晚期胆管癌患者一线应用化疗联合PD-1单抗的疗效评价及安全性分析  

Efficacy evaluation and safety analysis of first-line chemotherapy versus chemotherapy combined with PD-1 monoclonal antibody in patients with advanced cholangiocarcinoma

作　　者：李颖林 叶斯斯 乔迁 白莉[1] LI Yinglin;YE Sisi;QIAO Qian;BAI Li(Department of Oncology,The First Medical Center,Chinese PLA General Hospital,Beijing 100853,China)

机构地区：[1]解放军总医院第一医学中心肿瘤内科,北京100853 [2]解放军总医院研究院解放军医学院,100853

出　　处：《临床肿瘤学杂志》2022年第9期801-805,共5页Chinese Clinical Oncology

摘　　要：目的 初步探索晚期胆管癌患者一线应用化疗联合PD-1单抗的疗效及安全性。方法 回顾性分析2016年1月至2021年5月就诊于解放军总医院第一医学中心一线单用化疗及化疗联合PD-1单抗的晚期胆管癌患者。化疗组共52例,一线化疗方案多以白蛋白结合型紫杉醇或吉西他滨为基础;联合组共68例,在化疗的基础上联合PD-1单抗治疗。结果至随访截止时间,化疗联合PD-1单抗组和单用化疗组均无获完全缓解(CR)的患者,两组客观缓解率(ORR)分别为33.8%和17.3%(P=0.043),疾病控制率(DCR)分别为85.3%和55.8%(P<0.01)。化疗联合PD-1单抗组和单用化疗组的中位无疾病进展生存期(PFS)分别为6.1个月(95%CI:5.39~6.81个月)和4.0个月(95%CI:2.49~5.51个月),差异有统计学意义(P=0.03);中位生存期(OS)分别为12.8个月(95%CI:11.45~14.15个月)和12.4个月(95%CI:11.40~13.40个月),差异无统计学意义(P>0.05)。在药物的安全性方面,两组最常见的不良反应为恶心、呕吐,其次为血液学毒性、肝功能损害、皮疹等,均为1~2级,少数患者出现3~4级血液学毒性。结论 晚期胆管癌患者一线应用化疗联合PD-1单抗在一定程度上可延缓疾病的进展并具有良好的安全性,但在OS方面未见明显的优势。Objective To preliminarily explore the efficacy and safety of first-line chemotherapy combined with PD-1 monoclonal antibody in patients with advanced cholangiocarcinoma. Methods Patients with advanced cholangiocarcinoma treated with first-line chemotherapy alone or chemotherapy combined with PD-1 monoclonal antibody in the First Medical Center of PLA General Hospital from January 2016 to May 2021 were retrospectively analyzed. There were 52 patients in the chemotherapy group,and the firstline chemotherapy regimen was mostly based on albumin-bound paclitaxel or gemcitabine,and there were 68 patients in the combined group,all of whom were treaded with chemotherapy combined with PD-1 monoclonal antibody. Results Up to the deadline of followup,there were no complete remission( CR) patients in the chemotherapy combined with PD-1 monoclonal antibody group and the chemotherapy alone group. The objective reponse rate( ORR) of the combination group and the chemotherapy group was 33. 8% and17. 3%,respectively( P = 0. 043),and the disease control rate( DCR) was 85. 3% and 55. 8%,respectively( P<0. 01). The median progression free survival( PFS) was 6. 1 months( 95%CI: 5. 39-6. 81) in the chemotherapy combined with PD-1 monoclonal antibody group and 4. 0 months( 95% CI: 2. 49-5. 51) in the chemotherapy alone group,and the difference was statistically significant( P =0. 03). The median overall survival( OS) of two groups were 12. 8 months( 95%CI: 11. 45-14. 15) and 12. 4 months( 95%CI: 11. 40-13. 40),and the difference was not statistically significance( P>0. 05). In terms of drug safety,the most common adverse reaction in the chemotherapy group and the combination group were nausea and vomiting,followed by hematological toxicity,liver function damage,rash,etc. All of which were grade 1-2,and a few patients had grade 3-4 hematological toxicity. Conclusion First-line chemotherapy combined with PD-1 monoclonal antibody in patients with advanced cholangiocarcinoma can delay the progression of the disease to a certain extent and

关 键 词：晚期胆管癌 化学治疗 PD-1单抗 疗效 安全性 

分 类 号：R735.8[医药卫生—肿瘤]