Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial
Abstract 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 imm...
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BMC
2025-04-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-025-13792-y |
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| author | Stephane Kroudia Wasse Sandrine Tienhan Dabakuyo-Yonli David Gottlieb Florence Cymbalista Stephen Mulligan Marc Maynadie Thérèse Aurran-Schleinitz |
| author_facet | Stephane Kroudia Wasse Sandrine Tienhan Dabakuyo-Yonli David Gottlieb Florence Cymbalista Stephen Mulligan Marc Maynadie Thérèse Aurran-Schleinitz |
| author_sort | Stephane Kroudia Wasse |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-bdef5b9924e547e996feeb2f43798736 |
| institution | OA Journals |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
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| series | BMC Cancer |
| spelling | doaj-art-bdef5b9924e547e996feeb2f437987362025-08-20T02:17:57ZengBMCBMC Cancer1471-24072025-04-012511910.1186/s12885-025-13792-yImpact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trialStephane Kroudia Wasse0Sandrine Tienhan Dabakuyo-Yonli1David Gottlieb2Florence Cymbalista3Stephen Mulligan4Marc Maynadie5Thérèse Aurran-Schleinitz6Dijon-Bourgogne University Hospital, Registry of Hematological Malignancies of Côte d’OrUMR1231, Bourgogne University, INSERMDepartment of Haematology, University of Sydney, Westmead HospitalHematology Biology, Avicennes HospitalDepartment of Haematology, Royal North Shore Hospital, University of SydneyDijon-Bourgogne University Hospital, Registry of Hematological Malignancies of Côte d’OrHematology Department, Institut Paoli CalmettesAbstract 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.https://doi.org/10.1186/s12885-025-13792-yChronic lymphocytic leukemiaHealth-related quality of lifePatient-reported outcomesLenalidomideClinical trial |
| spellingShingle | Stephane Kroudia Wasse Sandrine Tienhan Dabakuyo-Yonli David Gottlieb Florence Cymbalista Stephen Mulligan Marc Maynadie Thérèse Aurran-Schleinitz Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial BMC Cancer Chronic lymphocytic leukemia Health-related quality of life Patient-reported outcomes Lenalidomide Clinical trial |
| title | Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial |
| title_full | Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial |
| title_fullStr | Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial |
| title_full_unstemmed | Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial |
| title_short | Impact of lenalidomide consolidation on health-related quality of life in chronic lymphocytic leukemia: ancillary study of the phase III CLL6-RESIDUUM trial |
| title_sort | impact of lenalidomide consolidation on health related quality of life in chronic lymphocytic leukemia ancillary study of the phase iii cll6 residuum trial |
| topic | Chronic lymphocytic leukemia Health-related quality of life Patient-reported outcomes Lenalidomide Clinical trial |
| url | https://doi.org/10.1186/s12885-025-13792-y |
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