Phase II evaluation of an intensified induction therapy with standard daunomycin and cytarabine followed by high dose cytarabine for adults with previously untreated acute myeloid leukemia: A southwest oncology group study (SWOG‐9500)

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Abstract
Induction therapy for acute myeloid leukemia (AML) usually consists of 7 days of cytarabine at 100–200 mg/m2/day and an anthracycline. Such combinations produce complete response (CR) rates of 60–80% in patients with de novo AML. On the basis of a previous report, suggesting a higher CR rate using a regimen of standard daunomycin and cytarabine followed by 3 days of high‐dose cytarabine (HDAC), 101 eligible patients received this regimen in a phase II trial. Sixty patients [59%, 95% confidence interval (CI) 49–69%] achieved a CR, and 10 patients died of infection during induction. Although cytogenetic risk group affected overall survival (P = 0.0016) and relapse‐free survival (P = 0.0043), it had no impact on CR rate (P = 0.63). Patients received postremission therapy with repetitive courses of alternate day high‐dose cytarabine; this was associated with considerable toxicity and the majority of patients could not receive all of the scheduled postremission therapy. The estimated median survival was 23 months (95% CI 15–34 months), and the estimated probability of surviving 5 years was 34% (95% CI 24–43%). The results of this intensive induction regimen were similar to that seen in previous trials and were not as promising as reported in the previous pilot study. Am. J. Hematol., 2007.

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