Pflug, Natali, Bahlo, Jasmin, Shanafelt, Tait D., Eichhorst, Barbara F., Bergmann, Manuela A., Elter, Thomas, Bauer, Kathrin, Malchau, Gebhart, Rabe, Kari G., Stilgenbauer, Stephan, Doehner, Hartmut, Jaeger, Ulrich, Eckart, Michael J., Hopfinger, Georg, Busch, Raymonde, Fink, Anna-Maria, Wendtner, Clemens-Martin, Fischer, Kirsten, Kay, Neil E. and Hallek, Michael (2014). Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood, 124 (1). S. 49 - 63. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 1528-0020

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Abstract

In addition to clinical staging, a number of biomarkers predicting overall survival (OS) have been identified in chronic lymphocytic leukemia (CLL). The multiplicity of markers, limited information on their independent prognostic value, and a lack of understanding of how to interpret discordant markers are major barriers to use in routine clinical practice. We therefore performed an analysis of 23 prognostic markers based on prospectively collected data from 1948 CLL patients participating in phase 3 trials of the German CLL Study Group to develop a comprehensive prognostic index. A multivariable Cox regression model identified 8 independent predictors of OS: sex, age, ECOG status, del(17p), del(11q), IGHV mutation status, serum beta(2)-microglobulin, and serum thymidine kinase. Using a weighted grading system, a prognostic index was derived that separated 4 risk categories with 5-year OS ranging from 18.7% to 95.2% and having a C-statistic of 0.75. The index stratified OS within all analyzed subgroups, including all Rai/Binet stages. The validity of the index was externally confirmed in a series of 676 newly diagnosed CLL patients from Mayo Clinic. Using this multistep process including external validation, we developed a comprehensive prognostic index with high discriminatory power and prognostic significance on the individual patient level. The studies were registered as follows: CLL1 trial (NCT00262782, http://clinicaltrials.gov), CLL4 trial (ISRCTN 75653261, http://www.controlled-trials.com), and CLL8 trial (NCT00281918, http://clinicaltrials.gov).

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Pflug, NataliUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shanafelt, Tait D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, Barbara F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bergmann, Manuela A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Elter, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bauer, KathrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Malchau, GebhartUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rabe, Kari G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jaeger, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eckart, Michael J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hopfinger, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Busch, RaymondeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Anna-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kay, Neil E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-434097
DOI: 10.1182/blood-2014-02-556399
Journal or Publication Title: Blood
Volume: 124
Number: 1
Page Range: S. 49 - 63
Date: 2014
Publisher: AMER SOC HEMATOLOGY
Place of Publication: WASHINGTON
ISSN: 1528-0020
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SERUM THYMIDINE KINASE; PREVIOUSLY UNTREATED PATIENTS; PHASE-II TRIAL; MUTATIONAL STATUS; PREDICTIVE-VALUE; SURVIVAL; FLUDARABINE; RITUXIMAB; NOTCH1; CLLMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/43409

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