In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 8503-8503
Abstract:
8503 Background: Hepatitis B reactivation is a serious complication in lymphoma patients treated with rituximab-contained chemotherapy despite lamivudine prophylaxis. The optimal prophylactic antiviral protocol is undetermined. This prospective study was designed to compare the efficacy of prophylactic entecavir and lamivudine in preventing hepatitis B reactivation in HbsAg-positive patients with untreated diffuse large B cell lymphoma (DLBCL) under R-CHOP treatment. Methods: HBsAg carriers with untreated DLBCL, normal liver function and low serum HBV DNA levels (less than 10 3 copys/ml)were randomized to receive entecavir or lamivudine during R-CHOP treatment and for 6 months after completion of chemotherapy. HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were performed prior to initiation of treatment. Serum alanine aminotransferase (ALT), and HBV-DNA levels were prospectively monitored before every cycle of chemo and every month after completion of chemotherapy. Results: Between February 2008 and December 2012, a total of 229 patients older than 18y with newly diagnosed DLBCL were included. The present analysis is based on 121 HBsAg-positive patients, including 61 patients randomly assigned to entecavir and 60 patients to lamivudine .The primary efficacy end point was the incidence of HBV-related hepatitis. The secondary end point was chemotherapy disruption due to hepatitis. Compared with the lamivadine group, the entecavir group had significantly lower rates of hepatitis(8.2% vs 23.3%,P=0.022), hepatitis B reactivation (0 vs 13.3%,P=0.003),HBV reactiviation(6.6% vs 30.0%,P=0.001), delayed HBV-related hepatitis (0 vs 8.3%,P=0.027) and disruption of chemotherapy (1.6% vs 18.3%,P=0.002). 7 of 8 patients with hepatitis B reactivation had advanced stage(III–IV) disease. Conclusions: In HBsAg-positive DLBCL patients undergoing R-CHOP chemotherapy, entecavir is more effective than lamivudine in preventing hepatitis B reactivation. For patients with advanced stage disease, entecavir should be considered the primary preventive therapy. Clinical trial information: CTR-TRC-11001687.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2013.31.15_suppl.8503
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2013
detail.hit.zdb_id:
2005181-5
