In 1991 we reported the results from a prospective randomised phase 3 trial comparing 7 days continuous infusion of cytosine arabinoside (ara-C) combined with either daunorubicin (DNR) or aclarubicin (ACR) as direct i.v. injection for 3 days as induction chemotherapy (CT) for patients with de novo acute myeloid leukemia (AML) followed by early intensive consolidation CT with two alternating cycles of high-dose ara-C and two cycles of amsacrine plus etoposide, and finally 3 days of daunomycin plus 7 days of ara-C as administered for induction of remission.
A total of 174 patients with de novo AML in the age group 17-65 years were included.
The patients have now been followed till death or for at least 7 years, and an evaluation of the long-term survival and the risk of developing secondary neoplasms has been made.
The overall survival rate 5-years after diagnosis was 23%, and after 10 years 19%. No difference was found between the two treatment regimens in overall survival or disease-free survival (DFS).
For the subgroup of 99 patients who achieved complete remission after one or two induction courses, 5-and 10-year survival rates were 35% and 31% respectively, with the highest survival rates in the age group 17-39 years (57% at 5 years) as compared with 27% in patients aged 40-60 years (P=0.007).
Seven secondary neoplasms were diagnosed simultaneously with or after the diagnosis of AML indicating a standardized incidence ratio (SIR) of 3.41, (95% Cl : 1.60-7.26). (...)
Mots-clés Pascal : Leucémie myéloblastique, Essai clinique phase III, Chimiothérapie, Aclarubicine, Antibiotique, Anticancéreux, Daunorubicine, Association médicamenteuse, Etude longitudinale, Cytarabine, Agent intercalant, Inhibiteur enzyme, Amsacrine, DNA topoisomerase (ATP-hydrolysing), Isomerases, Enzyme, Etoposide, Antimitotique, Survie, Long terme, Aigu, Pronostic, Second cancer, Complication, Traitement, Epidémiologie, Homme, Hémopathie maligne, Anthracyclines, Pyrimidine nucléoside, Acridine dérivé
Mots-clés Pascal anglais : Acute myelocytic leukemia, Phase III trial, Chemotherapy, Aclarubicin, Antibiotic, Antineoplastic agent, Daunorubicin, Drug combination, Follow up study, Cytarabine, Intercalating agent, Enzyme inhibitor, Amsacrine, DNA topoisomerase (ATP-hydrolysing), Isomerases, Enzyme, Etoposide, Antimitotic, Survival, Long term, Acute, Prognosis, Second cancer, Complication, Treatment, Epidemiology, Human, Malignant hemopathy, Anthracyclins, Pyrimidine nucleoside, Acridine derivatives
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0160758
Code Inist : 002B02R02. Création : 21/05/1997.