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dc.contributor.authorBakunina, Katerina
dc.contributor.authorPutter, Hein
dc.contributor.authorVersluis, Jurjen
dc.contributor.authorKoster, Eva A. S.
dc.contributor.authorvan der Holt, Bronno
dc.contributor.authorManz, Markus G.
dc.contributor.authorBreems, Dimitri A.
dc.contributor.authorGjertsen, Bjørn Tore
dc.contributor.authorCloos, Jacqueline
dc.contributor.authorValk, Peter J. M.
dc.contributor.authorPassweg, Jakob
dc.contributor.authorPabst, Thomas
dc.contributor.authorOssenkoppele, Gert J.
dc.contributor.authorLöwenberg, Bob
dc.contributor.authorCornelissen, Jan J.
dc.contributor.authorde Wreede, Liesbeth C.
dc.description.abstractClofarabine is an active antileukemic drug for subgroups of patients with acute myeloid leukemia (AML). Multi-state models can provide additional insights to supplement the original intention-to-treat analysis of randomized controlled trials (RCT). We re-analyzed the HOVON102/SAKK30/09 phase III RCT for newly diagnosed AML patients, which randomized between standard induction chemotherapy with or without clofarabine. Using multi-state models, we evaluated the effects of induction chemotherapy outcomes (complete remission [CR], measurable residual disease [MRD]), and post-remission therapy with allogeneic stem cell transplantation [alloSCT] on relapse and death. Through the latter a consistent reduction in the hazard of relapse in the clofarabine arm compared to the standard arm was found, which occurred irrespective of MRD status or post-remission treatment with alloSCT, demonstrating a strong and persistent antileukemic effect of clofarabine. During the time period between achieving CR and possible post-remission treatment with alloSCT, non-relapse mortality was higher in patients receiving clofarabine. An overall net benefit of treatment with clofarabine was identified using the composite endpoint current leukemia-free survival (CLFS). In conclusion, these results enforce and extend the earlier reported beneficial effect of clofarabine in AML and show that multi-state models further detail the effect of treatment on competing and series of events.en_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.titleThe added value of multi-state modelling in a randomized controlled trial: The HOVON 102 study re-analyzeden_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.rights.holderCopyright 2021 The Author(s)en_US
dc.source.journalCancer Medicineen_US
dc.identifier.citationCancer Medicine. 2022, 11 (3), 630-640.en_US

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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal