Intergroup study in elderly patients with AML to compare complete remission rate and overall survival after intermediate-dose or low-dose AraC.

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6618 Background: Until recently, elderly patients with AML were treated in protocols for younger pts or outside protocols. In order to evaluate the outcome of these pts in more detail, an intergroup study involving the AMLCG and the OSHO study groups was initiated and a 10:1 randomization in a common arm was established. Methods: The common arm consisted of AraC 100 mg/m2 c.i. over 7 days and Daunorubicin 60 mg/m2 over two hours on days 3-5. If blasts in the marrow were >5% a second induction was given. As postremission AraC 1 g/m2 was given as a three hour infusion on days 1, 3 and 5. A total of 834 eligible pts were randomized either in the common arm (n=84; 10.1%) or in the study arms (n=750; 89.9%). The median age was lower in the common arm (67, range 60 – 82 years) than in the study arms (median age: 68 and 70 years, p=0.03). Leucocytes and LDH at diagnosis, cytogenetic risk and the presence of NPM and FLT3 mutations did not differ between the common and the study arms. However, there were differences between secondary AML in the common arm (36%) compared to the study arms (42% and 27%; p=0.005). The majority of pts had intermediate risk cytogenetics in the common (65%) as well as in the study arms (65% and 61%). Results: CR was reached in 58% of pts in the common and in 62% in the study arms (p=n.s.). Of 69 pts in the common arm, 37 died (54%), as did 367 of the 591 pts (62%) in the study arms. There was no statistically significant difference between the common arm and the study arms in overall survival, which amounted to 37% at 2 years in the standard arm vs. 33% and 25% at 2 years in the study groups. Significant independent factors associated with OS were karyotype, disease characteristics, age and WBC. Relapse free survival at 2 years amounted to 40% in the common arm compared to 40% and 30% in the two study arms (p=n.s.). Significant independent risk factors associated with relapse free survival were karyotype and age, but not the allocation to the two arms. Conclusions: From this interim analysis we conclude that no significant differences were observed to date on CR between the common arm and the study arms. More follow up and patient entry is needed for OS and RFS and subgroup analysis to identify protocols with better outcome.

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