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Cyclophosphamide Plus Fludarabine Yields Better Outcome in Chronic Lymphocytic Leukemia Than Fludarabine Alone: Presented at ASH

By Roberta Friedman, PhD

SAN DIEGO, CA -- December 8, 2003 -- Adding a second drug can boost performance of the most effective single agent for chronic lymphocytic leukemia. The combined action of cyclophosphamide and fludarabine was evident in findings presented here December 8^th at the 45^th Annual Meeting of the American Society of Hematology.

Investigator Barbara Eichhorst, MD, reporting for the German CLL Study Group, said that "especially our younger patients need better regimens" to improve outcomes over what fludarabine offers.

Combining cyclophosphamide with fludarabine provided significantly longer time to progresssion and complete response rates. "Not surprisingly, intensified therapy was associated with increased toxicity," said Dr. Eichhorst, who is at the Grosshadern Clinic in Munich. "In spite of [more leukopenia], the combination did not produce an increased rate of infection."

For patients taking both agents, complete response rate of 20.6% contrasts to that of 8.6% with fludarabine alone. Median time to disease progression had not been reached for the combination regimen at more than 28.2 months. Time to progression for the single drug was 18.6 months.

Treatment-related deaths did not differ for the two groups. Five patients in the study died due to causes that could be attributed to their chemotherapy.

Of the 375 patients enrolled, median ages were 59 and 58 years for the single and combined treatment arms, respectively. A hundred or so patients were evaluable for each study arm. Six cycles of chemotherapy included either fludarabine alone or the combined agents.

"We have not seen more treatment-related deaths" by adding the second drug, said Dr. Eichhorst. Also, the treatment actually becomes cheaper due to the lower cost of cyclophosphamide, and the lower dose of fludarabine that is used in combination. Since hospitalization rates did not change with adding the cheaper drug, cost of the therapy declines with added drug, she noted.

Growth factors were not designed into the protocol, yet "some patients probably got them," Dr. Eichhorst said. She added that the investigators will see in future studies if "patients do better with growth factors" to combat the leukopenia.


[Study title: Fludarabine Plus Cyclophosphamide (FC) Induces Higher Remission Rates and Longer Progression-Free Survival (PFS) Than Fludarabine (F) Alone in First-Line Therapy of Advanced Chronic Lymphocytic Leukemia (CLL): Results of a Phase III Study (CLL4 Protocol) of the German CLL Study Group (GCLLSG). Abstract 243]

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