A randomized controlled study of preemptive lamivudine in patients receiving transarterial chemo-lipiodolization.
Reactivation of hepatitis B virus (HBV) during chemotherapy is well documented. However, there are limited data on this complication in patients with hepatocellular carcinoma (HCC) undergoing transarterial chemotherapy. The aim of this study was to evaluate the efficacy of preemptive lamivudine therapy in reducing hepatitis due to HBV reactivation in patients with HCC undergoing transarterial chemo-lipiodolization (TACL) and to seek predictors of this event. A total of 73 consecutive HCC patients undergoing TACL using epirubicin 50 mg/m2 and cisplatin 60 mg/m2 at monthly intervals were prospectively and randomly assigned to receive lamivudine 100 mg daily from the start of TACL (preemptive group) or not (control group). During the study, 11 (29.7%) of 37 patients in the control group and 1 (2.8%) of 36 patients in the preemptive group developed hepatitis due to HBV reactivation (P = .002). In addition, there were significantly more incidences of overall hepatitis (P = .021) and severe grade of hepatitis (P = .035) in the control group. With multivariate Cox regression model, a baseline HBV DNA level of more than 10(4) copies/mL was the only independent predictor of hepatitis due to HBV reactivation during chemo-lipiodolization (P = .046). In conclusion, preemptive lamivudine therapy demonstrated excellent efficacy in reducing hepatitis due to HBV reactivation and hepatic morbidity during TACL. Preemptive therapy should be considered in HCC patients with an HBV DNA level of more than 10(4) copies/mL. Further studies are needed to confirm the value of this approach in patients with low-level viremia.
Jang
Jeong Won
JW
Department of Internal Medicine, College of Medicine, WHO Collaborating Center on Viral Hepatitis, The Catholic University of Korea, Seoul, Korea.
Choi
Jong Young
JY
Bae
Si Hyun
SH
Yoon
Seung Kew
SK
Chang
U Im
UI
Kim
Chang Wook
CW
Cho
Se Hyun
SH
Han
Jun Yeol
JY
Lee
Young Sok
YS
D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects*; D006528:Carcinoma, Hepatocellular / Q000150:complications* / Q000628:therapy / Q000821:virology; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects*; D004279:DNA, Viral / Q000097:blood; D005260:Female; D019694:Hepatitis B, Chronic / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000150:complications* / Q000628:therapy / Q000821:virology; D008297:Male; D008875:Middle Aged; D055502:Secondary Prevention; D016896:Treatment Outcome; D019562:Viral Load; D014775:Virus Activation / Q000187:drug effects
D000970:Antineoplastic Agents; D004279:DNA, Viral; D019259:Lamivudine