学组神经毒性（FACT/GOG-Ntx）量表和美国国立癌症研究所不良事件通用毒性标准神经毒性分级来测量神经病变。定时功能测试结果和简明疼痛量表（BPI）为次要终点。
243名患者中有70名（29%）完成了研究（24周）。ALA组和安慰剂组的退出率相当。在FACT/GOG-Ntx评分、BPI评分和患者功能结局方面，ALA组和安慰剂组之间未发现统计学上的显著差异。
口服ALA这种策略在预防奥沙利铂或顺铂引起的神经毒性方面无效。由于患者依从性差和本试验中的给药方式导致的高损耗率表明该干预措施缺乏可行性。未来探索ALA作为神经保护剂的研究应注意本研究中遇到的障碍。
