The Pharmaceutical Journal
Vol 279 No 7463 p122
4 August 2007

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Combination treatment increases survival in CLL

Treatment of chronic lymphocytic leukaemia (CLL) with fludarabine plus cyclophosphamide increases response rates and progression-free survival compared with single agent fludarabine or chlorambucil, according to research published last month (Lancet 2007;370:230).

The study involved 777 patients with previously untreated CLL who were randomised to receive the combination of fludarabine plus cyclophosphamide or single agent fludarabine or chorambucil.

The researchers found that there was no difference in overall survival between the three groups. However, complete remission and overall response rates (including nodular partial remission and partial remission) were better with fludarabine plus cyclophosphamide than with fludarabine for all age groups (P<0.0001 for both).

Progression-free survival at five years was also better with fludarabine plus cyclophosphamide (36 per cent) than with fludarabine (10 per cent) or chlorambucil (10 per cent; P<0.00005). Median progression-free survival was three years and seven months with fludarabine plus cyclophosphamide compared with one year and 11 months with fludarabine and one year and eight months with chorambucil.

More cases of neutropenia and admissions to hospital were observed in the combination therapy and fludarabine-only groups than in the chlorambucil group. However, more cases of haemolytic anaemia were observed in the single agent groups than in the combination group.

“Fludarabine plus cyclophosphamide could become the basis for new protocols that incorporate monoclonal antibodies,” the UK-based researchers conclude. However, they add that the combination cannot be recommended for poor-prognosis patients who have a gene mutation characterised by a 17p (p53) deletion because they are unlikely to respond well to it.