Therapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) for Relapsed or Untreated Progressive Chronic Lymphocytic Leukemia (CLL). A Single Center Experience.

Purpose: To evaluate the efficacy of FCR in improving complete remission (CR), disease-free survival (DFS) and overall survival (OS) rates in patients previously treated with chlorambucil-prednisolone and untreated CLL patients.

Patients and methods: A total of 45 CLL patients started FCR. Forty-one patients completed treatment: 16 following previous relapse and 25 previously untreated with progressive disease. Four patients are still receiving treatment. Median patient age was 63 years (range 34–88 years). Binet’s stage were: A: 8%, B: 34% and C: 58%. CD38 expression was positive (> 7% of cells) in 56% of patients and negative in 44%. FCR consisted of: fludarabine (25 mg/m²/day × 3); cyclophosphamide (250 mg/m²/day × 3) and rituximab (375 mg/m²/day × 1), all given intravenously, every 4 weeks for 4–6 cycles. CR was defined by CLL/NCI-WG criteria. Minimal residual disease (MRD) negativity was < 1% CD19, CD5 positive cells in peripheral blood and bone marrow. Results: The results of this study are detailed in Table 1. To summarise: CR: 69%; nodular partial remission (PR): 15%; PR: 7% and stable disease: 2%. Grade 3–4 neutropenia occurred in 33% of patients and 34% required hospitalization due to infections.

Conclusions: FCR induces a high CR (74%) and DFS (83%) rate and increases MRD negativity (92%). Significantly higher DFS rates at 36 months were observed in patients who were CD38 negative vs. CD38 positive (100 % vs. 71% P=0.02).