Multicenter phase II study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity for the breast cancer patients (Kinki Multidisciplinary Breast Oncology Group: KMBOG-0605).

Abstract Abstract #4093 Background: We have learned from the questionnaire survey of description and hearing type that the onycholysis and skin toxicity occur in approximately 90% of patients(pts) treated with docetaxel (DTX) on hands and 65% on feet. Besides neurotoxicity and edema, these adverse events cause the worse quality of life (QOL) assessment because of the exposure, public noticed site. According to the report that the Elasto-Gel frozen glove (FG) was effective for the prevention of DTX-induced onycholysis and skin toxicity (Scotte F, JCO 23, 4424-29, 2005), we have planned to reanalyze the efficacy and safety of FG for Japanese breast cancer pts by the multicenter, prospective phase II study.
 Patients and Methods: Patients receiving DTX 75 mg/m2 alone or in combination chemotherapy more than 4 cycles were eligible for this case-control study. Each patient on case group wore an FG for a total of 90 minutes on the both hands. Her feet were not protected. The control data was obtained by the questionnaire survey from the pts who had not used FG during the chemotherapy. Onycholysis and skin toxicity were assessed at each cycle by National Cancer Institute Common Toxicity Criteria and documented by photography. This study had accomplished by multidisciplinary approach by nurses, pharmacists, and doctors. Wilcoxon matched-pairs rank test was used.
 Results: Between March 2006 and May 2007, 70 pts on case and 52 pts on control were evaluated. Median age were similar for each group, 52 [29-74 years] on case and 51 [25-73 years] on control. Onycholysis and skin toxicity were significantly lower in the FG-protected hands compared with the control hands (P = .0001). Onycholysis was grade (G) 0 in 41% v 8%, G1 in 54% v 74%, and G2 to 3 in 4.3% v 18% for the FG-protected hands and the control hands, respectively. For the feet, there was no difference in frequency between pts on case and on control. Skin toxicity was G0 in 76.6% v 44%, G1 in 13.6% v 42%, and G2 to 3 in 4.4% v 14% for the FG-protected hands and the control, respectively. 32 pts (46%) had experienced the deterioration of pigmentation on hands and/or feet, the FG had seemed not to be able to prevent these unfavorable events. Median time to nail and skin toxicity occurrence was not significantly different between the FG-protected and the control hands of feet, respectively. Although one pt (1.4%) experienced discomfort due to cold intolerance, there were no serious adverse events caused by FG.
 Conclusion: FG significantly reduces the nail and skin toxicity associated with DTX and is a safety tool on supportive care management. This should be provided in general practice widely to improve a patient's QOL. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4093.