Preliminary Report of a Multicenter Prospective Phase II Study of DA-EPOCH-R in MYC-Rearranged Aggressive B-Cell Lymphoma

Background: In diffuse large B-cell lymphoma (DLBCL), a MYC -rearrangement ( MYC -R) is present in approximately 10% of cases and has been associated with an inferior outcome following R-CHOP chemotherapy. In a previous report that retrospectively analyzed the prognostic impact of a MYC -R on survival following DA-EPOCH-R, patients with a MYC -R had a similar outcome to MYC negative cases (4 year EFS of 83% versus 76% respectively: p=0.46 Ann Oncol 2011 (22) Suppl 4 # 71). We set out to prospectively validate these results in a multicenter study. Methods: Patients were newly diagnosed with DLBCL or B-cell lymphoma unclassifiable (BCL-U) with features intermediate between DLBCL and Burkitt lymphoma (BL). Only cases that harbored a MYC translocation by fluorescent in-situ hybridization (FISH) or conventional cytogenetic testing were included in this report. Treatment consisted of 6 cycles of DA-EPOCH-R. R esults: 52 patients were included in this preliminary analysis. Characteristics were median (range) age 61 (29-80) years; male sex 37 (71%); stage III or IV disease 38 (73%); IPI score 0-2 in 35% versus 3-5 in 65%; HIV positive 4 (7%). Histologic diagnosis was DLBCL in 45 (86%) and BCL-U in 7 (14%). All cases had a MYC -rearrangement. BCL2 was rearranged in 14/31 (45%) and overexpressed by IHC in 24/43 (56%) cases tested. There were 3 deaths secondary to infectious complications and otherwise toxicities were similar to previous reports of the regimen. At a median follow-up time of 14 months, progression-free survival (PFS), time to progression (TTP) and overall survival (OS) were 79%, 86% and 77% respectively for all patients. PFS was 87% and 64% in cases that were FISH positive (double-hit) and IHC positive for BCL2 respectively. Conclusions: Albeit short follow-up, DA-EPOCH-R in MYC -R DLBCL demonstrates promising activity in a multicenter prospective setting. Further analysis of this data is planned with central pathology review of cases and longer follow-up. The principal arm of this study testing the regimen in BL remains open to accrual ([NCT01092182][1]). ![Figure 1][2] Figure 1 Disclosures LaCasce: Seattle Genetics, Inc.: Research Funding. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01092182&atom=%2Fbloodjournal%2F124%2F21%2F395.atom [2]: pending:yes