METHODS: Patients with advanced ICC who received PD-1 inhibitor combined with lenvatinib and Gemox chemotherapy were retrospectively screened at two medical centers. The primary endpoints were overall survival (OS) and progression-free survival (PFS), whereas the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and safety. Prognostic factors for survival were analyzed.
RESULTS: Fifty-three patients with advanced ICC were included in this study. The median follow-up time was 13.7 (95% confidence interval (CI): 12.9-17.2) months. The median OS and PFS were 14.3 (95% CI: 11.3-NR) and 8.63 (95% CI: 7.17-11.6) months, respectively. The ORR, DCR, and clinical benefit rate were 52.8, 94.3, and 75.5%, respectively. In the multivariate analysis, the tumor burden score (TBS), tumor-node metastasis classification (TNM) stage, and PD-L1 expression were independent prognostic factors for OS and PFS. All patients experienced adverse events (AEs), 41.5% (22/53) experienced grade 3 or 4 AEs, including fatigue (8/53, 15.1%) and myelosuppression (7/53, 13.2%). No grade 5 AEs were reported.
CONCLUSIONS: PD-1 inhibitors combined with lenvatinib and Gemox chemotherapy represent an effective and tolerable regimen for advanced ICC in a multicenter retrospective real-world study. TBS, TNM stage, and PD-L1 expression can be used as potential prognostic factors for OS and PFS.
方法:在两个医疗中心对接受PD-1抑制剂联合lenvatinib和Gemox化疗的晚期ICC患者进行回顾性筛查。主要终点是总生存期(OS)和无进展生存期(PFS),而次要终点是客观反应率(ORR),疾病控制率(DCR),和安全。分析影响生存的预后因素。
结果:本研究纳入了53例晚期ICC患者。中位随访时间为13.7个月(95%置信区间(CI):12.9-17.2)。中位OS和PFS分别为14.3个月(95%CI:11.3-NR)和8.63个月(95%CI:7.17-11.6),分别。ORR,DCR,临床获益率分别为52.8%、94.3%和75.5%,分别。在多变量分析中,肿瘤负荷评分(TBS),肿瘤淋巴结转移分类(TNM)分期,PD-L1表达是OS和PFS的独立预后因素。所有患者均出现不良事件(AE),41.5%(22/53)经历过3级或4级不良事件,包括疲劳(8/53,15.1%)和骨髓抑制(7/53,13.2%)。未报告5级AE。
结论:PD-1抑制剂联合lenvatinib和Gemox化疗在一项多中心回顾性真实世界研究中代表了晚期ICC的有效和可耐受方案。TBS,TNM阶段,PD-L1表达可作为OS和PFS的潜在预后因素。