Mannino Maria, Sollena Pietro, Di Stefani Alessandro, Rossi Ernesto, D'Argento Ettore, Schinzari Giovanni, Tortora Giampaolo, Peris Ketty
U.O.C. di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy.
Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
Dermatology. 2024;240(4):523-530. doi: 10.1159/000536332. Epub 2024 Apr 17.
Novel oncologic therapies, including epidermal growth factor receptor inhibitors (EGFR-Is) and immune checkpoint inhibitors (ICIs), are associated with a new spectrum of adverse reactions, with prominent cutaneous toxicities. The impact of cutaneous adverse events (cAEs) on patients' quality of life (QoL) represents an unmet clinical need.
The aims of this study were (1) to assess whether cutaneous toxicities directed therapies are effective in reducing the QoL burden via the submission of 2 patient reported outcome measures (PROMs); (2) to investigate whether class of oncologic therapy, type of cAE and toxicity severity differently impact on patients' QoL.
A prospective observational study was conducted at the Dermatology department of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, from October 2018 to October 2019. Patients aged ≥18 years, under therapy with EGFR-Is or ICIs and experiencing a treatment-related cAE were eligible for the study. Dermatology Life Quality Index (DLQI) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0 (EORTC QLQ-C30) were administered to patients at first clinical visit (T0), at 1-month (T1), and at 3-month (T2) dermatological follow-up.
Sixty cAEs of 51 patients have been recorded. A significant difference in the mean score for both DLQI and EORTC QLQ-C30 was found along the 3-months dermatological follow-up (p < 0.0001). A similar QoL improvement was reported for PROMs stratified by class of therapy and toxicity severity (p < 0.0001). No difference was reported for patients with pyogenic granuloma-like lesions and psoriasiform eruption as per DLQI. Class of therapy and toxicity severity did not differently impact on patients' QoL at selected timepoints; we reported a higher EORTC QLQ-C30 score at T2 for patients developing psoriasiform eruption compared to other types of cAEs.
Early patients' referral to dermatologists and tailored management could result in better QoL.
包括表皮生长因子受体抑制剂（EGFR-Is）和免疫检查点抑制剂（ICIs）在内的新型肿瘤治疗方法与一系列新的不良反应相关，其中皮肤毒性较为突出。皮肤不良事件（cAEs）对患者生活质量（QoL）的影响是一项尚未满足的临床需求。
本研究的目的是（1）通过提交2项患者报告结局指标（PROMs）来评估针对皮肤毒性的治疗方法是否能有效减轻生活质量负担；（2）研究肿瘤治疗类别、cAE类型和毒性严重程度对患者生活质量的影响是否不同。
2018年10月至2019年10月，在意大利罗马的圣心天主教大学综合医院基金会皮肤病科进行了一项前瞻性观察研究。年龄≥18岁、正在接受EGFR-Is或ICIs治疗且出现与治疗相关的cAE的患者符合研究条件。在首次临床就诊（T0）、1个月（T1）和3个月（T2）皮肤科随访时，对患者进行皮肤病生活质量指数（DLQI）和欧洲癌症研究与治疗组织生活质量问卷核心30版（EORTC QLQ-C30）评估。
记录了51例患者的60例cAEs。在3个月的皮肤科随访中，DLQI和EORTC QLQ-C30的平均得分均有显著差异（p<0.0001）。按治疗类别和毒性严重程度分层的PROMs报告了类似的生活质量改善（p<0.0001）。根据DLQI，化脓性肉芽肿样病变和银屑病样皮疹患者之间未报告差异。治疗类别和毒性严重程度在选定时间点对患者生活质量的影响没有差异；与其他类型的cAEs相比，我们报告银屑病样皮疹患者在T2时的EORTC QLQ-C30得分更高。
早期将患者转诊给皮肤科医生并进行针对性管理可能会带来更好的生活质量。
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