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Background <p>Lenvatinib stands out as a first-line therapy for individuals with advanced hepatocellular carcinoma (HCC). Concurrently, hepatic arterial infusion chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin (FOLFOX-HAIC) has emerged as a potential option for those with advanced HCC. It is necessary to investigate the efficacy and safety of lenvatinib plus FOLFOX-HAIC (lenvaHAIC) for advanced HCC in real-world situations.</p> Methods <p>In this retrospective analysis, 127 consecutive patients underwent lenvaHAIC, while 184 patients received lenvatinib alone as first-line treatment at six Chinese academic centers between January 2019 and June 2022. Following 1:1 propensity score matching, we established paired cohorts (113 patients in each group) for evaluating survival. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety profiles were compared between the two groups.</p> Results <p>The lenvaHAIC group exhibited significantly prolonged median PFS and OS than the lenvatinib group (PFS: 12.3 vs. 6.2&#xa0;months; OS: 25.6 vs. 12.3&#xa0;months; <i>P</i> &lt; .001 for each). In the propensity score-matched cohorts (113 pairs), both PFS and OS were notably extended in the lenvaHAIC group compared with those in the lenvatinib group (<i>P</i> &lt; .001). Multivariate analysis identified lenvaHAIC treatment as an independent factor for improved PFS (hazard ratio [HR] 0.45; <i>P</i> &lt; .001) and OS (HR 0.38; <i>P</i> &lt; .001). Grade 3–4 adverse events, including nausea, vomiting, diarrhea, thrombocytopenia, and neutropenia, were more prevalent in the lenvaHAIC group.</p> Conclusions <p>In this real-world study, lenvaHAIC, compared with lenvatinib monotherapy, was associated with significantly prolonged PFS and OS and a higher ORR, while demonstrating a manageable safety profile in patients with advanced HCC.</p>

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Lenvatinib plus hepatic arterial infusion chemotherapy of oxaliplatin, fluorouracil, and leucovorin versus lenvatinib alone for advanced hepatocellular carcinoma: a multicenter retrospective cohort study

  • 期刊论文

  • 发表日期：

    2026年4月10日

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  • Feng Shi,
  • Zhenwei Peng,
  • Shanshan Lian,
  • Qicong Mai,
  • Dongdong Xia,
  • Qi Li,
  • Meng Wang,
  • Song Chen,
  • Jie Mei,
  • Guohong Han,
  • Shuting Chen,
  • Ming Kuang,
  • Xiaoming Chen

摘要

Background

Lenvatinib stands out as a first-line therapy for individuals with advanced hepatocellular carcinoma (HCC). Concurrently, hepatic arterial infusion chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin (FOLFOX-HAIC) has emerged as a potential option for those with advanced HCC. It is necessary to investigate the efficacy and safety of lenvatinib plus FOLFOX-HAIC (lenvaHAIC) for advanced HCC in real-world situations.

Methods

In this retrospective analysis, 127 consecutive patients underwent lenvaHAIC, while 184 patients received lenvatinib alone as first-line treatment at six Chinese academic centers between January 2019 and June 2022. Following 1:1 propensity score matching, we established paired cohorts (113 patients in each group) for evaluating survival. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety profiles were compared between the two groups.

Results

The lenvaHAIC group exhibited significantly prolonged median PFS and OS than the lenvatinib group (PFS: 12.3 vs. 6.2 months; OS: 25.6 vs. 12.3 months; P < .001 for each). In the propensity score-matched cohorts (113 pairs), both PFS and OS were notably extended in the lenvaHAIC group compared with those in the lenvatinib group (P < .001). Multivariate analysis identified lenvaHAIC treatment as an independent factor for improved PFS (hazard ratio [HR] 0.45; P < .001) and OS (HR 0.38; P < .001). Grade 3–4 adverse events, including nausea, vomiting, diarrhea, thrombocytopenia, and neutropenia, were more prevalent in the lenvaHAIC group.

Conclusions

In this real-world study, lenvaHAIC, compared with lenvatinib monotherapy, was associated with significantly prolonged PFS and OS and a higher ORR, while demonstrating a manageable safety profile in patients with advanced HCC.