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Clinical Trials |
Departments of 1 Respiratory Medicine, 2 Pathology, 3 Cancer Imaging, and 4 Population and Preventive Oncology, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; 5 National Cancer Institute/DCP/Lung and Upper Aerodigestive Cancer Research Group, Bethesda, Maryland; 6 Department of Radiology, Vancouver General Hospital, Vancouver, British Columbia, Canada; 7 Pulmonary Research Laboratory, St. Paul’s Hospital, Vancouver, British Columbia, Canada; 8 National Cancer Institute/Division of Cancer Prevention/Gastrointestinal Cancer Research Group, Bethesda, Maryland; and 9 Hamon Center for Therapeutic Oncology & Department of Pathology, UT Southwestern Medical Center, Dallas, Texas
Purpose: Preclinical studies suggest that inhaled budesonide may be an effective chemopreventive agent for lung cancer. We conducted a phase IIb study to determine the effects of inhaled budesonide in smokers with bronchial dysplasia.
Experimental Design: A total of 112 smokers with more than or equal to one site of bronchial dysplasia > 1.2 mm in size identified by autofluorescence bronchoscopy-directed biopsy was randomly assigned to receive placebo or budesonide (Pulmicort Turbuhaler) 800 µg twice daily inhalation for 6 months. The primary end point was change in the histopathologic grade on repeat biopsy of the same sites at the end of 6 months.
Results: There were no significant differences in the regression or progression rates of bronchial dysplasia between the two groups. There was a statistically significant but modest decrease in p53 and BclII expression in the bronchial biopsies after 6 months of Pulmicort Turbuhaler versus placebo (P = 0.01 and P = 0.001, respectively). There was a small but statistically significant decrease in the proportion of computed tomography-detected lung nodules after Pulmicort Turbuhaler compared with placebo (P = 0.024).
Conclusions: Our results suggest that in smokers, inhaled budesonide in the dose of 1600 µg daily for 6 months had no effect in regression of bronchial dysplastic lesions or prevention of new lesions. Budesonide treatment resulted in a modest decrease in p53 and BclII protein expression in bronchial biopsies and a slightly higher rate of resolution of computed tomography-detected lung nodules. Whether budesonide truly has an effect in preneoplastic lesions in the peripheral airways and alveoli requires additional investigation.
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