Br J Haematol. 2008 Oct;143(1):54-9. Epub 2008 Aug 15.

High efficacy with five days schedule of oral

fludarabine phosphate and
cyclophosphamide in patients with previously
untreated chronic lymphocytic leukaemia.
Cazin B, Divine M, Leprtre S, Travade P, Tournilhac O, Delmer A, Jaubert J, Feugier P,
Dreyfus B, Mah B, Grosbois B, Maloisel F, Eghbali H, Dumontet C, Bnichou J, Guibon O,
Leleu X, Leporrier M, Maloum K.

Source
Department of Haematology, Claude Huriez University Hospital, Lille, France. b-cazin@chrulille.fr

Abstract
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.