Individualized 6-mercaptopurine increments in consolidation treatment of childhood acute lymphoblastic leukemia: A NOPHO randomized controlled trial.

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.

Frandsen, Thomas L (författare)
Abrahamsson, Jonas,1954Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för pediatrik,Institute of Clinical Sciences, Department of Pediatrics(Swepub:gu)xabrjo (författare)
Lund, Bendik (författare)
Vettenranta, Kim (författare)
Jonsson, Olafur Gisli (författare)
Marquart, Hanne Vibeke Hansen (författare)
Albertsen, Birgitte Klug (författare)
Heyman, MatsKarolinska Institutet (författare)
Schmiegelow, Kjeld (författare)
Göteborgs universitetInstitutionen för kliniska vetenskaper, Avdelningen för pediatrik (creator_code:org_t)

Av författaren/redakt...: Tulstrup, Morten; Frandsen, Thomas ...; Abrahamsson, Jon ...; Lund, Bendik; Vettenranta, Kim; Jonsson, Olafur ...; visa fler...; Marquart, Hanne ...; Albertsen, Birgi ...; Heyman, Mats; Schmiegelow, Kje ...; visa färre...

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Pediatrik

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