Randomized Phase II Trial of Inhaled Budesonide versus Placebo in High-Risk Individuals with CT Screen–Detected Lung Nodules
Articolo
Data di Pubblicazione:
2011
Citazione:
Randomized Phase II Trial of Inhaled Budesonide versus Placebo in High-Risk Individuals with CT Screen–Detected Lung Nodules / G. Veronesi, E. Szabo, A. DeCensi, A. Guerrieri-Gonzaga, D. Radice, S. Ferretti, G. Pelosi, M. Lazzeroni, D. Serrano, S.M. Lippman, A. Nardi-Pantoli, S. Harari, C. Varricchio, B. Bonanni, M. Bellomi, L. Spaggiari. - In: CANCER PREVENTION RESEARCH. - ISSN 1940-6207. - 4:1(2011 Jan), pp. 34-42. [10.1158/1940-6207.CAPR-10-0182]
Abstract:
Screening CT identifies small peripheral lung nodules, some of which may be pre- or early invasive neoplasia. Secondary end point analysis of a previous chemoprevention trial in individuals with bronchial dysplasia showed reduction in size of peripheral nodules by inhaled budesonide. We performed a randomized, double-blind, placebo-controlled phase IIb trial of inhaled budesonide in current and former smokers with CT-detected lung nodules that were persistent for at least 1 year. A total of 202 individuals received inhaled budesonide, 800 μg twice daily or placebo for 1 year. The primary endpoint was the effect of treatment on target nodule size in a per person analysis after 1 year. The per person analysis showed no significant difference between the budesonide and placebo arms (response rate 2% and 1%, respectively). Although the per lesion analysis revealed a significant effect of budesonide on regression of existing target nodules (P = 0.02), the appearance of new lesions was similar in both groups and thus the significance was lost in the analysis of all lesions. The evaluation by nodule type revealed a nonsignificant trend toward regression of nonsolid and partially solid lesions after budesonide treatment. Budesonide was well tolerated, with no unexpected side effects identified. Treatment with inhaled budesonide for 1 year did not significantly affect peripheral lung nodule size. There was a trend toward regression of nonsolid and partially solid nodules after budesonide treatment. Because a subset of these nodules is more likely to represent precursors of adenocarcinoma, additional follow-up is needed. Cancer Prev Res; 4(1); 34–42. ©2010 AACR.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
OBSTRUCTIVE PULMONARY-DISEASE ; GROUND-GLASS OPACITY ; BRONCHIAL EPITHELIUM ; CANCER ; CHEMOPREVENTION ; TUMORS ; CORTICOSTEROIDS ; CARCINOGENESIS ; FLUTICASONE ; PROGRESSION
Elenco autori:
G. Veronesi, E. Szabo, A. Decensi, A. Guerrieri Gonzaga, D. Radice, S. Ferretti, G. Pelosi, M. Lazzeroni, D. Serrano, S.M. Lippman, A. Nardi Pantoli, S. Harari, C. Varricchio, B. Bonanni, M. Bellomi, L. Spaggiari
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