Herling, Carmen D., Cymbalista, Florence, Gross-Ophoff-Mueller, Carolin, Bahlo, Jasmin, Robrecht, Sandra, Langerbeins, Petra, Fink, Anna-Maria, Al-Sawaf, Othman, Busch, Raymonde, Porcher, Raphael ORCID: 0000-0002-5277-4679, Cazin, Bruno, Dreyfus, Brigitte, Ibach, Stefan, Lepretre, Stephane, Fischer, Kirsten, Kaiser, Florian, Eichhorst, Barbara, Wentner, Clemens-Martin, Hoechstetter, Manuela A., Doehner, Hartmut, Leblond, Veronique, Kneba, Michael, Letestu, Remi, Boettcher, Sebastian, Stilgenbauer, Stephan, Hallek, Michael and Levy, Vincent (2020). Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial. Leukemia, 34 (8). S. 2038 - 2051. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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Abstract

We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with >= 2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care watch and wait for these patients.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Herling, Carmen D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cymbalista, FlorenceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gross-Ophoff-Mueller, CarolinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Robrecht, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Langerbeins, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Anna-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Al-Sawaf, OthmanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Busch, RaymondeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Porcher, RaphaelUNSPECIFIEDorcid.org/0000-0002-5277-4679UNSPECIFIED
Cazin, BrunoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyfus, BrigitteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ibach, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lepretre, StephaneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaiser, FlorianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wentner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoechstetter, Manuela A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Leblond, VeroniqueUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kneba, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Letestu, RemiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettcher, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Levy, VincentUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-344676
DOI: 10.1038/s41375-020-0747-7
Journal or Publication Title: Leukemia
Volume: 34
Number: 8
Page Range: S. 2038 - 2051
Date: 2020
Publisher: NATURE PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1476-5551
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INITIAL THERAPY; OPEN-LABEL; FLUDARABINE; RITUXIMAB; CYCLOPHOSPHAMIDE; SURVIVAL; PROGRESSION; CHEMOIMMUNOTHERAPY; QUANTIFICATION; GUIDELINESMultiple languages
Oncology; HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/34467

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