REAL-TIME CELL-OF-ORIGIN SUBTYPE IDENTIFICATION BY GENE EXPRESSION PROFILE IN THE PHASE 3 ROBUST TRIAL OF LENALIDOMIDE + R-CHOP VS PLACEBO + R-CHOP IN PREVIOUSLY UNTREATED ABC-TYPE DLBCL
(Abstract release date: 05/19/16)
EHA Library. Vitolo U. 06/09/16; 132503; E954
Dr. Umberto Vitolo
Contributions
Contributions
Abstract
Abstract: E954
Type: Eposter Presentation
Background
Gene expression profiling (GEP) represents a gold standard in identifying patients with activated B-cell–like (ABC) DLBCL, a subtype associated with inferior outcomes. Until recently, real-time identification of patients with ABC DLBCL as an integrated biomarker and inclusion criterion was not feasible due to technology limitations. The randomized, double-blind, global phase 3 ROBUST study (NCT02285062) compares lenalidomide + R-CHOP (R2-CHOP) with placebo + R-CHOP in patients with previously untreated ABC-type DLBCL with participating sites in Asia, Australia, Europe, New Zealand, and North America.
Aims
Explore the real-world feasibility of GEP screening to determine DLBCL cell of origin (COO) in a global phase 3 study and quantify turnaround time and the percentage of screened patients having ABC-subtype DLBCL.
Methods
ROBUST methods have been described (Nowakowski, ASCO 2015). Patients must provide written informed consent. A key entry criterion is previously untreated, histologically confirmed ABC-type CD20+ DLBCL. Formalin-fixed paraffin-embedded excisional/surgical or core needle biopsy samples (Storhoff, Blood 2015) are analyzed by central pathology using the NanoString Lymphoma Subtyping Test (LST; Wallden, JCO 2015), based on the Lymph2Cx GEP assay (Scott, Blood 2014). Turnaround time is defined as number of days between central pathology sample receipt and results being provided to the study site.
Results
As of 11 Jan 2016, 357 patients were screened for ROBUST using the LST. Samples were analyzed in 2 central pathology labs in the US and UK. COO was ABC and non-ABC in 118 (33%) and 212 (59%), respectively. 27 patients (8%) had samples that could not be processed for technical reasons (incorrect/insufficient slides or blocks, or low tissue RNA concentration and/or purity). Mean turnaround time was 2.25 days (range, 0-9). 86 patients have met all inclusion criteria and were enrolled in ROBUST.
Conclusion
Real-time COO assessment is feasible in a multi-center, global phase 3 DLBCL study with short turnaround time. The percentage of patients with ABC-type DLBCL was similar to that reported in the literature. Our findings have important implications for the design and size estimation of both current and future studies in newly diagnosed DLBCL utilizing COO as a biomarker, promising a significant step forward in precision medicine. Updated results will be presented.
Session topic: E-poster
Keyword(s): Diffuse large B cell lymphoma, Gene expression profile, Lymphoma
Type: Eposter Presentation
Background
Gene expression profiling (GEP) represents a gold standard in identifying patients with activated B-cell–like (ABC) DLBCL, a subtype associated with inferior outcomes. Until recently, real-time identification of patients with ABC DLBCL as an integrated biomarker and inclusion criterion was not feasible due to technology limitations. The randomized, double-blind, global phase 3 ROBUST study (NCT02285062) compares lenalidomide + R-CHOP (R2-CHOP) with placebo + R-CHOP in patients with previously untreated ABC-type DLBCL with participating sites in Asia, Australia, Europe, New Zealand, and North America.
Aims
Explore the real-world feasibility of GEP screening to determine DLBCL cell of origin (COO) in a global phase 3 study and quantify turnaround time and the percentage of screened patients having ABC-subtype DLBCL.
Methods
ROBUST methods have been described (Nowakowski, ASCO 2015). Patients must provide written informed consent. A key entry criterion is previously untreated, histologically confirmed ABC-type CD20+ DLBCL. Formalin-fixed paraffin-embedded excisional/surgical or core needle biopsy samples (Storhoff, Blood 2015) are analyzed by central pathology using the NanoString Lymphoma Subtyping Test (LST; Wallden, JCO 2015), based on the Lymph2Cx GEP assay (Scott, Blood 2014). Turnaround time is defined as number of days between central pathology sample receipt and results being provided to the study site.
Results
As of 11 Jan 2016, 357 patients were screened for ROBUST using the LST. Samples were analyzed in 2 central pathology labs in the US and UK. COO was ABC and non-ABC in 118 (33%) and 212 (59%), respectively. 27 patients (8%) had samples that could not be processed for technical reasons (incorrect/insufficient slides or blocks, or low tissue RNA concentration and/or purity). Mean turnaround time was 2.25 days (range, 0-9). 86 patients have met all inclusion criteria and were enrolled in ROBUST.
Conclusion
Real-time COO assessment is feasible in a multi-center, global phase 3 DLBCL study with short turnaround time. The percentage of patients with ABC-type DLBCL was similar to that reported in the literature. Our findings have important implications for the design and size estimation of both current and future studies in newly diagnosed DLBCL utilizing COO as a biomarker, promising a significant step forward in precision medicine. Updated results will be presented.
