A Multicenter Phase 2 Trial Evaluating the Efficacy and Safety of Preoperative Lenvatinib Therapy for Patients with Advanced Hepatocellular Carcinoma (LENS-HCC Trial)

Akihiko Ichida ¹, Junichi Arita ¹, Etsuro Hatano ^2,3

¹Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
²Department of Gastroenterological Surgery, Hyogo Medical University, Kobe, Japan.
³Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
⁴Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
⁵Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
⁶Department of Gastroenterological, Breast and Endocrine Surgery, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan.
⁷Hepatobiliary-Pancreatic Surgery Division, Department of Gastroenterological Surgery, Toranomon Hospital, Tokyo, Japan.
⁸Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, National Center for Global Health and Medicine, Tokyo, Japan.
⁹Department of Hepato-Biliary-Pancreatic Surgery, Kyorin University Hospital, Tokyo, Japan.
¹⁰Division of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital for Japanese Foundation for Cancer Research, Tokyo, Japan.
¹¹Department of Hepato-Biliary-Pancreatic Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
¹²JCRAC Data Center, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
¹³Biostatistics and Bioinformatics Course, The University of Tokyo, Tokyo, Japan.

⁰Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Liver Cancer +

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June 19, 2024

View abstract on PubMed

Summary

Preoperative lenvatinib therapy enabled surgical resection in 67.3% of patients with unresectable hepatocellular carcinoma (HCC), demonstrating promising safety and feasibility for improved patient outcomes.

Area Of Science

Hepatobiliary Surgery
Surgical Oncology
Medical Oncology

Background

The REFLECT trial established lenvatinib's superiority over sorafenib for unresectable hepatocellular carcinoma (HCC).
Assessing lenvatinib's role as a neoadjuvant therapy for HCC is crucial for potentially improving surgical outcomes.

Purpose Of The Study

To evaluate the efficacy and safety of preoperative lenvatinib in patients with oncologically or technically unresectable HCC.
To determine the surgical resection rate following neoadjuvant lenvatinib therapy.

Main Methods

A multicenter, single-arm, phase II trial enrolled 49 patients with advanced HCC and poor prognostic factors.
Patients received 8 weeks of lenvatinib therapy, followed by assessment for resectability and subsequent surgery if feasible.
Primary endpoint was surgical resection rate; secondary endpoints included overall survival (OS), objective response rate (ORR), and progression-free survival (PFS).

Main Results

The surgical resection rate was 67.3% (33/49 patients), with 76.2% of oncologically unresectable patients undergoing surgery.
Objective response rate (ORR) was 37.5% (mRECIST) and 12.5% (RECIST v1.1).
One-year OS rate was 75.9% and median PFS was 7.2 months, with no perioperative mortality.

Conclusions

Neoadjuvant lenvatinib therapy is safe and feasible for patients with oncologically or technically unresectable HCC.
This approach can achieve a significant surgical resection rate, offering a potential treatment option for this challenging patient group.
Further research is warranted to optimize neoadjuvant strategies in HCC management.

Keywords:

Hepatocellular carcinoma Lenvatinib Preoperative therapy

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