title: Equivalence of BCR-ABL transcript levels with complete cytogenetic remission in patients with chronic myeloid leukemia in chronic phase.
abstract: OBJECTIVE
  Chronic myeloid leukemia (CML) patients are monitored by both cytogenetic and molecular assessments, although present guidelines appear to switch from cytogenetic to molecular criteria. Due to the increasing use of molecular measurements, it was the aim of this work to identify a BCR-ABL level according to the international scale (BCR-ABL(IS)) as an equivalent substitute for complete cytogenetic remission (CCyR).
  
  
  METHODS
  In total, 1,329 paired data from 557 patients of the German CML-Study IV were evaluated. The data set was divided into a learning set and a validation set. The best cutoff was determined applying a minimal p value approach to the Fisher test.
  
  
  RESULTS
  In the learning set, we found BCR-ABL(IS) values between 0.2 and 1.1 % were well suited for predicting a CCyR. In the validation set, the cutoff level of 1 % led to a mean concordance rate of 90.1 %.
  
  
  CONCLUSIONS
  Our results suggest that there is no one-to-one cutoff for BCR-ABL(IS) representing CCyR, but we advise to use the 1 % BCR-ABL(IS) in order to avoid misclassification of CCyR patients.
authors: Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität, Munich, Germany.
authors: Michael
authors: M
authors: Lauseker
authors: Benjamin
authors: B
authors: Hanfstein
authors: Claudia
authors: C
authors: Haferlach
authors: Susanne
authors: S
authors: Schnittger
authors: Markus
authors: M
authors: Pfirrmann
authors: Alice
authors: A
authors: Fabarius
authors: Brigitte
authors: B
authors: Schlegelberger
authors: Susanne
authors: S
authors: Saußele
authors: Christian T
authors: CT
authors: Dietz
authors: Philipp
authors: P
authors: Erben
authors: Rüdiger
authors: R
authors: Hehlmann
authors: Joerg
authors: J
authors: Hasford
authors: Andreas
authors: A
authors: Hochhaus
authors: Martin C
authors: MC
authors: Müller
mesh_terms: D014408:Biomarkers, Tumor / Q000097:blood* / Q000235:genetics; D016044:Fusion Proteins, bcr-abl / Q000097:blood* / Q000235:genetics; D015870:Gene Expression; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000097:blood* / Q000473:pathology / Q000628:therapy; D025202:Molecular Diagnostic Techniques; D012333:RNA, Messenger / Q000097:blood* / Q000235:genetics; D012074:Remission Induction
chemical_list: D014408:Biomarkers, Tumor; D012333:RNA, Messenger; D016044:Fusion Proteins, bcr-abl