Pfirrmann, Markus, Saussele, Susanne, Hochhaus, Andreas ORCID: 0000-0003-0626-0834, Reiter, Andreas, Berger, Ute, Hossfeld, Dieter K., Nerl, Christoph, Scheid, Christof, Spiekermann, Karsten, Mayer, Jiri, Hellmann, Andrzej, Lechner, Klaus, Falge, Christiane, Sayer, Herbert G., Bunjes, Donald, Ganser, Arnold, Beelen, Dietrich W., Baldomero, Helen, Schanz, Urs, Heimpel, Hermann, Kolb, Hans-Jochem, Hasford, Joerg, Gratwohl, Alois and Hehlmann, Ruediger (2014). Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia. J. Cancer Res. Clin. Oncol., 140 (8). S. 1367 - 1382. NEW YORK: SPRINGER. ISSN 1432-1335

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Abstract

Purpose In the two consecutive German studies III and IIIA on chronic myeloid leukemia, between 1995 and 2004, 781 patients were randomized to receive either allogeneic hematopoietic stem cell transplantation with a related donor or continued drug treatment. Despite comparable transplantation protocols and most centers participating in both studies, the post-transplant survival probabilities for patients transplanted in first chronic phase were significantly higher in study IIIA (144 patients) than in study III (113 patients). Prior to the decision on a combined analysis of both studies, reasons for this discrepancy had to be investigated. Methods The Cox proportional hazard cure model was used to identify prognostic factors for post-transplant survival. Results Donor-recipient matching for human leukocyte antigen, patient age, time between diagnosis and transplantation, and calendar time showed a significant influence on survival and/or the incidence of cure. Added as a further factor, affiliation to study IIIA had no significant impact any longer. Conclusions Discrepancies in influential prognostic factors explained the different post-transplant survival probabilities between the studies. The significance of calendar time suggests a lack of consistency of transplantation practice over time. Accordingly, the prerequisite for a common assessment of overall survival in the two randomized transplantation arms was not met. Moreover, our analyses provide an independent validation of established prognostic factors and their cutoffs. The statistical approach in investigating and modeling potential prognostic factors for survival sets an example for the examination of studies with unexpected outcome differences in concurrent treatment arms.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Pfirrmann, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Saussele, SusanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hochhaus, AndreasUNSPECIFIEDorcid.org/0000-0003-0626-0834UNSPECIFIED
Reiter, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berger, UteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hossfeld, Dieter K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nerl, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheid, ChristofUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spiekermann, KarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mayer, JiriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hellmann, AndrzejUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lechner, KlausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Falge, ChristianeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sayer, Herbert G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bunjes, DonaldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ganser, ArnoldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beelen, Dietrich W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldomero, HelenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schanz, UrsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heimpel, HermannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kolb, Hans-JochemUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hasford, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gratwohl, AloisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hehlmann, RuedigerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-432656
DOI: 10.1007/s00432-014-1662-y
Journal or Publication Title: J. Cancer Res. Clin. Oncol.
Volume: 140
Number: 8
Page Range: S. 1367 - 1382
Date: 2014
Publisher: SPRINGER
Place of Publication: NEW YORK
ISSN: 1432-1335
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
BONE-MARROW-TRANSPLANTATION; INTERFERON-ALPHA; RISK SCORE; CURE; REGRESSION; CMLMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/43265

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