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OBJECTIVE: This article describes a study protocol for evaluating adherence to oral chemotherapy (OCT) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Spain. METHODS: This multicenter, observational, prospective study will be conducted by 6 hospital pharmacists from 6 Spanish hospitals. The study will include men and women aged 18â¯years or older with a diagnosis of locally advanced or metastatic NSCLC who are being treated or have been prescribed OCT. Once included, the patient will be active and prospectively followed up for 3â¯months, including 4 study visits to record information on sociodemographic variables, antineoplastic treatment and adherence, pharmaceutical care, clinical variables, and patient-reported outcomes (PRO) (the 3-level version of EQ-5D, the EORTC Core Quality of Life Questionnaire, the Brief Illness Perception Questionnaire, the Treatment Satisfaction with Medicines Questionnaire, and the PRO version of Common Terminology Criteria for Adverse Events). Twelve months after patient inclusion, we will record information on the disease progression status and dispensed prescriptions. The primary outcome is the percentage of treatment adherence that will be calculated based on the pill count as follows: the difference between the number of pills dispensed minus the number of unused pills will be divided by the number of days of treatment multiplied by the number of pills/day prescribed by the oncologist; this quotient will be multiplied by 100 to obtain the percentage of adherence. Based on the that pill count reconciliation, those with a percentage adherence >80% will be primarily categorized as adherent. Secondarily, treatment adherence will be also calculated based on the proportion of days covered and the 4-items Morisky Green Levine Medication Adherence Scale. To analyze the impact of patients' and treatment characteristics on adherence, bivariate analyses will be performed using different adherence cut-off points. To evaluate the impact of adherence on treatment efficacy as evaluated by progression-free survival, we will be using the Kaplan-Meier method and compare it with the log-rank test and univariate Cox regression analysis. CONCLUSIONS: We expect that our study will provide initial information on key aspects of adherence to OCT (i.e., measurement, facilitators, and barriers) and its relationship with patients' and clinically relevant outcomes in the setting of NSCLC, and that this information will help in designing pharmaceutical interventions to improve adherence.
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BACKGROUND: Patients with lung cancer (LC) are at significantly higher risk of developing venous thromboembolism (VTE), which may lead to increased use of health resources and the cost of management. The main aim of the study was to determine the cost of the management of VTE events in patients with LC treated with Low Molecular Weight Heparins (LMWH) in Spain. METHODS: Costecat was an, observational, ambispective pharmacoeconomic study. Patients with LC, with a first episode of VTE (symptomatic or incidental) in treatment with LMWH, were recruited from six third-level hospitals and followed up for six months. Sociodemographic, clinical and resource use variables of VTE-related implications and its treatment were collected. Direct healthcare costs and direct non-healthcare costs were recorded. Data collection was documented in an electronic case report. Unit costs were obtained from national databases. Costs (2018) were estimated from the healthcare perspective. Statistical analysis was performed using the statistical program R 3.4.3 version (30 November 2017). RESULTS: Forty-seven patients were included. Mean age was 65.4 years, 66.0% were male. The percentage of patients with LC who had metastatic disease was 78.7%. Twenty-three patients (48.9%) needed hospital admissions due to thromboembolic episode. Total average cost of patients with cancer associated VTE (CAT) was 109,696.6 per patient/semester. The hospitalizations represent 65.8% of total costs (7207.3 SD 13,996.9 ), followed by LMWH therapy which represents 18.6% (2033.8 SD:630.5 ). CONCLUSIONS: Venous thromboembolism episodes induce an economic impact on patients and healthcare systems. Direct healthcare costs are the major burden of the total cost, in which hospitalizations are the main drivers of cost.
