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Principal Investigator
Name
Juan Wisnivesky
Degrees
MD, DrPH
Institution
Icahn School of Medicine at Mount Sinai
Position Title
Professor of Medicine
Email
About this CDAS Project
Study
NLST (Learn more about this study)
Project ID
NLST-128
Initial CDAS Request Approval
Mar 13, 2015
Title
Impact of Lung Cancer Screening on Lung Cancer mortality in COPD patients
Summary
Chronic Obstructive Pulmonary Disease (COPD) is projected to be the third cause of death in 2020.
Lung cancer (LC) is one of the most frequent causes of death in Chronic Obstructive Pulmonary Disease (COPD) patients mostly in patients with mild to moderate degrees of airway obstruction (spirometric GOLD stages I-II).
The National Lung Screening Trial (NLST) demonstrated that performing a low dose Computed Tomography (LDCT) of the chest in a selected sample of active or former smokers could decrease LC mortality by 20% (2).

Links between COPD and Lung Cancer
Our group has explored the links between lung cancer and COPD based on our experience in running a lung cancer screening program in Pamplona, Spain and in recruiting, analyzing and comparing outcomes in the COPD observational BODE cohort of over 2500 patients followed over 10 years in 5 centers in Spain and the United States. No lung cancer screening has been implemented in the BODE sites other than Pamplona.
We have shown that emphysema observed on a low dose computed tomography in the setting of lung cancer screening is associated with a 2-3 fold risk of developing lung cancer. We also described the characteristics of LC in COPD patients and identified factors independently associated with LC. We have recently published in collaboration with researchers from the University of Pittsburgh (Dr. David Wilson and colleagues) results on the development and validation of a COPD Lung Cancer Screening Score (COPD-LUCSS) to help identify patients with COPD with the highest risk of developing LC.
Based on the observation that patients with COPD have a higher incidence of lung cancer in these cohorts, we explored the potential benefits of lung cancer screening specifically in COPD patients. We conducted a pilot study comparing matched individuals with COPD in GOLD stages I and II coming from two different cohorts: the BODE cohort and the Lung Cancer Screening cohort from Pamplona, Spain. The latter is part of the I-ELCAP cohort. We reported a significant LC stage shift in COPD patients with a greater proportion of early stage diagnosis in individuals undergoing screening. We determined a 10-fold difference in mortality in the not-screened compared with the screened program. The number of patients needed to screen (NND) was 34, approximately 1/10 of those needed in the NLST (NND = 320) study. However, our study was retrospective and was done in a rather small sample of patients.

Hypothesis: LC screening with low dose CT will have a significant favorable impact on mortality in COPD patients.
Performing an appropriately-designed LC screening study specifically in COPD patients is urgently needed since the potential impact on COPD mortality could be very significant. The NLST study includes the NLST- American College of Radiology Imaging Network (ACRIN) arm that performed spirometry in approximately 20,000 active or former smokers. This will allow the correct diagnosis of COPD and will allow an analysis of the effect of lung cancer screening on a large cohort of COPD patients.
Aims

Specific Aims:
1. Determine if screening with low dose CT will decrease LC mortality in spirometrically defined COPD patients.
2. Determine if screening with low dose CT results in a significant shift of LC stage from more advanced to earlier potentially curable stages.
3. Determine the potential role of the use of the COPD-LUCSS in the selection of COPD patients at higher risk of developing LC.

Collaborators

1. Juan Pablo de Torres, MD. Clínica Universidad de Navarra. Pamplona Spain.
2. Juan Pablo Wisnivesky, MD. Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. USA
3. Bartolome R. Celli, MD. Brigham and Women Hospital. Harvard Medical School. Boston. USA
4. Javier J. Zulueta, MD. Clínica Universidad de Navarra. Pamplona Spain.

Publications:

de Torres JP, Bastarrika G, Wisnivesky JP, Alcaide AB, Campo A, Seijo LM, Pueyo JC, Villanueva A, Lozano MD, Montes U, Montuenga L, Zulueta JJ.
Assessing the Relationship between Lung Cancer Risk and Emphysema
Chest. 2007;132:1932-8.

de Torres JP, Marín JM, Casanova C, Cote C, Carrizo S, Cordoba-Lanus E, Baz-Dávila R, Zulueta JJ, Aguirre-Jaime A, Saetta M, Cosio MG, Celli BR.
Lung Cancer in patients with COPD: Incidence and predicting factors.
Am J Respir Crit Care Med. 2011;184:913-9.

de-Torres JP, Casanova C, Marín JM, Zagaceta J, Alcaide AB, Seijo LM, Campo A, Carrizo S, Montes U, Cordoba-Lanus E, Baz-Dávila R, Aguirre-Jaime A, Celli BR, Zulueta JJ.
Exploring the impact of screening with low-dose CT on lung cancer mortality in mild to moderate COPD patients: A pilot study.
Respir Med. 2013 May;107(5):702-7.

de-Torres JP, Wilson DO, Sanchez-Salcedo P, Weissfeld JL, Berto J, Campo A, Alcaide AB, García-Granero M, Celli BR, Zulueta JJ.
Lung Cancer in COPD Patients: Development and Validation of the COPD LUng Cancer Screening Score (COPD-LUCSS).

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