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Today, The Visible Embryo is linked to over 600 educational institutions and is viewed by more than 1 million visitors each month. The field of early embryology has grown to include the identification of the stem cell as not only critical to organogenesis in the embryo, but equally critical to organ function and repair in the adult human. The identification and understanding of genetic malfunction, inflammatory responses, and the progression in chronic disease, begins with a grounding in primary cellular and systemic functions manifested in the study of the early embryo.

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Home | Pregnancy Timeline | News Alerts |News Archive Dec 10, 2013

 

"Gemtuzumab appears to have a real impact in increasing
the likelihood of long-term survival in high-risk patients."

Alan Gamis, MD, MPH







WHO Child Growth Charts

 

 

 

Treatment reduces relapse in AML child leukemia

The addition of a monoclonal antibody — called gemtuzumab — combined with standard chemotherapy, has shown significant reduction to the risk of relapse and increased rates of disease-free survival in children with acute myeloid leukemia (AML).

Post-treatment relapse rates are a major indicator of potential for long-term survival in children with the disease.

The study evaluated a total of 1,022 children averaging 10 years old at trial sites nationwide. It was led by Alan Gamis, MD, MPH, Associate Division Director, Section of Oncology at Children's Mercy Hospital in Kansas City.

The paper was highlighted in an oral presentation Monday, Dec. 9, at the 55th American Society of Hematology Annual Meeting and Exposition in New Orleans.


"Chemotherapy has limits. Particularly in children. Increasing doses can become too toxic for the child and still not achieve the desired effect on the cancer.

"This study is significant because it shows for the first time that targeted treatment can augment the effects of chemotherapy in children and effectively reduce their risk of relapse. We found it the most effective in patients with the most risk."


Alan Gamis, MD, MPH, Associate Division Director, Section of Oncology at Children's Mercy Hospital in Kansas City, Illinois.


Gemtuzumab was removed from the U.S. market in 2010 because the U.S. Food and Drug Administration felt the potential risks of the drug outweighed its potential benefits. Recent research has raised questions about whether that action was premature. This data supports recent findings in adults with AML that gemtuzumab reduced their risk of relapse when added to a standard chemotherapy regimen.


"This could be an important treatment option for critical patients.

"Gemtuzumab appears to have a real impact in increasing the likelihood of long-term survival in high-risk patients."

Alan Gamis, MD, MPH


In the study, patients were treated with either gemtuzumab or a standard  regimen. Comparing the two regimens, the addition of gemtuzumab was associated with better disease-free survival (61 vs. 55%) and reduced relapse risk (33 vs. 41%). However, it did not significantly improve overall survival (74 vs. 70%).

Chat Live with Dr. Gamis

Dr. Gamis will discuss this study and answer questions about pediatric oncology from medical professionals, media and the public via Twitter at 1 p.m. Central (2 p.m. Eastern) on Friday, Dec. 20, through the @ChildrensMercy account. Join the conversation by including #cancerchat and @ChildrensMercy in tweets.

Abstract
Background: Escalation of treatment intensity for childhood acute myeloid leukemia has improved EFS but with excessive toxicity and toxic mortality (TM), compelling a search for more targeted less toxic alternatives.

Objective: To determine if the addition of GO to standard chemotherapy improves EFS in pediatric AML.

Methods: Patients < 30 years of age were randomly assigned to receive standard therapy alone (noGO) or to receive two doses of GO 3 mg/m2/dose on day 6 of Induction I (IndI) and on day 7 of Intensification II (IntII) in a 5 cycle chemotherapy backbone previously piloted by COG (Cooper et al, Cancer 2012). Use of stem cell transplant (SCT) was stratified by overall risk group assignment (based on cytogenetics, FLT3-ITD high allelic ratio (HAR), and IndI response) in which high risk patients were allocated to best allogeneic donor SCT after Int I, low risk (LR) patients received chemotherapy only, and intermediate risk (IR) were assigned to SCT if there was a matched family donor (MFD).

Results: Between 2006-2010, 1022 of 1070 enrolled non-DS pts were eligible for analysis; characteristics are presented in Table 1. Median follow-up was 3.6 (range 0-6.4) years for those alive.

