Fludarabine, cyclophosphamide, and rituximab as first‐line treatment in patients with chronic lymphocytic leukemia: A long‐term analysis of the German CLL Study Group (GCLLSG) registry

• Published in: European journal of haematology 2024-08, Vol.113 (2), p.235-241
• Main Authors: Kutsch, Nadine, Giza, Adam, Robrecht, Sandra, Stumpf, Janina, Federhen, Anno, Stoltefuß, Andrea, Vehling‐Kaiser, Ursula, Koenigsmann, Michael, Tausch, Eugen, Schneider, Christof, Stilgenbauer, Stephan, Illmer, Thomas, Schlag, Rudolf, Dörfel, Steffen, Gaska, Tobias, Kiehl, Michael, Müller‐Hagen, Sigrun, Moorahrend, Enno, Linde, Hartmut, Schlenska‐Lange, Anke, Tresckow, Julia, Fischer, Kirsten, Eichhorst, Barbara, Hallek, Michael, Fink, Anna Maria
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chronic lymphocytic leukemia; Clinical trials; CLL; Cyclophosphamide; Cyclophosphamide - administration & dosage; Cyclophosphamide - therapeutic use; Data collection; FCR; Female; Fludarabine; GCLLSG registry; Germany - epidemiology; Humans; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell - diagnosis; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy; Leukemia, Lymphocytic, Chronic, B-Cell - mortality; Male; Middle Aged; Patients; Registries; Rituximab; Rituximab - administration & dosage; Rituximab - therapeutic use; Survival; Treatment Outcome; Vidarabine - administration & dosage; Vidarabine - analogs & derivatives; Vidarabine - therapeutic use
• ISSN: 0902-4441; 1600-0609; 1600-0609
• DOI: 10.1111/ejh.14220

Long‐term data of chronic lymphocytic leukemia (CLL) patients with favorable risk who were treated with fludarabine, cyclophosphamide, and rituximab (FCR) within clinical trials show good efficacy. We here report long‐term data collected within the GCLLSG registry. Altogether, 417 CLL patients who received first‐line treatment with FCR were analyzed, of which 293 (70.3%) were treated outside of clinical trials. The median observation time from first‐line was 95.8 (interquartile range 58.7–126.8) months. Focusing on data of 194 (46.5%) patients who received FCR first‐line treatment after 2013 (start of data collection within GCLLSG registry), responses were documented in 85% of the patients, non‐responses in 15%, and for 3.6% the assessment was missing. Median event‐free survival (EFS, time until disease progression, subsequent treatment, or death) was 60.2 months with a 5‐year EFS‐rate of 50.6%. Patients with higher‐risk disease, characterized by unmutated IGHV (N = 78), had a median EFS of 45.4 months with a 5‐year EFS rate of 36.3%, while the median EFS was 77.5 months with a 5‐year EFS rate of 60.3% in patients with mutated IGHV (N = 40). Median overall survival was not reached with a 5‐year survival rate of 92.7%. In summary, first‐line FCR was associated with long EFS, especially in patients exhibiting a mutated IGHV status.