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Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results

From Hopital du Haut-Leveque, Pessac (AP, VP, LRS); Hopital Caremeau, Nîmes (EJ); Institut Paoli Calmettes, Marseille (NV); Hopital Purpan, Toulouse (ND, FH); Hopital Michallon, Grenoble (J-JS); Hopital d’Angers, Angers (NI); Institut Bergonié, Bordeaux (JR), France

Correspondence: Arnaud Pigneux, Service des Maladies du Sang, Hopital du Haut-Leveque, Avenue de Magellan, 33604 Pessac Cedex, France. E-mail: arnaud.pigneux{at}chu-bor-deaux.fr

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\m² 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 (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.

Key words: AML, older patients, lomustine.