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inhaled STerOids for the Prevention of Lung Cancer. (STOP Lung Cancer)
Proposal
9115
Title of Proposed Research
inhaled STerOids for the Prevention of Lung Cancer. (STOP Lung Cancer)
Lead Researcher
Luis Seijo
Affiliation
Clínica Universidad de Navarra
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
24 April 2020
Lay Summary
Lung cancer remains the leading cause of cancer deaths worldwide. Despite advances in therapy and screening, mortality from lung cancer is expected to remain high for the foreseeable future, because the risk of lung cancer does not vanish once an individual stops smoking. A substantial body of evidence suggests that current or former smokers suffering from tobacco related chronic obstructive pulmonary disease (COPD) are at greater risk of lung cancer. While the links between COPD and lung cancer are a matter of current research, a common genetic susceptibility, alterations in DNA repair mechanisms, chronic inflammation, and a favorable milieu are obvious candidates. Chronic inflammation has been postulated as a key mechanism linking COPD and lung cancer. Inflammation causes cellular damage while promoting cell proliferation, thereby facilitating carcinogenesis. Inflammation and lung cancer may be linked through mechanisms associated with smoking, but potentially also independent of tobacco use. While smoking cessation is essential for lung cancer risk reduction, the search for medications capable of preventing the appearance of lung cancer in patients at risk has failed to deliver a strong candidate for so called chemo prevention. Given what we know about cancer, COPD and inflammation, anti-inflammatory therapy is an obvious choice for chemo prevention. Inhaled steroids (ICS) are already used in the treatment of many patients with COPD and have been the focus of epidemiological studies as potential chemo preventive agents. Unfortunately, the evidence is mixed with some studies suggesting a potential benefit while others showed no benefit at all. Inhaled steroids are excellent candidates for chemo prevention insofar as they are generally well tolerated, are associated with few local and/or systemic side-effects, and already indicated in many patients at risk for lung cancer. Results from recent COPD studies investigating the role of ICS in the management of this disease are now available. Some of these studies randomized patients to treatment arms with and without inhaled steroids. A directed analysis of such studies may shed light on the potential role of ICS in the chemo prevention of lung cancer.
Study Data Provided
[{ "PostingID": 416, "Title": "GSK-SCO30003", "Description": "A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (SERETIDE® inhaler) 50/500mcg BD, salmeterol 50mcg BD and fluticasone propionate 500mcg BD, all delivered via the DISKUS®/ACCUHALER® inhaler, on mortality and morbidity of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment" },{ "PostingID": 4109, "Title": "GSK-HZC113782", "Description": "A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease" }]
Statistical Analysis Plan
Publication Citation
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