Can ethanol intoxication secondary to docetaxel be predicted based on dose administered using a point-of-care saliva ethanol test?

Abstract

Background The Food and Drug Administration issued a drug safety alert highlighting the potential association of docetaxel infusion with signs and symptoms of alcohol intoxication. This concern is significant because patients treated with docetaxel often have comorbidities and are prescribed concomitant centrally active medications. As a result, these patients may be at risk for iatrogenic events. Objective The objective of this study was to identify a correlation with docetaxel infusion and saliva ethanol concentration using a point-of-care ethanol test. Methods In this pilot study, ethanol concentrations were measured using a validated saliva ethanol test in patients receiving intravenous docetaxel as part of their chemotherapy regimen. Both ethanol dose and infusion rate were calculated based on the amount of the specific docetaxel product administered. Saliva ethanol concentrations were measured at baseline, immediately after infusion completion, and at 30 and 60 min postinfusion. Results A total of 17 patients were included in the analysis. The mean ethanol dose administered was 2.6 ± 0.5 g of ethanol per infusion of docetaxel with a mean infusion rate of 3.2 ± 0.7 ml of ethanol per hour. At baseline, immediately after infusion, and 30 and 60 min postinfusion, all patients had a saliva ethanol test result of 0 mg/dl. Conclusion Based on this small pilot study, the prediction of patients who will experience ethanol intoxication using a point-of-care saliva ethanol test based on the docetaxel dose administered is challenging. This observation requires confirmation in larger and more heterogeneous populations.

Ethanol Exposure During the Intravenous Administration of Chemotherapeutic Drugs: An Analysis of Clinical Practice and a Literature Review

“…Seven articles analyzed the occurrence of ethanol-related symptoms and/or the detectability of ethanol in expired air, saliva, or blood plasma. 8,12,13,17,18,21,22 A retrospective comparison of five docetaxel formulations showed that the safety profile was worse when the dose of both excipients (ethanol and polysorbate) was high—notably with regard to injection site reactions ( P = .0012), hand-foot syndrome ( P = .0003), and oral mucositis ( P = .008). 13 Another study evaluated paclitaxel infusions in 25 patients with a polymorphism in the gene coding for type 2 aldehyde dehydrogenase ( ALDH2 ): five patients developed grade 1 ethanol-related adverse events.…”

“…However, our hypotheses about ethanol exposure are supported by the result of published clinical studies. 8,[10][11][12][13] Although our study was limited to the French market and to chemotherapy protocols of a single hospital, all countries are potentially affected by this issue. Consequently, pharmacists and physicians in every institution should be aware of this patients should be monitored before discharge from hospital-especially if they plan to drive home.…”

“…Moreover, the removal of ethanol from the paclitaxel solution in a patient with known ethanol intolerance abrogated the ethanol-related symptoms. 20 Ethanol levels in patients receiving gemcitabine, 8 docetaxel, 12 and paclitaxel 18,21,22 have been evaluated using a variety of methods, with detection in expired air, 8,21,22 saliva, 12 or blood plasma. 18 Of the three studies that evaluated the presence of ethanol in expired air, only one detected the substance.…”

“…9 Clinical consequences of the presence of ethanol in the formulation have been observed in patients treated with gemcitabine 8 or docetaxel. [10][11][12][13] Data on ethanol exposure during the routine intravenous administration of chemotherapy preparations are scarce. The objectives of this study were to identify situations that expose patients to high doses of ethanol during the intravenous administration of cytotoxic agents and to review the associated risks.…”