The UK CLL4 trial randomised 777 previously untreated patients between 1999–2004 to chlorambucil (Chl) or fludarabine +/− cyclophosphamide (F v. FC). Other trial endpoints are reported elsewhere in this meeting (Catovsky et al). The current study seeks to determine whether there is any difference in the quality of life (QoL) of patients according to treatment arm; and whether QoL correlates with baseline patient characteristics and/or with treatment outcomes. All patients were asked to complete the validated EORTC QLQ-C30 (version 2.0) at start of therapy (baseline), at 3, 6 and 12 months, and annually thereafter. Scores (0–100) within each of 15 different measures of QoL (5 functional scales, 3 symptom scales, 1 global health/QoL scale, and 6 single items) were calculated at each point in time (currently up to 1 year), and analysed according to the EORTC QLQ-C30 Scoring Manual. Statistical significance was determined by the use of ANOVA. Patient compliance was high: 599 questionnaires were completed at baseline, 557 at 3 months, 559 at 6 months and 470 at 12 months, respectively 77%, 74%, 77% and 78% of those who had so far reached the time-period and remained alive. Analysis of baseline and 12 month QoL assessment by treatment group and response is presented. QOL results were the same for each treatment group at baseline and at 12 months (Table 1). Quality of response to treatment correlated with QoL at 12 months (Table 2). With treatment approaches having potentially different risk and side effect profiles, and perhaps limited impact on overall survival, QOL forms an important component of treatment outcome assessment. Further analysis of QoL parameters (in particular their relationship to prognostic factors and further follow-up) will be forthcoming within the next year.

Table 1:

Mean QoL Scores by Treatment Group*

Functioning Scales
PhysicalRoleEmotionalCognitiveSocialGlobal Health
No.B 12MB 12MB 12MB 12MB 12MB 12M
Abbreviations: B = baseline; 12M = 12 months. 
Chl 175 81 78 74 75 75 78 83 82 79 77 66 69 
F 92 82 82 72 74 80 81 82 82 80 79 64 68 
FC 94 80 77 77 73 78 81 85 82 82 76 66 68 
 361       
Functioning Scales
PhysicalRoleEmotionalCognitiveSocialGlobal Health
No.B 12MB 12MB 12MB 12MB 12MB 12M
Abbreviations: B = baseline; 12M = 12 months. 
Chl 175 81 78 74 75 75 78 83 82 79 77 66 69 
F 92 82 82 72 74 80 81 82 82 80 79 64 68 
FC 94 80 77 77 73 78 81 85 82 82 76 66 68 
 361       
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Table 2:

Mean QoL Scores by Response to Treatment*

Functioning Scales
PhysicalRoleEmotionalCognitiveSocialGlobal Health
No.B 12MB 12MB 12MB 12MB 12MB 12M
Abbreviations: B = baseline; 12M = 12 months; CR/NPR = complete/nodular partial response; PR = partial response; NR/PD = no response/disease progression. P-values compare response groups with respect to the change in scores from baseline to 12 months. 
(* Only those patients are shown in the Tables for whom data is available at both time-points.) 
CR/NPR 159 84 84 76 80 78 84 86 85 82 83 67 73 
PR 125 79 76 73 73 78 78 82 79 80 77 63 68 
NR/PD 56 77 74 71 61 74 74 81 79 74 65 65 60 
 340  p=0.02 p=0.03   p=0.002 
Functioning Scales
PhysicalRoleEmotionalCognitiveSocialGlobal Health
No.B 12MB 12MB 12MB 12MB 12MB 12M
Abbreviations: B = baseline; 12M = 12 months; CR/NPR = complete/nodular partial response; PR = partial response; NR/PD = no response/disease progression. P-values compare response groups with respect to the change in scores from baseline to 12 months. 
(* Only those patients are shown in the Tables for whom data is available at both time-points.) 
CR/NPR 159 84 84 76 80 78 84 86 85 82 83 67 73 
PR 125 79 76 73 73 78 78 82 79 80 77 63 68 
NR/PD 56 77 74 71 61 74 74 81 79 74 65 65 60 
 340  p=0.02 p=0.03   p=0.002 
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Topics:
adverse effects, arm, chlorambucil, cyclophosphamide, disease progression, european organization for research and treatment of cancer, fludarabine, follow-up, partial response, prognostic factors

Author notes

Corresponding author

2005, The American Society of Hematology
2005
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