Abstract
8016 Background: The combination of rituximab plus CHOP chemotherapy (R-CHOP) is widely used as standard of care for DLBCL; however, long-term survival is low in patients (pts) with high (IPI) risk scores. Enzastaurin (ENZ) targets protein kinase C-β (PKCβ), an enzyme correlated with poor pt outcomes in DLBCL. In this trial, we compared the results of first-line treatment with R-CHOP + ENZ to standard R-CHOP. Methods: DLBCL pts were required to have intermediate or high-risk IPI scores (2-5). Pts were randomized (3:2 ratio) to receive six 21-day cycles of either R-CHOP plus ENZ therapy (Arm A) or R-CHOP alone (Arm B). After 6 cycles, responders in Arm A could continue single agent ENZ. An 1125 mg oral loading dose of ENZ was given on Day 2 followed by 500 mg ENZ daily. Response was evaluated (IWG criteria, 1999) q8 weeks. The primary endpoint was progression-free survival (PFS). Randomization of 100 pts allowed detection of an improvement in the PFS at 2 years from 65% (R-CHOP) to 80% with R-CHOP + ENZ (8...
Published Version
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