Fludarabine Versus No-Treatment In the Patients with CLL Stage A

Fludarabine is an effective treatment for chronic lymphocytic leukemia (CLL) alones and in combined terapy in untreatment CLL. The standard recomandation for the stage A Binet, is to delay any treatement until progression. We compared the benefit of early exposure to fludarabine versus no-treatment in the patients with CLL stage A.

Between 2000 and 2004, we randomzed 77 patients with CLL stage A to be treated; fludarabine 25 mg/m2, administered intravenously daily for 5 days every 28 days versus no treatment until disease progression. The treated group with received the assigned treatment for a maximum of 6 cycles. Both groups evaluated evry 2 month diseases progression. The NCI-WG response criteria for CLL was refered for analized result.

Among the 38 patients treated by fludarabine. Complet response and parcial response were observed 21 % and 74 % of cases respectively. The median Progression Free Survival (PFS) was 32 month in the treated group versus 31.5 months in the 39 patients of control group, (p 0.9). The median survival were 124 and 122 months respectively, p 0.7. Existing deletion p53, high risk stage A CLL had no impact on the result. The commonest grade III-IV toxicities were neutropenia (12 %) and trombocytopenia (11 %) in the tretaed group.

Fludarabine did not prolong PFS and survival in patients with stage A CLL. Despite the low tolerability of fludarabine there is no need to provide an early exposure in patients with stage A CLL.

No relevant conflicts of interest to declare.