In pediatric patients with acute myeloid leukemia (AML), the addition of a monoclonal antibody called gemtuzumab combined with standard chemotherapy has been shown to significantly reduce the risk of relapse and increase rates of disease-free survival.
Post-treatment relapse rates are a major indicator of potential for long-term survival in children with the disease.
The study (abstract #355) evaluated a total of 1,022 children averaging 10 years old at trial sites nationwide, led by Alan Gamis, MD, MPH, Associate Division Director, Section of Oncology at Children's Mercy Hospital in Kansas City. It will be highlighted in an oral presentation Monday, Dec. 9, at the American Society of Hematology annual meeting in New Orleans.
Gemtuzumab was removed from the U.S. market in 2010 because the U.S. Food and Drug Administration determined the potential risks of the drug outweighed the potential benefits. Recent research with the compound has raised questions about whether that action may have been premature. This data supports recent findings in adults with AML that gemtuzumab reduced their risk of relapse when added to standard chemotherapy.
"This could be an important treatment option for critical patients," said Dr. Gamis. "Gemtuzumab appears to have a real impact in increasing the likelihood of long-term survival in high-risk patients."
In this study, patients were treated with gemtuzumab or a standard treatment regimen. Compared with standard regimens, the addition of gemtuzumab was associated with better disease-free survival (61 vs. 55%) and reduced relapse risk (33 vs. 41%). It did not significantly improve overall survival (74 vs. 70%).