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Individualized 6-me...
Individualized 6-mercaptopurine increments in consolidation treatment of childhood acute lymphoblastic leukemia: A NOPHO randomized controlled trial.
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Tulstrup, Morten (author)
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Frandsen, Thomas L (author)
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- Abrahamsson, Jonas, 1954 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för pediatrik,Institute of Clinical Sciences, Department of Pediatrics
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Lund, Bendik (author)
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Vettenranta, Kim (author)
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Jonsson, Olafur Gisli (author)
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Marquart, Hanne Vibeke Hansen (author)
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Albertsen, Birgitte Klug (author)
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- Heyman, Mats (author)
- Karolinska Institutet
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Schmiegelow, Kjeld (author)
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(creator_code:org_t)
- 2017-11-09
- 2018
- English.
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In: European Journal of Haematology. - : Wiley. - 0902-4441 .- 1600-0609. ; 100:1, s. 53-60
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Abstract
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- This randomized controlled trial tested the hypothesis that children with non-high-risk acute lymphoblastic leukemia could benefit from individualized 6-mercaptopurine increments during consolidation therapy (NCT00816049). Primary and secondary end points were end of consolidation minimal residual disease (MRD) positivity and event-free survival.392 patients were randomized to experimental and 396 to standard therapy. Patients allocated to standard therapy received oral 6-mercaptopurine (25mg/m(2) /day) from days 30 to 85, while the experimental arm received stepwise increments of additional 25mg/m(2) /day beginning on days 50 and/or 71 unless dose-limiting myelosuppression had occurred.In the experimental arm, 166 patients (42%) received one dose increment, and 62 (16%) received two. Fifty-seven of 387 (15%) patients in the experimental arm were MRD positive at end of consolidation vs 77 of 389 (20%) in the control arm (P=.08). Five-year probability of event-free survival was 0.89 (95% CI: 0.85-0.93) in the experimental arm vs 0.93 (0.90-0.96) in the control arm (P=.13). The median accumulated length of 6-mercaptopurine treatment interruptions was 7 (IQR 2-12) in the experimental arm vs 4 (IQR 0-10) in the control arm (P=.002).This study found no benefit from individualized 6-mercaptopurine increments compared to standard therapy.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
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- ref (subject category)
- art (subject category)
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Tulstrup, Morten
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Frandsen, Thomas ...
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Abrahamsson, Jon ...
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Lund, Bendik
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Vettenranta, Kim
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Jonsson, Olafur ...
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show more...
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Marquart, Hanne ...
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Albertsen, Birgi ...
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Heyman, Mats
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Schmiegelow, Kje ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Pediatrics
- Articles in the publication
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European Journal ...
- By the university
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University of Gothenburg
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Karolinska Institutet