Long-term effects of inhaled budesonide on screening-detected lung nodules
Mené sur 202 patients présentant un ou plusieurs nodules pulmonaires non suspects et bénéficiant d'un contrôle annuel par tomographie numérique à faible dose de rayonnements (durée de suivi : 5 ans), cet essai évalue les effets à long terme du budésonide, un anti-inflammatoire glucocorticoïde administré par inhalation, sur le nombre de nouvelles lésions détectées, la taille des nodules et le nombre de cancers du poumon diagnostiqués
Background : A previously performed randomized phase IIb, placebo-controlled trial of one year of inhaled budesonide, that 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 one 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 five 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 five 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 number of lung cancers differed in the two arms. Conclusions : Inhaled budesonide given for one year significantly decreased the size of non-solid nodules detected by screening LDCT after five 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. Clinical trial number: