OBJECTIVE: This study was aimed at evaluating the effects of interferon (IFN)-alpha on survival rateafter resection of hepatocellular carcinoma. METHODS: In a randomized, controlled trial by the University Hospital, Medical Center and affiliated hospital in Osaka, Japan, 30 men were after surgery randomly allocated to anIFN-alpha group (15 patients) and to a control group. Patients in the IFN group received 6 MIU of IFN-alpha intramuscularly daily for 2 weeks, then three times a week for 14 weeks, and finally twice a week for 88 weeks. The incidence of recurrence and survival rate were then studied. RESULTS: The response to IFN was sustained viral response (SVR) in 2 patients, biochemical response (BR) in 6, partial response (PR) in 5, and no response (NR) in 2. In the control, 8 of the 15 patients demonstrated continuous abnormally high levels of ALT. At the end point of the study, intrahepatic recurrence was detected in 9 of the IFN group and in 13 of the control (p = 0.065, log-rank test). The cumulative survival rate was higher in the IFN group than in the controls (p = 0.041). CONCLUSION:Postoperative IFN therapy improves the outcome after resection of hepatitis C virus-related hepatocellular carcinoma.
RCT Entities:
OBJECTIVE: This study was aimed at evaluating the effects of interferon (IFN)-alpha on survival rate after resection of hepatocellular carcinoma. METHODS: In a randomized, controlled trial by the University Hospital, Medical Center and affiliated hospital in Osaka, Japan, 30 men were after surgery randomly allocated to an IFN-alpha group (15 patients) and to a control group. Patients in the IFN group received 6 MIU of IFN-alpha intramuscularly daily for 2 weeks, then three times a week for 14 weeks, and finally twice a week for 88 weeks. The incidence of recurrence and survival rate were then studied. RESULTS: The response to IFN was sustained viral response (SVR) in 2 patients, biochemical response (BR) in 6, partial response (PR) in 5, and no response (NR) in 2. In the control, 8 of the 15 patients demonstrated continuous abnormally high levels of ALT. At the end point of the study, intrahepatic recurrence was detected in 9 of the IFN group and in 13 of the control (p = 0.065, log-rank test). The cumulative survival rate was higher in the IFN group than in the controls (p = 0.041). CONCLUSION: Postoperative IFN therapy improves the outcome after resection of hepatitis C virus-related hepatocellular carcinoma.
Authors: Masao Omata; Laurentius A Lesmana; Ryosuke Tateishi; Pei-Jer Chen; Shi-Ming Lin; Haruhiko Yoshida; Masatoshi Kudo; Jeong Min Lee; Byung Ihn Choi; Ronnie T P Poon; Shuichiro Shiina; Ann Lii Cheng; Ji-Dong Jia; Shuntaro Obi; Kwang Hyub Han; Wasim Jafri; Pierce Chow; Seng Gee Lim; Yogesh K Chawla; Unggul Budihusodo; Rino A Gani; C Rinaldi Lesmana; Terawan Agus Putranto; Yun Fan Liaw; Shiv Kumar Sarin Journal: Hepatol Int Date: 2010-03-18 Impact factor: 6.047