Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Breast. 2019 Dec;48:89-97. doi: 10.1016/j.breast.2019.09.011. Epub 2019 Sep 19.
This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy.
This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials.
Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01).
While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.
本初步试验旨在评估在接受紫杉醇期间通过碎冰冷却手脚是否有助于预防周围神经病。
这项前瞻性、随机试验比较了冷冻疗法与标准护理在开始每周接受紫杉醇 12 个周期的患者中的应用。对于接受冷冻疗法的患者，在每次紫杉醇剂量前 15 分钟至后 15 分钟开始冷却手和脚。在基线时、每周 12 次、然后每月 6 次完成 EORTC QLQ-CIPN20。使用基线、调整基线后的亚量表评分的曲线下面积（AUC）进行比较，并比较两组之间的 AUC（Wilcoxon 秩和检验）。交叉研究比较使用了两项类似进行的神经病学试验的数据。
共纳入了 46 例患者。3 例患者退出，1 例患者不符合条件。在剩余的 42 例患者中（21 例冷冻治疗组，21 例对照组），有 39 例（19 例冷冻治疗组，20 例对照组）的 AUC 可进行分析。冷冻治疗耐受性良好，但在紫杉醇 12 周期间，CIPN20 感觉评分的 AUC 在研究组之间未发现差异（平均差异 3.45，95%CI -3.13 至 10.02，p=0.26）。然而，当前试验的对照组比之前两项类似试验的安慰剂组的神经病变发生率更低。当我们将冷冻治疗组与三项试验的所有对照组进行比较时，冷冻治疗组的神经病变发生率更低（Wilcoxon 秩和检验 p=0.01）。
虽然在当前的二期试验中，两组之间的 CIPN20 评分没有差异，但鉴于对照组的神经病变发生率低于预期，需要进一步研究。
