High efficacy with five days schedule of oral fludarabine phosphate and cyclophosphamide in patients with previously untreated chronic lymphocytic leukaemia.

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High efficacy with five days schedule of oral fludarabine phosphate and

cyclophosphamide in patients with previously untreated chronic lymphocytic

leukaemia.

Bruno Cazin, Marine Divine, Stephane Lepretre, Philippe Travade, Olivier

Tournilhac, Alain Delmer, Jerome Jaubert, Pierre Feugier, Brigitte Dreyfus,

Beatrice Mahe, Bernard Grosbois, Frederic Maloisel, Houchingue Eghbali,

Dumontet, Jacques Benichou, Odile Guibon, Xavier Leleu, Michel Leporrier, and

Karim Maloum

Br J Haematol, August 15, 2008; .

Department of Haematology, Claude Huriez University Hospital, Lille, France.

A multicentre single-arm study testing the efficacy and toxicity of the oral

combination of fludarabine and cyclophosphamide (FC) over 5 d in 75 patients

with untreated B cell-chronic lymphocytic leukaemia. Oral FC demonstrated high

efficacy with overall (OR) and complete response (CR) rates of 80% and 53%,

respectively. Out of the 30 CR patients studied for Minimal Residual Disease

(MRD) using 4-colour flow-cytometry and the 22 using Clonospecific polymerase

chain reaction, 22 (66%) and 16 (68%), respectively, were MRD negative. Median

survival and median treatment-free interval had not been reached at 7 years of

follow-up. Median progression-free survival (PFS) was 5 years. Toxicity was

acceptable, with 52% and 16% of National Cancer Institute grade 3/4 neutropenia

and infections, respectively. Gastrointestinal toxicity was mild. Oral FC

demonstrated a high efficacy and an acceptable safety profile and may be

considered as the standard first line treatment in chronic lymphocytic

leukaemia.

PMID: 18710390