Fondazione Poliambulanza, Brescia, Italy.
Integr Cancer Ther. 2020 Jan-Dec;19:1534735420943287. doi: 10.1177/1534735420943287.
Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse event of taxanes, with no effective prevention or treatment available and a highly negative impact on patient quality of life. The aim of this study is to asses that the constant application of cooled cuffs on the hands and feet prevent and mitigate CIPN.
Patients with breast, gynecologic, and pancreatic cancer who received weekly paclitaxel (PTX), PTX/carboplatin, and nab-paclitaxel (nab-PTX)/gemcitabine for any indication at the therapeutic scheduled dosage were included in this prospective study. Hilotherm Chemo care device forms a closed-loop system with cuffs and tubes through which a coolant flows at a temperature of 10 °C. CIPN was monitored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (edition 3.0), and the tolerability and side effects were scored by using the Common Terminology Criteria for Adverse Events (T4.03 2017).
To date, we have enrolled 64 patients. Of these, 54 (84%) completed all cooling cycles. Continuous cooling was well tolerated by all patients. No patients had grade >2 CIPN or had serious or lasting adverse events as a result of Hilotherapy. The median time to CIPN onset was 77 days for the entire population.
Hilotherapy has good effectiveness and tolerability and seems to be able to prevent or reduce the symptoms of CIPN. We are still recruiting patients to obtain more data and to collect data at 3 months after the end of chemotherapy. Prospective studies seem to be warranted.
化疗引起的周围神经病(CIPN)是紫杉烷类药物的一种不良反应,目前尚无有效的预防或治疗方法,极大地影响了患者的生活质量。本研究旨在评估持续应用冷却袖套对手脚进行预防和缓解 CIPN 的效果。
本前瞻性研究纳入了接受每周紫杉醇(PTX)、PTX/卡铂和 nab-紫杉醇(nab-PTX)/吉西他滨治疗的乳腺癌、妇科癌和胰腺癌患者,这些患者按治疗计划的规定剂量接受任何适应证的治疗。Hilotherm Chemo care 设备通过袖套和管道形成闭环系统,其中冷却剂以 10°C 的温度流动。使用欧洲癌症研究与治疗组织生活质量问卷(第 3.0 版)监测 CIPN,使用不良事件常用术语标准(T4.03 2017)对耐受性和副作用进行评分。
迄今为止,我们共纳入了 64 例患者。其中,54 例(84%)完成了所有冷却周期。所有患者均能很好地耐受持续冷却。没有患者出现>2 级 CIPN,也没有因 Hilotherapy 而出现严重或持久的不良事件。整个人群中 CIPN 发病的中位时间为 77 天。
Hilotherapy 具有良好的疗效和耐受性,似乎能够预防或减轻 CIPN 的症状。我们仍在招募患者以获得更多数据,并在化疗结束后 3 个月收集数据。似乎有必要进行前瞻性研究。