Dermatology Service, Rockefeller Outpatient Pavilion, Memorial Sloan-Kettering 53rd Street, 160 East 53rd Street, New York, NY 10022, USA.
Support Care Cancer. 2010 Apr;18(4):509-22. doi: 10.1007/s00520-009-0744-x. Epub 2010 Feb 10.
Accurate grading of dermatologic adverse events (AE) due to epidermal growth factor receptor (EGFR) inhibitors (EGFRIs) is necessary for drug toxicity determinations, interagent comparisons, and supportive care trials. The most widely used severity grading scale, the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0), was not designed specifically for this class of agents and may result in underreporting and poor grading of distinctive adverse events. We believe a class-specific grading scale is needed to help standardize assessment and improve reporting of EGFRI-associated dermatologic AEs.
The Multinational Association of Supportive Care in Cancer (MASCC) Skin Toxicity Study Group conducted an international multidisciplinary meeting that included 20 clinicians and researchers from academic centers and government agencies. Experts from different disciplines presented current information specific to EGFRI-induced dermatologic toxicities: grading scale development, pharmacovigilance safety reporting, health-related quality of life, patient reporting, and pharmacology. Group discussions, literature reviews, and professional expertise established the theoretical foundation for the proposed grading scale.
A new grading system is proposed for the most common events associated with EGFRI-induced dermatologic AEs: papulopustular reaction or acneiform rash, nail changes, erythema, pruritus, xerosis, hair changes, telangiectasias, hyperpigmentation, mucositis, flushing, radiation dermatitis, hyposalivation, and taste changes. The proposed scale maintains consistency with the grading principles and language of the existing CTCAE version 4.0 and MedDRA terminology and includes relevant patient-reported health-related quality of life factors.
A grading scale specific to EGFR inhibitor dermatologic AEs is presented for formal integration into future versions of CTCAE and for validation in clinical trial settings. The study group designed this scale to detect and report EGFRI-related toxicities with greater sensitivity, specificity, and range than the scales currently used. This scale should serve as a foundation for efforts to perform objective interdrug comparisons and assessments of supportive care treatment strategies more effectively than with current methods.
准确分级表皮生长因子受体（EGFR）抑制剂（EGFRIs）引起的皮肤不良事件（AE）对于药物毒性确定、药物间比较和支持性护理试验是必要的。最广泛使用的严重程度分级量表，即美国国立癌症研究所不良事件通用术语标准第 4.0 版（NCI-CTCAE v4.0），并非专门为此类药物设计，可能导致报告不足和对独特不良事件的分级不佳。我们认为需要一种特定于类别的分级量表来帮助标准化评估和改善 EGFR 相关皮肤 AE 的报告。
多国支持癌症生存协会（MASCC）皮肤毒性研究小组进行了一次国际多学科会议，其中包括来自学术中心和政府机构的 20 名临床医生和研究人员。来自不同学科的专家介绍了针对 EGFR 诱导的皮肤毒性的当前信息：分级量表的制定、药物警戒安全性报告、健康相关生活质量、患者报告和药理学。小组讨论、文献回顾和专业知识为拟议的分级量表奠定了理论基础。
针对与 EGFR 抑制剂引起的皮肤 AE 相关的最常见事件，提出了一种新的分级系统：脓疱性或痤疮样疹、指甲改变、红斑、瘙痒、干燥、毛发改变、毛细血管扩张、色素沉着、粘膜炎、潮红、放射性皮炎、唾液减少和味觉改变。拟议的量表与现有的 CTCAE 第 4.0 版和 MedDRA 术语的分级原则和语言保持一致，并包含相关的患者报告健康相关生活质量因素。
提出了一种针对 EGFR 抑制剂皮肤 AE 的分级量表，以便正式纳入未来的 CTCAE 版本，并在临床试验环境中进行验证。研究小组设计了这个量表，以比当前使用的量表更敏感、更特异和更广泛地检测和报告 EGFR 相关毒性。与当前方法相比，该量表应作为进行客观药物间比较和更有效地评估支持性护理治疗策略的努力的基础。
