Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group

Autor: Bertold Emmerich, Werner Freier, Martin Bentz, Hartmut Döhner, Lothar Müller, Kirsten Fischer, Manuela Hoechstetter, Dirk Winkler, Sandra Robrecht, Georg Hopfinger, Carmen D. Herling, Ilona Blau, Frank Hartmann, Georg Jacobs, Barbara Eichhorst, Ulrich Jäger, Jasmin Bahlo, Ursula Vehling-Kaiser, Maria Elisabeth Goebeler, Michael J. Eckart, Clemens M. Wendtner, Andreas Bühler, Michael Starck, Wolfgang Abenhardt, Hans Jürgen Hurtz, Harald Fuss, Stephan Stilgenbauer, Raymonde Busch, Michael Hallek
Rok vydání: 2020
Předmět:
Zdroj: Leukemia. 34:1038-1051
ISSN: 1476-5551
0887-6924
Popis: 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-microglobulin3.5 mg/dL, lymphocyte doubling time (LDT)12 months, and age60 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.
Databáze: OpenAIRE