Clinical efficacy and cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration for preoperative staging of non-small-cell lung cancer: Results of a French prospective multicenter trial (EVIEPEB)

Christos Chouaid, Mathieu Salaün, Valérie Gounant, Michel Febvre, Jean-Michel Vergnon, Vincent Jouniaux, Clément Fournier, Samy Lachkar, Christophe Hermant, Christophe Raspaud, Xavier Quantin, Jean-Jacques Quiot, Anita Molard, Charles Dayen, Charles-Hugo Marquette, Hervé Lena, Gérard Zalcman, Luc Thiberville, Christos Chouaid, Mathieu Salaün, Valérie Gounant, Michel Febvre, Jean-Michel Vergnon, Vincent Jouniaux, Clément Fournier, Samy Lachkar, Christophe Hermant, Christophe Raspaud, Xavier Quantin, Jean-Jacques Quiot, Anita Molard, Charles Dayen, Charles-Hugo Marquette, Hervé Lena, Gérard Zalcman, Luc Thiberville

Abstract

This two-step study evaluated the cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for presurgery staging of non-small cell lung cancer (NSCLC) in France (EVIEPEB; ClinicalTrial.gov identifier NCT00960271). Step 1 consisted of a high-benchmark EBUS-TBNA-training program in participating hospital centers. Step 2 was a prospective, national, multicenter study on patients with confirmed or suspected NSCLC and an indication for mediastinal staging with at least one lymph node > 1 cm in diameter. Patients with negative or uninformative EBUS-TBNA and positron-emission tomography-positive or -negative nodes, respectively, underwent either mediastinoscopy or surgery. Direct costs related to final diagnosis of node status were prospectively recorded. Sixteen of 22 participating centers were certified by the EBUS-TBNA-training program and enrolled 163 patients in Step 2. EBUS-TBNA was informative for 149 (91%) patients (75 malignant, 74 non-malignant) and uninformative for 14 (9%). Mediastinoscopy was avoided for 80% of the patients. With a 52% malignant-node rate, EBUS-TBNA positive- and negative-predictive values, respectively, were 100% and 90%. EBUS-TBNA was cost-effective, with expected savings of €1,450 per patient, and would have remained cost-effective even if all EBUS-TBNAs had been performed under general anesthesia or the cost of the procedure had been 30% higher (expected cost-saving of €994 and €1,427 per patient, respectively). After EBUS-TBNA training and certification of participating centers, the results of this prospective multicenter study confirmed EBUS-TBNA cost-effectiveness for NSCLC staging.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1
Flow chart of the study (EBUS-TBNA: endobronchial ultrasound-guided transbronchial needle aspiration, EBUS-TBNA positive: tumors cells, EBUS-TBNA negative: Lymphocytes and no tumor cells, PS: performans status, PET positive: significant uptake, PET negative: no significant uptake,.

