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

Introduction: During the last decade, strong prognostic factors and new compounds emerged for the treatment of CLL. The initial experience with the combination of FCR at MDACC as salvage therapy and later in untreated patients (pts) promote us to use these regimen since March 2001.

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

Patients and methods: A total of 32 CLL pts, 16 after relapse and 16 untreated with progressive disease completed treatment and evaluation, 3 pts are still on treatment. FCR consisted of Fludarabine 25 mg/m² iv on days 1 to 3, Cyclophosphamide 250 mg/m² iv on day 1 to 3 and Rituximab 375 mg/m² iv on day 1 given at 4 weeks interval up to 4–6 cycles. Response was assessed 4–8 weeks after treatment. CR was defined by CLL/NCI-WG. Minimal residual disease (MRD) negative was defined as <1% CD19, CD5 positive cells in peripheral blood and bone marrow as assessed by three colour flow cytometry. Median age was 63 years (range 34–80). Binet’s clinical stage were A: 9%, B: 31% and C: 60%. The CD38 expression was positive (>7% of cells) in 53% and negative in 47% of the cases.

Results: The CR was obtained in 66% of the pts, nodular partial remission (NPR) in 19%, PR in 9% and stable disease in 6%.

Neutropenia grade 3–4 was observed in 31% of the courses, 5% of the pts required hospitalisation due to infeccious episodes.

Conclusion: In patients with CLL, FCR induce a high CR, MRD negative and DFS rate. Patients with CD38 negative expression correlated with a better DFS.