Ipilimumab联合化疗治疗晚期肺鳞癌的单中心安全性观察

The single-center safety observation of ipilimumab combined with chemotherapy in the treatment of advanced squamous cell carcinoma

背景与目的:以检查点(checkpiont)为靶点的免疫治疗在实体瘤治疗领域有巨大的应用价值,引发了免疫靶向药物的研究热潮。一项研究结果为ipilimumab联合化疗治疗非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的后续研究提供了依据。该研究统计ipilimumab或安慰剂与紫杉醇和卡铂联合作为一线治疗方案治疗Ⅳ期或复发性、组织学为肺鳞状细胞癌的不良事件(adverse events,AEs),评价ipilimumab联合化疗治疗晚期肺鳞癌的安全性。方法:共入组13例经上海交通大学附属胸科医院收治的ⅣA期或ⅣB期ECOG评分标准均小于等于1的肺鳞癌患者。采用随机对照双盲试验,试验组方案为ipilimumab联合紫杉醇与卡铂,对照组方案为安慰剂联合紫杉醇与卡铂。统计治疗过程中发生的AEs。结果:最常见的AEs主要是1级和2级AEs。Ipilimumab单抗组出现的免疫相关AEs(immune-related AEs,ir AEs)包括Ⅰ级的腹泻及皮肤瘙痒,Ⅱ级的皮疹及皮肤瘙痒和Ⅲ级的垂体炎。结论:Ipilimumab单抗的不良反应轻微,可耐受,可处理。

Background and purpose： Checkpiont targeted immunotherapy in the field of solid tumor therapy has huge potential, triggering a boom in the study of immune targeted drugs. A study has provided a basis for the follow-up study of ipilimumab combined with chemotherapy in the treatment of non-small cell lung cancer （NSCLC） patients. This study counted the adverse event statistics that ipilimumab or placebo combined with paclitaxel and carboplatin as first-line therapy for the treatment of stage Ⅳ or recurrent squamous cell carcinoma to evaluate the safety of ipilimumab combined with chemotherapy in the treatment of advanced squamous cell carcinoma. Methods： This study selected 13 patients with ECOG scores ≤1 and stage ⅣA or ⅣB squamous cell carcinoma in the Shanghai Chest Hospital, Shanghai Jiao Tong University. Randomized controlled double blind trial was used in this study. The patients of experimental group were treated with ipilimumab combined with paclitaxel and carhoplatin, while the patients of control group were treated with the placebo combined with paclitaxel and carboplatin. Adverse events （AEs） were counted in the process of treatment. Results： The most common AEs were the 1/2 grade AEs. Immune-related AEs （irAEs） reported in the ipilimumab group included level Ⅰ of diarrhea and pruritus, level Ⅱ of rash and pruritus and level Ⅲ of hypophysitis. Conclusion： The side effects of ipilimumab were mild, tolerable and manageable.