A prospective, non-interventional study among patients diagnosed with locally advanced or metastatic non–small-cell lung cancer to assess the adherence to oral antineoplastic therapy from data collected through patient-reported questionnaires and tablets count in Spain: LOADH study.
Authors: Mangues Bafalluy Irene , Bernardez Beatriz , Arenaza Ainhoa , Navarro-Ruiz Andrés , Martín-Conde Maria Teresa , Rubio Salvador Ana Rosa , Rius Judith , Gilabert Marta , Touris Manuel , Peral Lara , Riu Gisela , Lopez Elena , García Monsalve Ana , Callejo Angel , Martinez Sesmero Jose Manuel 
Published: June 2023

e21101

Background: Oral treatments (OT) available in non-small cell lung cancer (NSCLC) directed at different targets are more effective and have a more favorable safety profile than traditional chemotherapy (CT). However, adherence is a challenge as it could affect the therapeutic outcome of patients (pt). The LOADH study aims to assess adherence from tablets count in pt with NSCLC treated with tyrosine kinase inhibitors (TKIs), as well as to evaluate the influence of pt and treatment characteristics on adherence, evaluate correlation between adherence and progression free survival (PFS) and to detect opportunities for improvement of the pharmaceutical intervention. Methods: Prospective, multicenter, observational study in which 6 Spanish hospitals participated. Adult pt diagnosed with NSCLC receiving or starting treatment with orally administered TKI, prescribed by the oncologist according to standard clinical practice, were included. Pt information was collected at the screening visit and at monthly visits during three consecutive months by virtual or face-to-face pharmaceutical care, during which a count of dispensed and unused tablets was also made. Adherence was calculated as: (N of tablets dispensed – N of unused tablets / N of days in treatment * N of tablets prescribed to be taken per day)*100 The cut-off point for adequate adherence was > 80%. The Chi-square test was used to compare adherence between groups. Results: A total of 99 pt were included, of which 95 were valid for the analysis. Mean age was 66 years (SD 13.1; 46.3% ≤65), 66.3% female, 57.9% non-smokers, 90.5% with metastases; 69.5% received TKI-EGFR, 28.4% ALK inhibitors and 2.1% others. ECOG 0: 51.6%; ECOG 1: 42.1%; ECOG ≥2: 6.3%. Adherence was > 80% in 85.3% of pt. Factors that are related to better adherence are ECOG (0: 91.8%; 1: 82.5%; ≥2: 50%; P = 0.020) previous CT (yes: 61.5%; no: 85.7%; P < 0.001) and Initiation of OT prior to the study (yes: 86.7%; no: 75.0%; P < 0.001). Median PFS from start of treatment was higher in adherent pt: 45.6 vs 18.2 months; P = 0.043; in a sensitivity analysis from start of study, PFS was also higher: 18.9 vs 6.5 months; P = 0.007. Although no statistically significant differences were found, conciliation, review and education are the pharmaceutical interventions that have more influence on adherence (percentage of adherent pt with vs without intervention: 95.7% vs 81.8%, 89.2% vs 82.7% and 87.7% vs 81.3% respectively). Conclusions: The percentage of pt with NSCLC adherent to oral TKIs in Spain is high. Previous CT, ECOG and having started OT before the study are correlated with adherence. Adherence is correlated with a better PFS. The interventions that seem to have the most impact on pt adherence are conciliation, education and review.