Comparison of drug-eluting bead transarterial chemoembolization combined with apatinib versus drug-eluting bead transarterial chemoembolization for the treatment of unresectable hepatocellular carcinoma: a randomized, prospective, multicenter phase III trial

Comparison of drug-eluting bead transarterial chemoembolization combined with apatinib versus drug-eluting bead transarterial chemoembolization for the treatment of unresectable hepatocellular carcinoma: a randomized, prospective, multicenter phase III trial

This randomized, prospective, multicenter (12 centers in China) phase III trial (Chinese Clinical Trial Registry #ChiCTR2000041170) compared drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with apatinib and DEB-TACE monotherapy for patients with unresectable hepatocellular carc...

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Published in:Signal transduction and targeted therapy Vol. 9; no. 1; pp. 304 - 9
Main Authors: Duan, Xuhua, Li, Hao, Kuang, Donglin, Chen, Pengfei, Zhang, Mengfan, Li, Tengfei, Jiao, Dechao, Li, Yanliang, He, Xiang, Xing, Cheng, Wang, Haibo, Liu, Yaoxian, Xie, Limin, Zhang, Shixi, Zhang, Qiang, Zhu, Peixin, Chang, Yongchuang, Xie, Jichen, Ren, Jianzhuang, Han, Xinwei
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 13-11-2024
Nature Publishing Group
Subjects:
692/4028/67
692/699/67
Cancer Research
Cell Biology
Chemoembolization
Diarrhea
Disease control
Drug delivery
Hepatic artery
Hepatocellular carcinoma
Internal Medicine
Liver cancer
Medicine
Medicine & Public Health
Oncology
Pathology
Patients
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Summary:This randomized, prospective, multicenter (12 centers in China) phase III trial (Chinese Clinical Trial Registry #ChiCTR2000041170) compared drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with apatinib and DEB-TACE monotherapy for patients with unresectable hepatocellular carcinoma (uHCC). Progression-free survival (PFS) was the primary endpoint. Overall survival (OS), mRECIST-based objective response rates (ORR) and disease control rates (DCR), and treatment-related adverse events (TRAEs) were secondary endpoints. Totally 243 cases were randomized, with 122 and 121 in the DEB-TACE + apatinib and DEB-TACE groups, respectively. Cases administered DEB-TACE + apatinib displayed markedly improved median PFS (7.1 months [95%CI 6.6–8.3] vs. 5.2 months [95%CI 5.0–5.9]) and OS (23.3 months [95%CI 20.7–29.6] vs. 18.9 months [95%CI 17.9–20.1] compared with those treated with DEB-TACE (both p  < 0.001). Additionally, patients administered DEB-TACE + apatinib had elevated ORR (56.6% vs. 38.8%) and DCR (89.3% vs. 80.2%) versus the DEB-TACE group (both p  < 0.001). Majority of TRAEs were mild and manageable. Regarding DEB-TACE-related TRAEs, the rates of hepatic artery thinning and spasms were elevated during the second DEB-TACE in cases administered DEB-TACE + apatinib vs. DEB-TACE. The commonest apatinib-related TRAEs in the DEB-TACE + apatinib group included hypertension, hand-foot syndrome, fatigue, and diarrhea. In conclusion, DEB-TACE plus apatinib demonstrates superior PFS versus DEB-TACE monotherapy in uHCC cases, maintaining a favorable safety profile with similar occurrences of AEs.
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ISSN:2059-3635
2095-9907
2059-3635
DOI:10.1038/s41392-024-02012-x