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Tytuł pozycji:

Improved outcomes for myeloid leukemia of Down syndrome: a report from the Children's Oncology Group AAML0431 trial.

Tytuł:
Improved outcomes for myeloid leukemia of Down syndrome: a report from the Children's Oncology Group AAML0431 trial.
Autorzy:
Taub JW; Division of Hematology/Oncology, Children's Hospital of Michigan, Wayne State University, Detroit, MI.
Berman JN; IWK Health Centre, Dalhousie University, Halifax, NS, Canada.
Hitzler JK; Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Sorrell AD; Children's Hospital of San Antonio, Baylor College of Medicine, San Antonio, TX.
Lacayo NJ; Lucile Packard Children's Hospital, Stanford University, Palo Alto, CA.
Mast K; Vanderbilt-Ingram Cancer Center, Nashville, TN.
Head D; Vanderbilt-Ingram Cancer Center, Nashville, TN.
Raimondi S; St. Jude Children's Research Hospital, Memphis, TN.
Hirsch B; Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, MN.
Ge Y; Department of Oncology and.; Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI.
Gerbing RB; Children's Oncology Group, Monrovia, CA.
Wang YC; Children's Oncology Group, Monrovia, CA.
Alonzo TA; Children's Oncology Group, Monrovia, CA.; Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Campana D; St. Jude Children's Research Hospital, Memphis, TN.; Department of Pediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Coustan-Smith E; St. Jude Children's Research Hospital, Memphis, TN.; Department of Pediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Mathew P; Department of Pediatrics, University of New Mexico, Albuquerque, NM; and.
Gamis AS; Division of Hematology/Oncology, Children's Mercy Hospitals and Clinics, Kansas City, MO.
Źródło:
Blood [Blood] 2017 Jun 22; Vol. 129 (25), pp. 3304-3313. Date of Electronic Publication: 2017 Apr 07.
Typ publikacji:
Clinical Trial, Phase III; Journal Article; Research Support, N.I.H., Extramural
Język:
English
Imprint Name(s):
Publication: 2021- : [New York] : Elsevier
Original Publication: New York, Grune & Stratton [etc.]
MeSH Terms:
Antibiotics, Antineoplastic/*therapeutic use
Antimetabolites, Antineoplastic/*therapeutic use
Cytarabine/*therapeutic use
Daunorubicin/*therapeutic use
Down Syndrome/*complications
Leukemia, Myeloid, Acute/*drug therapy
Myelodysplastic Syndromes/*drug therapy
Antibiotics, Antineoplastic/administration & dosage ; Antibiotics, Antineoplastic/adverse effects ; Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Child, Preschool ; Cytarabine/administration & dosage ; Cytarabine/adverse effects ; Cytogenetic Analysis ; Daunorubicin/administration & dosage ; Daunorubicin/adverse effects ; Disease-Free Survival ; Down Syndrome/genetics ; Female ; Humans ; Infant ; Leukemia, Myeloid, Acute/complications ; Leukemia, Myeloid, Acute/genetics ; Male ; Myelodysplastic Syndromes/complications ; Myelodysplastic Syndromes/genetics ; Neoplasm, Residual/diagnosis ; Neoplasm, Residual/genetics ; Treatment Outcome
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Grant Information:
U10 CA098413 United States CA NCI NIH HHS; U10 CA098543 United States CA NCI NIH HHS; R01 CA120772 United States CA NCI NIH HHS; U10 CA180899 United States CA NCI NIH HHS; U10 CA180886 United States CA NCI NIH HHS
Molecular Sequence:
ClinicalTrials.gov NCT00369317; NCT00369317
Substance Nomenclature:
0 (Antibiotics, Antineoplastic)
0 (Antimetabolites, Antineoplastic)
04079A1RDZ (Cytarabine)
ZS7284E0ZP (Daunorubicin)
Entry Date(s):
Date Created: 20170409 Date Completed: 20170828 Latest Revision: 20210202
Update Code:
20240105
PubMed Central ID:
PMC5482102
DOI:
10.1182/blood-2017-01-764324
PMID:
28389462
Czasopismo naukowe
Patients with myeloid leukemia of Down syndrome (ML-DS) have favorable event-free survival (EFS), but experience significant treatment-related morbidity and mortality. ML-DS blast cells ex vivo have increased sensitivity to cytarabine (araC) and daunorubicin, suggesting that optimizing drug dosing may improve outcomes while reducing toxicity. The Children's Oncology Group (COG) AAML0431 trial consisted of 4 cycles of induction and 2 cycles of intensification therapy based on the treatment schema of the previous COG A2971 trial with several modifications. High-dose araC (HD-araC) was used in the second induction cycle instead of the intensification cycle, and 1 of 4 daunorubicin-containing induction cycles was eliminated. For 204 eligible patients, 5-year EFS was 89.9% and overall survival (OS) was 93.0%. The 5-year OS for 17 patients with refractory/relapsed leukemia was 34.3%. We determined the clinical significance of minimal residual disease (MRD) levels as measured by flow cytometry on day 28 of induction I. MRD measurements, available for 146 of the 204 patients, were highly predictive of treatment outcome; 5-year disease-free survival for MRD-negative patients (n = 125) was 92.7% vs 76.2% for MRD-positive patients (n = 21) (log-rank P = .011). Our results indicated that earlier use of HD-araC led to better EFS and OS in AAML0431 than in past COG studies. A 25% reduction in the cumulative daunorubicin dose did not impact outcome. MRD, identified as a new prognostic factor for ML-DS patients, can be used for risk stratification in future clinical trials. This trial was registered at www.clinicaltrials.gov as #NCT00369317.
(© 2017 by The American Society of Hematology.)
Comment in: Blood. 2017 Jun 22;129(25):3273-3274. (PMID: 28642354)

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