厄罗替尼治疗晚期非小细胞肺癌致皮疹76例临床分析

Clinical analysis of 76 cases of erlotinib-induced skin rash in the treatment of non-small cell lung cancer

目的:评价厄罗替尼所致皮疹与临床疗效之间的关系,并探讨皮疹治疗的有效方法。方法:研究对象为2005年12月-2008年9月接受厄罗替尼治疗并发生皮疹的76例晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者,均经病理组织学或细胞学予以确诊。厄罗替尼治疗方案为150mg/d,每日连续服药直至疾病进展或出现不可耐受的不良反应。记录皮疹严重度,按照美国国立癌症研究院通用毒性标准(National Cancer Institute-Common Toxicity Criteria,NCI-CTC)对皮疹严重度进行分级,并观察其治疗结局。结果:76例患者发生皮疹的中位时间为8d,其中1度皮疹27例(35.5%)、2度皮疹44例(57.9%)、3度皮疹5例(6.6%)。1度和2～3度皮疹的疾病控制率分别为63.0%(部分缓解5例、稳定12例)和91.8%(部分缓解32例、稳定13例),差异有统计学意义(P<0.05)。1度皮疹和2～3度皮疹患者的中位疾病进展时间分别为5.1和9.7个月(P<0.01)。1度皮疹患者的中位生存期为10.0个月,2～3度皮疹患者的中位生存期为14.6个月(P<0.01)。有78.9%(60/76)的患者经治疗后皮疹得到缓解。结论:厄罗替尼所致皮疹是厄罗替尼临床获益的指标之一,且大多数患者可以耐受,给予恰当的治疗后可以获得缓解。

Objective：To evaluate the relationship between erlotinib-induced skin rash and clinical outcome and explore the effective way to prevent skin rash.Methods：The data from 76 non-small cell lung cancer（NSCLC） patients who experienced erlotinib-induced skin rash from Dec 2005 to Sep 2008 were collected.All the patients were confirmed with NSCLC by pathological and cytological examination and received erlotinib 150 mg/d till they had progressive disease or intolerable adverse reaction.The severity of skin rash was recorded and graded according to National Cancer Institute-Common Toxicity Criteria（NCI-CTC）.The therapeutic outcome of skin rash was observed.Results：The skin rash develops as early as 3 days after commencement of erlotinib therapy,with median onset at 8 days.Twenty-seven（35.5%） patients experienced grade 1 skin rash,44 patients（57.9%） had grade 2 and 5 cases（6.6%） had grade 3 skin rash.A statistically significant correlation was observed between skin rash and erlotinib therapy.The disease-controlling rate was 63.0% for grade 1 skin rash patients including 5 cases with partial remission and 12 cases with stable disease and 91.8% for grade 2/3 skin rash patients including 32 cases with partial remission and 13 cases with stable disease（P0.05）.The median time to progression（TTP） and median overall survival（OS） were prolonged in patients experienced grade 2/3 skin rash compared with those in patients with grade 1 skin rash（TTP：5.1 months vs 9.7 months,P0.01;OS：10.0 months vs 14.6 months,P0.01）.The skin rash was alleviated in 60 out of 76 patients（78.9%）.Conclusion：Skin rash is a potent surrogate marker of favorable outcome in patients who received erlotinib treatment.It was tolerable to most patients.Appropriate therapy may be useful in decreasing the severity of skin rash.