Kutsch, Nadine, Bahlo, Jasmin, Robrecht, Sandra, Franklin, Jeremy, Zhang, Can, Maurer, Christian, De Silva, Nisha, Lange, Elisabeth, Weide, Rudolf, Kiehl, Michael G., Soekler, Martin, Schlag, Rudolf, Vehling-Kaiser, Ursula, Koechling, Georg, Ploeger, Christoph, Gregor, Michael, Plesner, Torben, Herling, Marco, Fischer, Kirsten, Doehner, Hartmut, Kneba, Michael, Wendtner, Clemens-Martin, Klapper, Wolfram, Kreuzer, Karl-Anton, Boettcher, Sebastian, Stilgenbauer, Stephan, Fink, Anna Maria, Hallek, Michael and Eichhorst, Barbara (2020). Long Term Follow-up Data and Health-Related Quality of Life in Frontline Therapy of Fit Patients Treated With FCR Versus BR (CLL10 Trial of the GCLLSG). Hemasphere, 4 (1). PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 2572-9241

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Abstract

Fludarabine, cyclophosphamide and rituximab (FCR) was compared to bendamustine and rituximab (BR) in an international, randomized, open label, phase 3 trial in 561 previously untreated, fit patients with chronic lymphocytic leukemia (CLL) without del (17p). Primary endpoint was progression free survival (PFS). The final primary endpoint analysis after 37.1 months median follow up failed to show the non-inferiority of BR as compared with FCR. With extended median follow up of 58.2 months, median PFS was 42.3 months in BR-treated patients versus 57.6 months for FCR-treated patients (Hazard Ratio [HR] 1.593; 95% CI 1.271-1.996; p < 0.0001). For patients > 65 years, median PFS was 48.5 months with BR versus 57.9 months with FCR without reaching statistical significance (HR 1.352; 95% CI 0.912-2.006; p = 0.134). Median OS was not reached for both arms with 5-year OS rates of 80.1% vs 80.9%, respectively (HR 1.108; 95% CI 0.755-1.627; p = 0.599). No statistically significant difference was found in the time to secondary malignancy between the 2 groups (at 5 years, 86.6% free from secondary malignancies in the BR group vs 83.8% in the FCR group [HR 0.801; 95% CI 0.507-1.267; p = 0.344]). In patients >65 years secondary neoplasia occurred more frequently after FCR treatment [28 of 86 (32.6%) patients] as compared with BR [18 of 107 (16.8%) patients; p = 0.011]. Health-related quality of life was similar in both treatments. Despite the improved PFS for FCR, OS did not differ. These results also suggest an increase in secondary neoplasia associated with FCR in elderly fit CLL patients.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kutsch, NadineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Robrecht, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Franklin, JeremyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zhang, CanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maurer, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Silva, NishaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lange, ElisabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weide, RudolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kiehl, Michael G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soekler, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schlag, RudolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vehling-Kaiser, UrsulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koechling, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ploeger, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gregor, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Plesner, TorbenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herling, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kneba, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klapper, WolframUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreuzer, Karl-AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettcher, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Anna MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-345989
DOI: 10.1097/HS9.0000000000000336
Journal or Publication Title: Hemasphere
Volume: 4
Number: 1
Date: 2020
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 2572-9241
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CHRONIC LYMPHOCYTIC-LEUKEMIA; PREVIOUSLY UNTREATED PATIENTS; 2ND CANCERS; FLUDARABINE; RITUXIMAB; CHEMOIMMUNOTHERAPY; CYCLOPHOSPHAMIDE; BENDAMUSTINE; MALIGNANCIES; COMBINATIONMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/34598

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