TY - JOUR
T1 - ROBUST
T2 - Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma
AU - Nowakowski, Grzegorz S.
AU - Chiappella, Annalisa
AU - Witzig, Thomas E.
AU - Spina, Michele
AU - Gascoyne, Randy D.
AU - Zhang, Lei
AU - Flament, Jocelyne
AU - Repici, Jacqueline
AU - Vitolo, Umberto
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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-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.
AB - 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-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.
KW - chemotherapy
KW - hematologic/lymphoma
KW - molecular oncology
UR - http://www.scopus.com/inward/record.url?scp=84975864667&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84975864667&partnerID=8YFLogxK
U2 - 10.2217/fon-2016-0130
DO - 10.2217/fon-2016-0130
M3 - Article
AN - SCOPUS:84975864667
VL - 12
SP - 1553
EP - 1563
JO - Future Oncology
JF - Future Oncology
SN - 1479-6694
IS - 13
ER -