1. Enrollment on clinical trials does not improve survival for children with acute myeloid leukemia: A population-based study.
- Author
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Truong, Tony H., Pole, Jason D., Barber, Randy, Dix, David, Kulkarni, Ketan P., Martineau, Emilie, Randall, Alicia, Stammers, David, Strahlendorf, Caron, Strother, Douglas, and Sung, Lillian
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ACUTE myeloid leukemia in children , *CLINICAL trials , *PROGRESSION-free survival , *CHILDHOOD cancer , *ONCOLOGY - Abstract
Background: It is questionable whether enrollment on clinical trials offers any survival advantage at the population level over standard-of-care treatment. The objectives of this study were to describe the impact of trial enrollment on event-free survival and overall survival in pediatric acute myeloid leukemia (AML) using the Cancer in Young People in Canada (CYP-C) database.Methods: Children were included if they had had AML newly diagnosed between ages birth and 14 years from 2001 to 2012. CYP-C is a national pediatric cancer population-based database that includes all cases of pediatric cancer diagnosed and treated at 1 of the 17 tertiary pediatric oncology centers in Canada. Univariate and Cox proportional hazards models were used to evaluate the impact of initial trial enrollment on survival.Results: In total, 397 eligible children with AML were included in the analysis, of whom 94 (23.7%) were enrolled on a clinical trial at initial diagnosis. The most common reason for non-enrollment was that no trial was available. The event-free survival rate at 5 years was 57.8% ± 5.2% for those enrolled versus 54.8% ± 2.9% for those not enrolled (P = .75). The overall survival rate at 5 years was 70.1% ± 4.9% for those enrolled versus 66.3% ± 2.8% for those not enrolled (P = .58). Enrollment on a trial was not associated with improved event-free or overall survival in multiple regression analyses.Conclusions: Enrollment on a clinical trial was not associated with improved survival for children with AML in a population-based cohort. Rationale for trial enrollment should not include the likelihood of benefit compared with non-enrollment. [ABSTRACT FROM AUTHOR]- Published
- 2018
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