Abstract:
BACKGROUND AND OBJECTIVES: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. DESIGN AND 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. INTERPRETATION AND 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.
journal_name
Haematologicajournal_title
Haematologicaauthors
Pigneux A,Perreau V,Jourdan E,Vey N,Dastugue N,Huguet F,Sotto JJ,Salmi LR,Ifrah N,Reiffers Jdoi
10.3324/haematol.11068subject
Has Abstractpub_date
2007-10-01 00:00:00pages
1327-34issue
10eissn
0390-6078issn
1592-8721pii
92/10/1327journal_volume
92pub_type
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