Précis: Triple regimen appears promising for non-Hodgkin's lymphoma and lymphocytic leukemia
Advanced low-grade lymphomas and chronic lymphocytic leukemia (CLL) are relatively indolent, but are incurable with conventional treatments. The median survival duration from diagnosis is 7 to 9 years. The studies using new nucleoside analogs such as fludarabine for the treatment of low-grade lymphomas have shown promising response rates in phase II trials. In this phase II study, the researchers assessed the response rate and associated toxicity of a triple regimen using fludarabine and cyclophosphamide with filgrastim support.
Sixty patients who had previously untreated low-grade or intermediate-grade lymphoid malignancies due to non-Hodgkin's lymphoma (NHL) or CLL were included. The patients received intravenous cyclophosphamide on day 1 and fludarabine on days 1 through 5. Filgrastim was given subcutaneously on day 8. The regimen was repeated every 28 days for 6 cycles or until maximum response had been achieved.
Complete responses were observed in 51% and a partial response rate in 41% of patients.
Of the 17 patients with CLL, 47% achieved a complete response and 53% had a partial response.
Of the 43 patients with NHL, 60% achieved a complete response and 32% had a partial response.
Hematopoetic toxicity was mild with filgrastim support.
The combination of fludarabine, cyclophosphamide and filgrastim is a highly active, well-tolerated regimen for patients with low-grade lymphoid malignancies. The long-term complications are still unknown. This triple regimen versus single agent fludarabine is now being evaluated by the Eastern Cooperative Oncology Group in a randomized trial.