TUESDAY, Dec. 28 (HealthDay News) -- The addition of gemtuzumab ozogamicin (GO) to induction chemotherapy among younger patients with acute myeloid leukemia (AML) appears to improve survival with little additional toxicity, according to a study published online Dec. 20 in the Journal of Clinical Oncology.
In the open-label MRC AML15 trial, Alan K. Burnett, M.D., of the Cardiff University School of Medicine in the United Kingdom, and colleagues randomized 1,113 patients, mostly younger than 60 years of age, to receive a single dose of GO on day one of induction course 1 with one of three induction schedules: daunorubicin and cytarabine; cytarabine, daunorubicin, and etoposide; or fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin. In remission, 948 patients were randomized to GO in course 3 in combination with amsacrine, cytarabine, and etoposide or high-dose cytarabine.
A predefined analysis by cytogenetics revealed a highly significant interaction with induction GO, with significant survival benefit for patients with favorable cytogenetics and a trend for benefit in intermediate-risk patients. However, no benefit was found for patients with poor-risk disease. The investigators found that GO was well tolerated, with no significant increase in adverse events. An internally validated prognostic index identified about 70 percent of patients with a predicted benefit of 10 percent in five-year survival.
"In conclusion, this study demonstrates that antibody-directed chemotherapy can increase overall survival for the majority of younger patients with AML," the authors write.
One author disclosed a financial relationship with Wyeth (Pfizer).
Abstract
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