Variables Associated with Patient-Reported Symptoms in Patients with Chronic Myeloid Leukemia Receiving Tyrosine Kinase Inhibitors

Abstract

ObjectivesExplore the prevalence and severity of patient-reported symptoms in patients with chronic myeloid leukemia (CML) receiving tyrosine kinase inhibitors (TKIs), and identify associated demographics and clinical variables.MethodsA cross-sectional questionnaire, including questions assessing demographics [sex,age, household registration, marital status, education level and co-morbidity(ies)], TKI used (imatinib versus nilotinib versus dasatinib; branded drugs versus Chinese generics versus foreign generics), interval from diagnosis to starting TKI, TKI-therapy duration, therapy response [complete molecular response (CMR) versus complete cytogenetic response (CCyR) but no CMR versus no CCyR] and common patient-reported symptoms, was distributed to patients with CML in the chronic phase (CP) across China and anonymously answered. Symptoms were reported as (1) not at all; (2) mild; (3) moderate and (4) severe. Patients with CML in the CP >18 years and receiving a TKI for ≥3 months were eligible. Multivariate logistic regression model was built to identify variables associated with each symptom.ResultsData of 1142 respondents were analyzed. 724 (63%) were male. 558 (49%) had ≥bachelor degree. Median age was 42 years (range 18-88 years). 859 (75%) were receiving imatinib, 183 (16%), nilotinib; 100 (9%), dasatinib; 761 (66%), branded drugs; 225 (20%), Chinese generics; 156 (14%), foreign generics, when they answered the questionnaire. Median TKI-therapy duration was 30 months (range, 3-192 months). 472 (41%) had achieved a CMR. The top 10 common patient-reported symptoms were fatigue (77%), periorbital and lower limb edema (72%), chest distress/shortness of breath (61%), memory deterioration (54%), skin color change (44%), alopecia (44%), muscle cramp (42%), weight gain (42%), musculoskeletal pain (42%) (Figure). In multivariate analyses, female (OR 1.5-2.7, p=<0.001-0.007), urban registration (OR 1.4-1.6, p=0.004-0.023), co-morbidity(ies) (OR 1.4-2.3, p=<0.001-0.049), interval from diagnosis to starting TKI ≥6 months (OR 1.6-1.9, p=0.013-0.016), foreign generics (OR 1.5-4.0, p=<0.001-0.027), longer therapy duration (OR 1.5-4.5, p=<0.001-0.048) were factors associated with more common and severer symptoms. Unmarried person (OR 0.2-0.7, p=<0.001-0.051), nilotinib (OR 0.1-0.7, p=<0.001-0.046), achieving a CCyR but no CMR (OR 0.5-0.8, p=<0.001-0.052) were factors associated with fewer and milder symptoms. Different ages were associated with different prevalence and severity of the symptoms. Education level ≥bachelor (OR 1.4-2.1, p=0.004-0.024) was associated with more common and severer symptoms of skin color change and hypermenorrhea (in female ≤50 years), however, fewer and milder symptom of weight gain (OR 0.76, p=0.031).Conclusions This survey showed that demographics, current TKI used, therapy response and duration were associated with the prevalence and severity of patient-reported symptoms in patients with CML receiving TKIs. These results will contribute to making treatment decisions and improving quality of care and patients' quality of life. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.