TY - JOUR
T1 - Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance)
AU - Loprinzi, Charles L.
AU - Qin, Rui
AU - Dakhil, Shaker R.
AU - Fehrenbacher, Louis
AU - Flynn, Kathleen A.
AU - Atherton, Pamela
AU - Seisler, Drew
AU - Qamar, Rubina
AU - Lewis, Grant C.
AU - Grothey, Axel
PY - 2014/4/1
Y1 - 2014/4/1
N2 - 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 oxaliplatininduced acute neuropathy. Conclusion: This study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity.
AB - 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 oxaliplatininduced acute neuropathy. Conclusion: This study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity.
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U2 - 10.1200/JCO.2013.52.0536
DO - 10.1200/JCO.2013.52.0536
M3 - Article
C2 - 24297951
AN - SCOPUS:84901675767
SN - 0732-183X
VL - 32
SP - 997
EP - 1005
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 10
ER -