Background: R-HCVAD (rituximab-cyclphosphamide, vincristine, dexamethasone, doxorubicin) alternating with R-MTX-ARAC (rituximab, methotrexate-cytarabine) is a chemoimmunotherapy regimen with activity in ALL, mantle cell, and Burkitt’s lymphomas. Histological differentiation between BL. atypical BL, and DLBCL with high-grade features can be difficult. We treated patients with DLBCL with high-grade histological features, and/or poor-risk IPI. Patients who received at least one dose of R-HCVAD were included in this cohort.

Methods: Twenty-seven consecutive patients younger than 60 years, with information collected prospectively in the NCCN database, treated between 7/2002 and 10/05 at M.D. Anderson Cancer Center, 17 (63%) male, 15 (55%) HI and High IPI, 17 (63%) ↑LDH, 14 (52%) with Stage III/IV, 2 (5%) with PS>1, 60% had a Ki-67 higher than 80%.

Results: ORR was of 100% with (95%) CR/CRu. With a median follow-up of 26 months, 2 patients failed: One died of disease, and another received a SCT when the patient was in PR. Four patients have died, three of disease, one of pulmonary embolism. The 3-year OS is 96% (95% CI 77%–100%); 3-year FFS is 86% (95% CI 64%–100%). The 3-year FFS for patients with L/LI risk (2-failures of 12 pts) was 69% and for patients with HI/H age-adjusted IPI (0 failures of 15 pts) 100%.

Conclusions: R-HCVAD/R-MTC-ARAC is a very active regimen for DLBCL. Toxicity was mostly hematological and infectious. We are currently doing a prospective randomized phase II study comparing this regimen to standard R-CHOP in poor risk younger patients.

Disclosure:Research Funding: Genentech. Membership Information: Biogen Idec & Genentech

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