A trial of fludarabine and cyclophosphamide combination chemotherapy in the treatment of advanced refractory primary cutaneous T-cell lymphoma

Background The combination of fludarabine and cyclophosphamide shows synerg istic toxicity in vitro and has been used to treat nodal non-Hodgkin's lymp homa and relapsed chronic lymphocytic leukaemia. Objectives To test the efficacy of this combination in 12 patients with cut aneous T-cell lymphoma (CTCL). Methods Nine patients with erythrodermic CTCL were identified for the study , eight of whom met the criteria for Sezary syndrome (SS), and three with t umour-stage mycosis fungoides (MF). Patients received intravenous fludarabi ne and cyclophosphamide 3 days monthly for 3-6 months. Results Six patients tolerated at least three cycles. Five with SS had a re sponse (one had a complete clinical response and four a partial response) a nd one patient with MF had stable disease. The mean duration of the respons e was 10 months. Six patients had treatment withdrawn, five due to bone mar row suppression and one due to progressive disease. No difference in pretri al parameters were found in those who had treatment withdrawn and those who tolerated at least three courses. Survival since the trial was similar in both groups at 11 months. Conclusions These data indicate that the combination of fludarabine with cy clophosphamide may be of clinical benefit in patients with SS but does not affect patient survival. As with other multiagent chemotherapy regimens, bo ne marrow toxicity is a common and severe side-effect. These data suggest t hat this regimen should be considered palliative and should be reserved for patients with refractory disease without bone marrow suppression.