Durable remissions from fludarabine followed by the iodine I-131 tositumomab Bexxar therapeutic regimen for patients with previously untreated follicular non-Hodgkin's lymphoma (NHL)

6518 Background: The sequential combination of chemotherapy and radioimmunotherapy offers a novel strategy for the initial management of NHL. Tositumomab and iodine I 131 tositumomab (Bexxar) have been demonstrated to have substantial clinical activity in both untreated and relapsed/refractory low-grade NHL. Fludarabine synergizes in vitro with unlabeled and radiolabeled antibodies and can be employed as a “debulking” agent prior to radioimmunotherapy. Methods: Patients with previously untreated, advanced low-grade NHL were treated with IV fludarabine 25 mg/m2/day for 5 days, every 5 wks for 3 cycles followed in 6 to 8 wks by Bexxar therapy. Results: Between August 1998 and June 1999, 38 pts (51% follicular mixed, 49% follicular small cleaved) were enrolled and 97% had stage III/IV disease. Thirty-five subjects received both fludarabine and Bexxar therapy. Three patients came off study before or during fludarabine therapy (one due to cytopenias, 2 unrelated to toxicity or lymphoma progression). Response t...