Shang Peipei, Xu Heming, Zeng Tianmei, Lou Cheng, Wei Wei, Yang Guang, Cheng Zhuo, Cui Xiaowen, Hong Weipeng, Shen Weidong, Lian Zhicong, Yuan Zhengang
Eastern Hepatobiliary Surgical Hospital, Naval Military Medical University, Shanghai, China.
Medical Department, Oyeah Biotech, Shanghai, China.
Front Oncol. 2024 Nov 22;14:1482909. doi: 10.3389/fonc.2024.1482909. eCollection 2024.
Advanced biliary tract cancer (BTC) is associated with a poor prognosis and limited options for second-line treatment. The TOPAZ-1 and KEYNOTE-966 trials have demonstrated the benefits of combining immune checkpoint inhibitors (ICIs) with chemotherapy in treating BTC. However, the efficacy of FOLFOX as a second-line therapy is limited, highlighting the need for more effective treatment approaches.
This retrospective study compared a triple regimen-comprising ICIs, tyrosine kinase inhibitors, and chemotherapy-to standard chemotherapy in patients with metastatic BTC who had progressed on first-line gemcitabine-based therapy. The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), overall response rate (ORR), disease control rate (DCR), and safety.
Of the 121 patients, 86 received the triple regimen and 35 received standard chemotherapy. The triple regimen showed a significantly higher ORR (37.2% vs. 2.8%, p < 0.0001) and DCR (89.5% vs. 71.4%). The median PFS was 6 months for the triple regimen compared to 2.0 months for standard chemotherapy (HR 0.29, p < 0.0001). The median OS was 16.0 months for the triple regimen versus 6.0 months for standard chemotherapy (HR 0.35, p < 0.0001). Treatment-related adverse events were comparable between the groups.
The triple combination of immunotherapy offers superior survival benefits compared to standard chemotherapy as a second-line treatment for advanced BTC, warranting further investigation for potential clinical adoption.
晚期胆管癌（BTC）预后较差，二线治疗选择有限。TOPAZ-1和KEYNOTE-966试验已证明免疫检查点抑制剂（ICI）与化疗联合治疗BTC的益处。然而，FOLFOX作为二线治疗的疗效有限，凸显了对更有效治疗方法的需求。
本回顾性研究比较了三联方案（包括ICI、酪氨酸激酶抑制剂和化疗）与标准化疗在一线吉西他滨为基础的治疗进展后的转移性BTC患者中的疗效。主要终点是无进展生存期（PFS），次要终点包括总生存期（OS）、总缓解率（ORR）、疾病控制率（DCR）和安全性。
121例患者中，86例接受三联方案，35例接受标准化疗。三联方案显示出显著更高的ORR（37.2%对2.8%，p<0.0001）和DCR（89.5%对71.4%）。三联方案的中位PFS为6个月，而标准化疗为2.0个月（HR 0.29，p<0.0001）。三联方案的中位OS为16.0个月，标准化疗为6.0个月（HR 0.35，p<0.0001）。两组治疗相关不良事件相当。
作为晚期BTC的二线治疗，免疫疗法三联组合与标准化疗相比具有更好的生存获益，值得进一步研究以探讨其潜在的临床应用价值。
