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Lisha Zhang 1 Article
Gastrointestinal cancer
A Single-Arm Phase II Study of Nab-Paclitaxel Plus Gemcitabine and Cisplatin for Locally Advanced or Metastatic Biliary Tract Cancer
Ting Liu, Qing Li, Zhen Lin, Chunhua Liu, Wei Pu, Shasha Zeng, Jun Lai, Xuebin Cai, Lisha Zhang, Shuyang Wang, Miao Chen, Wei Cao, Hongfeng Gou, Qing Zhu
Cancer Res Treat. 2024;56(2):602-615.   Published online October 12, 2023
DOI: https://doi.org/10.4143/crt.2023.726
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Patients with advanced biliary tract cancer (BTC) have a poor survival. We aim to evaluate the efficacy and safety of nab-paclitaxel plus gemcitabine and cisplatin regimen in Chinese advanced BTC patients.
Materials and Methods
Eligible patients with locally advanced or metastatic BTC administrated intravenous 100 mg/m2 nab-paclitaxel, 800 mg/m2 gemcitabine, and 25 mg/m2 cisplatin every 3 weeks. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS) and adverse events, while exploratory endpoint was the association of biomarkers with efficacy.
Results
After the median follow-up of 25.0 months, the median PFS and OS of 34 enrolled patients were 7.1 months (95% confidence interval [CI], 5.4 to 13.7) and 16.4 months (95% CI, 10.9 to 23.6), respectively. The most common treatment-related adverse events at ≥ 3 grade were neutropenia (26.5%) and leukopenia (26.5%). Survival analyses demonstrated that carcinoembryonic antigen (CEA) levels could monitor patients’ survival outcomes. A significant increase in the number of infiltrating CD4+ cells (p=0.008) and a decrease in programmed death-1–positive (PD-1+) cells (p=0.032) were observed in the response patients.
Conclusion
In advanced BTC patients, nab-paclitaxel plus gemcitabine and cisplatin regimen showed therapeutic potential. Potential prognostic factors of CEA levels, number of CD4+ cells and PD-1+ cells may help us maximize the efficacy benefit.

Citations

Citations to this article as recorded by  
  • Efficacy and biomarker analysis of second‐line nab‐paclitaxel plus sintilimab in patients with advanced biliary tract cancer
    Xiaofen Li, Nan Zhou, Yu Yang, Zijian Lu, Hongfeng Gou
    Cancer Science.2024; 115(7): 2371.     CrossRef
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