Evaluation of Alternative, “Low-intensity” Induction Regimens in Elderly Adults with Acute Myeloid Leukemia (AML).

Abstract

Abstract Abstract 2066 Poster Board II-43 From 1999 to 2009, 298 adults, age 60 yrs and above, received initial induction therapy for untreated AML at Weill-Cornell Medical College/New York Presbyterian Hospital. Based on physician/patient preference and/or protocol eligibility, patients received either a traditional cytosine arabinoside/anthracycline-based induction regimen (n= 103) or an alternative, low-intensity regimen(n=195); either low-dose ara-C +/- arsenic trioxide (n=88) or tipifarnib +/- oral etoposide (n=107). Overall the median age was 72 yrs (range 60-89), 47% had an antecedent hematological disorder (AHD) and 42% had an unfavorable karyotype. Patients treated with low-intensity regimens were significantly older compared to those given standard induction (median age 75 vs 67 yrs) and had a higher percentage of unfavorable karyotypes (46% vs 33%). Complete remissions (CR) were achieved in 23% of patients receiving low-intensity regimens and 53% of patients treated with standard therapy. Thirty and 60 day mortality rates were 9.7% and 20.5% versus 14.5% and 25% for low-intensity and standard regimens respectively (p=0.29). Seventy two of the initial 195 patients (37%) treated with a low-intensity regimen received a second induction regimen for primary resistance or relapse; either a standard ara-C-anthracycline regimen (n=38) or a second non-intensive regimen (decitabine +/- gemtuzumab ozogamicin, low-dose ara-c, SGN-33,) (n=34). Overall 25/72 (35%) achieved a CR with salvage therapy; 16/38 CR's (42%) with standard induction and 9/34 CR's (26%) with a second low-intensity regimen. Median overall survival for all 298 patients was 6.7 months. By univariate analysis, no significant difference in survival was seen for patients initially treated with a low-intensity regimen compared to those receiving standard induction (median 6.2 vs 7.7 months; p=0.82 by log-rank test). By multivariate analysis, age over 75, prior AHD, unfavorable karyotype, ECOG performance status > 2, and male gender all predicted for shorter survival, whereas intensity of initial treatment did not. These results suggest that older patients with AML may receive initial therapy with a non-traditional, low-intensity induction regimen and have similar survival outcomes compared to patients given standard induction. A comparison of the quality of life of patients, as manifested by the percentage of days spent in hospital, frequency of transfusion support, and number of outpatient visits, will be presented. Death due to resistant disease remains the major problem for older patients with AML Disclosures: Off Label Use: arsenic trioxide to be used to enhance the effects of low-dose ara-C as part of a clinical trial.