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The safety and efficacy of gemtuzumab ozogamicin in infant AML patients
On 3rd July 2017, in a Letter to the Editor of Blood, Erin M. Guest from Children’s Mercy Kansas City, Kansas City, and colleagues report results from their study which aimed to determine the safety and efficacy of gemtuzumab ozogamicin (GO), an anti-CD33 humanized antibody, in infants with Acute Myeloid Leukemia (AML) who were treated on two Children Oncology Group (COG) trials, AAML03P1 (NCT00070174) and AAML0531 (NCT00372593).
In this study, the authors combined and analyzed data of infants (less than the age of 1 year) with de novo AML who were randomized to receive standard chemotherapy plus 0.1mg/kg GO in the experimental arm of the AAMLO3P1 study (n = 39 [GO-arm]) and infants in the control arm of the AAML0531 study (n = 103 [No-GO arm]) and standard chemotherapy alone.
The key results of the study were:
- 5-year Overall Survival (OS) in infant AML patients in the GO and No-GO arm from study entry; 66 ± 11% vs 57 ± 12%, P = 0.219
- 5-year Event Free Survival (EFS) in infant AML patients in the GO and No-GO arm from study entry; 47 ± 12% vs 37 ± 12%, P = 0.192
- Early Death (ED [death during induction cycle 1]) rate in infant AML patients in the GO and No-GO arm; 6% vs 5%, P = 0.730
- 5-year Disease Free Survival (DFS) in infant AML patients in the GO and No-GO arm from the end of induction 1; 57 ± 14% vs 42 ± 17%, P = 0.093
- 5-year Relapse Risk (RR) in infant AML patients in the GO and No-GO arm from the end of induction 1; 37 ± 14% vs 55 ± 18%, P = 0.061
- 5-year Treatment Related Mortality (TRM) in infant AML patients in the GO and No-GO arm from the end of induction 1; 2 ± 4% vs 11 ± 23%, P = 0.754
In summation, GO was “well tolerated” and associated with “favorable disease outcomes” in infant patients with de novo AML. The authors suggested that the result of their study “supports a clinical benefit of GO in infants with AML”. They further concluded by stating that “GO can be safely combined with intensive chemotherapy in infants with AML”.
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