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New Chemotherapy Regimen Promises to 'Raise Cure Rates' for Children and Adolescents with LeukemiaHeading

A study led by a physician at Maine Medical Center has resulted in new treatment standards nationally for patients with acute lymphoblastic leukemia (ALL), a fast growing cancer of white blood cells diagnosed in more than 4,000 children and adolescents each year.


Eric Larsen, MD, below, principal investigator of the study, is the director of the Maine Children's Cancer Program and the Division of Pediatric Hematology/ Oncology at The Barbara Bush Children's Hospital at Maine Medical Center. The randomized Phase III trial demonstrated improved five year, relapse-free, survival when using a chemotherapy agent called methotrexate in high doses in children and young adults.


Methotrexate, delivered intravenously, has been an essential component in treating children with ALL for more than 50 years. However, the optimal dose and its timing has been a matter of debate and clinical research.


For 20 years, the standard treatment for ALL called for increasing IV methotrexate based on the patient's tolerance, followed by a second chemotherapy drug called asparaginase.


Dr. Larsen's study tested a methotrexate regimen which delivers a dose 50 times the starting dose of the escalating regimen. The hypothesis was that doing so would increase the chance that methotrexate would infiltrate the central nervous system, hastening the healing process.


At a planned interim analysis, the five-year, event-free survival for patients who received high-dose methotrexate was 82 percent, compared to 75 percent for patients on the escalating methotrexate regimen. There were also significantly fewer bone marrow and central nervous system relapses in the high-dose group.


"Pediatric ALL was once a deadly form of leukemia, and now it's one of the most curable," says Dr. Larsen. "This trial helps us address an important need for patients with this disease. With these results, we now have an approach that will raise cure rates even higher. Based on the findings from this trial, all current and upcoming treatment protocols for children with most newly diagnosed ALL will use this regimen."


Findings were presented at the American Society for Clinical Oncology conference last month. The Phase III study, conducted by the Children's Oncology Group of the non-profit CureSearch for Children's Cancer, randomized 2,426 patients, ages 1 to 30, with newly diagnosed high-risk B-precursor ALL to high-dose methotrexate versus escalating methotrexate plus asparaginase during a two-month interim maintenance phase of therapy following standard induction and consolidation chemotherapy.



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