Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group
The heterogeneity of early stage CLL challenges prognostication, and refinement of prognostic indices for risk-adapted management in this population is essential. The aim of the multicenter, prospective CLL1 trial was to explore a novel prognostic model (CLL1-PM) developed to identify risk groups, s...
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| creator | Hoechstetter, Manuela A. Busch, Raymonde Eichhorst, Barbara Bühler, Andreas Winkler, Dirk Bahlo, Jasmin Robrecht, Sandra Eckart, Michael J. Vehling-Kaiser, Ursula Jacobs, Georg Jäger, Ulrich Hurtz, Hans Jürgen Hopfinger, Georg Hartmann, Frank Fuss, Harald Abenhardt, Wolfgang Blau, Ilona Freier, Werner Müller, Lothar Goebeler, Maria Wendtner, Clemens Fischer, Kirsten Herling, Carmen D. Starck, Michael Bentz, Martin Emmerich, Bertold Döhner, Hartmut Stilgenbauer, Stephan Hallek, Michael |
| description | The heterogeneity of early stage CLL challenges prognostication, and refinement of prognostic indices for risk-adapted management in this population is essential. The aim of the multicenter, prospective CLL1 trial was to explore a novel prognostic model (CLL1-PM) developed to identify risk groups, separating patients with favorable from others with dismal prognosis. A cohort of 539 clinically, biochemically, and genetically characterized Binet stage A patients were observed until progression, first-line treatment, or death. Multivariate analysis identified six independent factors associated with overall survival (OS) and time-to-first treatment (TTFT): del(17p), unmutated
IGHV
, del(11q), ß2-microglobulin >3.5 mg/dL, lymphocyte doubling time (LDT) 60 years. These factors were integrated into the CLL1-PM, which stratified patients into four risk groups. The CLL1-PM was prognostic for OS and TTFT, e.g., the risk of treatment at 5 years was 85.9, 51.8, 27.6, and 11.3% for very low (0–1.5), low (2–4), high (4.5–6.5), and very high-risk (7–14) scores, respectively (
P
|
| doi_str_mv | 10.1038/s41375-020-0727-y |
| format | Article |
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IGHV
, del(11q), ß2-microglobulin >3.5 mg/dL, lymphocyte doubling time (LDT) <12 months, and age >60 years. These factors were integrated into the CLL1-PM, which stratified patients into four risk groups. The CLL1-PM was prognostic for OS and TTFT, e.g., the risk of treatment at 5 years was 85.9, 51.8, 27.6, and 11.3% for very low (0–1.5), low (2–4), high (4.5–6.5), and very high-risk (7–14) scores, respectively (
P
< 0.001). Notably, in addition to factors comprising CLL-IPI, we substantiated del(11q) and LDT as prognostic factors in early CLL. Altogether, our findings would be useful to effectively stratify Binet stage A patients, particularly within the scope of clinical trials evaluating novel agents.</description><identifier>ISSN: 0887-6924</identifier><identifier>EISSN: 1476-5551</identifier><identifier>DOI: 10.1038/s41375-020-0727-y</identifier><identifier>PMID: 32042081</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/67/1990/283/1895 ; 692/308/2779/777 ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biomarkers, Tumor - genetics ; Cancer ; Cancer Research ; Care and treatment ; Chronic lymphocytic leukemia ; Clinical trials ; Critical Care Medicine ; Diagnosis ; Disease Progression ; Female ; Follow-Up Studies ; Health risk assessment ; Hematology ; Heterogeneity ; Humans ; Intensive ; Internal Medicine ; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy ; Leukemia, Lymphocytic, Chronic, B-Cell - genetics ; Leukemia, Lymphocytic, Chronic, B-Cell - pathology ; Lymphocytes ; Male ; Medical prognosis ; Medicine ; Medicine & Public Health ; Middle Aged ; Multivariate analysis ; Mutation ; Oncology ; Oncology, Experimental ; Patients ; Prognosis ; Prospective Studies ; Risk ; Risk Factors ; Risk groups ; Risk management ; Survival Rate ; Time-to-Treatment</subject><ispartof>Leukemia, 2020-04, Vol.34 (4), p.1038-1051</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Limited 2020</rights><rights>COPYRIGHT 2020 Nature Publishing Group</rights><rights>2020© The Author(s), under exclusive licence to Springer Nature Limited 2020</rights><rights>The Author(s), under exclusive licence to Springer Nature Limited 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-d88032c1e5a220c6ee58fc4ca61bdf61e36c30b4fb553bff2619c43f26995ce73</citedby><cites>FETCH-LOGICAL-c498t-d88032c1e5a220c6ee58fc4ca61bdf61e36c30b4fb553bff2619c43f26995ce73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41375-020-0727-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41375-020-0727-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32042081$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hoechstetter, Manuela A.</creatorcontrib><creatorcontrib>Busch, Raymonde</creatorcontrib><creatorcontrib>Eichhorst, Barbara</creatorcontrib><creatorcontrib>Bühler, Andreas</creatorcontrib><creatorcontrib>Winkler, Dirk</creatorcontrib><creatorcontrib>Bahlo, Jasmin</creatorcontrib><creatorcontrib>Robrecht, Sandra</creatorcontrib><creatorcontrib>Eckart, Michael J.</creatorcontrib><creatorcontrib>Vehling-Kaiser, Ursula</creatorcontrib><creatorcontrib>Jacobs, Georg</creatorcontrib><creatorcontrib>Jäger, Ulrich</creatorcontrib><creatorcontrib>Hurtz, Hans Jürgen</creatorcontrib><creatorcontrib>Hopfinger, Georg</creatorcontrib><creatorcontrib>Hartmann, Frank</creatorcontrib><creatorcontrib>Fuss, Harald</creatorcontrib><creatorcontrib>Abenhardt, Wolfgang</creatorcontrib><creatorcontrib>Blau, Ilona</creatorcontrib><creatorcontrib>Freier, Werner</creatorcontrib><creatorcontrib>Müller, Lothar</creatorcontrib><creatorcontrib>Goebeler, Maria</creatorcontrib><creatorcontrib>Wendtner, Clemens</creatorcontrib><creatorcontrib>Fischer, Kirsten</creatorcontrib><creatorcontrib>Herling, Carmen D.</creatorcontrib><creatorcontrib>Starck, Michael</creatorcontrib><creatorcontrib>Bentz, Martin</creatorcontrib><creatorcontrib>Emmerich, Bertold</creatorcontrib><creatorcontrib>Döhner, Hartmut</creatorcontrib><creatorcontrib>Stilgenbauer, Stephan</creatorcontrib><creatorcontrib>Hallek, Michael</creatorcontrib><title>Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group</title><title>Leukemia</title><addtitle>Leukemia</addtitle><addtitle>Leukemia</addtitle><description>The heterogeneity of early stage CLL challenges prognostication, and refinement of prognostic indices for risk-adapted management in this population is essential. The aim of the multicenter, prospective CLL1 trial was to explore a novel prognostic model (CLL1-PM) developed to identify risk groups, separating patients with favorable from others with dismal prognosis. A cohort of 539 clinically, biochemically, and genetically characterized Binet stage A patients were observed until progression, first-line treatment, or death. Multivariate analysis identified six independent factors associated with overall survival (OS) and time-to-first treatment (TTFT): del(17p), unmutated
IGHV
, del(11q), ß2-microglobulin >3.5 mg/dL, lymphocyte doubling time (LDT) <12 months, and age >60 years. These factors were integrated into the CLL1-PM, which stratified patients into four risk groups. The CLL1-PM was prognostic for OS and TTFT, e.g., the risk of treatment at 5 years was 85.9, 51.8, 27.6, and 11.3% for very low (0–1.5), low (2–4), high (4.5–6.5), and very high-risk (7–14) scores, respectively (
P
< 0.001). Notably, in addition to factors comprising CLL-IPI, we substantiated del(11q) and LDT as prognostic factors in early CLL. Altogether, our findings would be useful to effectively stratify Binet stage A patients, particularly within the scope of clinical trials evaluating novel agents.</description><subject>631/67/1990/283/1895</subject><subject>692/308/2779/777</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biomarkers, Tumor - genetics</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Care and treatment</subject><subject>Chronic lymphocytic leukemia</subject><subject>Clinical trials</subject><subject>Critical Care Medicine</subject><subject>Diagnosis</subject><subject>Disease Progression</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Health risk assessment</subject><subject>Hematology</subject><subject>Heterogeneity</subject><subject>Humans</subject><subject>Intensive</subject><subject>Internal Medicine</subject><subject>Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy</subject><subject>Leukemia, Lymphocytic, Chronic, B-Cell - genetics</subject><subject>Leukemia, Lymphocytic, Chronic, B-Cell - pathology</subject><subject>Lymphocytes</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Multivariate analysis</subject><subject>Mutation</subject><subject>Oncology</subject><subject>Oncology, Experimental</subject><subject>Patients</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Risk</subject><subject>Risk Factors</subject><subject>Risk groups</subject><subject>Risk management</subject><subject>Survival 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Michael</au><au>Bentz, Martin</au><au>Emmerich, Bertold</au><au>Döhner, Hartmut</au><au>Stilgenbauer, Stephan</au><au>Hallek, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group</atitle><jtitle>Leukemia</jtitle><stitle>Leukemia</stitle><addtitle>Leukemia</addtitle><date>2020-04-01</date><risdate>2020</risdate><volume>34</volume><issue>4</issue><spage>1038</spage><epage>1051</epage><pages>1038-1051</pages><issn>0887-6924</issn><eissn>1476-5551</eissn><abstract>The heterogeneity of early stage CLL challenges prognostication, and refinement of prognostic indices for risk-adapted management in this population is essential. The aim of the multicenter, prospective CLL1 trial was to explore a novel prognostic model (CLL1-PM) developed to identify risk groups, separating patients with favorable from others with dismal prognosis. A cohort of 539 clinically, biochemically, and genetically characterized Binet stage A patients were observed until progression, first-line treatment, or death. Multivariate analysis identified six independent factors associated with overall survival (OS) and time-to-first treatment (TTFT): del(17p), unmutated
IGHV
, del(11q), ß2-microglobulin >3.5 mg/dL, lymphocyte doubling time (LDT) <12 months, and age >60 years. These factors were integrated into the CLL1-PM, which stratified patients into four risk groups. The CLL1-PM was prognostic for OS and TTFT, e.g., the risk of treatment at 5 years was 85.9, 51.8, 27.6, and 11.3% for very low (0–1.5), low (2–4), high (4.5–6.5), and very high-risk (7–14) scores, respectively (
P
< 0.001). Notably, in addition to factors comprising CLL-IPI, we substantiated del(11q) and LDT as prognostic factors in early CLL. Altogether, our findings would be useful to effectively stratify Binet stage A patients, particularly within the scope of clinical trials evaluating novel agents.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>32042081</pmid><doi>10.1038/s41375-020-0727-y</doi><tpages>14</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0887-6924 |
| ispartof | Leukemia, 2020-04, Vol.34 (4), p.1038-1051 |
| issn | 0887-6924 1476-5551 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2353585289 |
| source | MEDLINE; SpringerLink Journals (MCLS) |
| subjects | 631/67/1990/283/1895 692/308/2779/777 Adult Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biomarkers, Tumor - genetics Cancer Cancer Research Care and treatment Chronic lymphocytic leukemia Clinical trials Critical Care Medicine Diagnosis Disease Progression Female Follow-Up Studies Health risk assessment Hematology Heterogeneity Humans Intensive Internal Medicine Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Leukemia, Lymphocytic, Chronic, B-Cell - genetics Leukemia, Lymphocytic, Chronic, B-Cell - pathology Lymphocytes Male Medical prognosis Medicine Medicine & Public Health Middle Aged Multivariate analysis Mutation Oncology Oncology, Experimental Patients Prognosis Prospective Studies Risk Risk Factors Risk groups Risk management Survival Rate Time-to-Treatment |
| title | Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T01%3A28%3A35IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Prognostic%20model%20for%20newly%20diagnosed%20CLL%20patients%20in%20Binet%20stage%20A:%20results%20of%20the%20multicenter,%20prospective%20CLL1%20trial%20of%20the%20German%20CLL%20study%20group&rft.jtitle=Leukemia&rft.au=Hoechstetter,%20Manuela%20A.&rft.date=2020-04-01&rft.volume=34&rft.issue=4&rft.spage=1038&rft.epage=1051&rft.pages=1038-1051&rft.issn=0887-6924&rft.eissn=1476-5551&rft_id=info:doi/10.1038/s41375-020-0727-y&rft_dat=%3Cgale_proqu%3EA619116603%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2384804086&rft_id=info:pmid/32042081&rft_galeid=A619116603&rfr_iscdi=true |