Shinya Hagiwara, Shigeru Kusumoto, Ryunosuke Machida, Ken Ohmachi, Junya Makiyama, Wataru Munakata, Kiyoshi Ando, Tomohiro Kinoshita, Kunihiro Tsukasaki, Hirokazu Nagai, Dai Maruyama
The impact of resolved hepatitis B virus (HBV) infection, defined as pretreatment hepatitis B surface antigen (HBsAg) negativity with antibody to hepatitis B core antigen (anti-HBc) positivity, on the clinical characteristics and outcomes of diffuse large B-cell lymphoma (DLBCL) remains unclear. JCOG0601 was a randomized phase II/III trial showing no improvement in progression-free survival (PFS) with dose-dense rituximab plus CHOP in previously untreated DLBCL. This supplementary analysis of JCOG0601 evaluated whether baseline anti-HBc positivity affects PFS and overall survival (OS) in patients with HBsAg-negative DLBCL treated with rituximab-containing CHOP-based therapy. Among 406 eligible patients randomly assigned in JCOG0601, 405 with available baseline HBV serologic data were included. Baseline characteristics and outcomes were compared according to anti-HBc status. Of the 405 patients, 87 were anti-HBc-positive and 318 were anti-HBc-negative. Anti-HBc-positive patients were older than anti-HBc-negative patients (median age, 63 vs. 61 years; p = 0.008). No significant differences in PFS or OS were observed between the two groups (3-year PFS, 78% vs. 81%; 3-year OS, 90% vs. 90%). HBV reactivation occurred in five anti-HBc-positive patients. Baseline anti-HBc positivity was more common in older patients but was not associated with inferior outcomes in HBsAg-negative DLBCL treated with rituximab-containing CHOP-based therapy.Clinical trial registration: JCOG0601 was registered in the Japan Registry of Clinical Trials (jRCTs031180139, date of registration; February 20, 2019).