Diagnosis of DLBCL was confirmed centrally by an expert hematopathologist (L.R.). The cell of origin designation was determined by the Hans algorithm, using antibodies for CD10, BCL6, and MUM1.14 (link) MYC and BCL2 expression was evaluated by immunohistochemistry, using cutoffs of 40% and 50%, respectively.
Translational goals of the study included assessing correlation of the following factors with PFS or OS: 1) Pre-treatment histone acetylation status and MHCII expression on the tumor cells; 2) pre-treatment percentage of CD8+ tumor infiltrating lymphocytes (TIL) and other lymphocyte subsets; and 3) baseline or changes in serum cytokine levels.
Since S0806 did not have a randomized control arm, accessible tissues from patients who participated in SWOG S0433 trial were obtained to compare the impact of translational endpoints on S0806 to that in non-HDACI-containing standard therapy. S0433 sequentially administered R-CHOP × 6, CHOP × 2 and then iodine-131 tositumomab to patients with newly diagnosed advanced stage DLBCL, with outcomes similar to those obtained with R-CHOP.15 (link)
Translational goals of the study included assessing correlation of the following factors with PFS or OS: 1) Pre-treatment histone acetylation status and MHCII expression on the tumor cells; 2) pre-treatment percentage of CD8+ tumor infiltrating lymphocytes (TIL) and other lymphocyte subsets; and 3) baseline or changes in serum cytokine levels.
Since S0806 did not have a randomized control arm, accessible tissues from patients who participated in SWOG S0433 trial were obtained to compare the impact of translational endpoints on S0806 to that in non-HDACI-containing standard therapy. S0433 sequentially administered R-CHOP × 6, CHOP × 2 and then iodine-131 tositumomab to patients with newly diagnosed advanced stage DLBCL, with outcomes similar to those obtained with R-CHOP.15 (link)
