晚期尿路上皮癌患者一线应用PD-1单抗联合化疗与单纯化疗临床疗效及安全性比较

Clinical outcome and safety of first-line anti-PD-1 therapy combined with chemotherapy versus chemotherapy alone in treatment of advanced urothelial carcinoma

背景免疫检查点抑制剂在尿路上皮癌(urothelial carcinoma,UC)的治疗中显示出较好疗效,但PD-1单抗联合化疗作为晚期UC患者一线治疗方案的疗效鲜有研究。目的比较晚期尿路上皮癌患者一线应用PD-1单抗联合化疗与单纯化疗的疗效及安全性。方法收集解放军总医院第一医学中心肿瘤内科2017年3月-2020年4月一线治疗的局部进展期或转移性UC患者。51例接受吉西他滨或紫杉醇(白蛋白结合型)联合铂类化疗的患者为化疗组,30例接受PD-1单抗联合化疗的患者为免疫联合化疗组。结果两组基线资料差异无统计学意义(P>0.05)。免疫联合化疗组的中位无进展生存期为15.8个月(95%CI:8.135~23.598),较化疗组的7.17个月(95%CI:5.94~8.40)显著延长(P=0.020)。免疫联合化疗组与化疗组的客观缓解率分别为46.7%和49.0%(P=0.999),疾病控制率分别为90.0%和80.4%(P=0.353),不良反应发生率分别为83.3%和84.3%(P=0.908),Ⅲ~Ⅳ级不良反应发生率分别为33.3%和35.3%(P=0.858),差异均无统计学意义。结论在晚期尿路上皮癌患者的一线治疗中,PD-1单抗联合化疗较单纯化疗有更好的疗效,两组不良反应相当。

Background Immune checkpoint inhibitors have shown promising efficacy in the treatment of patients with urothelial carcinoma,but there is limited evidence that anti-PD-1 therapy combined with chemotherapy as a first-line treatment option for advanced patients.Objective To explore the clinical outcome and safety of first-line anti-PD-1 therapy combined with chemotherapy versus chemotherapy alone in treatment of advanced urothelial carcinoma(UC).Methods Patients with advanced UC who received first-line treatment from March 2017 to April 2020 in the department of oncology,the First Medical Center of Chinese PLA General Hospital were included in our study.Patients who received gemcitabine or paclitaxel(albumin-bound)combined with platinum-based chemotherapy were in the chemotherapy group(n=51),and patients received PD-1 inhibitors plus chemotherapy were in the combination therapy group(n=30).Results There was no significant difference between the two groups in baseline data(P>0.05).The median progression-free survival(PFS)of the combination therapy group(15.8 months,95%CI:4.61-21.40)was significantly longer than the chemotherapy group(7.17 months,95%CI:5.94-8.40)(P=0.020).The objective response rates(ORR)of the combination therapy group and the chemotherapy group were 46.7%and 49.0%(P=0.999),and the disease control rates(DCR)were 90.0%and 80.4%,respectively(P=0.353).The incidence of adverse reactions of the combination therapy group and the chemotherapy group were 83.3%and 84.3%(P=0.908),and the incidence of grade III-IV adverse reactions were 33.3%and 35.3%(P=0.858),respectively.Conclusion In the first-line treatment of patients with advanced UC,anti-PD-1 therapy combined with chemotherapy has better efficacy than chemotherapy alone,while the adverse reactions are similar.