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dc.contributor.authorTulstrup, Morten
dc.contributor.authorFrandsen, Thomas L.
dc.contributor.authorAbrahamsson, Jonas
dc.contributor.authorLund, Bendik
dc.contributor.authorVettenranta, Kim
dc.contributor.authorJonsson, Olafur Gisli
dc.contributor.authorMarquart, Hanne Vibeke Hansen
dc.contributor.authorAlbertsen, Birgitte Klug
dc.contributor.authorHeyman, Mats
dc.contributor.authorSchmiegelow, Kjeld
dc.date.accessioned2018-01-31T14:47:41Z
dc.date.available2018-01-31T14:47:41Z
dc.date.issued2018-01
dc.date.submitted2018
dc.identifier.citationIndividualized 6-mercaptopurine increments in consolidation treatment of childhood acute lymphoblastic leukemia: A NOPHO randomized controlled trial 2018, 100 (1):53 European Journal of Haematologyen
dc.identifier.issn09024441
dc.identifier.doi10.1111/ejh.12979
dc.identifier.urihttp://hdl.handle.net/2336/620444
dc.descriptionTo access publisher's full text version of this article click on the hyperlink belowen
dc.description.abstractOBJECTIVES: 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. METHODS: 392 patients were randomized to experimental and 396 to standard therapy. Patients allocated to standard therapy received oral 6-mercaptopurine (25 mg/m2 /day) from days 30 to 85, while the experimental arm received stepwise increments of additional 25 mg/m2 /day beginning on days 50 and/or 71 unless dose-limiting myelosuppression had occurred. RESULTS: 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). CONCLUSION: This study found no benefit from individualized 6-mercaptopurine increments compared to standard therapy.
dc.description.sponsorshipSwedish Childhood Cancer Foundation Danish Cancer Society Danish Childhood Cancer Foundation Nordic Cancer Union Otto Christensen Foundation University Hospital Rigshospitalet Novo Nordic Foundationen
dc.language.isoenen
dc.publisherWileyen
dc.relation.urlhttp://doi.wiley.com/10.1111/ejh.12979en
dc.rightsArchived with thanks to European Journal of Haematologyen
dc.subjectBráðahvítblæðien
dc.subjectBörnen
dc.subjectLyfjagjöfen
dc.subjectPED12en
dc.subject.meshPrecursor Cell Lymphoblastic Leukemia-Lymphomaen
dc.subject.meshMercaptopurineen
dc.subject.meshChilden
dc.subject.meshConsolidation Chemotherapyen
dc.titleIndividualized 6-mercaptopurine increments in consolidation treatment of childhood acute lymphoblastic leukemia: A NOPHO randomized controlled trialen
dc.typeArticleen
dc.contributor.department[ 1 ] Univ Hosp Rigshosp, Dept Pediat & Adolescent Med, Copenhagen, Denmark Show more [ 2 ] Univ Gothenburg, Sahlgrenska Acad, Inst Clin Sci, Dept Pediat, Gothenburg, Sweden Show more [ 3 ] Trondheim Reg & Univ Hosp, St Olavs Hosp, Dept Pediat, Trondheim, Norway Show more [ 4 ] Norwegian Univ Sci & Technol, Fac Med & Hlth Sci Childrens & Womens Hlth, Dept Lab Med, Trondheim, Norway Show more [ 5 ] Univ Tampere, Dept Paediat, Tampere, Finland Show more [ 6 ] Landspitali Univ Hosp, Dept Pediat, Reykjavik, Iceland [ 7 ] Univ Hosp Rigshosp, Sect 7631, Dept Clin Immunol, Copenhagen, Denmark Show more [ 8 ] Skejby Hosp, Dept Pediat Oncol, Aarhus, Denmark [ 9 ] Astrid Lindgrens Hosp, Dept Pediat, Stockholm, Sweden Show more [ 10 ] Univ Copenhagen, Inst Clin Med, Copenhagen, Denmarken
dc.identifier.journalEuropean Journal of Haematologyen
dc.rights.accessNational Consortium - Landsaðganguren
dc.contributor.institutionDepartment of Pediatrics and Adolescent Medicine; University Hospital Rigshospitalet; Copenhagen Denmark
dc.contributor.institutionDepartment of Pediatrics and Adolescent Medicine; University Hospital Rigshospitalet; Copenhagen Denmark
dc.contributor.institutionDepartment of Pediatrics; Institution for Clinical Sciences; Sahlgrenska Academy; University of Gothenburg; Gothenburg Sweden
dc.contributor.institutionDepartment of Pediatrics; St. Olavs Hospital; Trondheim University Hospital; Trondheim Norway
dc.contributor.institutionDepartment of Paediatrics; University of Tampere; Tampere Finland
dc.contributor.institutionDepartment of Pediatrics; Landspitali University Hospital; Reykjavík Iceland
dc.contributor.institutionDepartment of Clinical Immunology, Section 7631; University Hospital Rigshospitalet; Copenhagen Denmark
dc.contributor.institutionDepartment of Pediatric Oncology; Skejby Hospital; Aarhus Denmark
dc.contributor.institutionDepartment of Pediatrics; Astrid Lindgrens Hospital; Stockholm Sweden
dc.contributor.institutionDepartment of Pediatrics and Adolescent Medicine; University Hospital Rigshospitalet; Copenhagen Denmark
dc.departmentcodePED12
html.description.abstractOBJECTIVES: 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. METHODS: 392 patients were randomized to experimental and 396 to standard therapy. Patients allocated to standard therapy received oral 6-mercaptopurine (25 mg/m2 /day) from days 30 to 85, while the experimental arm received stepwise increments of additional 25 mg/m2 /day beginning on days 50 and/or 71 unless dose-limiting myelosuppression had occurred. RESULTS: 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). CONCLUSION: This study found no benefit from individualized 6-mercaptopurine increments compared to standard therapy.


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