But combination therapy is associated with more adverse events than fludarabine monotherapy
TUESDAY, Oct. 11 (HealthDay News) -- The use of fludarabine plus alemtuzumab in patients with previously treated chronic lymphocytic leukemia (CLL) results in better survival, but is associated with more adverse events (AEs) than fludarabine monotherapy, according to a study published online Oct. 11 in The Lancet Oncology.
Thomas Elter, M.D., from the University of Cologne in Germany, and colleagues compared the safety and efficacy of the combination of fludarabine and alemtuzumab with fludarabine monotherapy in previously treated patients with relapsed or refractory CLL. A total of 235 patients aged 18 years or older with CLL were randomly assigned to receive either combination treatment or fludarabine monotherapy intravenously for a maximum of six 28-day cycles. Progression-free survival (PFS) was the major end point.
The investigators identified significantly better PFS and overall survival with combination treatment than with fludarabine monotherapy (hazard ratio, 0.61 and 0.65, respectively). All-cause AEs were found in 98 and 90 percent of patients in the combination treatment and monotherapy groups, respectively, with more cytomegalovirus events and grade 1 or 2 potentially alemtuzumab infusion-related adverse reactions in the combination group. Grade 3 and 4 toxicities seen in the combination and monotherapy groups included leukopenia (74 and 34 percent, respectively), lymphopenia (94 and 33 percent, respectively), neutropenia (59 and 68 percent, respectively), thrombocytopenia (11 and 17 percent, respectively), and anemia (14 and 28 percent, respectively). Deaths due to AEs were similar between the groups, but the incidence of serious AEs was higher in the combination treatment group (33 versus 25 percent).
"The combination of fludarabine and alemtuzumab is another treatment option for patients with previously treated CLL," the authors write.
Several authors disclosed financial relationships with Genzyme, which also funded the study.
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