Fax: (404) 727-4455
AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia
A report from the Children's Oncology Group
Article first published online: 15 JUL 2011
Copyright © 2011 American Cancer Society
Volume 118, Issue 3, pages 761–769, 1 February 2012
How to Cite
Cooper, T. M., Franklin, J., Gerbing, R. B., Alonzo, T. A., Hurwitz, C., Raimondi, S. C., Hirsch, B., Smith, F. O., Mathew, P., Arceci, R. J., Feusner, J., Iannone, R., Lavey, R. S., Meshinchi, S. and Gamis, A. (2012), AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia. Cancer, 118: 761–769. doi: 10.1002/cncr.26190
- Issue published online: 20 JAN 2012
- Article first published online: 15 JUL 2011
- Manuscript Accepted: 15 MAR 2011
- Manuscript Revised: 3 MAR 2011
- Manuscript Received: 27 JAN 2011
- gemtuzumab ozogamicin;
- newly diagnosed;
- childhood acute myeloid leukemia;
The development of antigen-targeted therapies may provide additional options to improve outcomes in children with acute myeloid leukemia (AML). The Children's Oncology Group AAML03P1 trial sought to determine the safety of adding 2 doses of gemtuzumab ozogamicin, a humanized anti-CD33 antibody-targeted agent, to intensive chemotherapy during remission induction and postremission intensification for children with de novo AML.
AAML03P1 enrolled 350 children with previously untreated AML. Patients with a matched family donor received 3 courses of chemotherapy followed by hematopoietic stem cell transplantation; those without a matched family donor received 5 courses of chemotherapy. Gemtuzumab ozogamicin 3 mg/m2/dose was administered on Day 6 of Course 1 and Day 7 of Course 4.
Toxicities observed in all courses of therapy were typical of AML chemotherapy regimens, with infection being most common. Patients achieved a complete remission rate of 83% after 1 course and 87% after 2 courses. The mortality rate was 1.5% after the first gemtuzumab ozogamicin-containing induction course and 2.6% after 2 induction courses. The 3-year event-free survival and overall survival rates were 53 ± 6% and 66 ± 5%, respectively.
This trial determined that it is safe and feasible to include gemtuzumab ozogamicin in combination with intensive chemotherapy. The survival rates compare favorably with the recently published results of clinical trials worldwide. Cancer 2012;. © 2011 American Cancer Society.