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| |  Addition of Alemtuzumab to Fludarabine Improves Progression-Free Survival in Patients With Chronic Lymphocytic Leukaemia: Presented at EHA By Jenny Powers BARCELONA, Spain -- June 17, 2010 -- Progression-free survival (PFS) was increased by adding alemtuzumab to fludarabine, compared with fludarabine alone, in patients with previously treated chronic lymphocytic leukaemia, according to a study presented here at the 15th Congress of the European Hematology Association (EHA). Andreas Eckert, MD, University Hospital of Cologne, Cologne, Germany, presented the findings here on June 12. The study randomised 335 patients to receive either intravenous alemtuzumab in escalating doses until well tolerated, followed by intravenous fludarabine 30 mg/m2 and alemtuzumab 30 mg/m2 on days 1 to 3 every 28 days or intravenous fludarabine 25 mg/m2 on days 1 to 5 every 28 days. Patients in both groups received up to 6 cycles. The median PFS for patients receiving the combination therapy was significantly longer compared with fludarabine alone (24.1 vs 15.4 months; P = .004). Superior PFS was also observed following treatment with alemtuzumab and fludarabine in patients aged 65 years and older, compared with fludarabine monotherapy (26.2 vs 14.7 months). High-risk (Rai Stage III-IV) patients also achieved prolonged progression-free survival with the combination therapy versus monotherapy (24.1 vs 15.4 months). Overall response and complete response rates for alemtuzumab/fludarabine versus fludarabine were 80.4% versus 74.3% (P = .186) and 12.5% versus 2.4% (P < .001), respectively. No differences in overall survival were observed; however, high-risk patients receiving combination therapy had significantly improved overall survival (P = .005). Adverse reactions occurred in >10% of the patients in the combination group. The incidence of grade 3/4 adverse events (AEs) was higher in the combination group than the monotherapy group and the AEs were mostly thrombocytopenia (17.7% vs 22.7%), neutropenia (63.7% vs 68.9%), and anaemia (13.4% vs 22.0%). The most commonly reported serious AEs were neutropenia and febrile neutropenia and occurred more frequently in the combination-therapy group. Funding for this study was provided by Genzyme Corporation. [Presentation title: Fludarabine (FLU) Plus Alemtuzumab (FlUCAM) Improves Progression Free Survival Versus Fludarabine in Previously Treated Chronic Lymphocytic Leukemia and Demonstrates Activity in High Risk Patients. Abstract 0768]
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