A Single-Arm Phase II Study of Nab-Paclitaxel Plus Gemcitabine and Cisplatin for Locally Advanced or Metastatic Biliary Tract Cancer
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
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| Enthalten in: |
Cancer research and treatment - 56(2024), 2 vom: 15. Apr., Seite 602-615 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Liu, Ting [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 15.04.2024 Date Revised 26.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.4143/crt.2023.726 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM363390537 |
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| 100 | 1 | |a Liu, Ting |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A Single-Arm Phase II Study of Nab-Paclitaxel Plus Gemcitabine and Cisplatin for Locally Advanced or Metastatic Biliary Tract Cancer |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 15.04.2024 | ||
| 500 | |a Date Revised 26.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Biliary tract neoplasms | |
| 650 | 4 | |a Cisplatin | |
| 650 | 4 | |a Gemcitabine | |
| 650 | 4 | |a Nab-paclitaxel | |
| 650 | 4 | |a Tumor microenvironment | |
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| 650 | 7 | |a Paclitaxel |2 NLM | |
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| 650 | 7 | |a Programmed Cell Death 1 Receptor |2 NLM | |
| 700 | 1 | |a Li, Qing |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Zhen |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Chunhua |e verfasserin |4 aut | |
| 700 | 1 | |a Pu, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Zeng, Shasha |e verfasserin |4 aut | |
| 700 | 1 | |a Lai, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Cai, Xuebin |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Lisha |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Shuyang |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Miao |e verfasserin |4 aut | |
| 700 | 1 | |a Cao, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Gou, Hongfeng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, Qing |e verfasserin |4 aut | |
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