The chemoimmunotherapy FCR (fludarabine and cyclophosphamide with rituximab) is the standard first-line treatment for physically fit chronic lymphocytic leukemia (CLL) patients. To assess the risks and benefits, we investigated health-related quality of life (HRQOL). 817 untreated CLL patients received either FC or FCR within the GCLLSG CLL8 trial. The European Organization for Research and Treatment of Cancer Quality of life Questionnaire C30 was sent to all patients at baseline, after 3, 6, and 12 months and then yearly as follow-up. A total of 769 (94%) of 817 patients completed at least one questionnaire. Comparing HRQOL of CLL patients with the general German population, CLL patients' health declined in most scales except for global health and pain. No major differences in HRQOL were found during treatment or follow-up between both treatment arms. Females were more likely to have treatment-related symptoms than males. Although FCR was associated with more side effects, this did not influence HRQOL. During follow-up after FCR only minor improvement of HRQOL compared with FC was assessed.

b Institute of Medical Statistics and Epidemiology Technical University Munich Germany

c Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic

Department 1 of Internal Medicine and Center of Integrated Oncology Cologne Bonn University Hospital of Cologne Cologne Germany

e Department of Internal Medicine 1 Vienna General Hospital Medical University of Vienna Vienna Austria

f Department of Hematology and Oncology Johannes Gutenberg Universitat Mainz Germany

g Praxis fur Hamatologie und Onkologie Cottbus Germany

h Department of Hematology Oncology Immunology Palliative Care Infectious Diseases and Tropical Medicine Klinikum Schwabing Munich Germany

Internal Medicine 5 University of Heidelberg Heidelberg Germany

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