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A review of long-term results of acute myeloid leukemia (AML) clinical trials at St. Jude Children's Research Hospital suggests that the "one-size-fits-all" approach of the past 20 years should be replaced with therapies designed for specific subtypes of AML.
The team analyzed the results of five clinical trials (AML-80, -83, -87, -91, -97) completed from 1980 to 2000 to identify principles of successful treatments that could guide the design of future therapy and improve outcomes. With the exception of protocol AML-83, the outcomes improved during the two decades, with the five-year event-free survival rising from about 31 percent for AML-80 to about 45 percent for AML-97.
"Our early intensive chemotherapy and excellent supportive care produces remission rates about 90 percent," said Raul Ribeiro, MD, director of St. Jude International Outreach.
The results agree with previous studies that showed about 40 percent of cases of AML are highly resistant to current therapy and that further intensification of treatment is unlikely to improve outcome.
The results also suggest that future clinical trials for AML should match treatment design to specific subsets of patients. For example, basing the decision to use hematopoietic stem cell transplantation (HSCT) on whether a matched donor is available might not be appropriate for all patients. Instead, it might be more rational to also consider which AML subtype the patient has, in addition to the patient’s initial response to therapy as assessed by measuring minimal residual disease. Also, it would be important to identify patients who are unlikely to benefit from intensive chemotherapy or HSCT and invite them to participate in innovative trials while their clinical conditions are still good.
A report on this study appears in the online, advance publication issue of Leukemia. Other authors of the paper include; Stan Pounds, PhD, St. Jude Biostatistics; and Nobuko Hijiya, MD, Ching-Hon Pui, MD, and Bassem Razzouk, MD, of St. Jude Hematology-Oncology and International Outreach.
Last update: December 2005