ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma

Grzegorz S. Nowakowski; Annalisa Chiappella; Thomas E. Witzig; Michele Spina; Randy D. Gascoyne; Lei Zhang; Jocelyne Flament; Jacqueline Repici; Umberto Vitolo

doi:10.2217/fon-2016-0130

ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma

Grzegorz S. Nowakowski, Annalisa Chiappella, Thomas E. Witzig, Michele Spina, Randy D. Gascoyne, Lei Zhang, Jocelyne Flament, Jacqueline Repici, Umberto Vitolo

Hematology

Research output: Contribution to journal › Article › peer-review

56 Scopus citations

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-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.

Original language	English (US)
Pages (from-to)	1553-1563
Number of pages	11
Journal	Future Oncology
Volume	12
Issue number	13
DOIs	https://doi.org/10.2217/fon-2016-0130
State	Published - Jul 2016

Keywords

chemotherapy
hematologic/lymphoma
molecular oncology

ASJC Scopus subject areas

Oncology
Cancer Research

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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-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.",

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author = "Nowakowski, {Grzegorz S.} and Annalisa Chiappella and Witzig, {Thomas E.} and Michele Spina and Gascoyne, {Randy D.} and Lei Zhang and Jocelyne Flament and Jacqueline Repici and Umberto Vitolo",

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year = "2016",

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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

N1 - Publisher Copyright: © Grzegorz S Nowakowski.

PY - 2016/7

Y1 - 2016/7

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.

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KW - hematologic/lymphoma

KW - molecular oncology

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ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma

Abstract

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