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F versus FC

Date: October 11, 2005

In this age of sexy monoclonal antibodies such as Rituxan and Campath (soon to be joined by Avastin, perhaps), we tend to forget that good old fashioned chemotherapy agents such as fludarabine (a purine analog) and cyclophosphamide (an alkylating agent) are still the mainstay of therapy options for much of the world.

Here is the latest take on comparing fludarabine monotherapy with a combination of fludarabine + cyclophosphamide (“Cytoxan”), as frontline therapy in younger patients. Too bad that there was no attempt to divvy up patients according to their prognostic indicators. As you would expect, the FC combo had more oomph, there were higher percentage of CRs (24% vs. 7%), higher percentage of overall responses (94% vs. 83%), and longer progression free remissions (48 months vs. 20 months).

But. The FC combo also gave rise to significantly more thrombocytopenia (too few platelets) and leukocytopenia (too low WBC).

And bottom line, they have not yet seen any difference in the overall survival rates, at least thus far. Since this study was based on patients recruited between 1999 and 2003, one can hope that more details on survival statistics will become clear as the months roll on by.

For my money, it seems to me that addition of Rituxan to F and FC (to make RF and RFC combos) is likely to give better bang for the buck. Aha, there is the rub, not all folks and all communities can afford the latest and greatest monoclonals, with their stiff price tag. We tend to get rather spoiled here in the U.S.A, at least those of us with good insurance coverage.

Be well,

Chaya
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Blood First Edition Paper, prepublished online October 11, 2005; DOI 10.1182/blood-2005-06-2395.

Fludarabine plus cyclophosphamide versus fludarabine alone in first line therapy of younger patients with chronic lymphocytic leukemia

Barbara F Eichhorst*, Raymonde Busch, Georg Hopfinger, Rita Pasold, Manfred Hensel, Cordelia Steinbrecher, Siegfried Siehl, Ulrich Jaeger, Manuela Bergmann, Stephan Stilgenbauer, Carmen Schweighofer, Clemens M Wendtner, Hartmut Doehner, Guenter Brittinger, Bertold Emmerich, and Michael Hallek

The combination chemotherapy with fludarabine plus cyclophosphamide (FC) was compared to the standard regimen of fludarabine monotherapy in first line treatment of younger patients with chronic lymphocytic leukemia (CLL). Between 1999 and 2003 a total of 375 patients with predominantly advanced CLL younger than 66 years were randomized to receive either fludarabine (25 mg/m2 for 5 days intravenously, repeated every 28 days) or FC combination therapy (fludarabine 30 mg/m2 plus cyclophosphamide 250 mg/m2 both for 3 days intravenously, repeated every 28 days). Both regimens were administered to a maximum of 6 courses. The FC combination chemotherapy resulted in a significantly higher complete remission rate (24%) and overall response rate (94%) compared to fludarabine alone (7% and 83%; P < .001 and P = .001). The FC treatment also resulted in a longer median progression-free survival (48 versus 20 months; P = .001), and a longer treatment-free survival (37 versus 25 months; P < .001). So far, no difference in the median overall survival could be observed. FC caused significantly more thrombocytopenia and leukocytopenia, but did not increase the number of severe infections. In summary first line treatment with FC increases the response rates and the treatment-free interval in young patients with advanced CLL.

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