國家衛生研究院 NHRI:Item 3990099045/6139
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    題名: Long-term results of a randomized, observation-controlled, phase III trial of adjuvant Interferon alfa-2b in hepatocellular carcinoma after curative resection
    作者: Chen, LT;Chen, MF;Li, LA;Lee, PH;Jeng, LB;Lin, DY;Wu, CC;Mok, KT;Chen, CL;Lee, WC;Chau, GY;Chen, YS;Lui, WY;Hsiao, CF;Whang-Peng, J;Chen, PJ
    貢獻者: National Institute of Cancer Research;Division of Clinical Trial Statistics
    摘要: OBJECTIVE:: To investigate the clinical efficacy of adjuvant interferon alfa-2b (IFNalpha-2b) therapy on recurrence-free survival (RFS) of patients with postoperative viral hepatitis-related hepatocellular carcinoma (HCC). BACKGROUND:: Despite most individual trials have failed to meet their primary endpoint, recent pooled-data meta-analyses suggest that adjuvant IFN therapy may significantly reduce the incidence of recurrence in curatively ablated HCC. METHODS:: Patients with curative resection of viral hepatitis-related HCC were eligible, and were stratified by underlying viral etiology and randomly allocated to receive either 53 weeks of adjuvant IFNalpha-2b treatment or observation alone. The primary endpoint of this study was RFS. RESULTS:: A total of 268 patients were enrolled with 133 in the IFNalpha-2b arm and 135 in the control arm. Eighty percent of them were hepatitis B surface antigen seropositive. At a median follow-up of 63.8 months, 154 (57.5%) patients had tumor recurrence and 84 (31.3%) were deceased. The cumulative 5-year recurrence-free and overall survival rates of intent-to-treat cohort were 44.2% and 73.9%, respectively. The median RFS in the IFNalpha-2b and control arms were 42.2 (95% confidence interval [CI], 28.1-87.1) and 48.6 (95% CI, 25.5 to infinity) months, respectively (P = 0.828, log-rank test). Adjuvant IFNalpha-2b treatment was associated with a significantly higher incidence of leucopenia and thrombocytopenia. Thirty-four (24.8%) of treated patients required dose reduction, and 5 (3.8%) of these patients subsequently withdrew from therapy because of excessive toxicity. Adjuvant IFNalpha-2b only temporarily suppressed viral replication during treatment period. CONCLUSIONS: In this study, adjuvant IFNalpha-2b did not reduce the postoperative recurrence of viral hepatitis-related HCC. More potent antiviral therapy deserves to be explored for this patient population. This study is registered at ClinicalTrials.gov and carries the identifier NCT00149565.
    日期: 2012-01
    關聯: Annals of Surgery. 2012 Jan;255(1):8-17.
    Link to: http://dx.doi.org/10.1097/SLA.0b013e3182363ff9
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0003-4932&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000298638900003
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84984555585
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