Quality of Life in the LRF CLL4 Trial.

Abstract

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 ScalesPhysicalRoleEmotionalCognitiveSocialGlobal HealthNo.B 12MB 12MB 12MB 12MB 12MB 12MChl17581 7874 7575 7883 8279 7766 69F9282 8272 7480 8182 8280 7964 68FC9480 7777 7378 8185 8282 7666 68361Abbreviations: B = baseline; 12M = 12 months.Table 2:Mean QoL Scores by Response to Treatment*Functioning ScalesPhysicalRoleEmotionalCognitiveSocialGlobal HealthNo.B 12MB 12MB 12MB 12MB 12MB 12MCR/NPR15984 8476 8078 8486 8582 8367 73PR12579 7673 7378 7882 7980 7763 68NR/PD5677 7471 6174 7481 7974 6565 60340p=0.02p=0.03p=0.002Abbreviations: 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.)