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Randomized Controlled Trial
. 2013 Nov 15;119(22):4036-43.
doi: 10.1002/cncr.28334. Epub 2013 Sep 4.

Gemtuzumab ozogamicin can reduce minimal residual disease in patients with childhood acute myeloid leukemia

Carol O'Hear  1 , Hiroto Inaba, Stanley Pounds, Lei Shi, Gary Dahl, W Paul Bowman, Jeffrey W Taub, Ching-Hon Pui, Raul C Ribeiro, Elaine Coustan-Smith, Dario Campana, Jeffrey E Rubnitz
Affiliations
Randomized Controlled Trial

Gemtuzumab ozogamicin can reduce minimal residual disease in patients with childhood acute myeloid leukemia

Carol O'Hear et al. Cancer. .

Abstract

Background: Gemtuzumab ozogamicin (GO) is an active agent for the treatment of CD33-postive acute myeloid leukemia (AML) and may improve the outcome of specific patient subgroups when combined with conventional chemotherapy. However, to the best of the authors' knowledge, the effects of GO on levels of minimal residual disease (MRD) are unknown.

Methods: Pediatric patients with AML who received GO, either alone or in combination with chemotherapy on the AML02 multicenter trial, were analyzed to determine the effects of GO on MRD and outcome.

Results: Among 17 patients who received GO alone because of persistent leukemia, 14 had a reduction in their MRD level and 13 became MRD negative. Of the 29 who received chemotherapy in combination with GO after responding poorly to chemotherapy, 28 demonstrated reduced MRD and 13 became MRD negative. Treatment with GO effectively reduced MRD before hematopoietic stem cell transplantation and was not found to be associated with increased treatment-related mortality after transplantation.

Conclusions: GO is effective in reducing MRD levels in pediatric patients with AML and may improve the outcome of those patients at high risk of disease recurrence.

Keywords: acute myeloid leukemia; gemtuzumab ozogamicin; minimal residual disease; treatment-related mortality.

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Conflict of interest statement

CONFLICT OF INTEREST DISCLOSURES

Drs. Inaba, Pui, and Rubnitz were supported by National Institutes of Health (NIH) grant CA21765. Dr. Pui is an American Cancer Society Professor. Dr. Campana was supported by an NIH grant and a grant from the National Medical Research Council of Singapore. He has received honoraria for solicited review articles in the British Journal of Haematology and Blood Research. He currently has a patent pending on novel markers for residual disease detection in patients with acute lymphoblastic lymphoma.

Figures

Figure 1
Figure 1
Patient flow chart is shown demonstrating minimal residual disease (MRD) levels and the therapy received. An MRD level ≥ 0.1% was considered positive. “Decreased” indicates that MRD levels were lower, but still positive. ADE indicates cytarabine, daunorubicin, and etoposide; GO, gemtuzumab ozogamicin.
Figure 2
Figure 2
(A) Overall survival and (B) event-free survival are shown according to induction 2 therapy. ADE indicates cytarabine, daunorubicin, and etoposide; GO, gemtuzumab ozogamicin.
Figure 3
Figure 3
(A) Overall survival, (B) event-free survival, (C) cumulative incidence of disease recurrence, and (D) cumulative incidence of treatment-related mortality after hematopoietic stem cell transplantation are shown according to treatment with gemtuzumab ozogamicin (GO).
See this image and copyright information in PMC

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