Degree of freezing does not affect efficacy of frozen gloves for prevention of docetaxel-induced nail toxicity in breast cancer patients.
Degree of freezing does not affect efficacy of frozen gloves for prevention of docetaxel-induced nail toxicity in breast cancer patients.
复制标题
DOI：
10.1007/s00520-011-1308-4
复制
发表时间：
2012-09
影响因子：
3.1
通讯作者：
Fukushima, M.
中科院分区：
文献类型：
--
作者：
Ishiguro, H.;Takashima, S.;Yoshimura, K.;Yano, I.;Yamamoto, T.;Niimi, M.;Yamashiro, H.;Ueno, T.;Takeuchi, M.;Sugie, T.;Yanagihara, K.;Toi, M.;Fukushima, M.
冷冻手套(FG)在预防多西紫杉醇引起的指甲毒性(DNT)方面有效，但不舒服。使用标准(−25至−30°C)或更舒适的(−10至−20°C)制剂，比较FG对DNT的预防效果。接受多西紫杉醇治疗的乳腺癌患者符合条件。每个患者佩戴FG(在−10至−20°C下准备，90分钟)60分钟，右手不更换。用标准方法保护左手(在−25℃至−30°C的温度下制备FG过夜，佩戴90分钟，45分钟更换)。主要终点是5个月时发生DNT。次要终点包括暴露于多西紫杉醇[累积剂量和血药浓度时间曲线下面积(AUC)]，直至发生DNT和FG带来的不适。对多西他赛的药代动力学进行了研究。在2006年12月至2010年6月期间登记的23名患者中，7名接受多西紫杉醇治疗不到5个月的患者被排除在评估之外。多西紫杉醇累积剂量的中位数为700 mg/m2(340-1430 mg/m2)。在FG使用的5个月内，没有人在两个手中开发出协议定义的DNT。2名患者(13%)分别在−10~−20°C时发生DNT，分别为7.2月和7.3月。在对照手(−25~−30°C)中，92%的患者出现不适，而试验手(−10~−20°C)的不适率为15%。5名患者(22%)在−25至−30°C时出现疼痛，但在−10至−20℃时无一例出现疼痛。在我们的研究中，多西紫杉醇的暴露程度与DNT的发生无关。在−10至−20°C下方便地制备FG几乎与在−25至−30°C下的标准制备一样有效，而且明显减少了不适感。
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. 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. 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/m2 (340–1430 mg/m2). 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. 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.
登录
查看更多内容
影响因子：
45.3
作者：
Harvey, Vernon;Mouridsen, Henning;Cold, Soeren
通讯作者：
Cold, Soeren
影响因子：
45.3
作者：
Miles, David W.;Chan, Arlene;Romieu, Gilles
通讯作者：
Romieu, Gilles
影响因子：
50.5
作者：
Minisini, AM;Tosti, A;Puglisi, F
通讯作者：
Puglisi, F
影响因子：
8.4
作者：
Lemenager, M;Lecomte, S;Bonneterre, J
通讯作者：
Bonneterre, J
影响因子：
3.1
作者：
Ridderheim, M;Bjurberg, M;Gustavsson, A
通讯作者：
Gustavsson, A