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

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.

A pilot phase II trial of all-trans retinoic acid (Vesanoid) and paclitaxel (Taxol) in patients with recurrent or metastatic breast cancer.

PURPOSE: We investigated a combination therapy with weekly paclitaxel and all trans-retinoic acid (ATRA) for tolerability, response to treatment, time to progression and survival in previously treated patients with metastatic or recurrent breast cancer. Our rationale was based on preclinical studies demonstrating potentiation of the cytotoxic effects of taxanes and induction of differentiation by ATRA. PATIENTS AND METHODS: Seventeen patients with previously treated metastatic or recurrent breast cancer were enrolled to a regimen of all-trans retinoic acid (Vesanoid, tretinoin, Hoffman-La Roche, Inc.) 45 mg/m(2) PO daily for 4 days starting 2 days before a 1 h treatment with paclitaxel (Taxol, Bristol-Myers Squibb, Plainsboro, NJ) 80 mg/m(2) IV administered weekly for 3 weeks, repeated in 28 day cycles until disease progression or until no longer tolerated. Patients were evaluated for toxicity, response, time to progression and survival. Patients were primarily African American and Latino, representative of the population served by our Cancer Center. RESULTS: The regimen was relatively well tolerated. There were nine grade 3 and one grade 4 toxic events. We administered 162 treatment cycles with a mean of 7.5 per patient (range 1-22, median 5). Three patients had a partial response (17.6%) and ten patients had stable disease (58.8%), with an overall clinical benefit of 76.4%. Median time to progression was 6.0 months (range 1-21, mean 7.7 months). Fourteen evaluable patients had a median survival of 16 months (range 1-68 months, mean 25.2 months). CONCLUSIONS: The data suggest this is a well tolerated regimen with modest response rates but with time to progression and survival rates similar to those reported for paclitaxel alone and relatively high rates of stable disease in this sample of patients.