Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium and Magnesium to Prevent Oxaliplatin-Induced Sensory Neurotoxicity (N08CB/Alliance)
Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium and Magnesium to Prevent Oxaliplatin-Induced Sensory Neurotoxicity (N08CB/Alliance)
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DOI：
10.1200/jco.2013.52.0536
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发表时间：
2014-04-01
影响因子：
45.3
通讯作者：
Grothey, Axel
中科院分区：
文献类型：
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作者：
Loprinzi, Charles L.;Qin, Rui;Grothey, Axel
目的累积性神经毒性是奥沙利铂治疗的主要毒性。静脉注射钙和镁已被广泛用于减少奥沙利铂诱导的神经毒性。这项试验的目的是明确测试是否钙/镁降低oxaliplatin-related neuronotoxicity.Patients和方法在所有，353例结肠癌患者接受辅助治疗FOLFOX（氟尿嘧啶，甲酰四氢叶酸，奥沙利铂）被随机分配到静脉钙/镁之前和之后奥沙利铂，安慰剂之前和之后，或钙/镁之前和安慰剂之后。主要终点是通过欧洲癌症研究和治疗组织的生活质量量表-化疗诱导的周围神经病变20工具的感觉量表测量的累积神经毒性。包括临床医生通过使用国家癌症研究所不良事件通用术语标准量表或奥沙利铂特异性神经病变量表确定的至2级神经病变时间的测量。此外，钙/镁并没有实质上减少奥沙利铂引起的急性neuropathy.Conclusion本研究不支持使用钙/镁，以防止奥沙利铂引起的神经毒性。
Purpose Cumulative neurotoxicity is a prominent toxicity of oxaliplatin-based therapy. Intravenous calcium and magnesium have been extensively used to reduce oxaliplatin-induced neurotoxicity. This trial was designed to definitively test whether calcium/magnesium decreases oxaliplatin-related neurotoxicity.Patients and Methods In all, 353 patients with colon cancer undergoing adjuvant therapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) were randomly assigned to intravenous calcium/magnesium before and after oxaliplatin, a placebo before and after, or calcium/magnesium before and placebo after. The primary end point was cumulative neurotoxicity measured by the sensory scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 tool.Results There were no statistically significant neuropathy differences among the study arms as measured by the primary end point or additional measures of neuropathy, including clinician-determined measurement of the time to grade 2 neuropathy by using the National Cancer Institute Common Terminology Criteria for Adverse Events scale or an oxaliplatin-specific neuropathy scale. In addition, calcium/magnesium did not substantially decrease oxaliplatin-induced acute neuropathy.Conclusion This study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity.