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Mitoxantrone Versus Liposomal Daunorubicin in Induction of Pediatric AML With Risk Stratification Based on Flow Cytometry Measurement of Residual Disease

Tierens, Anne (författare)
Laboratory Medicine Program, University Health Network, Toronto General Hospital, ON, Toronto, Canada
Arad-Cohen, Nira (författare)
Department of Pediatric Hemato-Oncology, Rambam Health Care Campus, Haifa, Israel
Cheuk, Daniel (författare)
Department of Pediatrics and Adolescent Medicine, Hong Kong Children’s Hospital and Hong Kong Pediatric Hematology and Oncology Study Group (HKPHOSG), Hong Kong
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De Moerloose, Barbara (författare)
Department of Pediatric Hematology-Oncology, Ghent University Hospital, Gent, Belgium
Fernandez Navarro, Jose Maria (författare)
Department of Pediatric Hemato-Oncology, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Hasle, Henrik (författare)
Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark
Jahnukainen, Kirsi (författare)
New Children’s Hospital, Pediatric Research Center, University of Helsinki, Helsinki University Hospital, Helsinki, Finland
Juul-Dam, Kristian Løvvik (författare)
Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark
Kaspers, Gertjan (författare)
Princess Maxima Center for Pediatric Oncology, Utrecht, Netherlands; Emma Children’s Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Pediatric Oncology, Amsterdam, Netherlands
Kovalova, Zanna (författare)
Department of Paediatric Oncology/Haematology, Children’s Clinical University Hospital, Riga, Latvia
Lausen, Birgitte (författare)
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
Norén-Nyström, Ulrika (författare)
Umeå universitet,Pediatrik
Palle, Josefine (författare)
Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden
Pasauliene, Ramune (författare)
Center of Oncology and Hematology, BMT Unit, Vilnius University Children’s Hospital, Vilnius, Lithuania
Pronk, Cornelis Jan (författare)
Childhood Cancer Center, Skåne University Hospital, Lund, Sweden
Saks, Kadri (författare)
Department of Paediatrics, SA Tallinna Lastehaigla, Tallinn, Estonia
Zeller, Bernward (författare)
Department of Pediatrics, Oslo University Hospital, Oslo, Norway
Abrahamsson, Jonas (författare)
Institution for Clinical Sciences, Department of Pediatrics, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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 (creator_code:org_t)
Lippincott Williams & Wilkins, 2024
2024
Engelska.
Ingår i: Journal of Clinical Oncology. - : Lippincott Williams & Wilkins. - 0732-183X .- 1527-7755. ; 42:18, s. 2174-2185
Relaterad länk:
https://urn.kb.se/re...
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https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • PURPOSE Measurable residual disease (MRD) by using flow cytometry after induction therapy is strongly prognostic in pediatric AML, and hematopoietic stem-cell transplant (hSCT) may counteract a poor response. We designed a phase III study with intensified response-guided induction and MRD-based risk stratification and treated poor induction response with hSCT. The efficacy of liposomal daunorubicin (DNX) in induction was compared with mitoxantrone.METHODS The study planned to randomly assign 300 patients, but the production of DNX ceased in 2017. One hundred ninety-four patients were randomly assigned to mitoxantrone or experimental DNX in induction 1. Ninety-three non–randomly assigned patients served as an observation cohort. Primary end point was fraction of patients with MRD <0.1% on day 22 after induction 1. Patients with MRD ≥15% after induction 1 or ≥0.1% after induction 2 or FLT3-ITD with NPM1 wildtype were stratified to high-risk therapy, including hSCT.RESULTS Outcome for all 287 children was good with 5-year event-free survival (EFS5y) 66.7% (CI, 61.4 to 72.4) and 5-year overall survival (OS5y) 79.6% (CI, 75.0 to 84.4). Overall, 75% were stratified to standard-risk and 19% to high-risk. There was no difference in the proportion of patients with MRD <0.1% on day 22 after induction 1 (34% mitoxantrone, etoposide, araC [MEC], 30% DNX, P 5 .65), but the proportion increased to 61% for MEC versus 47% for DNX (P 5 .061) at the last evaluation before induction 2. EFS5y was significantly lower, 56.6% (CI, 46.7 to 66.5) versus 71.9% (CI, 63.0 to 80.9), and cumulative incidence of relapse (CIR) was higher, 35.1% (CI, 25.7 to 44.7) versus 18.8% (CI, 11.6 to 27.2) for DNX. The inferior outcome for DNX was only in standard-risk patients with EFS5y 55.3% (CI, 45.1 to 67.7) versus 79.9% (CI, 71.1 to 89.9), CIR 39.5% (CI, 28.4 to 50.3) versus 18.7% (CI, 10.5 to 28.7), and OS5y 76.2% (CI, 67.2 to 86.4) versus 88.6% (CI, 81.4 to 96.3). As-treated analyses, including the observation cohort, supported these results. For all high-risk patients, 85% received hSCT, and EFS5y was 77.7 (CI, 67.3 to 89.7) and OS5y was 83.0 (CI, 73.5 to 93.8).CONCLUSION The intensification of induction therapy with risk stratification on the basis of response to induction and hSCT for high-risk patients led to improved outcomes. Mitoxantrone had a superior anti-leukemic effect than liposomal daunorubicin.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Pediatrik (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Pediatrics (hsv//eng)

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