帕博利珠单抗联合阿昔替尼治疗晚期肾细胞癌的初步疗效分析

Preliminary analysis of the efficacy of pembrolizumab combined with axitinib in the treatment of advanced renal cell carcinoma

目的初步评价帕博利珠单抗联合阿昔替尼治疗晚期肾细胞癌(肾癌)的有效性和安全性。方法选取北京大学人民医院2019年1月至2019年12月收治的晚期转移性肾癌患者13例为研究对象,男11例,女2例,中位年龄为58.9(48~66)岁。所有患者均发生远处转移,其中单一脏器转移8例,多脏器转移5例。10例患者既往行原发肿瘤切除术确诊,3例患者经穿刺病理确诊,病理类型均为透明细胞癌。帕博利珠单抗200 mg静脉滴注,每3周1次;阿昔替尼5 mg,每日2次连续口服。联合用药至少2个周期后进行1次疗效评价,分析治疗效果和相关并发症发生情况。结果中位随访时间为9.1(4~13)个月,13例均可评价疗效,其中部分缓解8例,疾病稳定3例,疾病进展2例。总体客观缓解率为61.5%(8/13)、疾病控制率为84.6%(11/13)。常见不良反应包括高血压(7/13)、疲劳(6/13)、腹泻(5/13)、食欲减退(4/13)、手足皮肤反应(4/13)、转氨酶水平升高(3/13)、蛋白尿(2/13)、皮疹(2/13)、甲状腺功能减退(1/13)、免疫相关性肺炎(1/13)。本组未见重症肌无力患者。结论帕博利珠单抗联合阿昔替尼治疗晚期转移性肾癌效果显著,可以作为一线靶向治疗进展后的后线治疗。

Objective To evaluate the efficacy and safety of pembrolizumab combined with axitinib in the treatment of advanced renal cell carcinoma(RCC).Method From January 2019 to December 2019,13 patients with advanced metastatic RCC were enrolled,including 11 male and 2 female,with a median age of 58.9 years(range from 48~66 years).Distant metastasis occurred in all patients,including 8 cases of solitary metastasis and 5 cases of multiple organ metastasis.Ten patients were diagnosed with previously nephrectomy,and three patients were histologically confirmed by percutaneous biopsy.All pathological type was clear cell carcinoma.200 mg of pembrolizumab was given intravenously once every three weeks,and 5 mg of axitinib was taken orally twice daily continuously.After at least two cycles of combined medications,the treatment effect and related complications were analyzed.Result The median follow-up time was 9.1 months(range from 4~13 months),and all 13 cases could be evaluated.Eight patients achieved partial remission,3 patients showed stable disease and 2 patients experienced disease progression.The overall objective remission rate was 61.5%(8/13),and disease control rate was 84.6%(11/13).Common adverse events included hypertension(7/13),fatigue(6/13),diarrhea(5/13),decreased appetite(4/13),hand-foot syndrome(4/13),increased aminotransferase(3/13),proteinuria(2/13),rash(2/13),hypothyroidism(1/13)and pneumonitis(1/13).There was no incidence of myasthenia gravis in this group.Conclusion The efficacy of pembrolizumab combined with axitinib in the treatment of advanced RCC is impressive,and it can be used as a later-line therapy after the progression of first-line targeted therapy.