Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial.

BACKGROUND

Within the French-Australian CLL6 RESIDUUM trial, an ancillary study aimed at assessing the health-related quality of life (HRQoL) of patients with chronic lymphocytic leukemia (CLL) receiving a two-year consolidation of lenalidomide (LEN) or observation (OBS) after classical immunochemotherapy leaving them with detectable residual disease.

METHODS

Data from French patients involved in this the trial were used here. The EORTC QLQ-C30 version 3 questionnaire was completed by patients at baseline, and then at months 3, 6, 12, 18 and 24 after consolidation. Repeated measures mixed-effects models were used to assess HRQoL changes between baseline and each checkpoint for each HRQoL scale.

RESULTS

Baseline data showed overall a good global health status with mean scores of 76.3 and 72.1 in the LEN and OBS arms respectively, on the 0-100 scale. At 12 months, LEN patients had significantly more diarrhea than OBS patients (p = 0.003) and social functioning was significantly impaired at month 18 (p = 0.05). A 10-point difference appeared in the LEN arm for dyspnea and digestive disorders from month 12 on. Multivariate analysis showed a deleterious effect of LEN on global health (p = 0.02) and functional scales (p = 0.003).

CONCLUSION

This study provides HRQoL values in a French cohort of CLL patients in consolidation treatment. Supplementation with lenalidomide as consolidation therapy in CLL leads to late health deterioration, especially diarrhea, after 12 months of treatment. Quantitative assessment of HRQoL should be balanced against benefits in disease control to determine overall health benefits.