Fischer, Kirsten, Bahlo, Jasmin, Fink, Anna Maria, Goede, Valentin, Herling, Carmen Diana, Cramer, Paula, Langerbeins, Petra, von Tresckow, Julia, Engelke, Anja, Maurer, Christian, Kovacs, Gabor, Herling, Marco, Tausch, Eugen, Kreuzer, Karl-Anton, Eichhorst, Barbara, Boettcher, Sebastian, Seymour, John F., Ghia, Paolo ORCID: 0000-0003-3750-7342, Marlton, Paula, Kneba, Michael, Wendtner, Clemens-Martin, Doehner, Hartmut, Stilgenbauer, Stephan and Hallek, Michael (2016). Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood, 127 (2). S. 208 - 216. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 1528-0020

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Abstract

Despite promising results with targeted drugs, chemoimmunotherapy with fludarabine, cyclophosphamide (FC), and rituximab (R) remains the standard therapy for fit patients with untreated chronic lymphocytic leukemia (CLL). Herein, we present the long-term follow-up of the randomized CLL8 trial reporting safety and efficacy of FC and FCR treatment of 817 treatment-naive patients with CLL. The primary end point was progression-free survival (PFS). With a median follow-up of 5.9 years, median PFS were 56.8 and 32.9 months for the FCR and FC group (hazard ratio[HR], 0.59; 95% confidence interval [CI], 0.5-0.69, P<.001). Median overall survival (OS) was not reached for the FCR group and was 86.0 months for the FC group (HR, 0.68; 95% CI, 0.54-0.89, P = .001). In patients with mutated IGHV(IGHV MUT), FCR improved PFS and OS compared with FC(PFS: HR, 0.47; 95% CI, 0.33-0.68, P<.001; OS: HR, 0.62; 95% CI, 0.34-1.11, P = .1). This improvement remained applicable for all cytogenetic subgroups other than del(17p). Long-term safety analyses showed that FCR had a higher rate of prolonged neutropenia during the first year after treatment (16.6% vs 8.8%; P = .007). Secondary malignancies including Richter's transformation occurred in 13.1% in the FCR group and in 17.4% in the FC group(P=.1). First-line chemoimmunotherapy with FCR induces long-term remissions and highly relevant improvement in OS in specific genetic subgroups of fit patients with CLL, in particular those with IGHV MUT. This trial was registered at www.clinicaltrials.gov as #NCT00281918.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Anna MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goede, ValentinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herling, Carmen DianaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Langerbeins, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engelke, AnjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maurer, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kovacs, GaborUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herling, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tausch, EugenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreuzer, Karl-AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettcher, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seymour, John F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghia, PaoloUNSPECIFIEDorcid.org/0000-0003-3750-7342UNSPECIFIED
Marlton, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kneba, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-287289
DOI: 10.1182/blood-2015-06-651125
Journal or Publication Title: Blood
Volume: 127
Number: 2
Page Range: S. 208 - 216
Date: 2016
Publisher: AMER SOC HEMATOLOGY
Place of Publication: WASHINGTON
ISSN: 1528-0020
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CHRONIC LYMPHOCYTIC-LEUKEMIA; PROGRESSION-FREE; INITIAL THERAPY; CD38 EXPRESSION; MUTATION STATUS; SINGLE-ARM; OPEN-LABEL; RITUXIMAB; FLUDARABINE; SURVIVALMultiple languages
HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/28728

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