Long-Term Follow-Up Of A 10-Year Single-Center Experience With High-Dose Pharmacokinetics-Directed Intravenous Busulfan In Combination With Cyclophosphamide And Etoposide As Preparative Regimen For Intermediate- And High-Grade Non-Hodgkin Lymphoma.

e19521 Background: High dose chemotherapy followed by autologous hematopoietic stem cell transplantation (AHSCT) is indicated for patients with Non-Hodgkin Lymphoma (NHL) recurring after or resistant to primary therapy. Busulfan (Bu) based regimens are commonly used. At University of Alabama at Birmingham we have been using a regimen of the intravenous formulation of Bu (IVBu) since its FDA approval in April 1999. AHSCT patients have been treated with a regimen of pharmacokinetics directed (PK) Bu together with cyclophosphamide and etoposide (IVBuCyE). We here report the long term follow up of this experience. Methods: Between April 1999 and November 2009, 69 consecutive transplant eligible patients with intermediate or high risk NHL ranging in age from 19 to 74 with a median age of 54 were treated with a IVBu “test dose” of one 60 mg vial adjusting the remaining doses to achieve an exposure of 20,000 uMol-min total Bu AUC followed by Cy (2.5 g/m2) and E (1800 mg/m2). Results: The average hospital stay was 25 days. There were 2 patient deaths prior to hospital discharge (sepsis and heart failure) and 3 additional deaths within the 100 day post-transplant period*. At a minimum follow-up of 3 years the overall survival and disease free survival were 59% and 56%, respectively, for patients less than 54 years of age and 57% and 54%, respectively, for patients more than 54 years of age. The 100 day mortality, 1 year mortality, overall survival and relapse-free survival were similar in regardless of age (p value 0.5). Conclusions: PK directed Bu and CyE regimen followed by AHSCT resulted in 58% 3 year overall and disease free survival in intermediate or high risk NHL patients. Survival outcomes were similar regardless of patient age at the time of transplant. Diffuse large B-ell lymphoma (n=40) Follicular Llymphoma (n=15) Mantle cell lymphoma (n=14) 100-day mortality* 2 (5%) 2 (13%) 1 (7%) 100-day - 1-year mortality 8 (20%) 4 (26%) 1 (7%) 3-year overall survival 63% 47% 57% 3-year relapse-free survival 60% 46% 50% *Causes of 100-day mortality Intracranial hemorrhage, disease Heart failure, sepsis Sepsis