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

#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.

Supportive Cryotherapy: A Review From Head to Toe

“…Two further studies, each reported in abstract form, found similar benefits with frozen glove therapy with no serious adverse effects reported except discomfort. 91, 92 …”

Prophylactic management for taxane‐induced nail toxicity: A systematic review and meta‐analysis

“…Most of these studies were excluded from our final review for the following reasons: 10 were retrospective or review studies, one evaluated ST and NT caused by epidermal growth factor receptor inhibitors, and two compared the outcomes of different degrees of cryotherapy for prevention of docetaxel‐induced NT. The remaining nine studies were finally selected for our meta‐analysis (Can et al, ; Hayashi et al, ; Kim et al, ; Matsumoto et al, ; McCarthy, Shaban, Gillespie, & Vick, ; Sakurai et al, ; Scotté et al, , ; Thomas, Williams, Cauchi, Berkovitz, & Smith, ).…”

“…The patient sample sizes ranged from 28 to 200, and the final total sample size was 708. Four studies (Hayashi et al, ; Kim et al, ; Matsumoto et al, ; Sakurai et al, ) recruited only patients with breast cancer, whereas the other studies recruited patients with breast cancer as well as those with other cancers (Can et al, ; McCarthy et al, ; Scotté et al, , ; Thomas et al, ). Among the chemotherapy regimens, the patients received taxane alone or in combination with chemotherapy at different doses and cycles in each study.…”

“…Among the chemotherapy regimens, the patients received taxane alone or in combination with chemotherapy at different doses and cycles in each study. Most included studies reported at least three chemotherapy cycles (Can et al, ; Hayashi et al, ; Kim et al, ; Matsumoto et al, ; McCarthy et al, ; Sakurai et al, ); however, in the study by Thomas et al, the patients received an average of 4.4 and 5.2 chemotherapy cycles in the plant balm and placebo groups, respectively (Thomas et al, ). Moreover Scotté et al (, ) enrolled patients who had undergone 1–9 chemotherapy cycles.…”

“…McCarthy et al (), Hayashi et al ( ) and Matsumoto et al () randomised the patients’ left or right hands to the FG intervention or control, whereas Scotte et al designated the right hand or foot as the cryotherapy intervention side and the left hand or foot as the control side (Hayashi et al, ; Matsumoto et al, ; McCarthy et al, ; Scotté et al, , ). Can et al and Sakurai et al randomised their patients into cryotherapy and control groups (Can et al, ; Sakurai et al, ). The patients in the study by McCarthy et al () were divided into two intervention subgroups depending on the cryotherapy temperature; the temperatures from −25°C to −30°C were used in their pilot study, whereas temperatures from −4°C to −10°C were used in their main study.…”