High efficacy with five days schedule of oral fludarabine phosphate and cyclophosphamide in patients with previously untreated chronic lymphocytic leukaemia.
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.
Cazin
Bruno
B
Department of Haematology, Claude Huriez University Hospital, Lille, France. b-cazin@chru-lille.fr
Divine
Marine
M
Leprêtre
Stéphane
S
Travade
Philippe
P
Tournilhac
Olivier
O
Delmer
Alain
A
Jaubert
Jérôme
J
Feugier
Pierre
P
Dreyfus
Brigitte
B
Mahé
Béatrice
B
Grosbois
Bernard
B
Maloisel
Frédéric
F
Eghbali
Houchingue
H
Dumontet
Charles
C
Bénichou
Jacques
J
Guibon
Odile
O
Leleu
Xavier
X
Leporrier
Michel
M
Maloum
Karim
K
D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000652:urine; D003404:Creatinine / Q000652:urine; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005434:Flow Cytometry; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome; D001084:Vidarabine Phosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D015415:Biomarkers; D007166:Immunosuppressive Agents; D001084:Vidarabine Phosphate; C042382:fludarabine phosphate; D003520:Cyclophosphamide; D003404:Creatinine