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Offner, Fritz,Samoilova, Olga,Osmanov, Evgenii,Eom, Hyeon-Seok,Topp, Max S.,Raposo, Joã,o,Pavlov, Viacheslav,Ricci, Deborah,Chaturvedi, Shalini,Zhu, Eugene,van de Velde, Helgi,Enny, Christopher American Society of Hematology 2015 Blood Vol.126 No.16
<P>This phase 2 study evaluated whether substituting bortezomib for vincristine in frontline rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy could improve efficacy in non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL), centrally confirmed by immunohistochemistry (Hans method). In total, 164 patients were randomized 1:1 to receive six 21-day cycles of rituximab 375 mg/m<SUP>2</SUP>, cyclophosphamide 750 mg/m<SUP>2</SUP>, and doxorubicin 50 mg/m<SUP>2</SUP>, all IV day 1, prednisone 100 mg/m<SUP>2</SUP> orally days 1-5, plus either bortezomib 1.3 mg/m<SUP>2</SUP> IV days 1, 4, 8, 11 (rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib [VR-CAP]; n = 84) or vincristine 1.4 mg/m<SUP>2</SUP> (maximum 2 mg) IV day 1 (R-CHOP; n = 80). There were no significant differences between VR-CAP and R-CHOP in complete response rate (64.5%, 66.2%; odds ratio [OR], 0.91; <I>P</I> = .80), overall response rate (93.4%, 98.6%; OR, 0.21; <I>P</I> = .11), progression-free survival (hazard ratio [HR], 1.12; <I>P</I> = .76), or overall survival (HR, 0.89; <I>P</I> = .75). Rates of grade ≥3 adverse events (AEs; 88%, 89%), serious AEs (38%, 34%), discontinuations due to AEs (7%, 3%), and deaths due to AEs (2%, 5%) were similar with VR-CAP and R-CHOP. Grade ≥3 peripheral neuropathy rates were 6% and 3%, respectively. VR-CAP did not improve efficacy vs R-CHOP in non-GCB DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT01040871.</P>