ABSTRACT
ABSTRACT Objective: To assess cost differences between EBUS-TBNA and mediastinoscopy for mediastinal staging of non-small cell lung cancer (NSCLC). Methods: This was an economic evaluation study with a cost-minimization analysis. We used a decision analysis software program to construct a decision tree model to compare the downstream costs of mediastinoscopy, EBUS-TBNA without surgical confirmation of negative results, and EBUS-TBNA with surgical confirmation of negative results for the mediastinal staging of NSCLC. The study was conducted from the perspective of the Brazilian public health care system. Only direct medical costs were considered. Results are shown in Brazilian currency (Real; R$) and in International Dollars (I$). Results: For the base-case analysis, initial evaluation with EBUS-TBNA without surgical confirmation of negative results was found to be the least costly strategy (R$1,254/I$2,961) in comparison with mediastinoscopy (R$3,255/I$7,688) and EBUS-TBNA with surgical confirmation of negative results (R$3,688/I$8,711). The sensitivity analyses also showed that EBUS-TBNA without surgical confirmation of negative results was the least costly strategy. Mediastinoscopy would become the least costly strategy if the costs for hospital supplies for EBUS-TBNA increased by more than 300%. EBUS-TBNA with surgical confirmation of negative results, in comparison with mediastinoscopy, will be less costly if the prevalence of mediastinal lymph node metastasis is ≥ 38%. Conclusions: This study has demonstrated that EBUS-TBNA is the least costly strategy for invasive mediastinal staging of NSCLC in the Brazilian public health care system.
RESUMO Objetivo: Avaliar as diferenças de custo entre EBUS-TBNA e mediastinoscopia no estadiamento mediastinal do câncer de pulmão não pequenas células (CPNPC). Métodos: Estudo de avaliação econômica com análise de custo-minimização. Utilizamos um software de análise de decisão para a construção de um modelo de árvore de decisão para comparar os custos à jusante da mediastinoscopia, de EBUS-TBNA sem confirmação cirúrgica de resultados negativos e de EBUS-TBNA com confirmação cirúrgica de resultados negativos no estadiamento mediastinal do CPNPC. O estudo foi realizado sob a perspectiva do sistema público de saúde brasileiro. Foram considerados apenas os custos médicos diretos. Os resultados são apresentados em moeda brasileira (reais; R$) e em dólares internacionais (I$). Resultados: Na análise de caso base, a avaliação inicial com EBUS-TBNA sem confirmação cirúrgica de resultados negativos foi a estratégia menos dispendiosa (R$ 1.254/I$ 2.961) em comparação com a mediastinoscopia (R$ 3.255/I$ 7.688) e EBUS-TBNA com confirmação cirúrgica de resultados negativos (R$ 3.688/I$ 8.711). As análises de sensibilidade também mostraram que EBUS-TBNA sem confirmação cirúrgica de resultados negativos foi a estratégia menos dispendiosa. A mediastinoscopia se tornaria a estratégia menos dispendiosa se os custos com insumos hospitalares para a realização de EBUS-TBNA aumentassem mais de 300%. EBUS-TBNA com confirmação cirúrgica de resultados negativos, em comparação com a mediastinoscopia, será menos dispendiosa se a prevalência de metástase linfonodal mediastinal for ≥ 38%. Conclusões: Este estudo demonstrou que EBUS-TBNA é a estratégia menos dispendiosa para o estadiamento mediastinal invasivo do CPNPC no sistema público de saúde brasileiro.
