Abstract Introduction: Health-related quality of life (HRQOL) will change for the 20,700 people1 who will be diagnosed with chronic lymphocytic leukemia (CLL) in the US in 2024. 2-4 As the most common adult leukemia, little HRQOL data are available for inclusion in discussions between patients and their healthcare team to improve shared decision-making. With 88.5% of patients with CLL alive at five years and 82% alive 10 years after diagnosis, 1,5 most (70%) patients will need treatment at some point 6 and HRQOL is an important consideration. First-line treatment options include Bruton tyrosine kinase inhibitors (BTKi), b-cell lymphoma 2 inhibitors (BCL2i), and chemoimmunotherapy (CIT) or immunotherapy. 7 For treatment discussions to be most meaningful to patients, they must include information on how the treatment impacts HRQOL. 8This is a knowledge gap in treatment discussions between the healthcare team and patients with CLL. The aims of the study are to: 1) Compare the differences in HRQOL scores measured by the Functional Assessment of Cancer Therapy –Leukemia version for patients receiving BTKi, and BCL2i within 7 days of beginning treatment and at days 30, 60, 90, and 180, 1 year, 1.5 years, and 2 years following initiation of treatment; 2) Evaluate HRQOL predictors of CLL patients from age, comorbidity, fatigue, symptoms, and disease characteristics; 3) Test the moderating effect of treatment with age, comorbidity, and fatigue on HRQOL. Methods (Specific Aims 1, 2, and 3). Setting and Subjects. A total of 100 participants (75 expected to complete the study) will be recruited from Moffitt Cancer Center, Tampa, Florida. Inclusion criteria. All patients with pathology-confirmed diagnoses of CLL who are within 7 days of starting treatment with a BTKi +/- an anti-CD 20 monoclonal antibody or BCL2i with obinutuzumab treatment will be included. Subjects must be able to read and speak English and Spanish at the 8th grade level. Exclusion criteria. Patients 18 years of age, and patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from the study. Cognitive status will be assessed by orientation to person, place, and time The statistical analysis for the aims are as follows: Patient demographic and clinical characteristics, along with levels of the quality-of-life outcomes at each timepoint, will be summarized using conventional descriptive statistics. Aim 1 of this project will compare quality of life across multiple timepoints between BTKi and BCL2i. The main quality-of-life outcome, the FACT-Leu, will be assessed in a linear growth curve (2 treatments by 5 timepoints) model. We will evaluate the intercept (overall group differences) and the slope (different trajectories over time). Using maximum likelihood estimation, these models can accommodate some missing timepoints (data) without eliminating participants. We will assume an unstructured covariance matrix and because the study is exploratory, we will keep our alpha at 0.05 (not adjusting for multiple comparisons). The study will be powered to test Aim 1. With 50 patients per group, we will be able to detect an effect size of 1.06 or larger for the intercept difference, and 0.63 or larger for the slope difference between groups. For the second aim we will be using the same approach, but rather than testing for treatment differences, we will test how age, comorbidity, fatigue, symptoms, and disease characteristics are related to HRQOL in separate models. For the last aim, we again will use linear growth curves, and use interactions with treatment (e.g., treatment*age) as the covariate in each model. Conclusion: This study will provide valuable information for the healthcare team to inform discussions for CLL patients beginning treatment. This will provide the data for a more comprehensive approach by delivering detailed information about how the treatment has affected patients with CLL with similar comorbidities, frailty, fatigue, and symptoms. Registered on clinicaltrials.gov. NCT 07030400. Funded by the National Comprehensive Cancer Network/Astra Zeneca
Sara Tinsley (Mon,) studied this question.