Addition of lomustine to idarubicin and cytarabine improves the outcome of elderly patients with de novo acute myeloid leukemia: a report from the GOELAMS.
OBJECTIVE
No significant improvement in treatment outcome has been seen in elderly patients with acute myeloid leukemia (AML) over the past 20 years. This retrospective analysis investigated the prognostic factors for complete remission (CR) and survival in older patients with AML.


METHODS
The study involved 847 patients older than 60 years enrolled onto three trials carried out in France between 1995 and 2005. Induction therapy consisted of idarubicin (8 mg/m(2), days 1 through 5) and cytarabine (100 mg/m(2), days 1 through 7; group I, 339 patients) or the same drugs plus lomustine (200 mg/m(2) orally on day 1; group II, 508 patients). Consolidation therapy consisted of anthracycline and cytarabine courses at lower doses, preceded or not by a first course of intermediate-dose cytarabine.


RESULTS
The rate of CR was significantly higher in patients in group II compared with group I (68% v 58%; P = .002). The rate of toxic death was similar in the two groups. In multivariate analysis, two prognostic factors were linked to CR: nonadverse cytogenetic (P < .003) and addition of lomustine to induction chemotherapy (P = .002). Median overall survival was significantly improved in patients treated with lomustine (median and SE, 12.7 +/- 2.2 months v 8.7 +/- 2.7 months; P = .004). In multivariate analysis, five prognostic factors positively affected overall survival: addition of lomustine (P = .002), age < or = 69 years (P < .001), Eastern Cooperative Oncology Group performance status lower than 2 (P = .002), French-American-British subgroup 1/2 (P = .02), and nonadverse cytogenetic (P < .001).


CONCLUSIONS
Lomustine improves the rate of CR and survival in elderly patients with de novo AML when added to standard induction therapy.
Pigneux
Arnaud
A
Hopital du Haut-Leveque, Pessac, France.
Harousseau
Jean-Luc
JL
Witz
Francis
F
Sauvezie
Mathieu
M
Bene
Marie-Christine
MC
Luquet
Isabelle
I
Hunault-Berger
Mathilde
M
Recher
Christian
C
Lioure
Bruno
B
Himberlin
Chantal
C
Escoffre-Barbe
Martine
M
Berthou
Christian
C
Lissandre
Severine
S
Fegueux
Nathalie
N
Cahn
Jean-Yves
JY
Jourdan
Eric
E
Dreyfus
François
F
Reiffers
Josy
J
Milpied
Noël
N
Ifrah
Norbert
N
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015331:Cohort Studies; D003561:Cytarabine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008130:Lomustine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
D003561:Cytarabine; D008130:Lomustine; D015255:Idarubicin