Fludarabine monophosphate as salvage for refractory chronic lymphocytic leukaemia.

Objective: To assess the efficacy of the purine analogue fludarabine monophosphate (FAMP) as salvage therapy in patients at Groote Schuur Hospital with chronic lymphocytic leukaemia (CLL) refractory to standard therapy.

Design: Non-randomised trial.

Setting: Tertiary care, referral academic hospital.

Patients: Seven patients with B-lineage CLL, 4 in Rai stage IV and 1 each in stages A(I), A(II) and A(III), refractory to treatment with chlorambucil or cyclophosphamide, with or without whole-body irradiation.

Intervention: Intravenous FAMP at a dose of 25 mg/m2 daily for 5 days every 28 days.

Main Outcome Measures: Partial remission, complete remission, stable disease or progressive disease.

Results: Two patients entered CR and 4 PR after a median of 8 courses of treatment (range 2 - 12). One patient died of Pneumocystis carinii pneumonia after 3 courses of therapy. The most common adverse effect of the treatment was myelosuppression, with the nadir of neutrophil counts being less than 0.5 x 10(9)/1 in 5 patients. Three developed infections and required hospitalisation while on therapy.

Conclusion: FAMP is effective as a cytoreductive agent in patients with CLL refractory to alkylating agents, with or without whole-body irradiation.