Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial

Neal Navani, Matthew Nankivell, David R Lawrence, Sara Lock, Himender Makker, David R Baldwin, Richard J Stephens, Mahesh K Parmar, Stephen G Spiro, Stephen Morris, Sam M Janes, Lung-BOOST trial investigators, Neal Navani, Matthew Nankivell, David R Lawrence, Sara Lock, Himender Makker, David R Baldwin, Richard J Stephens, Mahesh K Parmar, Stephen G Spiro, Stephen Morris, Sam M Janes, Lung-BOOST trial investigators

Abstract

Background: The diagnosis and staging of lung cancer is an important process that identifies treatment options and guides disease prognosis. We aimed to assess endobronchial ultrasound-guided transbronchial needle aspiration as an initial investigation technique for patients with suspected lung cancer.

Methods: In this open-label, multicentre, pragmatic, randomised controlled trial, we recruited patients who had undergone a CT scan and had suspected stage I to IIIA lung cancer, from six UK centres and randomly assigned them to either endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) or conventional diagnosis and staging (CDS), for further investigation and staging. If a target node could not be accessed by EBUS-TBNA, then endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) was allowed as an alternative procedure. Randomisation was stratified according to the presence of mediastinal lymph nodes measuring 1 cm or more in the short axis and by recruiting centre. We used a telephone randomisation method with permuted blocks of four generated by a computer. Because of the nature of the intervention, masking of participants and consenting investigators was not possible. The primary endpoint was the time-to-treatment decision after completion of the diagnostic and staging investigations and analysis was by intention-to-diagnose. This trial is registered with ClinicalTrials.gov, number NCT00652769.

Findings: Between June 10, 2008, and July 4, 2011, we randomly allocated 133 patients to treatment: 66 to EBUS-TBNA and 67 to CDS (one later withdrew consent). Two patients from the EBUS-TBNA group underwent EUS-FNA. The median time to treatment decision was shorter with EBUS-TBNA (14 days; 95% CI 14-15) than with CDS (29 days; 23-35) resulting in a hazard ratio of 1·98, (1·39-2·82, p<0·0001). One patient in each group had a pneumothorax from a CT-guided biopsy sample; the patient from the CDS group needed intercostal drainage and was admitted to hospital.

Interpretation: Transbronchial needle aspiration guided by endobronchial ultrasound should be considered as the initial investigation for patients with suspected lung cancer, because it reduces the time to treatment decision compared with conventional diagnosis and staging techniques.

Funding: UK Medical Research Council.

Copyright © 2015 Navani et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

Figures

Figure 1
Figure 1
Trial profile EBUS-TBNA=endobronchial ultrasound-guided transbronchial needle aspiration. EUS-FNA=endoscopic ultrasound-guided fine needle aspiration. NSCLC=non-small-cell lung cancer.
Figure 2
Figure 2
Time to treatment decision in all patients (A) and in those with non-small-cell lung cancer (B) Kaplan-Meier plots for (A) all patients and (B) patients with non-small-cell lung cancer only undergoing CDS or EBUS-TBNA. CDS=conventional diagnosis and staging. NSCLC=non-small-cell lung cancer. EBUS-TBNA=endobronchial ultrasound-guided transbronchial needle aspiration. HR=hazard ratio.
Figure 3
Figure 3
Overall survival of patients with non-small-cell lung cancer Survival of patients with non-small-cell lung cancer undergoing CDS or EBUS-TBNA. NSCLC=non-small-cell lung cancer. CDS=conventional diagnosis and staging. EBUS-TBNA=endobronchial ultrasound-guided transbronchial needle aspiration. HR=hazard ratio.

References

    1. Jemal A, Bray F, Center MM. Global cancer statistics. CA Cancer J Clin. 2011;61:69–90.
    1. NICE Lung cancer guidelines. 2011. (accessed Jan 22, 2015).
    1. Ramnath N, Dilling TJ, Harris LJ. Treatment of non-small cell lung cancer-stage IIIA: treatment of stage III non-small cell lung cancer: diagnosis and management of lung cancer, 3rd edn. American college of chest physicians evidence-based clinical practice guidelines. Chest. 2013;143:e314S–e340S.
    1. National Lung Cancer Audit Report, 2013. (accessed Jan 22, 2015).
    1. Silvestri GA, Gonzalez AV, Jantz MA. Methods for staging non-small cell lung cancer: diagnosis and management of lung cancer, 3rd edn. American college of chest physicians evidence-based clinical practice guidelines. Chest. 2013;143:e211S–e250S.
    1. Anon Cancer patient experience survey 2011–12. (accessed Jan 22, 2015).
    1. Navani N, Nankivell M, Stephens RJ. Inaccurate clinical nodal staging of non-small cell lung cancer: evidence from the MRC LU22 multicentre randomised trial. Thorax. 2010;65:463.
    1. Silvestri GA, Gould MK, Margolis ML. Noninvasive staging of non-small cell lung cancer: ACCP evidenced-based clinical practice guidelines, 2nd edn. Chest. 2007;132:178–201S.
    1. Gu P, Zhao YZ, Jiang LY, Zhang W, Xin Y, Han BH. Endobronchial ultrasound-guided transbronchial needle aspiration for staging of lung cancer: a systematic review and meta-analysis. Eur J Cancer. 2009;45:1389–1396.
    1. Navani N, Lawrence DR, Kolvekar S. 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.
    1. Sogaard R, Fischer BM, Mortensen J, Rasmussen TR, Lassen U. The optimality of different strategies for supplemental staging of non-small-cell lung cancer: a health economic decision analysis. Value Health. 2013;16:57–65.
    1. Goldstraw P, Crowley JJ, IASLC International Staging Project The International Association for the Study of Lung Cancer International Staging Project on Lung Cancer. J Thorac Oncol. 2006;1:281–286.
    1. NICE 2005 lung cancer guideline (accessed Jan 22, 2015).
    1. Navani N, Spiro SG, Janes SM. Mediastinal staging of NSCLC with endoscopic and endobronchial ultrasound. Nat Rev Clin Oncol. 2009;6:278–286.
    1. NHS reference costs 2010–11. (accessed Jan 22, 2015).
    1. UK NHS Cancer Plan. 2005. (accessed Jan 22, 2015).
    1. Fischer B, Lassen U, Mortensen J. Preoperative staging of lung cancer with combined PET-CT. N Engl J Med. 2009;361:32–39.
    1. Annema JT, van Meerbeeck JP, Rintoul RC. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA. 2010;304:2245–2252.
    1. Navani N, Brown JM, Nankivell M. 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.

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