Wasse Stephane Kroudia, Dabakuyo-Yonli Sandrine Tienhan, Gottlieb David, Cymbalista Florence, Mulligan Stephen, Maynadie Marc, Aurran-Schleinitz Thérèse
Dijon-Bourgogne University Hospital, Registry of Hematological Malignancies of Côte d'Or, BP 87900, 7 Boulevard Jeanne d'Arc, Dijon Cedex, 21079, France.
UMR1231, Bourgogne University, INSERM, Dijon, France.
BMC Cancer. 2025 Apr 16;25(1):712. doi: 10.1186/s12885-025-13792-y.
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.
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.
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).
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.
在法国 - 澳大利亚CLL6残留病试验中，一项辅助研究旨在评估慢性淋巴细胞白血病（CLL）患者在接受经典免疫化疗后接受两年来那度胺（LEN）巩固治疗或观察（OBS）且仍有可检测残留病的健康相关生活质量（HRQoL）。
这里使用了参与该试验的法国患者的数据。患者在基线时，然后在巩固治疗后的第3、6、12、18和24个月完成欧洲癌症研究与治疗组织（EORTC）QLQ - C30第3版问卷。重复测量混合效应模型用于评估每个HRQoL量表在基线和每个检查点之间的HRQoL变化。
基线数据总体显示全球健康状况良好，在0 - 100分制中，LEN组和OBS组的平均得分分别为76.3和72.1。在12个月时，LEN组患者的腹泻明显多于OBS组患者（p = 0.003），并且在第18个月时社会功能明显受损（p = 0.05）。从第12个月起，LEN组在呼吸困难和消化系统疾病方面出现了10分的差异。多变量分析显示LEN对整体健康（p = 0.02）和功能量表（p = 0.003）有有害影响。
本研究提供了法国CLL患者巩固治疗队列中的HRQoL值。在CLL中使用来那度胺作为巩固治疗会导致治疗12个月后健康状况出现后期恶化，尤其是腹泻。HRQoL的定量评估应与疾病控制方面的益处相权衡，以确定总体健康益处。
