Campana L G, Quaglino P, de Terlizzi F, Mascherini M, Brizio M, Spina R, Bertino G, Kunte C, Odili J, Matteucci P, MacKenzie Ross A, Schepler H, Clover J A P, Kis E
Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK.
Department of Surgery, Manchester University NHS Foundation Trust, Manchester, UK.
J Eur Acad Dermatol Venereol. 2022 Jul 23. doi: 10.1111/jdv.18456.
Electrochemotherapy (ECT) effectively controls skin metastases from cutaneous melanoma.
This study aimed to evaluate health-related quality of life (HRQoL) in melanoma patients pre-/post-ECT and its effect on treatment outcome.
The analysis included prospective data from the International Network for Sharing Practices of ECT register. Following the Standard Operating Procedures, patients received intravenous or intratumoural bleomycin (15,000 IU/m ; 1000 IU mL/cm ) followed by 100-microsecond, 1000-V/cm electric pulses. Endpoints included response (RECIST v3.0), local progression-free survival (LPFS), toxicity (CTCAE v5.0), and patient-reported HRQoL at baseline, one, two, four and ten months (EuroQol [EQ-5D-3L], including 5-item utility score [EQ-5D] and visual analogue scale for self-reported health state [EQ-VAS]). Comparisons within/between subgroups were made for statistical and minimal important differences (MID). HRQoL scores and clinical covariates were analysed to identify predictors of response in multivariate analysis.
Median tumour size was 2 cm. Complete response rate, G3 toxicity and one-year LPFS in 378 patients (76% of the melanoma cohort) were 47%, 5%, and 78%. At baseline, age-paired HRQoL did not differ from the general European population. Following ECT, both EQ-5D and EQ-VAS scores remained within MID boundaries, particularly among complete responders. A subanalysis of the EQ-5D items revealed a statistically significant deterioration in pain/discomfort and mobility (restored within four months), and self-care and usual activities (throughout the follow-up) domains. Concomitant checkpoint inhibition correlated with better EQ-5D and EQ-VAS trajectories. Baseline EQ-5D was the exclusive independent predictor for complete response (RR 14.76, p=0.001).
HRQoL of ECT melanoma patients parallels the general population and is preserved in complete responders. Transient deterioration in pain/discomfort and mobility and persistent decline in self-care and usual activities may warrant targeted support interventions. Combination with checkpoint inhibitors is associated with better QoL outcomes. Baseline HRQoL provides predictive information which can help identify patients most likely to respond.
电化学疗法(ECT)可有效控制皮肤黑色素瘤的皮肤转移。
本研究旨在评估黑色素瘤患者在ECT治疗前后的健康相关生活质量(HRQoL)及其对治疗结果的影响。
分析纳入了来自ECT登记共享实践国际网络的前瞻性数据。按照标准操作程序,患者接受静脉或瘤内注射博来霉素(15,000 IU/m²;1000 IU/mL/cm²),随后给予100微秒、1000 V/cm的电脉冲。终点指标包括缓解情况(RECIST v3.0)、局部无进展生存期(LPFS)、毒性反应(CTCAE v5.0)以及患者在基线、1个月、2个月、4个月和10个月时报告的HRQoL(欧洲五维度健康量表[EQ-5D-3L],包括5项效用评分[EQ-5D]和自我报告健康状态的视觉模拟量表[EQ-VAS])。对亚组内/亚组间进行比较,以分析统计学差异和最小重要差异(MID)。分析HRQoL评分和临床协变量,以确定多变量分析中缓解情况的预测因素。
肿瘤中位大小为2 cm。378例患者(占黑色素瘤队列的76%)的完全缓解率、3级毒性反应和1年LPFS分别为47%、5%和78%。在基线时,年龄匹配的HRQoL与欧洲普通人群无差异。ECT治疗后,EQ-5D和EQ-VAS评分均保持在MID范围内,尤其是在完全缓解者中。对EQ-5D项目的亚组分析显示,疼痛/不适和活动能力(在4个月内恢复)、自我护理和日常活动(在整个随访期间)领域有统计学意义的恶化。同时使用检查点抑制剂与更好的EQ-5D和EQ-VAS轨迹相关。基线EQ-5D是完全缓解的唯一独立预测因素(RR 14.76,p = 0.001)。
ECT治疗的黑色素瘤患者的HRQoL与普通人群相当,且在完全缓解者中得以保留。疼痛/不适和活动能力的短暂恶化以及自我护理和日常活动的持续下降可能需要针对性的支持干预措施。与检查点抑制剂联合使用与更好地生活质量结果相关。基线HRQoL可提供预测信息,有助于识别最可能缓解的患者。