Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial.
OBJECTIVE
Recurrence after resection of hepatocellular carcinoma (HCC) is a frequent event. This study evaluated the effect of postoperative interferon alpha (IFN alpha) treatment on recurrence and survival in patients with hepatitis B virus (HBV)-related HCC.


METHODS
Two hundred and thirty six patients were randomized after resection into IFN alpha treatment (5 micro i.m. tiw for 18 months) and control groups. Treatment was terminated if recurrence was diagnosed, and recurrence was managed the same way in both groups. Statistical analysis was based on the method of intent-to-treat.


RESULTS
The two groups were comparable in all clinicopathological parameters. The median overall survival was 63.8 months in the treatment group and 38.8 months in the control group (P=0.0003); the median disease-free survival period was 31.2 versus 17.7 months (P=0.142). Fever, leucocytopenia, and thrombocytopenia were adverse effects in the treatment group, but were mostly manageable.


CONCLUSIONS
IFN alpha treatment improved the overall survival of patients with HBV-related HCC after curative resection, probably by postponing recurrence.
Sun
Hui-Chuan
HC
Liver Cancer Institute and Zhong Shan Hospital, Fudan University, 136 Yi Xue Yuan Road, 200032, Shanghai, People's Republic of China.
Tang
Zhao-You
ZY
Wang
Lu
L
Qin
Lun-Xiu
LX
Ma
Zeng-Chen
ZC
Ye
Qin-Hai
QH
Zhang
Bo-Heng
BH
Qian
Yong-Bin
YB
Wu
Zhi-Quan
ZQ
Fan
Jia
J
Zhou
Xin-Da
XD
Zhou
Jian
J
Qiu
Shuang-Jian
SJ
Shen
Yue-Fang
YF
D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery / Q000821:virology; D005260:Female; D006498:Hepatectomy; D006515:Hepatitis B virus / Q000302:isolation & purification*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery / Q000821:virology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D016019:Survival Analysis; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D000998:Antiviral Agents; D016898:Interferon-alpha