Session topic: E-poster
Keyword(s): Diffuse large B cell lymphoma, Gene expression profile, Lymphoma
Abstract: E954
Type: Eposter Presentation
Background
Gene expression profiling (GEP) represents a gold standard in identifying patients with activated B-cell–like (ABC) DLBCL, a subtype associated with inferior outcomes. Until recently, real-time identification of patients with ABC DLBCL as an integrated biomarker and inclusion criterion was not feasible due to technology limitations. The randomized, double-blind, global phase 3 ROBUST study (NCT02285062) compares lenalidomide + R-CHOP (R2-CHOP) with placebo + R-CHOP in patients with previously untreated ABC-type DLBCL with participating sites in Asia, Australia, Europe, New Zealand, and North America.
Aims
Explore the real-world feasibility of GEP screening to determine DLBCL cell of origin (COO) in a global phase 3 study and quantify turnaround time and the percentage of screened patients having ABC-subtype DLBCL.
Methods
ROBUST methods have been described (Nowakowski, ASCO 2015). Patients must provide written informed consent. A key entry criterion is previously untreated, histologically confirmed ABC-type CD20+ DLBCL. Formalin-fixed paraffin-embedded excisional/surgical or core needle biopsy samples (Storhoff, Blood 2015) are analyzed by central pathology using the NanoString Lymphoma Subtyping Test (LST; Wallden, JCO 2015), based on the Lymph2Cx GEP assay (Scott, Blood 2014). Turnaround time is defined as number of days between central pathology sample receipt and results being provided to the study site.
Results
As of 11 Jan 2016, 357 patients were screened for ROBUST using the LST. Samples were analyzed in 2 central pathology labs in the US and UK. COO was ABC and non-ABC in 118 (33%) and 212 (59%), respectively. 27 patients (8%) had samples that could not be processed for technical reasons (incorrect/insufficient slides or blocks, or low tissue RNA concentration and/or purity). Mean turnaround time was 2.25 days (range, 0-9). 86 patients have met all inclusion criteria and were enrolled in ROBUST.
Conclusion
Real-time COO assessment is feasible in a multi-center, global phase 3 DLBCL study with short turnaround time. The percentage of patients with ABC-type DLBCL was similar to that reported in the literature. Our findings have important implications for the design and size estimation of both current and future studies in newly diagnosed DLBCL utilizing COO as a biomarker, promising a significant step forward in precision medicine. Updated results will be presented.
Session topic: E-poster
Keyword(s): Diffuse large B cell lymphoma, Gene expression profile, Lymphoma
Type: Eposter Presentation
Background
Gene expression profiling (GEP) represents a gold standard in identifying patients with activated B-cell–like (ABC) DLBCL, a subtype associated with inferior outcomes. Until recently, real-time identification of patients with ABC DLBCL as an integrated biomarker and inclusion criterion was not feasible due to technology limitations. The randomized, double-blind, global phase 3 ROBUST study (NCT02285062) compares lenalidomide + R-CHOP (R2-CHOP) with placebo + R-CHOP in patients with previously untreated ABC-type DLBCL with participating sites in Asia, Australia, Europe, New Zealand, and North America.
Aims
Explore the real-world feasibility of GEP screening to determine DLBCL cell of origin (COO) in a global phase 3 study and quantify turnaround time and the percentage of screened patients having ABC-subtype DLBCL.
Methods
ROBUST methods have been described (Nowakowski, ASCO 2015). Patients must provide written informed consent. A key entry criterion is previously untreated, histologically confirmed ABC-type CD20+ DLBCL. Formalin-fixed paraffin-embedded excisional/surgical or core needle biopsy samples (Storhoff, Blood 2015) are analyzed by central pathology using the NanoString Lymphoma Subtyping Test (LST; Wallden, JCO 2015), based on the Lymph2Cx GEP assay (Scott, Blood 2014). Turnaround time is defined as number of days between central pathology sample receipt and results being provided to the study site.
Results
As of 11 Jan 2016, 357 patients were screened for ROBUST using the LST. Samples were analyzed in 2 central pathology labs in the US and UK. COO was ABC and non-ABC in 118 (33%) and 212 (59%), respectively. 27 patients (8%) had samples that could not be processed for technical reasons (incorrect/insufficient slides or blocks, or low tissue RNA concentration and/or purity). Mean turnaround time was 2.25 days (range, 0-9). 86 patients have met all inclusion criteria and were enrolled in ROBUST.
Conclusion
Real-time COO assessment is feasible in a multi-center, global phase 3 DLBCL study with short turnaround time. The percentage of patients with ABC-type DLBCL was similar to that reported in the literature. Our findings have important implications for the design and size estimation of both current and future studies in newly diagnosed DLBCL utilizing COO as a biomarker, promising a significant step forward in precision medicine. Updated results will be presented.
Session topic: E-poster
Keyword(s): Diffuse large B cell lymphoma, Gene expression profile, Lymphoma
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