Outcomes in refractory aggressive diffuse large b-cell lymphoma (DLBCL): Results from the international SCHOLAR-1 study.

7516 Background: Patients with relapsed/refractory DLBCL have heterogeneous outcomes to subsequent therapy. The subgroup of these patients with refractory disease (r-DLBCL) have a worse prognosis. A multi-cohort study, SCHOLAR-1 (Retrospective Non-Hodgkin Lymphoma Research) was performed to evaluate outcomes for patients with r-DLBCL and serve as a benchmark for future clinical trials in this population. Methods: Eligible subjects had r-DLBCL defined as progressive disease (PD) or stable disease (SD) as best response to chemotherapy (duration of SD <12 mos and at least 4 cycles of first-line or 2 cycles of later line therapy) or relapse ≤12 mos of ASCT. Patients must have received an anti-CD20 monoclonal antibody (unless CD20-) and an anthracycline as one of their prior regimens. Data from 2 phase 3 studies (LYSARC-CORAL and Canadian Cancer Trials Group-LY.12), and 2 observational cohorts (MD Anderson Cancer Center (MDACC), and Mayo Clinic / University of Iowa (MC/IA) Specialized Program of Research Excellence) were integrated. Response rate (RR) and overall survival (OS) were estimated from start of salvage therapy. Results: Data for 861 patients with DLBCL were available for analysis and 597 patients with r-DLBCL were identified, with subgroups and outcomes shown in the table. An integrated analysis of outcomes will be presented. Conclusions: In this large multi-center dataset, patients with r-DLBCL have homogenous outcomes with a response rate of 20%-30% and median overall survival of approximately 6 mos. This consistently poor outcome represents a significant unmet medical need. MDACC (n=152) MC / IA (n =84) CCTG LY.12 (n=190) CORAL (n=171) Median agea (range) 55 (20, 79) 61 (20, 84) 54 (25, 68) 54 (19, 65) RR (%) 19 23 24 36 CR 7 8 2 18 PR 13 14 23 18 RR by subgroup (%) Primary refractory (n=142) NA 28 24 NA Refractory to > 2nd line therapy (n=306) 19 26 NA 36 Relapse < 1 year post ASCT (n=149) 21 11 NA 35 Median OS (Q1, Q3) - mos 6.9 (5.8, 8.2) 4.6 (3.9, 5.8) 6.8 (5.8, 8.2) 6.7 (5.6, 8.8) aCORAL included subjects 18 – 65, Ly.12 studies included subjects ≥ 16; subjects > 65 were not recommended for inclusion. NA – due to study design.