Long-term follow-up after fludarabine treatment in pretreated patients with chronic lymphocytic leukemia

Background and Objectives. A study update to assess long-term survival foll owing fludarabine salvage treatment in previously treated patients with chr onic lymphocytic lymphoma (CLL). Design and Methods. From September 1992 to December 1995, 74 patients with advanced, relapsing B-cell CLL were enrolled in the study. Fludarabine was given for 5 consecutive days at the dose of 25 mg/m(2)/day in a 30 min infu sion. Treatment was repeated every 28 days for a maximum of 6 courses. Results. Nineteen (26%) patients achieved a complete response (CR) and 20 ( 27%) patients had a partial response (PR), giving an overall response rate of 53%. The median overall survival was 68 months, and there was a strong n egative correlation with the number of previous treatments. The median time to progression was 18 months for patients who achieved a CR and 12 months for those with a PR. Interpretation and Conclusions. The results obtained with fludarabine alone in this subset of CLL patients indicate the existence of a conspicuous dis ease-free survival period. This time window could be used to consolidate th e initial response with either biological approaches or high-dose therapeut ic strategies such as autologous bone marrow transplantation, with the aim of eventual eradication of the disease. (C) 2000 Ferrata Storti Foundation.