Baseline Characteristics Associated with Quality of Life in CLL Patients Requiring Therapy.

There is little systematic information about the experience of patients with active untreated CLL and its impact on their health-related quality of life (HRQoL). Using the EORTC QLQ-C30 questionnaire we measured HRQoL in patients requiring first-line treatment for CLL, at the time of randomisation into the LRF CLL4 trial. Patients were scored 0–100 within each of 15 different domains. Tests of significance used were Mann-Whitney U-test (comparing 2 categories) or Kruskall-Wallis test (3 or more categories). Only p-values ≤0.01 are reported here. A difference between groups of ≥10 points was deemed clinically significant and is indicated below by an asterisk. 431 patients completed a baseline questionnaire before the start, or on the first day, of therapy. Of these 131 had Binet stage C disease, 186 stage B and 114 stage A-progressive. Stage A-progressive was defined by at least one of the following: persistent rise in lymphocyte count with doubling time <12 months; a downward trend in hemoglobin and/or platelets; >50% increase in the size of liver and/or spleen and/or lymph nodes, or appearance of these signs if not previously present; constitutional symptoms attributable to the disease. Hemoglobin <11g/dl and Binet stage C were each associated with lower (poorer) HRQoL scores in physical (p<0.001, p=0.001) and role (p<0.001*, p=0.003*) functioning and global QoL (p=0.001, p=0.01) and with greater dyspnoea (p=0.001, p=0.001*). Hemoglobin <11g/dl was also associated with poorer social functioning (p=0.01). Mean scores for Stage A-progressive were higher than for stage C but lower than stage B in all these domains and not significantly different from either, possibly due to the constitutional symptoms experienced by some patients in this group. Fatigue was reported by 81% of patients, compared to the next most common symptoms: insomnia (56%) and dyspnoea (49%). Hemoglobin <11g/dl was associated with further increased fatigue (p=0.004), in addition to the effect of the disease itself. Women reported more insomnia than men (p=0.005*). Older age (≥70 years) was associated with lower physical functioning scores (p<0.001) and fewer financial difficulties (p<0.001*). Thrombocytopenia (platelets <100×109/l) was only associated with dyspnoea (p=0.01*). There was no association between spleen, liver or lymph node enlargement, or lymphocytosis, and HRQoL. No other significant differences between groups were found in any HRQoL domain, including emotional and cognitive functioning, nausea and vomiting, pain, appetite loss, constipation and diarrhea. Patients classified as stage C because of thrombocytopenia alone did not have different scores in any domain compared to stage A-progressive and B patients. On the other hand, stage C patients with hemoglobin <10g/dl had significantly lower scores than stage A-progressive and B patients in physical (p<0.001*), role (p=0.001*) and social (p=0.01) functioning and global QoL (p=0.001*) and more dyspnoea (p=0.003*). The highest mean HRQoL scores, and the least fatigue and dyspnoea, were seen in stage B patients with hemoglobin ≥12g/dl. These findings confirm the need to begin treatment for CLL when haemoglobin levels fall in order to improve quality of life for patients.