Abstract
As survival of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) increases and the number of patients who live long rises, health-related quality of life (HRQoL) becomes a relevant endpoint. Few studies investigated this, mainly as a secondary endpoint in randomized clinical trials where patients with early stage CLL/SLL, and elderly/frail patients were underrepresented. The aim of our study was to assess HRQoL in a population-based setting, including these previously underrepresented patients. Out of 175 patients diagnosed with CLL/SLL between 2004 and 2011, 136 (78 %) returned the HRQoL questionnaire. The outcomes were compared to an age- and sex-matched norm population. Detailed data on stage and treatment were extracted from a population-based hematological registry (PHAROS). Patients ever treated for CLL/SLL reported significantly poorer HRQoL than the norm population (p < 0.01 with large clinically important differences. Interestingly, no differences were observed between the norm population and patients under active surveillance. In contrast to our hypothesis, patients treated with chlorambucil reported the lowest HRQoL scores. Drastic, long-lasting negative effects of starting treatment on HRQoL cannot be excluded, whereas active surveillance does not seem to provoke worrying, anxiety, or depressive symptoms. Further elaborate research into the impact of starting therapy on HRQoL is needed, especially in patients that are underrepresented in most clinical trials, and thoroughly consider its results during revision of treatment guidelines.
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Acknowledgments
We thank all patients and their doctors for their participation in the study. Specialists in the following hospitals provided cooperation: Catharina-Hospital, Eindhoven; Jeroen Bosch Hospital, ‘s Hertogenbosch; Maxima Medical Centre, Eindhoven and Veldhoven; Sint Anna Hospital, Geldrop; St. Elisabeth Hospital, Tilburg; Twee Steden Hospital, Tilburg; VieCuri Hospital, Venlo and Venray and Hospital Bernhoven, Oss.
We are grateful for the dedicated data collection by the registration team of the Eindhoven Cancer Registry, especially Anke Willemse, Boudewijn Hopman, Carolien Peddemors, Marrigje van der Beek and Sendy van Heel. Special thanks go to Nicole Horevoorts for assistance with data collection and Dr. M. van Bommel for independent advice and answering questions of patients, invited to participate.
Conflict of interest
The authors have declared no conflicts of interest.
This study was financially supported by the Jonker-Driessen Foundation and ZonMW: the Netherlands organization for health research and development, and through PHAROS: Population-based HAematological Registry for Observational Studies (ZonMW grant 152001007).
Prof. Lonneke van de Poll-Franse is supported by a Cancer Research Award from the Dutch Cancer Society (No. UVT-2009-4349).
The study sponsors had no role in the study design, in the collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.
Ethical standards
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
Informed consent was obtained from all patients with regard to the HRQoL-questionnaires. Due to its observational nature, informed consent is not applicable for the ECR and PHAROS.
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van den Broek, E.C., Oerlemans, S., Nijziel, M.R. et al. Impact of active surveillance, chlorambucil, and other therapy on health-related quality of life in patients with CLL/SLL in the Netherlands. Ann Hematol 94, 45–56 (2015). https://doi.org/10.1007/s00277-014-2161-6
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DOI: https://doi.org/10.1007/s00277-014-2161-6