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http://ir.nhri.org.tw/handle/3990099045/9215
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| Title: | Randomized, phase III trial of adjuvant adeforvir vs. therapeutic lamivudine in post-operative BCLC stage 0 or A HBV-related HCC: The Taiwan Cooperative Oncology Group T1206 study |
| Authors: | Chen, LT;Jeng, LB;Hsiao, CF;Wu, CC;Lee, WC;Wang, TE;Lee, PH;Chen, CL;Chen, IS;Lee, KT;Hsieh, CB;Hwang, WS;Yang, MD;Yang, YS;Lin, DY;Chen, MF;Chen, PJ;Taiwan Cooperative Oncology, G |
| Contributors: | National Institute of Cancer Research;Division of Clinical Trial Statistics |
| Abstract: | Background: To investigate the role of adjuvant anti-viral nucleoside in tertiary prevention of HCC relapse in post-operative BCLC stage 0 or A HBV-related HCC. Methods: Patients with curative resection of BCLC stage 0 or A and solitary tumor < 5 cm, HBV-related (HbsAg+/anti-HCV-) HCC were eligible. Accruals were stratified by HBV genotype (C vs. non-C) and serum viral titer ( < 20,000 vs. > 20,000 IU/mL) and randomly assigned to receive either 3 years of adeforvir treatment from study entry or observation alone, in which 18 months of lamivudine would be given when their HBV DNA titer > 20,000 IU/mL and ALT > 2.0 x UNL. The primary endpoint was late RFS. Results: Between April 2007 and August 2010 (early terminated because lamivudine was no longer the standard care for chronic HBV infection), a total of 117 patients were enrolled. The demographic characteristics were well-balanced between adefovir (N = 58) and control (N = 59) arms. At a median follow-up of 57.9 months, 53 (45.3%) had recurrence and 17 (14.5%) were deceased. The cumulative 5-year FRS and OS rates of ITT cohort were 52.6% and 86.4%, respectively. The median RFS were not reached yet in adefovir arm and 6.4 years in control arm; while the 5-year RFS rate in corresponding arm was 53.8% (95% confidence interval [CI], 38.8% to 66.6%) and 51.6% (95% CI, 37.4% to 64.0%), respectively (P = 0.692, log-rank test). In Cox’s regression univariate analysis, only baseline HBeAg and HBV DNA titer significantly affected RFS, with a HR of 2.988 (95% CI: 1.489 - 5.994, p = 0.0021) and 1.916 (95% CI: 1.083 - 3.388, p = 0.0255), respectively. Late RFS in those with RFS > 2 years was also similar between two study arms. Conclusions: Despite earlier trials showed adjuvant anti-HBV nucleoside (vs. no treament) can significantly improve the RFS and OS in post-operative HBV-related HCC (JCO 2013 and Ann Surg 2015). In current study, 3 years of adjuvant adeforvir did not reduce the postoperative recurrence as well as late recurrence of HBV-related HCC as compared to observation followed by lamivudine when their HBV DNA titer > 20,000 IU/mL and ALT > 2.0 x UNL. |
| Date: | 2015-05 |
| Relation: | Journal of Clinical Oncology. 2015 May;33(15, Suppl.):4101. |
| Link to: | http://meeting.ascopubs.org/cgi/content/abstract/33/15_suppl/4101 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0732-183X&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000358036900939 |
| Appears in Collections: | [陳立宗] 會議論文/會議摘要
[蕭金福] 會議論文/會議摘要
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| ISI000358036900939.pdf | | 57Kb | Adobe PDF | 617 | View/Open |
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