Zhao Lu, Zhang Zhengfeng, Wang Dazhen, Yang Liu, Liu Ze, Lou Changjie
Department of Gastroenterology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang Province, China.
Clin Exp Med. 2025 Mar 19;25(1):87. doi: 10.1007/s10238-025-01623-0.
To assess the efficacy and safety of lenvatinib/bevacizumab combined with programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors and gemcitabine/oxaliplatin (GEMOX) as first-line treatments in patients with advanced biliary tract cancer (BTC). Patients with advanced BTC who received lenvatinib/bevacizumab combined with PD-1/PD-L1 inhibitors plus gemcitabine/oxaliplatin (GEMOX) chemotherapy were retrospectively screened. 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. A total of 172 individuals were enrolled and categorized into four groups: Group A received GEMOX plus PD-1 antibody (sintilimab or camrelizumab) and lenvatinib; group B received GEMOX and PD-1 antibody (sintilimab or camrelizumab) and bevacizumab; group C received GEMOX and PD-1 antibody (sintilimab or camrelizumab); and group D received GEMOX alone. The median OS was 13.63 months (95% confidence interval [CI]: 12.37-14.89), 12.41 months (95% CI: 10.67-12.32), 11.23 months (95% CI: 9.39-13.07), and 8.86 months (95% CI: 7.28-10.44) in groups A, B, C, and D, respectively (P = 0.312). In groups A, B, C, and D, the median PFS was 12.42 months, 11.05 months, 8.89 months, and 6.02 months. A statistically significant difference was observed (t = 2, 95% CI: 11.31-13.53, P < 0.01). The ORR was 45.00% (17/40) in group A, 34.78% (16/46) in group B, 16.67% (5/30) in group C, and 17.86% (10/56) in group D. The DCR was 87.50% (35/40), 78.26% (36/46), 76.67% (23/30), and 58.93% (33/56) in groups A, B, C, and D, respectively. In addition, regression analysis showed that patients' metastasis site, whether the neutrophil-lymphocyte ratio was < 2.3, and whether chemotherapy was administered through hepatic artery embolization and was independent prognostic factors influencing median OS and PFS. Almost all patients included in the study experienced treatment-related adverse events (TRAEs) of varying degrees of severity, with grade 1-2 adverse events predominating. Lenvatinib/bevacizumab combined with programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors and gemcitabine/oxaliplatin (GEMOX) represent an effective and tolerable regimen for advanced BTC in a multicenter retrospective real-world study.
评估乐伐替尼/贝伐单抗联合程序性死亡-1（PD-1）/程序性死亡配体1（PD-L1）抑制剂及吉西他滨/奥沙利铂（GEMOX）作为晚期胆管癌（BTC）患者一线治疗方案的疗效和安全性。对接受乐伐替尼/贝伐单抗联合PD-1/PD-L1抑制剂加吉西他滨/奥沙利铂（GEMOX）化疗的晚期BTC患者进行回顾性筛查。主要终点为总生存期（OS）和无进展生存期（PFS），次要终点为客观缓解率（ORR）、疾病控制率（DCR）和安全性。分析生存的预后因素。共纳入172例患者并分为四组：A组接受GEMOX加PD-1抗体（信迪利单抗或卡瑞利珠单抗）及乐伐替尼；B组接受GEMOX和PD-1抗体（信迪利单抗或卡瑞利珠单抗）及贝伐单抗；C组接受GEMOX和PD-1抗体（信迪利单抗或卡瑞利珠单抗）；D组仅接受GEMOX。A、B、C和D组的中位OS分别为13.63个月（95%置信区间[CI]：12.37 - 14.89）、12.41个月（95% CI：10.67 - 12.32）、11.23个月（95% CI：9.39 - 13.07）和8.86个月（95% CI：7.28 - 10.44）（P = 0.312）。A、B、C和D组的中位PFS分别为12.42个月、11.05个月、8.89个月和6.02个月。观察到有统计学显著差异（t = 2，95% CI：11.31 - 13.53，P < 0.01）。A组的ORR为45.00%（17/40），B组为34.78%（16/46），C组为16.67%（5/30），D组为17.86%（10/56）。A、B、C和D组的DCR分别为87.50%（35/40）、78.26%（36/46）、76.67%（23/30）和58.93%（33/56）。此外，回归分析显示患者的转移部位、中性粒细胞与淋巴细胞比值是否<2.3以及化疗是否通过肝动脉栓塞给药是影响中位OS和PFS的独立预后因素。该研究纳入的几乎所有患者都经历了不同严重程度的治疗相关不良事件（TRAEs），以1 - 2级不良事件为主。在一项多中心回顾性真实世界研究中，乐伐替尼/贝伐单抗联合程序性死亡-1（PD-1）/程序性死亡配体1（PD-L1）抑制剂及吉西他滨/奥沙利铂（GEMOX）是晚期BTC一种有效且可耐受的治疗方案。
