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Calcium, magnesium failed to reduce oxaliplatin-induced neurotoxicity
Calcium and magnesium did not protect against oxaliplatin-induced neurotoxicity in patients with colon cancer who received adjuvant therapy with FOLFOX, according to results of a phase 3 study.
The analysis included 353 patients (median age, 56 years) who received oxaliplatin (Eloxatin, Sanofi-Aventis) as part of their FOLFOX chemotherapy regimen.
Researchers sought to determine the effects of IV calcium and magnesium, which have been “extensively used to reduce oxaliplatin-induced neurotoxicity,” they wrote.
The study included three cohorts.
Researchers assigned 118 patients calcium and magnesium before and after oxaliplatin. Another 116 patients received calcium and magnesium before oxaliplatin and placebo after. The remaining 119 patients received only placebo.
The primary endpoint was cumulative neurotoxicity, assessed using the sensory scale of the EORTC Quality of Life Questionnaire — Chemotherapy-Induced Peripheral Neuropathy 20 tool.
Results indicated that there were no significant differences in occurrence of sensory neuropathy in patients who received calcium and magnesium before and after oxaliplatin (P=.292) and only before oxaliplatin (P=.727) compared with patients who received placebo.
There also were no significant differences when evaluating motor and autonomic neuropathy.
Researchers found no significant differences in chemotherapy-induced peripheral neuropathy when using the oxaliplatin-specific neuropathy scale to evaluate time to grade 2 or worse neuropathy (P=.972, when comparing all arms).
“Given that calcium and magnesium does not appear to be the solution to the problem of oxaliplatin-induced neuropathy, a prominent chronic problem for some patients, what options are there to further address this problem?” the researchers wrote. “One is to define a patient’s risk for developing neuropathy on the basis of genetic factors. A second is to look at other agents that might prevent toxicity. Efforts are ongoing to study the benefits of a serotonin/norepinephrine reuptake inhibitor as a means of preventing oxaliplatin neuropathy based on preliminary evidence suggesting that this approach may be beneficial.”
Disclosure: The researchers report research funding from Sanofi-Aventis.