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Randomized Controlled Trial
Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance).
- Charles L Loprinzi, Rui Qin, Shaker R Dakhil, Louis Fehrenbacher, Kathleen A Flynn, Pamela Atherton, Drew Seisler, Rubina Qamar, Grant C Lewis, and Axel Grothey.
- Charles L. Loprinzi, Rui Qin, Pamela Atherton, Drew Seisler, and Axel Grothey, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; Shaker R. Dakhil, Wichita Community Clinical Oncology Program, Wichita, KS; Louis Fehrenbacher, Kaiser Permanente-Vallejo, Vallejo, CA; Kathleen A. Flynn, Michigan Cancer Research Consortium, Ann Arbor, MI; Rubina Qamar, Aurora Cancer Care-Milwaukee West, Wauwatosa, WI; and Grant C. Lewis, Summit Cancer Care, Savannah, GA.
- J. Clin. Oncol. 2014 Apr 1;32(10):997-1005.
PurposeCumulative 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 MethodsIn 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.ResultsThere 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.ConclusionThis study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity.
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