Fludarabine, cyclophosphamide, and rituximab for the treatment of patients with chronic lymphocytic leukemia or indolent non‐hodgkin lymphoma

BACKGROUND The combination of fludarabine, cyclophosphamide, and rituximab (FC‐R) shows significant in vitro synergism and may improve patient outcome with little overlapping toxicity. METHODS Between December 2000 and June 2005, 77 patients completed therapy after a median of 4 cycles of FC‐R (fludarabine at a dose of 25 mg/m2 intravenously [i.v.] on Days 1–3, cyclophosphamide at a dose of 250 mg/m2 i.v. on Days 1–3, and rituximab at a dose of 375 mg/m2 on Day 1). The median age of the patients was 59 years, 65% were male; 31% had previously untreated disease; and 44% had chronic lymphocytic leukemia (CLL), 29% had follicular lymphoma, and 27% other indolent lymphoid malignancies. In addition to standard disease response criteria, patients underwent evaluation using flow cytometric and/or molecular studies. RESULTS Objective responses (OR) and complete responses (CR) were observed in 83% and 42%, respectively, of evaluable patients (n = 76), respectively. For patients with CLL, the respective OR and CR rates were 100% and 67% as firstline therapy, and 95% and 14% as salvage therapy. For patients with follicular lymphoma, the respective OR and CR rates were 100% and 86% as firstline therapy, and 87% and 67% as salvage therapy. Responders who had no detectable disease on flow cytometric and/or molecular studies experienced prolonged remissions with no recurrences reported at a median 25 months of follow‐up. Peripheral stem cell collection using stem cell factor plus granulocyte–colony‐stimulating factor was successful in 10 of 13 patients who underwent mobilization (77%). CONCLUSIONS FC‐R is highly active as initial or salvage therapy in patients with CLL or indolent non‐Hodgkin lymphoma. Collection of autologous stem cells during molecular remission is feasible and may facilitate future exploration of high‐dose therapy in these patients. Cancer 2006. © 2006 American Cancer Society. In an observational series of 77 consecutive patients with indolent lymphoid diseases receiving chemoimmunotherapy with fludarabine and cyclophosphamide (FC) and rituximab, significant activity with no increase in toxicity over those expected for FC alone was seen.