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Eek, D.1; Blowfield, M.2; Krogh, C.3; Chung, H.4; Eyre, T. A.5

doi: 10.1097/
Publication Only: Chronic lymphocytic leukemia and related disorders - Clinical

1AstraZeneca, Gothenburg, Sweden

2IQVIA, Reading, United Kingdom

3IQVIA, Cambridge

4AstraZeneca, Gaithersburg, United States

5Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, United Kingdom

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A comprehensive conceptual model (CM) of chronic lymphocytic leukemia (CLL) is required to help researchers understand patients' unmet needs and direct future advancements in the field, particularly in developing patient-centered endpoints to evaluate the benefits of new therapies within clinical trials.

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The current study aimed to create a CM of disease- and treatment-related signs, symptoms and impacts in patients with first-line (1L) or relapsed/refractory (R/R) CLL.

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The CM was based on literature searches, review of CLL patient blogs/forums, interviews with expert hematologists, and semi-structured concept elicitation interviews with 40 patients with CLL (20 1L, 20 R/R; with fatigue, weight loss, fever, and/or night sweats in previous week). To identify salient concepts, the number of patients mentioning each concept and the concept's mean disturbance rating (from 0 [not at all] to 10 [very]) were mapped.

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Literature searches identified 32 prevalent concepts, with the most common being fatigue/tiredness. Patient blogs/forums revealed further symptoms (muscle/joint aches, headaches, weakness) and impacts (stress, fear of death, uncertainty). Clinicians reported recurrent infections and enlarged lymph nodes as key signs of CLL and noted that fatigue is related to both symptoms (e.g. tiredness) and impacts (e.g. needing to rest and limit daily activities). In patient interviews, 50 concepts were revealed, with 42 present in both 1L and R/R; fatigue was the most prominent and impactful. Fatigue-related sub-concepts were identified, covering symptoms (tiredness/need for sleep, lack of energy, weakness, cognitive fatigue) and impacts (decreased ability to maintain social/familial/professional role, decreased physical functioning, frustration). Three versions of the CM were created: an overall model with all identified concepts, and two models highlighting the most salient concepts in 1L and R/R (Figure 1). Muscle/joint aches, night sweats, bruising, fatigue-related symptoms, fever and recurrent infections/illness were salient symptoms in both 1L and R/R. Salient impacts in both 1L and R/R were fatigue-related impacts, insomnia, decreased cognitive/emotional functioning, anxiety/worry, stress, depression, financial difficulty, and fear of death. Dyspnea and cough were salient in 1L only, and enlarged lymph nodes, headaches, pain/discomfort, weight loss, nausea/vomiting, and infusion reactions were salient in R/R only.



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The three versions of the CM can help to inform patient-centered endpoints to evaluate new treatments for 1L and/or R/R CLL.

Copyright © 2019 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.