ABSTRACT
BACKGROUND: In case of suspicious lymph nodes on computed tomography (CT) or fluorodeoxyglucose positron emission tomography (FDG-PET), advanced tumour size or central tumour location in patients with suspected non-small cell lung cancer (NSCLC), Dutch and European guidelines recommend mediastinal staging by endosonography (endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)) with sampling of mediastinal lymph nodes. If biopsy results from endosonography turn out negative, additional surgical staging of the mediastinum by mediastinoscopy is advised to prevent unnecessary lung resection due to false negative endosonography findings. We hypothesize that omitting mediastinoscopy after negative endosonography in mediastinal staging of NSCLC does not result in an unacceptable percentage of unforeseen N2 disease at surgical resection. In addition, omitting mediastinoscopy comprises no extra waiting time until definite surgery, omits one extra general anaesthesia and hospital admission, and may be associated with lower morbidity and comparable survival. Therefore, this strategy may reduce health care costs and increase quality of life. The aim of this study is to compare the cost-effectiveness and cost-utility of mediastinal staging strategies including and excluding mediastinoscopy. METHODS/DESIGN: This study is a multicenter parallel randomized non-inferiority trial comparing two diagnostic strategies (with or without mediastinoscopy) for mediastinal staging in 360 patients with suspected resectable NSCLC. Patients are eligible for inclusion when they underwent systematic endosonography to evaluate mediastinal lymph nodes including tissue sampling with negative endosonography results. Patients will not be eligible for inclusion when PET/CT demonstrates 'bulky N2-N3' disease or the combination of a highly suspicious as well as irresectable mediastinal lymph node. Primary outcome measure for non-inferiority is the proportion of patients with unforeseen N2 disease at surgery. Secondary outcome measures are hospitalization, morbidity, overall 2-year survival, quality of life, cost-effectiveness and cost-utility. Patients will be followed up 2 years after start of treatment. DISCUSSION: Results of the MEDIASTrial will have immediate impact on national and international guidelines, which are accessible to public, possibly reducing mediastinoscopy as a commonly performed invasive procedure for NSCLC staging and diminishing variation in clinical practice. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register on July 6th, 2017 ( NTR 6528 ).
Subject(s)
Carcinoma, Non-Small-Cell Lung/pathology , Endosonography/methods , Lung Neoplasms/pathology , Mediastinoscopy/methods , Carcinoma, Non-Small-Cell Lung/surgery , Cost-Benefit Analysis , Humans , Lung Neoplasms/surgery , Lymph Nodes/pathology , Mediastinum/pathology , Neoplasm Staging , Netherlands , Positron Emission Tomography Computed Tomography , Positron-Emission Tomography , Quality of Life , Tomography, X-Ray ComputedABSTRACT
OBJECTIVE: To assess the cost-effectiveness of various modes of mediastinal staging in non-small cell lung cancer (NSCLC) in a single-payer health care system. METHODS: We performed a decision analysis to compare the health outcomes and costs of 4 mediastinal staging strategies: no invasive staging, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), mediastinoscopy, and EBUS-TBNA followed by mediastinoscopy if EBUS-TBNA is negative. We determined incremental cost effectiveness ratios (ICER) for all strategies and performed comprehensive deterministic sensitivity analyses using a willingness to pay threshold of $80,000/quality adjusted life year (QALY). RESULTS: Under the base-case scenario, the no invasive mediastinal staging strategy was least effective (QALY, 5.80) and least expensive ($11,863), followed by mediastinoscopy, EBUS-TBNA, and EBUS-TBNA followed by mediastinoscopy with 5.86, 5.87, and 5.88 QALYs, respectively. The ICER was â¼$26,000/QALY for EBUS-TBNA staging and â¼$1,400,000/QALY for EBUS-TBNA followed by mediastinoscopy. The mediastinoscopy strategy was dominated. Once pN2 exceeds 2.5%, EBUS-TBNA staging is cost-effective (â¼$80,000/QALY). Once the pN2 reaches 57%, EBUS-TBNA followed by mediastinoscopy is cost-effective (ICER â¼$79,000/QALY). Once EBUS-TBNA sensitivity exceeds 25%, EBUS-TBNA staging is cost-effective (ICER â¼$79,000/QALY). Once pN2 exceeds 25%, confirmatory mediastinoscopy should be added, in cases of EBUS-TBNA sensitivity ≤ 60%. CONCLUSIONS: Invasive mediastinal staging in NSCLC is unlikely to be cost-effective in clinical N0 patients if pN2 <2.5%. In patients with probability of mediastinal metastasis between 2.5% and 57% EBUS-TBNA is cost-effective as the only staging modality. Confirmatory mediastinoscopy should be considered in high-risk patients (pN2 > 57%) in case of negative EBUS-TBNA.
