Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial.

Autor:	Bühler A; Department of Internal Medicine III, Ulm University, Ulm, Germany., Wendtner CM; Klinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany.; Department I of Internal Medicine, University of Cologne, Cologne, Germany., Kipps TJ; University of California San Diego Moores Cancer Center, La Jolla, CA, USA., Rassenti L; University of California San Diego Moores Cancer Center, La Jolla, CA, USA., Fraser GA; McMaster University, Juravinski Cancer Centre, Hamilton, ON, Canada., Michallet AS; Hospices civils de Lyon, Centre Hospitalier Lyon Sud, Lyon, France., Hillmen P; St James's Institute of Oncology, Leeds, UK., Dürig J; University Hospital Essen, Essen, Germany., Gregory SA; Rush University Medical Center, Chicago, IL, USA., Kalaycio M; Cleveland Clinic, Cleveland, OH, USA., Aurran-Schleinitz T; Institut Paoli Calmettes, Marseille, France., Trentin L; Padua University School of Medicine, Padua, Italy., Gribben JG; Barts Cancer Institute, Queen Mary, University of London, London, UK., Chanan-Khan A; Mayo Clinic, Jacksonville, FL, USA., Purse B; Celgene Corporation, Summit NJ, USA., Zhang J; Celgene Corporation, Summit NJ, USA., De Bedout S; Celgene Corporation, Boudry, Switzerland., Mei J; Celgene Corporation, Summit NJ, USA., Hallek M; Department I of Internal Medicine, University of Cologne, Cologne, Germany.; Cologne Cluster of Excellence in Cellular Stress Responses in Aging-associated Diseases (CECAD), Cologne, Germany., Stilgenbauer S; Department of Internal Medicine III, Ulm University, Ulm, Germany.
Jazyk:	angličtina
Zdroj:	Blood cancer journal [Blood Cancer J] 2016 Mar 11; Vol. 6, pp. e404. Date of Electronic Publication: 2016 Mar 11.
DOI:	10.1038/bcj.2016.9
Abstrakt:	Efficacy of lenalidomide was investigated in 103 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated on the prospective, multicenter randomized phase-II CLL-009 trial. Interphase cytogenetic and mutational analyses identified TP53 mutations, unmutated IGHV, or del(17p) in 36/96 (37.5%), 68/88 (77.3%) or 22/92 (23.9%) patients. The overall response rate (ORR) was 40.4% (42/104). ORRs were similar irrespective of TP53 mutation (36.1% (13/36) vs 43.3% (26/60) for patients with vs without mutation) or IGHV mutation status (45.0% (9/20) vs 39.1% (27/68)); however, patients with del(17p) had lower ORRs than those without del(17p) (21.7% (5/22) vs 47.1% (33/70); P=0.049). No significant differences in progression-free survival and overall survival (OS) were observed when comparing subgroups defined by the presence or absence of high-risk genetic characteristics. In multivariate analyses, only multiple prior therapies (⩾3 lines) significantly impacted outcomes (median OS: 21.2 months vs not reached; P=0.019). This analysis indicates that lenalidomide is active in patients with relapsed/refractory CLL with unfavorable genetic profiles, including TP53 inactivation or unmutated IGHV. (ClinicalTrials.gov identifier: NCT00963105).
Databáze:	MEDLINE
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