Friday, October 1, 2010 (Last Updated: 10/04/2010)
FRIDAY, Oct. 1 (HealthDay News) -- Adding the monoclonal antibody rituximab to the standard chemotherapy regimen of fludarabine plus cyclophosphamide significantly extends the lives of chronic lymphocytic leukemia (CLL) patients compared to chemotherapy alone, according to the results of a phase III trial published in the Oct. 2, cancer-themed issue of The Lancet.
Michael Hallek, M.D., of the University of Cologne in Germany, and colleagues randomized treatment-naive adult patients with CD20-positive CLL to treatment with intravenous fludarabine and cyclophosphamide plus rituximab (chemoimmunotherapy group) or fludarabine and cyclophosphamide only (chemotherapy group). The primary study end point was progression-free survival.
Three years after randomization, the researchers found that 87 percent of patients in the chemoimmunotherapy group were alive compared to 83 percent in the chemotherapy group, while 65 and 45 percent of patients, respectively, were progression-free. However, the chemoimmunotherapy group had more grade 3 and 4 neutropenia and leucocytopenia than the chemotherapy group (34 versus 21 percent for neutropenia and 24 versus 12 percent for leucocytopenia). Eight treatment-related deaths (2 percent) were recorded in the chemoimmunotherapy group compared with 10 deaths (3 percent) in the chemotherapy group.
"Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab improves progression-free survival and overall survival in patients with CLL. Moreover, the results suggest that the choice of a specific first-line treatment changes the natural course of CLL," the authors write.
The study was funded by F. Hoffmann-La Roche. Several study authors disclosed financial ties to Roche and other pharmaceutical companies.
Hematology & Oncology
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