Department of Oncology Nursing, University Hospitals Leuven, Leuven, Belgium; Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium.
Department of Oncology Nursing, University Hospitals Leuven, Leuven, Belgium; Department of Digestive Oncology, University Hospitals Leuven, Leuven, Belgium.
ESMO Open. 2023 Apr;8(2):101205. doi: 10.1016/j.esmoop.2023.101205. Epub 2023 Apr 3.
Both acute and chronic symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) affect patients' treatment dose and duration as well as quality-of-life. Hand/foot-cooling has been shown to reduce taxane-induced peripheral neuropathy but there is unclear evidence in the setting of oxaliplatin.
In a monocentric, open-label phase II trial, patients with malignancies of the digestive system receiving oxaliplatin-based chemotherapy were randomly assigned to receive either continuous cooling of hands and feet using hilotherapy at 11°C during oxaliplatin infusion compared with usual care (no cooling). The primary endpoint was grade ≥2 neuropathy-free rate in 12 weeks after initiation of chemotherapy. Secondary endpoints included OIPN-related treatment alterations, acute OIPN symptoms and perceived comfort of the intervention.
The intention-to-treat population included 39 patients in the hilotherapy group and 38 in the control group. The grade ≥2 neuropathy-free rate at 12 weeks was 100% in the experimental group versus 80.5% in the control group (P = 0.006). This effect was persistent at 24 weeks (66.0% versus 49.2%, respectively) (P = 0.039). Next, treatment alterations-free rate at week 12 was 93.5% in the hilotherapy group compared with 83.3% in the control group (P = 0.131). Patients in the hilotherapy group experienced significantly less acute OIPN symptoms of numbness or tingling [odds ratio (OR) 0.05, 95% confidence interval (CI) 0.02-0.11, P < 0.0001], pain (OR 0.06, 95% CI 0.02-0.15, P < 0.0001) and/or cold sensitivity (OR 0.02, 95% CI 0.01-0.05, P < 0.0001) in fingers or toes as well as less pharyngeal cold sensitivity (OR 0.14, 95% CI 0.05-0.42, P = 0.0005). The majority of patients in the hilotherapy group rated the intervention as neutral, rather comfortable or very comfortable.
In this first study on hand/foot-cooling in oxaliplatin alone, hilotherapy significantly reduced the incidence of grade ≥2 OIPN at 12 and 24 weeks. Hilotherapy also reduced acute OIPN symptoms and was generally well tolerated.
奥沙利铂引起的周围神经病变（OIPN）的急性和慢性症状都会影响患者的治疗剂量和持续时间以及生活质量。手部/足部冷却已被证明可减少紫杉烷类药物引起的周围神经病变，但在奥沙利铂治疗中证据尚不明确。
在一项单中心、开放标签的 II 期试验中，接受奥沙利铂为基础的化疗的消化系统恶性肿瘤患者被随机分配接受奥沙利铂输注时使用 hilotherapy 进行手部和足部连续冷却（11°C）与常规护理（无冷却）。主要终点是在化疗开始后 12 周时无 2 级以上神经病变的患者比例。次要终点包括 OIPN 相关治疗改变、急性 OIPN 症状和干预的感知舒适度。
意向治疗人群包括 hilotherapy 组 39 例和对照组 38 例。在 12 周时，实验组的 2 级以上神经病变无发生率为 100%，对照组为 80.5%（P=0.006）。这一效果在 24 周时仍持续存在（分别为 66.0%和 49.2%）（P=0.039）。其次，在 12 周时，hilotherapy 组的治疗改变无发生率为 93.5%，对照组为 83.3%（P=0.131）。hilotherapy 组患者手指或脚趾麻木或刺痛感[比值比（OR）0.05，95%置信区间（CI）0.02-0.11，P<0.0001]、疼痛（OR 0.06，95%CI 0.02-0.15，P<0.0001）和/或冷敏感性（OR 0.02，95%CI 0.01-0.05，P<0.0001）以及咽冷敏感性（OR 0.14，95%CI 0.05-0.42，P=0.0005）的急性 OIPN 症状明显减少。hilotherapy 组的大多数患者认为干预措施为中性、相当舒适或非常舒适。
在这项单独使用奥沙利铂的手部/足部冷却的首次研究中，hilotherapy 显著降低了 12 周和 24 周时 2 级以上 OIPN 的发生率。hilotherapy 还减少了急性 OIPN 症状，且总体耐受性良好。
