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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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Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia. / Pfirrmann, Markus; Saussele, Susanne; Hochhaus, Andreas; 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; Hehlmann, Rüdiger; Schweizerische Arbeitsgemeinschaft für Klinische Forschung (SAKK).

in: J CANCER RES CLIN, Jahrgang 140, Nr. 8, 2014, S. 1367-81.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Pfirrmann, M, Saussele, S, Hochhaus, A, Reiter, A, Berger, U, Hossfeld, DK, Nerl, C, Scheid, C, Spiekermann, K, Mayer, J, Hellmann, A, Lechner, K, Falge, C, Sayer, HG, Bunjes, D, Ganser, A, Beelen, DW, Baldomero, H, Schanz, U, Heimpel, H, Kolb, H-J, Hasford, J, Gratwohl, A, Hehlmann, R & Schweizerische Arbeitsgemeinschaft für Klinische Forschung (SAKK) 2014, 'Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia', J CANCER RES CLIN, Jg. 140, Nr. 8, S. 1367-81. https://doi.org/10.1007/s00432-014-1662-y

APA

Pfirrmann, M., Saussele, S., Hochhaus, A., Reiter, A., Berger, U., Hossfeld, D. K., Nerl, C., Scheid, C., Spiekermann, K., Mayer, J., Hellmann, A., Lechner, K., Falge, C., Sayer, H. G., Bunjes, D., Ganser, A., Beelen, D. W., Baldomero, H., Schanz, U., ... Schweizerische Arbeitsgemeinschaft für Klinische Forschung (SAKK) (2014). Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia. J CANCER RES CLIN, 140(8), 1367-81. https://doi.org/10.1007/s00432-014-1662-y

Vancouver

Pfirrmann M, Saussele S, Hochhaus A, Reiter A, Berger U, Hossfeld DK et al. Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia. J CANCER RES CLIN. 2014;140(8):1367-81. https://doi.org/10.1007/s00432-014-1662-y

Bibtex

@article{1f3b8aa1049b4416a0e9e013eadfd7fe,
title = "Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia",
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.",
keywords = "Adolescent, Adult, Child, Female, Hematopoietic Stem Cell Transplantation, Humans, Kaplan-Meier Estimate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Male, Middle Aged, Multivariate Analysis, Prognosis, Proportional Hazards Models, Risk Factors, Transplantation Immunology, Transplantation, Homologous, Young Adult",
author = "Markus Pfirrmann and Susanne Saussele and Andreas Hochhaus and Andreas Reiter and Ute Berger and Hossfeld, {Dieter K} and Christoph Nerl and Christof Scheid and Karsten Spiekermann and Jiri Mayer and Andrzej Hellmann and Klaus Lechner and Christiane Falge and Sayer, {Herbert G} and Donald Bunjes and Arnold Ganser and Beelen, {Dietrich W} and Helen Baldomero and Urs Schanz and Hermann Heimpel and Hans-Jochem Kolb and Joerg Hasford and Alois Gratwohl and R{\"u}diger Hehlmann and {Schweizerische Arbeitsgemeinschaft f{\"u}r Klinische Forschung (SAKK)}",
year = "2014",
doi = "10.1007/s00432-014-1662-y",
language = "English",
volume = "140",
pages = "1367--81",
journal = "J CANCER RES CLIN",
issn = "0171-5216",
publisher = "Springer",
number = "8",

}

RIS

TY - JOUR

T1 - Explaining survival differences between two consecutive studies with allogeneic stem cell transplantation in patients with chronic myeloid leukemia

AU - Pfirrmann, Markus

AU - Saussele, Susanne

AU - Hochhaus, Andreas

AU - Reiter, Andreas

AU - Berger, Ute

AU - Hossfeld, Dieter K

AU - Nerl, Christoph

AU - Scheid, Christof

AU - Spiekermann, Karsten

AU - Mayer, Jiri

AU - Hellmann, Andrzej

AU - Lechner, Klaus

AU - Falge, Christiane

AU - Sayer, Herbert G

AU - Bunjes, Donald

AU - Ganser, Arnold

AU - Beelen, Dietrich W

AU - Baldomero, Helen

AU - Schanz, Urs

AU - Heimpel, Hermann

AU - Kolb, Hans-Jochem

AU - Hasford, Joerg

AU - Gratwohl, Alois

AU - Hehlmann, Rüdiger

AU - Schweizerische Arbeitsgemeinschaft für Klinische Forschung (SAKK)

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Child

KW - Female

KW - Hematopoietic Stem Cell Transplantation

KW - Humans

KW - Kaplan-Meier Estimate

KW - Leukemia, Myelogenous, Chronic, BCR-ABL Positive

KW - Male

KW - Middle Aged

KW - Multivariate Analysis

KW - Prognosis

KW - Proportional Hazards Models

KW - Risk Factors

KW - Transplantation Immunology

KW - Transplantation, Homologous

KW - Young Adult

U2 - 10.1007/s00432-014-1662-y

DO - 10.1007/s00432-014-1662-y

M3 - SCORING: Journal article

C2 - 24718719

VL - 140

SP - 1367

EP - 1381

JO - J CANCER RES CLIN

JF - J CANCER RES CLIN

SN - 0171-5216

IS - 8

ER -