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inhaled STerOids for the Prevention of Lung Cancer. (STOP Lung Cancer)

inhaled STerOids for the Prevention of Lung Cancer. (STOP Lung Cancer)

Luis Seijo

Clínica Universidad de Navarra

24 April 2020

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.

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Statistical Analysis Plan