References

    1. Porte H, Roumilhac D, Eraldi L, Cordonnier C, Puech P, Wurtz A. The role of mediastinoscopy in the diagnosis of mediastinal lymphadenopathy. Eur J Cardiothorac Surg. 1998;13:196–199.
    1. Mountain CF, Dressler CM. Regional lymph node classification for lung cancer staging. Chest. 1997;111:1718–1723.
    1. Colt HG, Davoudi M, Murgu SD. Scientific evidence and principles for the use of endobronchial ultrasound and transbronchial needle aspiration. Expert Rev Med Devices. 2011;8:493–513. 10.1586/erd.11.14
    1. Currie GP, McKean ME, Kerr KM, Denison AR, Chetty M. Endobronchial ultrasound-transbronchial needle aspiration and its practical application. QJM. 2011;104:653–662. 10.1093/qjmed/hcr071
    1. Ernst A, Silvestri GA, Johnstone D. American College of Chest Physicians. Interventional pulmonary procedures: guidelines from the American College of Chest Physicians. Chest. 2003;123:1693–1717.
    1. Miller D, Mahendra P, Bruce V, Kerr KM, McKean M, Chetty M, et al. Endobronchial ultrasound transbronchial needle aspiration at Aberdeen Royal Infirmary: the initial experience. QJM. 2012;105:607–608. 10.1093/qjmed/hcs049
    1. Ye T, Hu H, Luo X, Chen H. The role of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) for qualitative diagnosis of mediastinal and hilar lymphadenopathy: a prospective analysis. BMC Cancer 2011;11:100 10.1186/1471-2407-11-100
    1. Andrade RS, Podgaetz E, Rueth NM, Majumder K, Hall E, Saric C, et al. Endobronchial ultrasonography versus mediastinoscopy: a single-institution cost analysis and waste comparison. Ann Thorac Surg. 2014;98:1003–1007. 10.1016/j.athoracsur.2014.04.104
    1. Ang SY, Tan RW, Koh MS, Lim J. Economic analysis of endobronchial ultrasound (EBUS) as a tool in the diagnosis and staging of lung cancer in Singapore. Int J Technol Assess Health Care. 2010;26:170–174. 10.1017/S0266462310000176
    1. Callister ME, Gill A, Allott W, Plant PK. Endobronchial ultrasound guided transbronchial needle aspiration of mediastinal lymph nodes for lung cancer staging: a projected cost analysis. Thorax. 2008; 63:384.
    1. Harewood GC, Pascual J, Raimondo M, Woodward T, Johnson M, McComb B, et al. Economic analysis of combined endoscopic and endobronchial ultrasound in the evaluation of patients with suspected non-small cell lung cancer. Lung Cancer. 2010;67:366–371. 10.1016/j.lungcan.2009.04.019
    1. Sharples LD, Jackson C, Wheaton E, Griffith G, Annema JT, Dooms C, et al. Clinical effectiveness and cost-effectiveness of endobronchial and endoscopic ultrasound relative to surgical staging in potentially resectable lung cancer: results from the ASTER randomised controlled trial. Health Technol Assess. 2012;16:1–75.
    1. Ministère de la Santé et des Solidarités. Arrêté du 27 février 2007 relatif à la classification et à la prise en charge des prestations d’hospitalisation pour les activités de médecine, chirurgie, obstétrique et odontologie et pris en application de l’article L 162-22-6 du code de la sécurité sociale. Journal Officiel n°50 du 28 février 2007, texte 72.
    1. Nomenclature Générale des Actes Professionnels. Union des Caisses Nationales de Sécurité Sociale (UCANSS). Paris.
    1. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. BMJ. 2003;326:41–44.
    1. Davoudi M, Colt HG, Osann KE, Lamb CR, Mullon JJ. Endobronchial ultrasound skills and tasks assessment tool: assessing the validity evidence for a test of endobronchial ultrasound-guided transbronchial needle aspiration operator skill. Am J Respir Crit Care Med. 2012;186:773–779. 10.1164/rccm.201111-1968OC
    1. Wahidi MM, Silvestri GA, Coakley RD, Ferguson JS, Shepherd RW, Moses L, et al. A prospective multi-center study of competency metrics and educational interventions in the learning of bronchoscopy among starting pulmonary fellows. Chest. 2010;137:1040–1049. 10.1378/chest.09-1234
    1. Unroe MA, Shofer SL, Wahidi MM. Training for endobronchial ultrasound: methods for proper training in new bronchoscopic techniques. Curr Opin Pulm Med. 2010;16:295–300. 10.1097/MCP.0b013e32833a047a
    1. McComb BL, Wallace MB, Pascual JM, Othman MO. Mediastinal staging of non small cell lung carcinoma by endoscopic and endobronchial ultra-sound–guided fine needle aspiration. J Thorac Imaging. 2011;26:147–161. 10.1097/RTI.0b013e3182171dc9
    1. Lee HS, Lee GK, Lee HS, Kim MS, Lee JM, Kim HY, et al. Real-time endobronchial ultrasound-guided transbronchial needle aspiration in mediastinal staging of non-small cell lung cancer: how many aspirations per target lymph node station? Chest. 2008;134:368–374. 10.1378/chest.07-2105
    1. Navani N, Lawrence DR, Kolvekar S, Hayward M, McAsey D, Kocjan G, et al. Endobronchial ultrasound–guided transbronchial needle aspiration prevents mediastinoscopies in the diagnosis of isolated mediastinal lymphadenopathy: a prospective trial. Am J Respir Crit Care Med. 2012;186:255–260. 10.1164/rccm.201203-0393OC
    1. Navani N, Brown JM, Nankivell M, Woolhouse I, Harrison RN, Jeebun V, et al. Suitability of endobronchial ultrasound-guided transbronchial needle aspiration specimens for subtyping and genotyping of non-small cell lung cancer: a multicenter study of 774 patients. Am J Respir Crit Care Med. 2012;185:1316–1322 10.1164/rccm.201202-0294OC
    1. Um SW, Kim HK, Jung SH, Han J, Lee KJ, Park HY, et al. Endobronchial ultrasound versus mediastinoscopy for mediastinal nodal staging of non-small-cell lung cancer. J Thorac Oncol. 2015;10:331–337. 10.1097/JTO.0000000000000388
    1. Hwangbo B, Kim SK, Lee HS, Lee HS, Kim MS, Lee JM, et al. Application of endobronchial ultrasound-guided transbronchial needle aspiration following integrated PET/CT in mediastinal staging of potentially operable non-small cell lung cancer. Chest. 2009;135:1280–1287. 10.1378/chest.08-2019
    1. Steinfort DP, Liew D, Conron M, Hutchinson AF, Irving LB. Cost-benefit of minimally invasive staging of non-small cell lung cancer: a decision tree sensitivity analysis. J Thorac Oncol. 2010;5:1564–1570 10.1097/JTO.0b013e3181e8b2e6
    1. Medford AR, Agrawal S, Free CM, Bennett JA. A performance and theoretical cost analysis of endobronchial ultrasound-guided transbronchial needle aspiration in a UK tertiary respiratory centre. QJM. 2009;102:859–864. 10.1093/qjmed/hcp136
    1. Hergott CA, Maceachern P, Stather DR, Tremblay A. Repair costs for endo bronchial ultrasound bronchoscopes. J Bronchology Interv Pulmonol. 2010;17:223–227. 10.1097/LBR.0b013e3181e77280

Source: PubMed

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