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Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.

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 ?g 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.

SUBMITTER: Veronesi G

PROVIDER: S-EPMC3017323 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.

Veronesi Giulia G Szabo Eva E Decensi Andrea A Guerrieri-Gonzaga Aliana A Bellomi Massimo M Radice Davide D Ferretti Stefania S Pelosi Giuseppe G Lazzeroni Matteo M Serrano Davide D Lippman Scott M SM Spaggiari Lorenzo L Nardi-Pantoli Angela A Harari Sergio S Varricchio Clara C Bonanni Bernardo B

Cancer prevention research (Philadelphia, Pa.) 20101216 1

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 ...[more]

PMID: 21163939

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Dataset Information

Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.

Publications

Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules.

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