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Interferon‐alpha 2b (IFNα) for Early‐Phase Chronic Lymphocytic Leukaemia with High Risk for Disease Progression: Results of a Randomized Multicentre Study

The efficacy of interferon‐alpha 2b (IFNα) to prolong progression‐free (PFS) and/or overall survival (OS) in early B‐CLL (Binet stage A) was examined in a risk‐adapted phase III study. 99 previously untreated B‐CLL patients were recruited. 44 patients with expected high risk for disease progression, defined by non‐nodular bone marrow infiltration and lymphocyte doubling time ≤12 months or serum thymidine kinase levels ≥5 U/l, were randomized to either receive IFNα (group 1, n = 21) or not (group 2, n = 23). 55 low‐risk patients were observed to evaluate this risk stratification (group 3). During a median observation time of 36 months, four patients in the IFNα group achieved a partial remission (PR), no patient had stable disease (SD), and 17 patients experienced progressive disease (PD). The four responders had less extensive disease at study entry and tended to exhibit a rise in serum IgG levels. In group 2, no PR, seven SD and 16 PD, whereas in group 3, no PR, 37 SD and 18 PD occurred. PFS in group 1 (6.7 months) was not different from group 2 (13.3 months, P = 0.22), but PFS of groups 1 and 2 differed from group 3 (37 months, P ≤ 0.001). OS was 44.9 months (group 1), 43.1 months (group 2) and 57.9 months (group 3). OS was not significantly different for group 1 v 2, but was significant between groups 1 and 3 (P = 0.023). The higher percentage of PD in group 2 compared to group 3 (70% v 29%) shows that the selected risk factors allow the definition of CLL stage A patients at risk for disease progression within about a year. In conclusion, our data indicate that IFNα does not prolong PFS or OS in stage A CLL patients with high risk for disease progression.