ASSESSMENT OF IMATINIB 400MG AS FIRST LINE TREATMENT OF CHRONIC MYELOID LEUKEMIA: 10 -YEAR SURVIVAL RESULTS OF THE RANDOMIZED CML STUDY IV
Author(s): ,
Ruediger Hehlmann
Affiliations:
Medical Faculty Mannheim,Ruprecht Karls University Heidelberg,Mannheim,Germany
,
Michael Lauseker
Affiliations:
Medical Faculty,Ludwig-Maximilians University of Munich,Munich,Germany
,
Susanne Saussele
Affiliations:
Medical Faculty Mannheim,Ruprecht Karls University Heidelberg,Mannheim,Germany
,
Markus Pfirrmann
Affiliations:
Medical Faculty,Ludwig-Maximilians University of Munich,Munich,Germany
,
Stefan Krause
Affiliations:
Medical Clinic 5,University Hospital Erlangen,Erlangen,Germany
,
Hans-Jochem Kolb
Affiliations:
Medical Department,Ludwig-Maximilians University of Munich,Munich,Germany
,
A. Neubauer
Affiliations:
Medical Department of Haematology,University Hospital Giessen,Giessen,Germany
,
Dieter K. Hossfeld
Affiliations:
Oncology Department,University Hospital Hamburg,Hamburg,Germany
,
Christoph Nerl
Affiliations:
Medical Department of Haematology,University Hospital Schwabing,Munich,Germany
,
Alois Gratwohl
Affiliations:
Medical Department of Haematology,University Hospital Basel,Basel,Switzerland
,
Gabriela M. Baerlocher
Affiliations:
Department of Clinical Research,University Hospital Bern,Bern,Switzerland
,
Dominik Heim
Affiliations:
Department of Surgery,University Hospital Basel,Basel,Switzerland
,
Alice Fabarius
Affiliations:
Medical Faculty Mannheim,Ruprecht-Karls University Heidelberg,Mannheim,Germany
,
Claudia Haferlach
Affiliations:
Dept of Haematology and Oncology,MHP Munich,Munich,Germany
,
Brigitte Schlegelberger
Affiliations:
Institute of Cell and Molecular Pathology,Hannover Medical School,Hannover,Germany
,
Martin C. Mueller
Affiliations:
Medical Department,Ruprecht Karls University Heidelberg,Mannheim,Germany
,
Sabine Jeromin
Affiliations:
Dept of Haematology and Oncology,MHP Munich,Munich,Germany
,
Ulrike Proetel
Affiliations:
Medical Faculty Mannheim,Ruprecht Karls University Heidelberg,Mannheim,Germany
,
Katharina Kohlbrenner
Affiliations:
Medical Faculty Mannheim,Ruprecht Karls University Heidelberg,Mannheim,Germany
,
Andreas Burchert
Affiliations:
Medical Department,Philipps University Marburg,Marburg,Germany
,
Astghik Voskanyan
Affiliations:
Medical Faculty Mannheim,Ruprecht Karls University Heidelberg,Mannheim,Germany
,
Sebastien Rinaldetti
Affiliations:
Medical Faculty Mannheim,Ruprecht Karls University Heidelberg,Mannheim,Germany
,
M.E. Goebeler
Affiliations:
Medical Department,University Hospital Wuerzburg,Würzburg,Germany
,
Jolanta Dengler
Affiliations:
Oncology Practice,Heilbronn,Germany
,
Anthony Ho
Affiliations:
Department of Medicine V,University Hospital Heidelberg,Heidelberg,Germany
,
Christiane Falge
Affiliations:
Ambulant Treatment Center,Hospital Nuremberg North,Nuremberg,Germany
,
Lothar Kanz
Affiliations:
Medical Faculty,University Hospital Tuebingen,Tuebingen,Germany
,
Michael Kneba
Affiliations:
Medical Department,University Hospital Kiel,Kiel,Germany
,
Frank Stegelmann
Affiliations:
Medical Department III,University Hospital Ulm,Ulm,Germany
,
Michael Pfreundschuh
Affiliations:
Medical Department I,University Hospital,Homburg,Germany
,
Cornelius F Waller
Affiliations:
Department of Haematology/Oncology,University Hospital Freiburg,Freiburg,Germany
,
Karsten Spiekermann
Affiliations:
Medical Department III,University Hospital Munich,Munich,Germany
,
Roland Fuchs
Affiliations:
Oncology Department,University Hospital Eschweiler,Eschweiler,Germany
,
Christoph Scheid
Affiliations:
Medical Department,University Hospital Cologne,Cologne,Germany
,
Mathias Hänel
Affiliations:
Medical Department,University Hospital,Chemnitz,Germany
,
Claus-Henning Köhne
Affiliations:
Department of Haematology/Oncology,University Hospital Oldenburg,Oldenburg,Germany
,
Tim Hendrik Brümmendorf
Affiliations:
Department of Haematology/Oncology,University Hospital Aachen,Aachen,Germany
,
Hans-Walter Lindemann
Affiliations:
Department of Haematology/Oncology,Catholic Hospital Hagen,Hagen,Germany
,
Wolfgang E. Berdel
Affiliations:
Medical Department,University Hospital Münster,Münster,Germany
,
Peter Staib
Affiliations:
Department of Haematology/Oncology,St. Antonius Hospital Eschweiler,Eschweiler,Germany
,
Leopold Balleisen
Affiliations:
Medical Department,Protestant Hospital Hamm,Hamm,Germany
,
Peter Brossart
Affiliations:
Department of Haematology/Oncology,University Hospital Bonn,Bonn,Germany
,
Michael Schenk
Affiliations:
Department of Haematology/Oncology,KBB Regensburg,Regensburg,Germany
,
Rudolf Zankovich
Affiliations:
Department of Haematology/Oncology,Darmzentrum Köln,Köln,Germany
,
Thomas Geer
Affiliations:
Department of Haematology/Oncology,Diakonie Hospital Schwäbisch-Hall,Schwäbisch-Hall,Germany
,
Bernd Hertenstein
Affiliations:
Medical Department,Hospital Bremen,Bremen,Germany
,
Stephan Bildat
Affiliations:
Department of Haematology/Oncology,Hospital Herford,Herford,Germany
,
Andreas Hochhaus
Affiliations:
Department of Haematology/Oncology,University Hospital Jena,Jena,Germany
Jörg Hasford
Affiliations:
Institute of Medical Informatics,Ludwig-Maximilians University of Munich,Munich,Germany
EHA Learning Center. Hehlmann R. Jun 24, 2017; 181711
Prof. R Hehlmann
Prof. R Hehlmann

