CLL6 RESIDUUM trial: Impact of lenalidomide consolidation on HRQoL in CLL

The randomized phase III CLL6 RESIDUUM trial (ACTRN12610000060044) assessed the efficacy of lenalidomide (LEN) as consolidation therapy in patients with CLL, with MRD following classical immunochemotherapy treatment.¹ While significant benefit with LEN was demonstrated in the final CLL6 RESIDUUM analysis, LEN supplementation was associated with severe AEs such as fatigue, thrombocytopenia, and neutropenia.¹

Wasse et al. conducted an ancillary study of the CLL6 RESIDUUM French cohort (N = 66), to assess HRQoL and PROs in patients receiving LEN (n = 32) vs observation (OBS; n = 34), using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).¹ Findings from this analysis were published in BMC Cancer.¹

Key learnings

At Month 12, significantly more patients receiving LEN consolidation therapy reported diarrhea than those in the OBS arm (p = 0.003), and social functioning was significantly impaired at Month 18 (p = 0.05) with LEN vs OBS. 

From Month 12 onwards, 10-point differences in mean EORTC QLQ-C30 scores were observed in the LEN arm for dyspnea and digestive disorders.

Multivariate analysis demonstrated a detrimental effect of LEN on global health (p = 0.02) and functional scales (p = 0.003) scores.

The deterioration in HRQoL associated with LEN vs OBS after 12 months of LEN treatment highlights the importance of assessing HRQoL as well as therapeutic benefit when treating patients with LEN as consolidation therapy for CLL.