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

Autor: Karim Maloum, Jérôme Jaubert, Jacques Benichou, Frédéric Maloisel, Brigitte Dreyfus, Marine Divine, Pierre Feugier, Odile Guibon, Olivier Tournilhac, Philippe Travade, Charles Dumontet, Stéphane Leprêtre, Michel Leporrier, Alain Delmer, Houchingue Eghbali, Beatrice Mahe, Bruno Cazin, Xavier Leleu, Bernard Grosbois
Rok vydání: 2008
Předmět:
Zdroj: British Journal of Haematology. 143:54-59
ISSN: 1365-2141
0007-1048
DOI: 10.1111/j.1365-2141.2008.07309.x
Popis: 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.
Databáze: OpenAIRE