title: Frontline rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib (VR-CAP) or vincristine (R-CHOP) for non-GCB DLBCL.
abstract: 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(2), cyclophosphamide 750 mg/m(2), and doxorubicin 50 mg/m(2), all IV day 1, prednisone 100 mg/m(2) orally days 1-5, plus either bortezomib 1.3 mg/m(2) IV days 1, 4, 8, 11 (rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib [VR-CAP]; n = 84) or vincristine 1.4 mg/m(2) (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; P = .80), overall response rate (93.4%, 98.6%; OR, 0.21; P = .11), progression-free survival (hazard ratio [HR], 1.12; P = .76), or overall survival (HR, 0.89; P = .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.
authors.affiliation: Department of Hematology, University Hospital Ghent, Ghent, Belgium;
authors.forename: Fritz
authors.initials: F
authors.lastname: Offner
authors.affiliation: Nizhniy Novgorod Region Clinical Hospital, Nizhniy Novgorod, Russian Federation;
authors.forename: Olga
authors.initials: O
authors.lastname: Samoilova
authors.affiliation: N.N. Blokhin Cancer Research Center, Russian Academy of National Sciences, Moscow, Russian Federation;
authors.forename: Evgenii
authors.initials: E
authors.lastname: Osmanov
authors.affiliation: National Cancer Center, Goyang Gyeonggi, Republic of Korea;
authors.forename: Hyeon-Seok
authors.initials: HS
authors.lastname: Eom
authors.affiliation: Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany;
authors.forename: Max S
authors.initials: MS
authors.lastname: Topp
authors.affiliation: Servicio de Hematologia, Santa Maria Hospital, Lisbon, Portugal;
authors.forename: João
authors.initials: J
authors.lastname: Raposo
authors.affiliation: Medical Scientific Radiology Center, Obninsk, Russian Federation;
authors.forename: Viacheslav
authors.initials: V
authors.lastname: Pavlov
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ;
authors.forename: Deborah
authors.initials: D
authors.lastname: Ricci
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA;
authors.forename: Shalini
authors.initials: S
authors.lastname: Chaturvedi
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ;
authors.forename: Eugene
authors.initials: E
authors.lastname: Zhu
authors.affiliation: Janssen Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium; and.
authors.forename: Helgi
authors.initials: H
authors.lastname: van de Velde
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ;
authors.forename: Christopher
authors.initials: C
authors.lastname: Enny
authors.affiliation: Janssen Research & Development, LLC, Raritan, NJ;
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Rizo
authors.affiliation: Department of Internal Medicine, Division of Hematology, Koc University, Istanbul, Turkey.
authors.forename: Burhan
authors.initials: B
authors.lastname: Ferhanoglu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000069286:Bortezomib / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D000069283:Rituximab / Q000008:administration & dosage; D015996:Survival Rate; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; C571759:R-CHOP protocol; D000069283:Rituximab; D014750:Vincristine; D000069286:Bortezomib; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone