GM-006 Compliance with FDA recommendations about overdosing with carboplatin

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Diaz CM, Fenix-Caballero SF, Palomo-Palomo C, Gandara-Ladronde Guevera MJ, Alegre-DelRey EJ, Blanco-Castano MA, Lopez-Vallejo JF, Diaz-Navarro J, Borrero-Rubio JM, Rios-Sanchez E

GM-006 Compliance with FDA recommendations about overdosing with carboplatin

European Journal of Hospital Pharmacy: Science and Practice. 2014 Feb 24;21(Suppl 1):A116.

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Background At the end of 2010, the FDA issued an alert regarding the use of a new method for serum creatinine determination. The IDMS method appears to underestimate serum creatinine values compared to older methods when the serum creatinine values are relatively low (e.g., ~0.7 mg/dL). This could lead to higher doses than necessary and carboplatin toxicity. It was therefore recommended the use of fixed maximum doses for each target AUC value. Purpose To determine compliance with FDA recommendations about carboplatin dosage, and to assess the toxicity that emerged at doses higher than recommended. Materials and methods The overall number of patients and carboplatin courses, sex, age, diagnosis and percentage overdose were extracted from the Farmis database on cytostatics management, from January 2011 to September 2013. Overdoses were designated: carboplatin dosing >900 mg for a target AUC = 6; carboplatin dosing >750 mg for a target AUC = 5; carboplatin dosing >600 mg for a target AUC = 4. In the event of overdosing (Common Terminology Criteria for Adverse Events (CTCAE) criteria), blood tests were sought before the next round of treatment and the need to delay the chemotherapy treatment were evaluated. Results A total of 195 patients and 763 courses of carboplatin were identified; 18 patients (2%) had been given an excessive dose. Toxicity was caused in 3 women and 4 men by overdosing with carboplatin, with an average of 48 years and different cancers: lung (N = 2), stomach (N = 1), ovary (N = 2) and unknown origin (N = 2). Following evaluation of the eighteen patients who had received an excessive dose, 22.2% of their chemotherapy courses were delayed. Conclusions As so many patients are exposed to toxicity in this way, it is necessary to set up an automated alert system based on FDA recommendations. Neutropenia was the only adverse event for which chemotherapy had to be postponed; there was no thrombocytopenia.

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