Background:Theoptimalstrategyforadjuvanttherapyaftercurativeresectionforhepatocellularcarcinoma(HCC)patientswithsolitarytumorandmicrovascularinvasion(MVI)iscontroversial.Thistrialevaluatedtheefficacyandsafetyofadjuvanttranscatheterarterialchemoembolization(TACE)afterhepatectomyversushepatectomyaloneinHCCpatientswithasolitarytumor≥5cmandMVI.
背景：关于伴微血管侵犯(MVI)的单发性肝细胞癌(HCC)患者在根治术后辅助治疗的最佳方案一直存在争议。本试验旨在评估肝切除术后辅助经动脉化疗栓塞(TACE)与单纯肝切除术对直径≥5cm单发肿瘤伴MVI的HCC患者的疗效和安全性。
Methods:Inthisrandomized,open-labeled,phaseIIItrial,HCCpatientswithasolitarytumor≥5cmandMVIwererandomlyassigned(1:1)toreceiveeither1–2cyclesofadjuvantTACEafterhepatectomy(Hepatectomy-TACE)orhepatectomyalone(HepatectomyAlone).Theprimaryendpointwasdisease-freesurvival(DFS);thesecondaryendpointsincludedoverallsurvival(OS)andadverseevents.
方法：在本随机、开放性、Ⅲ期试验中，将直径≥5cm单发肿瘤伴MVI肝细胞癌患者随机分为两组(1：1)：在肝切除术后接受1-2个周期的辅助TACE治疗(肝切除-TACE组)或单纯接受肝切除(单纯肝切除组)。主要终点是无病生存期(DFS)，次要终点包括总生存期(OS)和不良事件。
Results:BetweenJune1,,andDecember31,,patientswereenrolledandrandomlyassignedtotheHepatectomy-TACEgroup(n=)ortheHepatectomyAlonegroup(n=).Clinicopathologicalcharacteristicswerebalancedbetweenthetwogroups.Themedianfollow-uptimefromrandomizationwas37.5months[interquartilerange18.3–48.2months].ThemedianDFSwassignificantlylongerintheHepatectomy-TACEgroupthanintheHepatectomyAlonegroup[17.45months(95%confidenceinterval[CI]11.99–29.14)vs.9.27months(95%CI6.05–13.70),hazardratio[HR]=0.70(95%CI0.52–0.95),P=0.],respectively.ThemedianOSwasalsosignificantlylongerintheHepatectomy-TACEgroupthanintheHepatectomyAlonegroup[44.29months(95%CI25.99–62.58)vs.22.37months(95%CI10.84–33.91),HR=0.68(95%CI0.48–0.97),P=0.].Treatment-relatedadverseeventsweremorefrequentlyobservedintheHepatectomy-TACEgroup,althoughtheseweregenerallymildandmanageable.Themost北京中科曝光郑华国