Novel Treatments Demonstrate Improvements in Overall Survival and Response Rates in Difficult-To-Treat Forms of Leukemia an... (of patients responded to treatment with ...)

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Novel Treatments Demonstrate Improvements in Overall Survival and Response Rates in Difficult-To-Treat Forms of Leukemia and Lymphoma

Date:12/6/2008

of patients responded to treatment, with 11 percent experiencing a complete response and 18 percent experiencing a partial response. The most common severe (grade 3 and 4) side effects associated with pralatrexate were thrombocytopenia (31 percent), mucositis (14 percent), anemia (12 percent), and neutropenia (11 percent).

Immunochemotherapy With Fludarabine, Cyclophosphamide, and Rituximab VersusFludarabine and Cyclophosphamide Improves Response Ratesand Progression-Free Survival of Previously Untreated Patients With Advanced Chronic Lymphocytic Leukemia [Abstract #325]

Michael Hallek, M.D., University of Cologne,Cologne,Germany, and German CLL Study Group

Results from this multinational phase III clinical trial suggest that fludarabine, cyclophosphamide, and rituximab (FCR) chemoimmunotherapy may become the new standard first-line therapy for the treatment of advanced chronic lymphocytic leukemia.

In this study, a total of 817 patients with previously untreated chronic lymphocytic leukemia were randomized to receive six 28-day cycles of fludarabine (25 mg/m^2 intravenously on days 1 to 3) and cyclophosphamide (FC) (250 mg/m^2 intravenously on days 1 to 3) alone or FCR (375 mg/m^2 intravenously at start of first cycle and 500 mg/m^2 on day 1 for all subsequent cycles). The primary objective of the study was to determine response rates and progression-free survival.

After an average follow-up of 25.5 months, a total of 761 patients were evaluable for response and 787 were evaluable for progression-free survival and overall survival. The overall response rate was significantly higher in the FCR arm (95 percent) as compared with the FC arm (88 percent). The complete response rate was also sign
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