title: Long-term effects of inhaled budesonide on screening-detected lung nodules.
abstract: BACKGROUND
  A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT.
  
  
  METHODS
  We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed.
  
  
  RESULTS
  The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms.
  
  
  CONCLUSIONS
  Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications.
  
  
  BACKGROUND
  NCT01540552.
authors: Divisions of Thoracic Surgery. Electronic address: giulia.veronesi@ieo.it.
authors: G
authors: G
authors: Veronesi
authors: Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors: M
authors: M
authors: Lazzeroni
authors: Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda.
authors: E
authors: E
authors: Szabo
authors: Department of Clinical Cancer Prevention, University of Texas MD Anderson Cancer Center, Houston, USA.
authors: P H
authors: PH
authors: Brown
authors: Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy; Division of Medical Oncology, Ospedali Galliera, Genoa.
authors: A
authors: A
authors: DeCensi
authors: Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors: A
authors: A
authors: Guerrieri-Gonzaga
authors: Division of Radiology, European Institute of Oncology, Milan; University of Milan, Milan.
authors: M
authors: M
authors: Bellomi
authors: Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy.
authors: D
authors: D
authors: Radice
authors: Division of Radiology, European Institute of Oncology, Milan.
authors: M C
authors: MC
authors: Grimaldi
authors: Divisions of Thoracic Surgery; University of Milan, Milan.
authors: L
authors: L
authors: Spaggiari
authors: Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors: B
authors: B
authors: Bonanni
mesh_terms: D000230:Adenocarcinoma / Q000000981:diagnostic imaging / Q000517:prevention & control*; D000077192:Adenocarcinoma of Lung; D000280:Administration, Inhalation; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D017322:Clinical Trials, Phase II as Topic; D055088:Early Detection of Cancer / Q000379:methods; D006801:Humans; D008175:Lung Neoplasms / Q000000981:diagnostic imaging / Q000517:prevention & control*; D061330:Multidetector Computed Tomography; D055613:Multiple Pulmonary Nodules / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011230:Precancerous Conditions / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011237:Predictive Value of Tests; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012307:Risk Factors; D003074:Solitary Pulmonary Nodule / Q000000981:diagnostic imaging / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D019819:Budesonide
keywords: budesonide; chemoprevention; low-dose computed tomography; lung cancer; screening