Lenvatinib with or without Concurrent Drug-Eluting Beads Transarterial Chemoembolization in Patients with Unresectable, Advanced Hepatocellular Carcinoma: A Real-World, Multicenter, Retrospective Study

Dongdong Xia; Wei Bai; Enxin Wang; Jiaping Li; Xiaoming Chen; Zhexuan Wang; Mingsheng Huang; Ming Huang; Junhui Sun; Weizhu Yang; Zhengyu Lin; Jianbing Wu; Zixiang Li; Shufa Yang; Xu Zhu; Zaizhong Chen; Yanfang Zhang; Wenzhe Fan; Qicong Mai; Rong Ding; Chunhui Nie; Long Feng; Xueda Li; Wukui Huang; Jun Sun; Qiuhe Wang; Yong Lv; Xiaomei Li; Bohan Luo; Zhengyu Wang; Jie Yuan; Wengang Guo; Kai Li; Bing Li; Ruijun Li; Zhanxin Yin; Jielai Xia; Guohong Han

doi:10.1159/000523849

Lenvatinib with or without Concurrent Drug-Eluting Beads Transarterial Chemoembolization in Patients with Unresectable, Advanced Hepatocellular Carcinoma: A Real-World, Multicenter, Retrospective Study

Liver Cancer. 2022 Mar 9;11(4):368-382. doi: 10.1159/000523849. eCollection 2022 Jul.

Authors

Dongdong Xia^{1

2}, Wei Bai^{1

2}, Enxin Wang^{1

3}, Jiaping Li⁴, Xiaoming Chen⁵, Zhexuan Wang², Mingsheng Huang⁶, Ming Huang⁷, Junhui Sun⁸, Weizhu Yang⁹, Zhengyu Lin¹⁰, Jianbing Wu¹¹, Zixiang Li¹², Shufa Yang¹³, Xu Zhu¹⁴, Zaizhong Chen¹⁵, Yanfang Zhang¹⁶, Wenzhe Fan⁴, Qicong Mai⁵, Rong Ding⁷, Chunhui Nie⁸, Long Feng¹¹, Xueda Li¹², Wukui Huang¹³, Jun Sun², Qiuhe Wang², Yong Lv², Xiaomei Li¹, Bohan Luo¹, Zhengyu Wang¹, Jie Yuan¹, Wengang Guo¹, Kai Li², Bing Li¹, Ruijun Li¹, Zhanxin Yin¹, Jielai Xia¹⁷, Guohong Han^{1

2}

Affiliations

¹ Department of Liver Diseases and Interventional Radiology, Digestive Diseases Hospital, Xi'an International Medical Center Hospital, Northwest University, Xi'an, China.
² Department of Liver Disease and Digestive Interventional Radiology, National Clinical Research Center for Digestive Disease and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
³ Department of Medical Affairs, Air Force Hospital of Western Theater Command, Chengdu, China.
⁴ Department of Interventional Radiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
⁵ Department of Interventional Radiology, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Provincial Academy of Medical Sciences, Guangzhou, China.
⁶ Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
⁷ Department of Minimally Invasive International Therapy, The Third Affiliated Hospital of Kunming University, Tumor Hospital of Yunnan Province, Kunming, China.
⁸ Department of Hepatobiliary and Pancreatic Interventional Cancer, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
⁹ Department of Interventional Radiology, Fujian Medical University Union Hospital, Fuzhou, China.
¹⁰ Department of Interventional Radiology, First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
¹¹ Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
¹² Department of Interventional Radiology, The Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China.
¹³ Interventional Medical Center of the Affiliated Hospital of Qingdao University, Qingdao, China.
¹⁴ Department of Interventional Radiology, Peking University Cancer Hospital, Beijing, China.
¹⁵ Department of Interventional Radiology, Peking University Shenzhen Hospital, Shenzhen, China.
¹⁶ Department of Interventional Radiology, Shenzhen People's Hospital, Shenzhen, China.
¹⁷ Department of Health Statistics, Fourth Military Medical University, Xi'an, China.

Abstract

Introduction: Lenvatinib is the first-line treatment for advanced hepatocellular carcinoma (HCC). We aimed to compare the clinical outcomes of lenvatinib plus drug-eluting beads transarterial chemoembolization (DEB-TACE) versus lenvatinib alone in real-world practice.

Methods: This retrospective analysis included 142 consecutive patients who received lenvatinib plus DEB-TACE and 69 patients who received lenvatinib alone as first-line treatment from 15 Chinese academic centers from November 2018 to November 2019. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) were evaluated by modified Response Evaluation Criteria in Solid Tumors criteria, and safety profiles were compared between the two groups.

Results: The median OS and PFS were significantly longer in the combined therapy group than in the monotherapy group in whole cohort (median OS, 15.9 vs. 8.6 months, p = 0.0022; median PFS, 8.6 vs. 4.4 months, p < 0.001) and after propensity score matching analysis (median OS, 13.8 vs. 7.8 months, p = 0.03; median PFS, 7.8 vs. 4.5 months, p = 0.009). Moreover, the treatment option was an independent prognostic factor for OS and PFS with adjustment based upon baseline characteristics (adjusted hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.36-0.78, p = 0.001, and adjusted HR: 0.42, 95% CI: 0.30-0.60, p < 0.001, respectively) and propensity score (adjusted HR: 0.52, 95% CI: 0.36-0.76, p = 0.001, and adjusted HR: 0.46, 95% CI: 0.33-0.64, p < 0.001, respectively). Moreover, a greater ORR was observed in the combined group (ORR: 46.48% vs. 13.05%, p < 0.001). Furthermore, the most common adverse events (AEs) were elevated aspartate aminotransferase (54.9%) and fatigue (46.4%) in the lenvatinib plus DEB-TACE group and lenvatinib group, respectively. Most AEs were mild-to-moderate and manageable.

Conclusions: With well-tolerated safety, lenvatinib plus DEB-TACE was more effective than lenvatinib monotherapy in improving OS, PFS, and ORR. Thus, it may be a promising treatment for advanced HCC. Future prospective studies confirming these findings are warranted.

Keywords: Drug-eluting beads transarterial chemoembolization; Efficacy; Hepatocellular carcinoma; Lenvatinib; Safety.