Results of a fludarabine induction and α‐interferon maintenance protocol in pretreated patients with chronic lymphocytic leukemia and low‐grade non‐Hodgkin's lymphoma

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Abstract
The activity of fludarabine monophosphate (FLU) and α‐interferon (α‐IFN) in low‐grade non‐Hodgkin's lymphoma (LG‐NHL) and B‐cell chronic lymphocytic leukemia (B‐CLL) has been demonstrated in several clinical trials. In a study of 137 previously treated patients, of whom 77 had B‐CLL and 60 with LG‐NHL, we used FLU as salvage chemotherapy. Dosages of 25 mg/m2 were given in 30‐min infusions for 5 consecutive d. Treatment was repeated every 28 d depending on the patient's clinical status for a maximum of 6 cycles. Entrance to the α‐IFN maintenance portion of the study depended on patient response to initial FLU. All patients who had obtained a complete or partial response after the FLU therapy were randomized to receive α‐IFN or no further therapy. The α‐IFN dose was 3×106 units 3 times per wk until disease progression. At 4 yr with a median follow‐up of 22 months the percentage of patients with persistent response ranged between 20% and 30% among all the responders. Thirty‐five (45%) B‐CLL patients achieved major responses (complete/partial response), as did 29 (48%) of those with LG‐NHL. Among the 64 patients who achieved a good response to initial therapy and who have entered the second part of the trial, there has been a rate of prolongation of remission in favour of maintenance α‐IFN (p = 0.02). FLU therapy is an effective drug inducing remission in pretreated B‐CLL and LH‐NHL patients. However, as with other therapeutic modalities, remission is rarely maintained beyond 2 yr. So far, maintenance α‐IFN has not been shown to produce significantly longer remission after treatment with FLU in LG‐NHL, and there is no trend towards prolonged remission in B‐CLL patients. The role of FLU needs to be further evaluated in the management of lymphoproliferative disorders by introducing it in combination with other drugs (α‐IFN) in the induction phase and in maintenance treatment.

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