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Abstract
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Abstract: S424

Type: Oral Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 12:00 - 12:15

Location: Hall D

Background
The optimum initial treatment of chronic myeloid leukemia (CML) is unknown.

Aims
CML-study IV was designed to confirm the International Randomized Study on Interferon (IFN) and STI571 (IRIS) and to explore whether treatment with imatinib (IM) at 400mg/day could be optimized.

Methods
From July 2002 to March 2012, 1551 newly diagnosed patients in chronic phase (CP) were randomized into a 5-arm study. 1536 patients were evaluable, 400 for IM400mg, 430 for IM + IFN, 420 for IM800mg, 158 for IM + cytarabine and 128 for IM-after-IFN-failure. Recruitment to the latter two arms was stopped after a pilot-phase.

Results
After a median observation time of 9.5 years, 10-year overall survival (OS) of all patients was 82%, 10-year progression free survival 80% and, 10-year relative survival 92%. 10-year OS was 80% with IM400mg, 84% with IM + IFN, 79% with IM800mg, 84% with IM + cytarabine and 79% with IM after IFN (Figure 1). The differences were not significant in spite of faster response with IM800mg. In a multivariate analysis, risk group, comorbidities, major route chromosomal aberrations, smoking and type of treatment center (academic vs other) influenced survival, but not gender, transcript type or any form of treatment optimization. Patients reaching the molecular response milestones at 3, 6 and 12 months had a significantly better survival, the faster response of a treatment group (IM800mg) did not translate into a detectable survival advantage.

Conclusion
Monotherapy with IM400mg provides a close to normal life expectancy. Faster response does not necessarily translate into better survival. Outcome of CML is currently more determined by disease biology and demographics than by treatment optimization.

Session topic: 8. Chronic myeloid leukemia - Clinical

Keyword(s): Chronic myeloid leukemia, Survival, imatinib

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