Endobronchial ultrasound and value of PET for prediction of pathological results of mediastinal hot spots in lung cancer patients.

SUMMARY: In the staging of lung cancer with positron emission tomography (PET) positive mediastinal lymph nodes, tissue sampling is required. The performance of transbronchial needle aspiration (TBNA) using linear endobronchial ultrasound (real-time EBUS-TBNA) under local anaesthesia and the value of PET for prediction of pathological results were assessed in that setting. The number of eluded surgical procedures was evaluated. All consecutive patients with suspected/proven lung cancers and FDG-PET positive mediastinal adenopathy were included. If no diagnosis was reached, further surgical sampling was required. Lymph node SUVmax (maximum standardized uptake value) was assessed in patients whose PET was performed in the leading centre. One hundred and six patients were included. The average number of TBNA samples per patient was 4.9+/-1.1. The prevalence of lymph node metastasis was 58%. Sensitivity, accuracy and negative predictive value of EBUS-TBNA in the staging of mediastinal hot spots were 95, 97 and 91%. Patients without malignant lymph node involvement showed lower SUVmax (respective median values of 3.7 and 10.0; p<0.0001). Surgical procedures were eluded in 56% of the patients. Real-time EBUS-TBNA should be preferred over mediastinoscopy as the first step procedure in the staging of PET mediastinal hot spots in lung cancer patients. In case of negative EBUS, surgical staging procedure should be undertaken. The addition of SUVmax cut-off may allow further refinement but needs validation.

24-hour bronchodilator efficacy of single doses of indacaterol in subjects with COPD: comparison with placebo and formoterol.

OBJECTIVE: To assess the bronchodilator efficacy, safety and tolerability of indacaterol, a novel, once-daily inhaled beta(2)-agonist bronchodilator, in patients with chronic obstructive pulmonary disease (COPD). METHODS: This crossover, double-blind, double-dummy study was conducted to evaluate the 24-h bronchodilator effect of a range of single doses of indacaterol (150 microg, 300 microg and 600 microg), given in the morning via single-dose dry powder inhaler (SDDPI) in subjects with COPD, compared with placebo and with the daily therapeutic dose of formoterol (two 12 microg doses 12 h apart, via an SDDPI). Tolerability and safety were also assessed. RESULTS: Fifty-one subjects with moderate-to-severe COPD received each of the five treatments on separate study days in randomised sequence. The 24-h trough FEV(1) (primary endpoint; mean [95% CI]) was 1.46 (1.43, 1.49) L with indacaterol 600 microg (p < 0.001 vs. placebo, p < 0.01 vs. formoterol, p < 0.05 vs. indacaterol 150 microg), 1.45 (1.42, 1.48) L with indacaterol 300 microg (p < 0.001 vs. placebo, p < 0.05 vs. formoterol), 1.42 (1.39, 1.45) L with indacaterol 150 microg (p < 0.001 vs. placebo), 1.41 (1.38, 1.43) L with formoterol (p < 0.001 vs. placebo) and 1.28 (1.25, 1.31) L with placebo. All treatments were well tolerated and there was little effect on serum potassium, blood glucose or QTc interval. CONCLUSION: All doses of indacaterol were effective in providing 24-h bronchodilation and were well-tolerated in subjects with COPD. The bronchodilator efficacy of indacaterol (150, 300 and 600 microg) at 24 h post-dose was at least as efficacious as formoterol 12 microg twice daily.