BackgroundWe evaluated real-world clinical outcomes and toxicity data and assessed treatment-related costs in patients with advanced breast cancer who received treatment with cyclin-dependent kinase inhibitors (CDKi).Patients and methodsWe conducted a prospective–retrospective analysis of patients with advanced hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who received a CDKi, in combination with endocrine therapy, at any line of treatment. The primary endpoint was progression-free survival (PFS). Cost analysis was conducted from a public third-payer (National Organization for Healthcare Services Provision (EOPYY)) perspective, assessing only costs related to direct medical care, including drug therapy costs and adverse drug reaction (ADR)-related costs.ResultsFrom July 2015 to October 2019, 365 women received endocrine therapy combined with CDKi; median age was 61 years, postmenopausal 290 (80.6%) patients. CDKi were administered as first-line treatment in 149 (40.9%) patients, second-line treatment in 96 (26.4%) and third-line treatment and beyond in 119 (32.7%) patients. The most common adverse events were neutropenia, anaemia, thrombocytopenia and fatigue. Grade 3–4 adverse events occurred in 86 (23.6%) patients, whereas 8 (2.2%) patients permanently discontinued treatment due to toxicity. The median PFS for patients who received CDKi as first-line, second-line and third-line treatment and beyond was 18.7, 12 and 7.4 months, respectively. The median overall survival since the initiation of CDKi treatment was 29.9 months (95% CI: 23.0–not yet reached (NR)). The mean pharmaceutical therapy cost estimated per cycle was 2 724.12 € for each patient, whereas the main driver of the ADR-related costs was haematological adverse events.ConclusionsTreatment with CDKi was well tolerated, with a low drug discontinuation rate. Patients who received CDKi as first-line treatment had improved PFS and OS compared with second-line treatment and beyond. The main component of direct medical costs assessed in the cost analysis comprises CDKi pharmaceutical therapy costs.Trial registration numberNCT04133207
Background and Aims Although routine blood pressure (BP) measurements taken shortly before or after dialysis provide imprecise reflection of interdialytic ambulatory BP, this method continues to form the basis for the diagnosis of hypertension among patients on hemodialysis. Home BP monitoring (HBPM) is a guideline-recommended technique that may improve the diagnosis of hypertension in this population. Using 44-hour ambulatory BP monitoring (ABPM) as the reference-standard method, this study aimed to compare the diagnostic performance of home versus routine pre- and postdialysis BP recordings in hemodialysis patients. Method In 70 stable patients with end-stage kidney disease receiving thrice-weekly hemodialysis, BP was assessed with the following methods: (i) routine predialysis and postdialysis BP measurements averaged over 2 weeks; (ii) HBPM for 7 days (dublicate morning and evening measurements, Microlife WatchBP Home N); (iii) ABPM (20 min intervals over an entire interdialytic interval - 44 hours, Microlife WatchBPO3). Results The mean age of the patients was 65.3±13.3 years; 45 patients (64%) were males, and 62 (88.7%) had a known history of hypertension. The mean [95% confidence interval (CI)] of the difference between ambulatory systolic BP (SBP) and (i) predialysis SBP was 11.43 (8.24, 14.62) mmHg, (ii) postdialysis SBP was 3.9 (0.37, 7.56) mmHg, and (iii) home SBP was 8.61 (6.05, 11.17). The area under the receiver operating characteristic curve for the detection of an ambulatory daytime SBP ≥135 mmHg was significantly higher for home SBP measurements 0.934 (95% CI: 0.871-0.996) as compared to predialysis 0.778 (95% CI: 0.643-0.913) and postdialysis 0.766 (95% CI: 0.623-0.909) BP recordings (P = 0.02 for both comparisons). 1-week averaged home SBP at the cut-off point of 141.0 mmHg provided the best combination of high sensitivity (85.7%) and high specificity (92.9%) in diagnosing systolic ambulatory hypertension. Conclusion The present study shows that among patients on hemodialysis, HBPM for 1 week provides greater accuracy than 2-week averaged routine pre- and postdialysis BP recordings in the diagnosis of hypertension confirmed by the reference-standard method of interdialytic ABPM.
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the preferred first-line option for patients with advanced, EGFR-mutant non-small cell lung cancer (NSCLC). Afatinib, a second-generation irreversible EGFR-TKI, has been extensively used in Greece in this setting; however, real-world data regarding molecular epidemiology and financial implications of afatinib use are lacking. Materials and Methods: This was an observational, non-interventional, multicenter, retrospective cohort study, based on real-world data collected from the medical charts/records of patients treated with afatinib between 15/03/2015 and 25/06/2020 and were recorded on a web-based data capture system. Cox models were used to assess the prognostic significance of clinicopathological parameters with respect to clinical outcomes of interest. Cost analysis was conducted from a public third-payer perspective, and only direct medical costs reimbursed by the payer were considered. Results: A total of 59 patients were treated with afatinib for their EGFR mutation-positive advanced NSCLC; the median age was 61 years (range: 37-91). Performance status was zero in 61%, and brain metastases were present in 13.6%. Forty-four patients (74.6%) had a deletion in exon 19 only, while nine (15.3%) had a mutation in exon 21, 8 of them in L858R and one in L861Q. At a median follow-up of 41.8 months (95% CI 35.9-51.4), the median PFS was 14.3 months (95% CI 12.2-16.4), and the median OS was 29 months (95% CI 25.6-33.4). Corresponding values for patients with deletion 19 only were 14.3 months (95% CI 11.5-18.5) and 28.1 months (95% CI 21.1-32.6), respectively. The mean expenditure for the treatment of each patient equals €25,333.68; with €21,865.06 being attributed to drug acquisition costs, €3325.35 to monitoring costs and €143.27 to adverse event treatmentrelated costs. Conclusion:Long-term data in the real-world setting in Greece confirm activity, tolerability and cost-effectiveness of afatinib as first-line treatment of patients with advanced EGFRmutant NSCLC. Clinical Trial Registration: Clinicaltrials.gov NCT04640870.
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