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.