This study suggests that the ASP-guided de-escalation of carbapenems led to comparable clinical success, fewer adverse effects and a lower incidence of the development of resistance. This approach is safe and practicable, and should be a key component of an ASP.
TO THE EDITOR: We read the article written by Grothey et al 1 with great interest. The authors designed a prospective study to evaluate the efficacy of intravenous calcium and magnesium (Ca/Mg) to reduce oxaliplatin-induced sensory neurotoxicity in patients with adjuvant colon cancer. The study was terminated early because of safety concerns that were observed in another study, Combined Oxaliplatin Neurotoxicity Prevention Trial (CONcePT). 2 In this study, Grothey et al 1 demonstrated clinically important reductions in neurotoxicity of grades 2 and greater in their study. We would like to praise the authors' effort to elucidate the role of Ca/Mg infusions to reduce oxaliplatininduced neurotoxicities; however, we have identified a number of methodologic issues for which it would be important to seek clarifications from the authors.First, although patients who had pre-existing peripheral neuropathy or had received prior treatment with neurotoxic chemotherapy were excluded from this study, patients with several conditions and comorbidities that might predispose them to higher risk for neuropathy were not excluded. These should be addressed sufficiently under patient demographics, such as the number of patients who had diabetes and/or vitamin B12 deficiency. Similarly, it is unclear whether patients utilizing over-the-counter supplement and vitamins (such as vitamins B and E, which are known to provide neuroprotective effects), and diuretics (which are capable of eliminating electrolytes, such as calcium and magnesium, by the kidneys) were excluded in this study.Second, the protocol design allowed patients to receive cetuximab in combination with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX). It is uncertain, from the report, whether any patients enrolled on this study have received cetuximab. Reductions of magnesium concentrations frequently occur in patients receiving cetuximab (up to 55% of incidence), and greater than 10% are classified as severe events. 3 In this study, the number of patients manifesting hypermagnesemia were seemingly high in the placebo arm (16% in placebo arm v 14% in Ca/Mg arm), which makes one wonder whether any of the patients in the treatment arm had also received cetuximab infusion. It may not be likely that these patients had received cetuximab, because these patients were receiving adjuvant treatment for their colon cancers. It is also unclear whether patients who had hypermagnesemia on baseline were excluded from this study.Third, results from this study favor the use of Ca/Mg to prevent the occurrence of sensory neurotoxicity induced by oxaliplatin. However, to our surprise, none of the cold-sensitive toxicities were reduced with Ca/Mg infusions. According to the authors, these data points were captured by using a questionnaire, with questions answered on a 0-to-10 Likert scale. It is unknown, however, how a patient interpreted this scale and whether this scale was previously validated. This may have resulted in the authors' inability to capture the reduction of cold-s...
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