Zhang Ting, Zhu Chengpei, Zhang Nan, Zhang Longhao, Wang Shanshan, Xun Ziyu, Xu Yiyao, Yang Xiaobo, Lu Xin, Zhao Haitao
Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, China.
Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing, China; Department of General Surgery Center, Beijing Youan Hospital, Clinical Center for Liver Cancer, Capital Medical University, Beijing, China.
Int Immunopharmacol. 2024 Mar 10;129:111642. doi: 10.1016/j.intimp.2024.111642. Epub 2024 Feb 6.
To compare the treatment efficacy and safety of lenvatinib and programmed cell death 1 (PD-1) inhibitor combined with oxaliplatin plus gemcitabine (Gemox) chemotherapy or hepatic arterial infusion chemotherapy (HAIC) for patients with advanced biliary tract cancer (BTC).
This study involved 86 patients with advanced BTC receiving PD-1 inhibitor and lenvatinib combined with HAIC (P-L-H group) or Gemox chemothrapy (P-L-G group). Propensity score matching (PSM) (1:1) analysis was used to balance potential bias. 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.
After PSM, a total of 60 patients were enrolled with 30 in the P-L-G group and 30 in the P-L-H group. The median PFS was significantly longer with P-L-G group (13.7 versus 6.0 months, p < 0.0001) than with the P-L-H group. The median OS was 23.8 months in the P-L-G group versus 11.6 months in the P-L-H group (p < 0.0001). Patients in the P-L-G group exhibited a better ORR (73.3 % vs 30 %, p = 0.002) compared to the P-L-H group. The DCR was the same in both groups, 96.7 %, respectively. The P-L-G group had a higher incidence of grade 3-4 AEs than the P-L-H group. However, there was no significant difference in the any grade or grade 3-4 of AEs between the two groups.
PD-1 inhibitor plus lenvatinib and Gemox are promising first-line regimens for the treatment of advanced BTC in the multicenter retrospective real-world study.
比较乐伐替尼与程序性细胞死亡蛋白1（PD-1）抑制剂联合奥沙利铂加吉西他滨（Gemox）化疗或肝动脉灌注化疗（HAIC）治疗晚期胆管癌（BTC）患者的疗效和安全性。
本研究纳入86例接受PD-1抑制剂和乐伐替尼联合HAIC（P-L-H组）或Gemox化疗（P-L-G组）的晚期BTC患者。采用倾向评分匹配（PSM）（1:1）分析来平衡潜在偏倚。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。
PSM后，共纳入60例患者，P-L-G组和P-L-H组各30例。P-L-G组的中位PFS显著长于P-L-H组（13.7个月对6.0个月，p<0.0001）。P-L-G组的中位OS为23.8个月，而P-L-H组为11.6个月（p<0.0001）。与P-L-H组相比，P-L-G组患者的ORR更高（73.3%对30%，p=0.002）。两组的DCR相同，均为96.7%。P-L-G组3-4级不良事件的发生率高于P-L-H组。然而，两组在任何级别或3-4级不良事件方面均无显著差异。
在多中心回顾性真实世界研究中，PD-1抑制剂加乐伐替尼和Gemox是治疗晚期BTC有前景的一线方案。
