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ASH international clinical collaboration replicates high cure rate of APL in developing countries
Date:1/14/2013

n the IC-APL registry study conducted in Brazil, Chile, Mexico, and Uruguay compared to regimens used in trials in developed countries was the replacement of the commonly used anthracycline idarubicin with the less expensive and more readily available drug daunorubicin. Patients enrolled in the trial received combination therapy including oral ATRA in two daily doses until complete remission and daunorubicin given intravenously on days 2, 4, 6, and 8. Throughout the trial, participating sites registered all cases using common clinical record forms in the Pediatric Oncology Network Database (POND) and collaborated with national clinical trial coordinators and reference laboratories to confirm the integrity and accuracy of treatment data.

After approximately three years of follow-up, investigators observed incredibly promising results: 80 percent of patients achieved two-year OS and 91 percent achieved DFS, all with a low cumulative incidence of relapse (4.5%). Early patient mortality (death occurring between diagnosis and first evaluation at 30 days) in the trial was reduced by nearly half compared to historical controls, and overall survival improved by 30 percent. Of the 180 evaluable patients that participated in the four host countries, 153 (85%) achieved complete remission.

After five years of follow-up, 75.4 percent of all patients enrolled and 90.2 percent of those who achieved CR remained alive. Early death occurred in 27 patients (15%). These rates of death are considerably lower than other population-based studies analyzing early mortality of APL patients conducted in the United States and Sweden (17.3% and 29%, respectively), further demonstrating the safety of this treatment combination. The most frequent hematologic toxicity was grade 4 neutropenia (low neutrophil count), which was observed in a small group (3.3%) of patients. No significant toxicities were reported during maintenance therapy and no secondary malignancies were reporte
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Contact: Andrea Slesinski
aslesinski@hematology.org
American Society of Hematology
Source:Eurekalert

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