title: ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma.
abstract: Activated B-cell-like (ABC) diffuse large B-cell lymphoma (DLBCL), the major constituent of nongerminal center B-cell-like (non-GCB) DLBCL, is associated with poorer survival outcomes than GCB-type DLBCL. In Phase II studies, lenalidomide combined with R-CHOP (R(2)-CHOP) improved outcomes relative to historical R-CHOP in newly diagnosed DLBCL, particularly in non-GCB cases. ROBUST (CC-5013-DLC-002) is a randomized, double-blind, global, Phase III study of oral lenalidomide (15 mg, days 1-14) plus R-CHOP21 × 6 versus placebo-R-CHOP21 × 6 in patients with previously untreated ABC-type DLBCL. Subtyping is done within 3 calendar days by central laboratory gene-expression profiling of formalin-fixed paraffin-embedded biopsy tissue. The primary end point is progression-free survival. Secondary end points include response rates, overall survival and health-related quality of life.
authors.affiliation: Division of Hematology, Mayo Clinic, Rochester, MN 55902, USA.
authors.forename: Grzegorz S
authors.initials: GS
authors.lastname: Nowakowski
authors.affiliation: Division of Hematology, Città della Salute e della Scienza Hospital & University, Torino, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Chiappella
authors.affiliation: Division of Hematology, Mayo Clinic, Rochester, MN 55902, USA.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
authors.affiliation: Division of Medical Oncology, National Cancer Institute, Aviano, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Spina
authors.affiliation: Department of Pathology & Lymphoid Cancer Research, BC Cancer Agency & BC Cancer Research Centre, Vancouver, BC, Canada.
authors.forename: Randy D
authors.initials: RD
authors.lastname: Gascoyne
authors.affiliation: Celgene Corporation, Summit, NJ 07901, USA.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Celgene Corporation, Summit, NJ 07901, USA.
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Flament
authors.affiliation: Celgene Corporation, Summit, NJ 07901, USA.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Repici
authors.affiliation: Division of Hematology, Città della Salute e della Scienza Hospital & University, Torino, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
mesh_terms: D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004311:Double-Blind Method; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy*; D008297:Male; D011241:Prednisone / Q000008:administration & dosage; D012107:Research Design; D000069283:Rituximab; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives*; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; C571759:R-CHOP protocol; D000069283:Rituximab; D013792:Thalidomide; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000077269:Lenalidomide; D011241:Prednisone
keywords: chemotherapy; hematologic/lymphoma; molecular oncology