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Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia |
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| Authors: | Markus Pfirrmann Susanne Saussele Andreas Hochhaus Andreas Reiter Ute Berger Dieter K Hossfeld Christoph Nerl Christof Scheid Karsten Spiekermann Jiri Mayer Andrzej Hellmann Klaus Lechner Christiane Falge Herbert G Sayer Donald Bunjes Arnold Ganser Dietrich W Beelen Helen Baldomero Urs Schanz Hermann Heimpel Hans-Jochem Kolb Joerg Hasford Alois Gratwohl Rüdiger Hehlmann |
| Institution: | 1. Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie - IBE, Ludwig-Maximilians-Universit?t, Marchioninistra?e 15, 81377, Munich, Germany 2. III. Medizinische Klinik, Universit?tsmedizin Mannheim, Universit?t Heidelberg, Mannheim, Germany 3. Abteilung H?matologie/Onkologie, Klinik für Innere Medizin II, Universit?tsklinikum Jena, Jena, Germany 4. II. Medizinische Klinik, Universit?tsklinikum Hamburg-Eppendorf (UKE), Hamburg, Germany 5. Klinik für H?matologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie und Tropenmedizin, Klinikum Schwabing, Munich, Germany 6. Klinik I für Innere Medizin, Uniklinik K?ln, Cologne, Germany 7. Medizinische Klinik III und Poliklinik, Klinikum der Ludwig-Maximilians-Universit?t München, Munich, Germany 8. Department of Internal Medicine, Hematology and Oncology, University Hospital Brno and Masaryk University, Brno, Czech Republic 9. Department of Hematology and Transplantology, University Clinical Center, Medical University of Gdansk, Gdańsk, Poland 10. Allgemeine H?matologie/H?mostaseologie, Universit?tsklinik für Innere Medizin I, Vienna, Austria 11. Medizinische Klinik 5, Klinikum Nürnberg Nord, Nuremberg, Germany 12. Klinik für Innere Medizin III, Universit?tsklinikum Ulm, Ulm, Germany 13. Klinik für H?matologie, H?mostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, Germany 14. Deutsches Register für Stammzelltransplantation (DRST) und Klinik für Knochenmarktransplantation, Universit?tsklinikum Essen, Essen, Germany 15. Abteilung für H?matologie, Universit?tshospital Basel, Basel, Switzerland 16. Swiss Blood Stem Cell Transplantation (SBST), Bern, Switzerland 17. 3. Medizinische Klinik, Klinikum rechts der Isar, Technische Universit?t, Munich, Germany 18. Behandlungszentrum Stammzelltransplantation, Universit?tsspital Basel, Basel, Switzerland |
| Abstract: | PurposeIn 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.MethodsThe Cox proportional hazard cure model was used to identify prognostic factors for post-transplant survival.ResultsDonor–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.ConclusionsDiscrepancies 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. |
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