De Tursi Michele, Zilli Marinella, Carella Consiglia, Auriemma Matteo, Lisco Maria Nadia, Di Nicola Marta, Di Martino Giuseppe, Natoli Clara, Amerio Paolo
Department of Medical, Oral and Biotechnological Sciences, Medical Oncology Unit.
Department of Dermatology and Venereology.
Onco Targets Ther. 2017 Jun 16;10:3007-3015. doi: 10.2147/OTT.S127795. eCollection 2017.
The effectiveness of evaluation of the severity of epidermal growth-factor receptor inhibitor (EGFRI)-associated dermatological toxicities remains a topic of debate. This study was designed to assess the correlation between quality of life (QoL) and severity of dermatological toxicity, evaluated using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) and our novel scale, the Eruption Scoring System (ESS), in metastatic colorectal cancer (CRC) patients treated with first-line chemotherapy combined with cetuximab.
Cutaneous toxicity was evaluated, by oncologists and dermatologists, in patients (n=30) with histologically confirmed metastatic CRC who were scheduled to begin first-line chemotherapy combined with the EGFRI, cetuximab, using the NCI-CTCAE and ESS tools. Health-related QoL (HRQoL) was evaluated using the Skindex-29 and Skindex-17 dermatology-specific instruments. Correlations between QoL and skin toxicity severity were assessed using Spearman's rank tests. Interclass correlation coefficients were used to assess interoperator agreement for ESS and NCI-CTCAE v4.0 scoring.
A positive correlation was identified between dermatology HRQoL and the severity of dermatological toxicities assessed using the NCI-CTCAE v4.0 scale for cutaneous papulopustular acneiform rash; however, a stronger correlation was observed between HRQoL and toxicities evaluated using the ESS tool. Both NCI-CTCAE v4.0 and ESS tools demonstrated good interobserver agreement for grading of skin toxicity.
There is a strong correlation between the scores generated by the ESS and NCI-CTCAE tools to grade cutaneous toxicity related to treatment with the anti-EGFR monoclonal antibody, cetuximab. ESS can be considered a valid instrument for identification and grading of the severity of skin toxicity induced by cetuximab, with some advantages over the standard NCI-CTCAE scoring system.
评估表皮生长因子受体抑制剂（EGFRI）相关皮肤毒性严重程度的有效性仍是一个有争议的话题。本研究旨在评估在接受一线化疗联合西妥昔单抗治疗的转移性结直肠癌（CRC）患者中，生活质量（QoL）与皮肤毒性严重程度之间的相关性，皮肤毒性严重程度使用美国国立癌症研究所的不良事件通用术语标准（NCI-CTCAE）以及我们新的皮疹评分系统（ESS）进行评估。
由肿瘤学家和皮肤科医生使用NCI-CTCAE和ESS工具，对30例组织学确诊为转移性CRC且计划开始一线化疗联合EGFRI西妥昔单抗治疗的患者的皮肤毒性进行评估。使用Skindex-29和Skindex-17皮肤病专用工具评估健康相关生活质量（HRQoL）。使用Spearman秩检验评估QoL与皮肤毒性严重程度之间的相关性。组内相关系数用于评估ESS和NCI-CTCAE v4.0评分的观察者间一致性。
使用NCI-CTCAE v4.0量表评估皮肤丘疹脓疱性痤疮样皮疹时，皮肤病HRQoL与皮肤毒性严重程度之间存在正相关；然而，使用ESS工具评估时，HRQoL与毒性之间的相关性更强。NCI-CTCAE v4.0和ESS工具在皮肤毒性分级方面均显示出良好的观察者间一致性。
ESS和NCI-CTCAE工具生成的评分与抗EGFR单克隆抗体西妥昔单抗治疗相关的皮肤毒性分级之间存在很强的相关性。ESS可被认为是一种用于识别和分级西妥昔单抗诱导的皮肤毒性严重程度的有效工具，相对于标准的NCI-CTCAE评分系统具有一些优势。
