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This global phase III study showed that although both groups had very high response rates (total response rate of 91%), they did not reach the median total PFS.
This global phase III study showed that although both groups had very high response rates (total response rate of 91%), they did not reach the median total PFS.
Yesterday JCO released the results of lenalidomide+R-CHOP and placebo+R-CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL) activated B-cell-like (ABC) subtype.
Before random assignment and research treatment, the histology and cell types of origin were analyzed prospectively through central pathology.
Before random assignment and research treatment, the histology and cell types of origin were analyzed prospectively through central pathology.
A total of 570 ABC-DLBCL patients were stratified according to the international prognostic index score, age and mass disease, and were randomly divided into R2-CHOP group or placebo/R-CHOP group, with 285 cases in each group.
Overall, the median age of patients was 65 years (52% ≥ 65 years old and 2% ≥ 80 years old).
Overall, the median age of patients was 65 years (52% ≥ 65 years old and 2% ≥ 80 years old).
The 2-year PFS of R2-CHOP was 67%, and the placebo/R-CHOP was 64%.
The 2-year PFS of R2-CHOP was 67%, and the placebo/R-CHOP was 64%.
The total remission rate of both groups was 91%, and the complete remission rates of R2-CHOP and placebo/R-CHOP were 69% and 65%, respectively
The total remission rate of both groups was 91%, and the complete remission rates of R2-CHOP and placebo/R-CHOP were 69% and 65%, respectivelyThe safe population included 283 R2-CHOP and 284 placebo/R-CHOP patients.
The safe population included 283 R2-CHOP and 284 placebo/R-CHOP patients.
Compared with the placebo/R-CHOP group, the most common grade 3/4 adverse reactions in the R2-CHOP group were neutropenia (60%v 48%), anemia (22%v 14%), and thrombocytopenia Disease (17%v 11%) and leukopenia (14%v 15%).
Previous Phase II studies have shown that in the future, the addition of "standard rituximab + cyclophosphamide, doxorubicin, vincristine, and prednisone" (R-CHOP) to Nalidomide can improve the prognosis of ABC DLBCL.
Previous Phase II studies have shown that in the future, the addition of "standard rituximab + cyclophosphamide, doxorubicin, vincristine, and prednisone" (R-CHOP) to Nalidomide can improve the prognosis of ABC DLBCL.
ROBUST is the first DLBCL Phase III study that integrates biomarker-driven identification of ABC patients.
Grzegorz S.
Nowakowski, Annalisa Chiappella, Randy D.
Gascoyne, et al.
org/doi/abs/10.
1200/JCO.
20.
01366">ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma .
Journal of Clinical Oncology 0 0:0.
Published online February 23, 2021.
1200/JCO.
20.
01366">ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma in this message