摘要
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 DEBTACE 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.
基金
supported by the National Natural Science Foundation of China(No.U2004119)
Major Science and Technology Projects in Henan Province(No.221100310100)
the Henan Province Medical Science and Technology Public Relations Plan Province Department joint construction project(No.SBGJ202102100).
