Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results.
OBJECTIVE
Treatment of acute myeloid leukemia (AML) in older patients remains unsatisfactory. The BGMT 95 trial for older patients set out to improve the outcome of these patients by adding a third drug (lomustine) to a 5+7 idarubicin and cytarabine schedule at induction and evaluating intermediate-dose cytarabine as consolidation.


METHODS
A multicenter randomized trial was performed comparing induction therapy with idarubicin and cytarabine, 5+7 (IC) to induction therapy with the same drugs plus lomustine (CCNU), 200 mg\m(2) orally on day 1 (ICL). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.


RESULTS
Between 1995 and 2001, 364 patients (>or=60 years) from ten centers were included. The CR rate was 58% for patients in the IC arm and 67% for patients in the ICL arm (p=0.104). The median overall survival (OS) was 7 and 12 months respectively (p=0.05), but OS at 2 years was not statistically different: 31+/-7% for patients in the ICL arm vs 24+/-6% for those in the IC arm. The two post-remission strategies yielded similar results.


CONCLUSIONS
Adding lomustine to induction with idarubicin and cytarabine therapy did not statistically improve survival in elderly patients with AML. Adding intermediate-dose cytarabine to consolidation therapy did not improve outcome.
Pigneux
Arnaud
A
Service des Maladies du Sang, Hopital du Haut-Leveque, Avenue de Magellan, 33604 Pessac Cedex, France. arnaud.pigneux@chu-bor-deaux.fr
Perreau
Virginie
V
Jourdan
Eric
E
Vey
Norbert
N
Dastugue
Nicole
N
Huguet
Françoise
F
Sotto
Jean-Jacques
JJ
Salmi
L Rachid
LR
Ifrah
Norbert
N
Reiffers
Josy
J
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D003561:Cytarabine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000009:adverse effects / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D008130:Lomustine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome
D003561:Cytarabine; D008130:Lomustine; D015255:Idarubicin