The best approach to elderly patients with relapsing
chronic lymphocytic leukemia (CLL) or disease refractory to conventional
therapy with
alkylating agents has not yet been established.
Fludarabine and its combination with
mitoxantrone and/or
cyclophosphamide, which is the most effective treatment in younger patients, has not been extensively utilized in the elderly CLL. Here we report our results with
fludarabine-based
chemotherapy in 32 previously treated patients over the age of 65 years. The overall response rate was 59% with no complete remission, 3 nodular partial remissions and 16 partial remissions. The median time to progression of disease was 7 months. Only 10 patients completed the entire treatment program, because of poor compliance due to toxicity. Eight patients developed neutropenic
fever, 14 severe
bacterial infections and 2 patients showed progressive
encephalopathy. For comparison, in a younger group of patients with refractory CLL (< 65 years), 38 of 50 patients completed the treatment plan, and the ORR was 80% (10 CR, 11 PR-nodular, 19 PR) with a median response of 12 months. Neutropenic
fever was diagnosed in 10 and severe
bacterial infection in 4 patients. In conclusion,
fludarabine-based
chemotherapy is effective for refractory CLL, however, excessive toxicity such as severe
infections and neurological complications, do not allow completion of treatment in the majority of the elderly patients. Because maintenance of a good quality of life should be the main goal in the elderly CLL population,
dose reduction of
fludarabine and the appropriate use of myeloid
growth factors and prophylactic
antibiotics appear mandatory in this group of patients.