Endosonographic mediastinal lymph node staging of lung cancer.

BACKGROUND: It is unclear whether endoscopic mediastinal lymph node (LN) staging techniques are equivalent to surgical mediastinal staging (SMS) techniques in patients with potentially operable non-small cell lung cancer (NSCLC).

METHODS: A total of 166 patients with confirmed or suspected NSCLC who required SMS based on current guidelines were enrolled in this prospective controlled trial comparing endosonographic mediastinal LN staging with SMS. Each patient served as his or her own control. All patients underwent endobronchial ultrasound (EBUS), endoscopic ultrasound (EUS), and SMS during a single procedure. Results of EBUS, EUS, and combined EBUS/EUS were compared with SMS (gold standard) and in patients with negative LN staging results, with LN sampling at pulmonary resection.

RESULTS: EBUS, EUS, combined EBUS/EUS, and SMS sampled a mean of 2.2, 1.7, 3.9, and 3.1 LN stations, respectively. The prevalence of mediastinal nodal disease (N2/N3) was 32% (53 of 166 patients). The sensitivity, negative predictive value, and diagnostic accuracy of the endoscopic staging modalities, respectively, were EBUS, 72% (95% CI, 0.58-0.83), 88% (0.81-0.93), and 91% (0.85-0.95); EUS, 62% (0.48-0.75), 85% (0.78-0.91), and 88% (0.82-0.92); and combined EBUS/EUS, 91% (0.79-0.97), 96% (0.90-0.99), and 97% (0.93-0.99). Endosonography was diagnostic for N2/N3/M1 disease in 24 patients in whom SMS findings were negative, preventing futile thoracotomy in an additional 14% of patients.

CONCLUSIONS: The combined EBUS/EUS procedure can replace surgical mediastinal staging in patients with potentially resectable NSCLC. Additionally, endosonography leads to improved staging compared with SMS because it allows the biopsy of LNs and metastases unattainable with SMS techniques.

TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01011595; URL: www.clinicaltrials.gov.