Respiratory Trials·org

Lung cancer · Staging the mediastinum

ASTER randomised trial

Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer

ASTER trial design and results
Design Randomised controlled trial
Treatment Endosonography (endobronchial and endoscopic ultrasound) followed by surgical staging if negative
Control Surgical staging alone
Population 241 patients with known or suspected non-small-cell lung cancer
Follow-up 6 months
Primary endpoint Sensitivity for mediastinal nodal metastases
Result Sensitivity was 79% (41 of 52, 95% CI 66% to 88%) for surgical staging alone versus 85% (56 of 66, 74% to 92%) for endosonography (p=0.47) and 94% (62 of 66, 85% to 98%) for the combined strategy (p=0.02). Unnecessary thoracotomy occurred in 21 (18%) with mediastinoscopy versus 9 (7%) with endosonography (p=0.02). Complication rates were similar.
Secondary endpoints Unnecessary thoracotomy, complications

Among patients with (suspected) NSCLC, a staging strategy combining endosonography and surgical staging compared with surgical staging alone resulted in greater sensitivity for mediastinal nodal metastases and fewer unnecessary thoracotomies.

The trial authors, in the published abstract

How it has aged

Made EBUS the first-line mediastinal staging investigation and pushed mediastinoscopy into a confirmatory role. The important number is the 18% to 7% fall in unnecessary thoracotomy — a major operation avoided in one patient in nine.

Publications

Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial

Annema JT, van Meerbeeck JP, Rintoul RC, et al. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA 2010 Nov 24;304(20):2245-52.

  • Sensitivity 94% for the combined strategy versus 79% for surgical staging alone
  • Unnecessary thoracotomy reduced from 18% to 7%
  • Similar complication rates