Background/Objectives: Until now, no meta-analysis has been published to evaluate the diagnostic performance of next-generation sequencing (NGS) panel using circulating tumor (ctDNA) in patients with advanced non-small cell lung cancer (aNSCLC). The aim of the study was to carry out a systematic review and a meta-analysis in order to determine the accuracy of NGS of ctDNA to detect six oncogenic driver alterations: epidermal growth factor receptor (EGFR); anaplastic lymphoma kinase (ALK); ROS proto-oncogene 1, receptor tyrosine kinase (ROS-1); serine/threonine-protein kinase B-RAF (BRAF); RET proto-oncogene (RET); and MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 in patients with aNSCLC.
Methods: MEDLINE/PubMed, Cochrane Library, Latin American and Caribbean Health Sciences Literature (LILACS), and Centre for Reviews and Dissemination databases and articles obtained from other sources were searched for relevant studies that evaluate the accuracy (sensitivity and specificity) of NGS using ctDNA in patients with aNSCLC. The studies were eligible when NGS of ctDNA was compared with tissue tests to detect at least one of the six oncogenic driver alterations. Diagnostic measures (sensitivity and specificity) were pooled with a bivariate diagnostic random effect. All statistical analyses were performed with software R, v.4.0.0.
Results: Ten studies were eligible for data extraction. The overall pooled estimates of sensitivity and specificity were 0.766 (95% CI: 0.678-0.835); 0.999 (95% CI: 0.990-1.000), respectively.
Conclusions: The analysis has demonstrated that the NGS panel using ctDNA has a high accuracy to identify the six actionable oncogenic driver alterations in patients with aNSCLC. Therefore, it can be considered a reliable alternative to guide the patients with aNSCLC to the right treatment who cannot undergo an invasive procedure or have insufficient tissue material for molecular tests.
To perform a treatment cost comparison of pirfenidone versus nintedanib on the treatment of idiopathic pulmonary fibrosis (IPF) under the Brazilian private healthcare system perspective. MethOds: Both treatment's ex-factory prices were obtained from official published lists, by the Brazilian Ministry of Health, considering the incidence of taxes (ICMS 18%). Annual treatment cost was calculated based on the dosage of pirfenidone (2.403 mg/day) and nintedanib (150 mg BID) obtained from their respective Brazilian labels. A year was assumed to be 12 months with 30 days each. Results were shown for 2 scenarios: first year (including initial dose ramp up for pirfenidone) and maintenance phases. Results: Pirfenidone and nintedanib unitary costs were BRL 9,144 (BRL 33.87 per 267 mg tablet) and BRL 14,916 (BRL 248.60 per 150 mg tablet), respectively, according to their list prices. Pirfenidone showed an annual treatment cost of BRL 107,591 and BRL 109,724 on the first year and subsequent years of treatment, respectively. Nintedanib incurred an annual cost of BRL 178,988 independent of year of treatment. Those results led to savings of approximately BRL 70,000 per year per patient treated with pirfenidone compared to those treated with nintedanib (a relative reduction of approximately 40%). Pirfenidone's dose ramp up, on the first year of treatment, did not decrease significantly the treatment cost, implying on a reduction of just 2% when compared to subsequent years. cOnclusiOns: Pirfenidone was lower than the cost of nintedanib.
e13097 Background: The IMpassion130 trial has demonstrated that atezolizumab plus nab-paclitaxel results in significant clinical benefits for patients with unresectable locally advanced or metastatic (aTNBC). The SP142 IHC assay is a clinically validated and FDA-approved PD-L1 test to identify patients with aTNBC for treatment with atezolizumab plus nab-paclitaxel. A post hoc analysis of IMpassion130 evaluated two other PD-L1 IHC assays, 22C3 and SP263, for analytical and clinical concordance with SP142 and the PD-L1 prevalence by each assay. The prevalence of PD-L1+ per SP142 (tumor-infiltrating immune cells 1%), 22C3 (combined positive score1) and SP263 (tumor-infiltrating immune cells 1%), were 46%, 81% and 75%, respectively. The study compared only SP142 assay with 22C3 assay because patients with SP142 negative and 22C3 positive did not demonstrate a significant clinical benefit for progression-free survival (PFS) and overall survival (OS). Therefore the study aimed to demonstrate the economic impact of these assays in the treatment with atezolizumab plus nab-paclitaxel. Methods: Data of PFS and OS from the post hoc analysis of Impassion130 were extracted to develop a Markov model to simulate the clinical and economic impact of the patient with atezolizumab plus nab-paclitaxel guided by SP142 and 22C3 assays. The analysis considered the cost of atezolizumab+nab-paclitaxel, the cost associated with the management of the adverse events and the cost of the assay. The costs were based on CBHPM (Classificação Brasileira Hierarquizada de Procedimentos Médicos), CMED PF18% (Câmara de Regulação do Mercado de Medicamentos) and local publications. An univariate sensitivity analysis was performed. Results: The study demonstrated that SP142 assay has the potential to save 175,917 BRL (45,595 USD) with atezolizumab plus nab-paclitaxel per patients with aTNBC in three years. Conclusions: The SP142 assay can optimize the use of atezolizumab plus nab-paclitaxel avoiding its use in patient who will not have a significant clinical improvement.
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