Protocol therapy was well tolerated with a TM of 2% in induction and 5% overall with no difference by study arm. VOD was observed in 3% (severe in 0.6%) with no difference by study arm. From time of enrollment, GO was significantly associated with better overall EFS (hazard ratio (HzR) 0.83 (95% CI: 0.7-0.99; p=.04) and relapse-free survival (HzR 0.74 (0.6-0.93; p=.01)) whereas OS was not significantly improved (HzR 0.91 (0.74-1.13)). At 3 yr, noGO v GO EFS was 47 v 53%, p=.05 and OS was 65 v 69%, p=.18. In multivariate analyses, GO was significantly associated with improved EFS than standard therapy after adjustment for significant adverse risk factors: age <2yr, initial WBC>100,000x109/L, and black race. GO was not associated with significantly better induction complete remission (CR) when compared to standard therapy (88% v 85%; p=NS). Table 2 illustrates the overall results by randomized arm and by overall risk group from time of CR showing a consistent reduction in relapse risk in all risk groups. Further risk group analysis found several unique results. In the LR group, relapse rates (RR) trended lower in the GO arm but the benefit was reduced by TM during Int 2 & 3 that was significantly worse in the GO arm (3 v 10%, p=.02). In the IR group, EFS, RR, and OS trended towards improvement with GO. However when pts were censored at the time of SCT (as treated), the outcomes were not significantly different between arms (log-rank p=.14 EFS and p=.81 OS). Table 1 shows an imbalance for SCT received in assigned IR pts with fewer actually receiving SCT in the noGO arm. As such, Table 2 shows outcomes by intent-to-treat for IR pts with MFD censored and by as treated for IR pts receiving MFD SCT. Noteworthy in the IR group alone who did receive a SCT, GO arm pts had a significantly better DFS than the noGO arm (intent to treat: p=.022; as treated: p=.044). However, for the IR pts randomized to the noGO arm, SCT failed to provide benefit. For HR pts achieving CR they as well trended towards better survival & RR in the GO arm.

Table 2: Outcomes by randomized treatment assignment following CR
3 year Survival

Overall Survival

* - ≤.1; + - ≤.01; ^ - intent-to-treat; & - as treated from end of Int 1

Conclusion: GO improves EFS in children, adolescents and young adults with AML by reducing the risk of relapse among those achieving remission.

Alan S. Gamis, MD, MPH1, Richard Aplenc, MD, PhD2, Todd A. Alonzo, PhD3, Lillian Sung, MD, PhD4, Soheil Meshinchi, MD, PhD5, Robert B. Gerbing, MA6*, Susana C. Raimondi, PhD7, Betsy Hirsch, PhD8*, Samir Kahwash, MD9*, Amy Heerema-McKenney, MD10*, Laura Winter, PharmD11*, Kathleen Glick, CCRP12*, Stella M. Davies, MBBS, PhD13, Patti Byron, MSN, RN14* and Franklin O. Smith, MD15

1Division of Hematology/Oncology/Bone Marrow Transplantation, Children's Mercy Hospitals and Clinics, Kansas City, MO
2Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA
3Keck School of Medicine, University of Southern California, Monrovia, CA
4Haematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada
5Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA
6Children's Oncology Group, Arcadia, CA
7Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN
8Dept. of Laboratory Med and Pathology, University of Minnesota, Minneapolis, MN
9Nationwide Children's Hospital, Columbus, OH
10Stanford University, Palo Alto, CA
11Children's Hospital and Regional Medical Center, Seattle, WA
12Maine Children's Cancer Program, Scarborough, ME
13Division of Bone Marrow Transplantation and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
14British Columbia Children's Hospital, Vancouver, BC, Canada
15Division of Hematology/Oncology, University of Cincinnati College of Medicine, Cincinnati, OH

Disclosures: Off Label Use: Gemtuzumab, when available at the time of the study, had an approved label indication for use in older adult patients with refractory AML.

About Children's Mercy Hospital
Children's Mercy, located in Kansas City, Mo., is one of the nation's top pediatric medical centers. The 354-bed hospital provides care for children from birth through the age of 21, and has been ranked by U.S. News & World Report as one of "America's Best Children's Hospitals" and recognized by the American Nurses Credentialing Center with Magnet designation for excellence in nursing services. Its faculty of 600 pediatricians and researchers across more than 40 subspecialties are actively involved in clinical care, pediatric research, and educating the next generation of pediatric subspecialists. For more information about Children's Mercy and its research, visit childrensmercy.org or download our mobile phone app CMH4YOU for all phone types. For breaking news and videos, follow us on Twitter, YouTube and Facebook.