Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion : A Multicenter, Phase III, Randomized Study
PURPOSE: To report the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with 5-fluorouracil and oxaliplatin (FOLFOX) in hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI).
PATIENTS AND METHODS: In this randomized, open-label, multicenter trial, histologically confirmed HCC patients with MVI were randomly assigned (1:1) to receive adjuvant FOLFOX-HAIC (treatment group) or routine follow-up (control group). The primary end point was disease-free survival (DFS) by intention-to-treat (ITT) analysis while secondary end points were overall survival, recurrence rate, and safety.
RESULTS: Between June 2016 and August 2021, a total of 315 patients (ITT population) at five centers were randomly assigned to the treatment group (n = 157) or the control group (n = 158). In the ITT population, the median DFS was 20.3 months (95% CI, 10.4 to 30.3) in the treatment group versus 10.0 months (95% CI, 6.8 to 13.2) in the control group (hazard ratio, 0.59; 95% CI, 0.43 to 0.81; P = .001). The overall survival rates at 1 year, 2 years, and 3 years were 93.8% (95% CI, 89.8 to 98.1), 86.4% (95% CI, 80.0 to 93.2), and 80.4% (95% CI, 71.9 to 89.9) for the treatment group and 92.0% (95% CI, 87.6 to 96.7), 86.0% (95% CI, 79.9 to 92.6), and 74.9% (95% CI, 65.5 to 85.7) for the control group (hazard ratio, 0.64; 95% CI, 0.36 to 1.14; P = .130), respectively. The recurrence rates were 40.1% (63/157) in the treatment group and 55.7% (88/158) in the control group. Majority of the adverse events were grade 0-1 (83.8%), with no treatment-related death in both groups.
CONCLUSION: Postoperative adjuvant HAIC with FOLFOX significantly improved the DFS benefits with acceptable toxicities in HCC patients with MVI.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 41(2023), 10 vom: 01. Apr., Seite 1898-1908 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Li, Shao-Hua [VerfasserIn] |
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| Links: |
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| Themen: |
Adjuvants, Immunologic |
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| Anmerkungen: |
Date Completed 31.03.2023 Date Revised 10.04.2023 published: Print-Electronic ClinicalTrials.gov: NCT03192618 Citation Status MEDLINE |
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| doi: |
10.1200/JCO.22.01142 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM350374902 |
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| 100 | 1 | |a Li, Shao-Hua |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion |b A Multicenter, Phase III, Randomized Study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 31.03.2023 | ||
| 500 | |a Date Revised 10.04.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03192618 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: To report the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with 5-fluorouracil and oxaliplatin (FOLFOX) in hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI) | ||
| 520 | |a PATIENTS AND METHODS: In this randomized, open-label, multicenter trial, histologically confirmed HCC patients with MVI were randomly assigned (1:1) to receive adjuvant FOLFOX-HAIC (treatment group) or routine follow-up (control group). The primary end point was disease-free survival (DFS) by intention-to-treat (ITT) analysis while secondary end points were overall survival, recurrence rate, and safety | ||
| 520 | |a RESULTS: Between June 2016 and August 2021, a total of 315 patients (ITT population) at five centers were randomly assigned to the treatment group (n = 157) or the control group (n = 158). In the ITT population, the median DFS was 20.3 months (95% CI, 10.4 to 30.3) in the treatment group versus 10.0 months (95% CI, 6.8 to 13.2) in the control group (hazard ratio, 0.59; 95% CI, 0.43 to 0.81; P = .001). The overall survival rates at 1 year, 2 years, and 3 years were 93.8% (95% CI, 89.8 to 98.1), 86.4% (95% CI, 80.0 to 93.2), and 80.4% (95% CI, 71.9 to 89.9) for the treatment group and 92.0% (95% CI, 87.6 to 96.7), 86.0% (95% CI, 79.9 to 92.6), and 74.9% (95% CI, 65.5 to 85.7) for the control group (hazard ratio, 0.64; 95% CI, 0.36 to 1.14; P = .130), respectively. The recurrence rates were 40.1% (63/157) in the treatment group and 55.7% (88/158) in the control group. Majority of the adverse events were grade 0-1 (83.8%), with no treatment-related death in both groups | ||
| 520 | |a CONCLUSION: Postoperative adjuvant HAIC with FOLFOX significantly improved the DFS benefits with acceptable toxicities in HCC patients with MVI | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
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| 650 | 7 | |a Adjuvants, Immunologic |2 NLM | |
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| 700 | 1 | |a Wang, Qiao-Xuan |e verfasserin |4 aut | |
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| 700 | 1 | |a Jiang, Yu-Chuan |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Rong-Ce |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Liang-He |e verfasserin |4 aut | |
| 700 | 1 | |a Zou, Jing-Wen |e verfasserin |4 aut | |
| 700 | 1 | |a Deng, Min |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Wen-Ping |e verfasserin |4 aut | |
| 700 | 1 | |a Guan, Ren-Guo |e verfasserin |4 aut | |
| 700 | 1 | |a Wen, Yu-Hua |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Ji-Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Zheng, Lie |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Zhi-Xing |e verfasserin |4 aut | |
| 700 | 1 | |a Ling, Yi-Hong |e verfasserin |4 aut | |
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| 700 | 1 | |a Wei, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Rong-Ping |e verfasserin |4 aut | |
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