Degree of freezing does not affect efficacy of frozen gloves for prevention of docetaxel-induced nail toxicity in breast cancer patients

PURPOSE: Frozen gloves (FG) are effective in preventing docetaxel-induced nail toxicity (DNT), but uncomfortable. The preventive effect of FG for DNT was compared using a standard (−25 to −30°C) or more comfortable (−10 to −20°C) preparation. METHODS: Breast cancer patients receiving docetaxel were eligible. Each patient wore an FG (prepared at −10 to −20°C for 90 min) for 60 min without replacement on the right hand. The left hand was protected by standard methods (FG prepared at −25 to −30°C overnight and worn for 90 min with replacement at 45 min). The primary endpoint was DNT occurrence at 5 months. Secondary endpoints included docetaxel exposure [cumulative dose and area under the blood concentration time curve (AUC)] until DNT occurrence and discomfort from FG. The pharmacokinetics of docetaxel was assessed. RESULTS: From 23 patients enrolled between December 2006 and June 2010, seven who received docetaxel for less than 5 months were excluded from evaluation. The median accumulated docetaxel dose was 700 mg/m(2) (340–1430 mg/m(2)). Within 5 months of FG use, none developed protocol-defined DNT in either hand. Two patients (13%) developed DNT at 7.2 and 7.3 months, respectively, both at −10 to −20°C. In the control hand (−25 to −30°C), discomfort occurred in 92% of the cycles, compared to 15% in the experimental hand (−10 to −20°C). Five patients (22%) experienced pain at −25 to −30°C, but none did at −10 to −20°C. The degree of docetaxel exposure was not related to DNT occurrence in our study. CONCLUSION: A convenient preparation of FG at −10 to −20°C is almost as effective as a standard preparation at −25 to −30°C, with significantly less discomfort.