90Y Ibritumomab Tiuxetan (Zevalin) Combined With BEAM (Z -BEAM) Conditioning Regimen Plus Autologous Stem Cell Transplantation in Relapsed or Refractory Low-grade CD20-positive B-cell Lymphoma. A GELA Phase II Prospective Study

BackgroundThis study was designed to evaluate the safety and efficacy of a conventional dose of yttrium-90 (90Y) ibritumomab tiuxetan combined with the etoposide rabinoside acytarabine melphalan (BEAM) regimen before autologous stem cell transplantation (ASCT) in chemosensitive relapsed or refractory low-grade B-cell lymphomas.Patients and MethodsFrom March 2005 to August 2006, 77 prospective patients were included, 69 (90%) with follicular lymphomas.ResultsThe last salvage chemotherapy regimen included rituximab for 74 patients and ASCT for 75 patients. Before ASCT, rates of complete response/unconfirmed response (CR/CRu) and partial response were 77% and 23%, respectively. After zevaline-BEAM (Z-BEAM), time to >1 × 109/L neutrophils was 12 days (range, 9-35 days), and time to >20 × 109/L platelets was 12 days (range, 3-42 days). No other significant extrahematologic toxicity was observed. Three months after ASCT, 68 patients (88%) were in CR/CRu. After a median follow-up of 28 months, 2-year event-free survival (EFS) and overall survival were 63% and 97%, respectively, but EFS for first-relapsed patients was 72%. When using patients as their own controls, 2-year EFS was superior after ASCT and compared favorably with the duration of response of last chemotherapy (62% vs. 37%, P = .007) (Point 1.10).ConclusionZ-BEAM appears safe and needs to be further evaluated in a randomized trial.