Improved progression-free, but not overall survival with fludarabine plus cyclophosphamide in patients with chronic lymphocytic leukemia

Researchers in the United Kingdom have reported increased progression-free, but not overall survival with fludarabine plus cyclophosphamide in patients with chronic lymphocytic leukemia (CLL), in a study presented in The Lancet this week.

In this study, 777 patients with CLL received fludarabine plus cyclophosphamide, fludarabine alone, or chlorambucil alone. There was no significant difference in overall survival between all three treatments groups. Complete and overall response rates (CR and ORR) were significantly higher with fludarabine plus cyclophosphamide than with fludarabine (CR: 38% vs 15%, respectively; ORR: 94% vs 80%, respectively; p<0•0001), which were significantly higher than with chlorambucil (CR: 7%; ORR: 72%; p=0•006 and 0•04, respectively). Progression-free survival was significantly higher with fludarabine plus cyclophosphamide than with fludarabine or chlorambucil (36% vs 10% vs 10%, respectively; p<0•00005).

A meta-analysis of data from this study and of two other Phase III trials showed a consistent benefit with fludarabine plus cyclophosphamide in terms of progression-free survival.

Author’s conclusions: fludarabine plus cyclophosphamide should now become the standard treatment for chronic lymphocytic leukaemia and the basis for new protocols that incorporate monoclonal antibodies.

Source: http://www.thelancet.com/journals/lancet/article/PIIS0140673607611258/abstract