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Gemtuzumab Ozogamicin in Children and Adolescents With De Novo Acute Myeloid Leukemia Improves Event-Free Survival by Reducing Relapse Risk: Results From the Randomized Phase III Children's Oncology Group Trial AAML0531
Open accessAbstract
Purpose: To improve survival rates in children with acute myeloid leukemia (AML), we evaluated gemtuzumab-ozogamicin (GO), a humanized immunoconjugate targeted against CD33, as an alternative to further chemotherapy dose escalation. Our primary objective was to determine whether adding GO to standard chemotherapy improved event-free survival (EFS) and overall survival (OS) in children with newly diagnosed AML. Our secondary objectives examined outcomes by risk group and method of intensification. Patients and Methods: Children, adolescents, and young adults ages 0 to 29 years with newly diagnosed AML were enrolled onto Children's Oncology Group trial AAML0531 and then were randomly assigned to either standard five-course chemotherapy alone or to the same chemotherapy with two doses of GO (3 mg/m 2 /dose) administered once in induction course 1 and once in intensification course 2 (two of three). Results: There were 1,022 evaluable patients enrolled. GO significantly improved EFS (3 years: 53.1% v 46.9%; hazard ratio [HzR], 0.83; 95% CI, 0.70 to 0.99; P = .04) but not OS (3 years: 69.4% v 65.4%; HzR, 0.91; 95% CI, 0.74 to 1.13; P = .39). Although remission was not improved (88% v 85%; P = .15), posthoc analyses found relapse risk (RR) was significantly reduced among GO recipients overall (3 years: 32.8% v 41.3%; HzR, 0.73; 95% CI, 0.58 to 0.91; P = .006). Despite an increased postremission toxic mortality (3 years: 6.6% v 4.1%; HzR, 1.69; 95% CI, 0.93 to 3.08; P = .09), disease-free survival was better among GO recipients (3 years: 60.6% v 54.7%; HzR, 0.82; 95% CI, 0.67 to 1.02; P = .07). Conclusion: GO added to chemotherapy improved EFS through a reduction in RR for children and adolescents with AML.
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Metadata
- Authors
- Gamis, A. S., Alonzo, T. A., Meshinchi, S., Sung, L., Gerbing, R. B., Raimondi, S. C., Hirsch, B. A., Kahwash, S. B., Heerema-McKenney, A., Winter, L., Glick, K., Davies, S. M., Byron, P., Smith, F. O., & Aplenc, R.
- Venue
- Journal of Clinical Oncology
- Published
- 2014-09-20
- Volume
- 32
- Issue
- 27
- Pages
- 3021-3032
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2169923083
- Cited by
- 486
- References
- 41
- FWCI
- 22.65
- Type
- journal article
- Language
- en
- Open access
- bronze
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- CoChat. (2026). Citation check: Gemtuzumab Ozogamicin in Children and Adolescents With De Novo Acute Myeloid Leukemia Improves Event-Free Survival by Reducing Relapse Risk: Results From the Randomized Phase III Children's Oncology Group Trial AAML0531. https://app.cochat.ai/papers/10.1200/jco.2014.55.3628
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- Gamis, A. S., Alonzo, T. A., Meshinchi, S., Sung, L., Gerbing, R. B., Raimondi, S. C., Hirsch, B. A., Kahwash, S. B., Heerema-McKenney, A., Winter, L., Glick, K., Davies, S. M., Byron, P., Smith, F. O., & Aplenc, R. (2014). Gemtuzumab Ozogamicin in Children and Adolescents With De Novo Acute Myeloid Leukemia Improves Event-Free Survival by Reducing Relapse Risk: Results From the Randomized Phase III Children's Oncology Group Trial AAML0531. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2014.55.3628
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
