ALBERT

Description: Background: Long-term impairment of quality of life and elevated fatigue levels in Hodgkin Lymphoma (HL) survivors have been frequently reported. However, few longitudinal data and no knowledge on types of fatigue development exist. Therefore, the German Hodgkin Study Group (GHSG) assessed the patients´ fatigue within the prospectively randomized HD13-15 studies (G5) aiming at a detailed longitudinal evaluation and classification of fatigue curves in these studies. Methods: Fatigue measurements used the respective scale of the EORTC QLQ-C30 with scores between 0 and 100. Patients answered the questionnaires before, during, and at the end of therapy and at regular follow-up visits. Longitudinal development of fatigue up to 5 years after end of therapy is given with means and 95%-confidence intervals. The impact of different risk factors and treatments was estimated with linear multiple regression. Analysis of treatment effects was performed separately within the studies for long term fatigue, 2 and 5 years after end of treatment. These analyses were adjusted for age, gender and baseline scores of fatigue. Growth mixture models using Mplus were applied to identify different types of fatigue trajectories within the clinically best arms of the studies which represent current GHSG standards. The level of significance was set to 0.05 and no correction for multiple testing was made. Full information maximum likelihood techniques (FIML) were used to account for missing data. Results: 5,306 patients ≤ 60 years qualified, 325 patients from the early stopped arms B and D in HD13 were excluded and 3,619 survivors contributed at least a baseline fatigue score. Before therapy, fatigue scores were increased in all stages with a significant impact of stage (HD13: 30.8, HD14: 39.8, HD15: 49.0). The respective percentages of patients with very severe fatigue ≥ 50 were 22.3% in HD13, 36.8% in HD14 and 48.2% in HD15. Significant risk factors for baseline fatigue were female gender, albumin 〈 4g/dl, Hb 〈 10.5 g/dl, stage IV disease and high ESR (all P