Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial

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, Bottcher, Sebastian, Seymour, John F., Ghia, Paolo, Marlton, Paula, Kneba, Michael, Wendtner, Clemens-Martin, Dohner, 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: 208-215. doi:10.1182/blood-2015-06-651125


Author 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
Bottcher, Sebastian
Seymour, John F.
Ghia, Paolo
Marlton, Paula
Kneba, Michael
Wendtner, Clemens-Martin
Dohner, Hartmut
Stilgenbauer, Stephan
Hallek, Michael
Title Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial
Journal name Blood   Check publisher's open access policy
ISSN 1528-0020
1872-6089
Publication date 2016-01-14
Sub-type Article (original research)
DOI 10.1182/blood-2015-06-651125
Open Access Status Not yet assessed
Volume 127
Issue 2
Start page 208
End page 215
Total pages 8
Place of publication Washington, DC, United States
Publisher American Society of Hematology
Language eng
Formatted 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-näive 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], 0.50- 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, =.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.
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Institutional Status UQ

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Sub-type: Article (original research)
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