In pts < 60 yrs. old, therapy for advanced stage DLBCL remains in flux, with R-CHOP-21 the current standard of care. For pts with high-intermediate (HIR) or high risk (HR) disease based upon the international prognostic index (IPI), consolidation with high dose therapy (HDT) and ASCT is commonly administered. However, the results with this approach are controversial; there is little evidence that overall survival is improved compared to the use of HDT and ASCT in the relapsed setting. We initiated a risk-adapted phase II study for patients with clinical stage (CS) IIX, III and IV, DLBCL with 1–3 risk factors defined by the age-adjusted (aa) IPI. Induction therapy was 4 cycles of R-CHOP q14 days (Rituximab [R] 375 mg/m2-, cyclophosphamide 1000 mg/m2, doxorubicin 50 mg/m2 and un-capped vincristine at 1.4 mg/m2; an additional dose of R was given on day -3 of cycle 1). Interim restaging was performed after cycle 4 with CT scan and FDG-PET. Pts with a negative (neg) PET scan received non-cross resistant consolidation chemotherapy with ICE x 3 cycles (
Disclosures: Bristol Myers, Genentech.