1. Screen discovered nodules: What next? Anil Vachani, MD, MS Assistant Professor of Medicine Director, Lung Nodule Program University of Pennsylvania Medical Center 18 th Annual Perspectives in Thoracic Oncology

2. Disclosures Research Funding – NIH, DOD – Integrated Diagnostics, Allegro Diagnostics, Scientific Advisory Board – Allegro Diagnostics

3. Nodule, Biopsy and Benign Disease Rates Percent of patients in screened arm 2 3 0 1 4 5 RCT

4. Ost & Gould, AJRCCM 2011

5. Assessing the Probability of Cancer Most Important Factors to consider: – Nodule size and characteristics – Smoking history – Age – Family history of lung cancer – Emphysema

6. http://www.brocku.ca/lung-cancer-risk-calculator

8. Importance of Nodule Size Nodule SizeConfirmed Lung CancerPPV (%) YesNo 4-7 mm18 (7%)3642 (53%)0.5 7-10 mm35 (13%)2079 (30%)1.7 11-20 mm111 (41%)821 (12%)11.9 21-30 mm58 (22%)137 (2%)29.7 > 30 mm45 (17%)64 (1%)41.3 NLST Investigators. NEJM 2013

9. Guidelines

10. Fleischner Society Guidelines Nodule SizeLow RiskHigh Risk ≤ 4 mmNo follow-up needed12 mo > 4-6 mm12 mo6-12 mo > 6-8 mm6-12 mo3-6 mo > 8 mm3 mo, PET, and/or biopsy McMahon, et al. Radiology 2005; 237:395-400

12. Recommendations for Subsolid Nodules Nodule TypeManagement Recommendation Solitary pure GGN ≤ 5 mmNo CT follow-up required

13. Thick vs. Thin Sections for Small Nodules Naidich D P et al. Radiology 2013;266:304-317

14. Recommendations for Subsolid Nodules Nodule TypeManagement Recommendation Solitary pure GGN ≤ 5 mmNo CT follow-up required > 5 mmInitial CT at 3 months; annual surveillance CT for minimum 3 years

15. Pure GGN larger than 5mm Lesions are frequently due to preinvasive AAH or AIS Up to 20% of persistent GGOs are benign Growth of a GGO can suggest presence of an invasive adenocarcinoma

16. Serial Imaging to Assess Growth (1mm cuts) Naidich D P et al. Radiology 2013;266:304-317

17. Rapid Enlargement of a GGO Naidich D P et al. Radiology 2013;266:304-317

18. Recommendations for Subsolid Nodules Nodule TypeManagement Recommendation Solitary pure GGN ≤ 5 mmNo CT follow-up required > 5 mmInitial CT at 3 months; annual surveillance CT for minimum 3 yrs Solitary part-solidInitial CT at 3 months; if persistent and solid component 5mm, then biopsy or surgery

20. Rationale Part solid nodules have a high likelihood of malignancy Development of a solid component within a pure GGO

21. Recommendations for Subsolid Nodules Nodule TypeManagement Recommendation Solitary pure GGN ≤ 5 mmNo CT follow-up required > 5 mmInitial CT at 3 months; annual surveillance CT for minimum 3 yrs Solitary part-solidInitial CT at 3 months; if persistent and solid component 5mm, then biopsy or surgery Multiple subsolid nodules Pure GGNs < 5 mmObtain follow-up CT at 2 and 4 years Pure GGNs > 5mm without a dominant lesion Initial CT at 3 months; then annual surveillance for a minimum of 3 yrs Dominant nodule with part solid or solid component Initial CT at 3 months; If persistent, biopsy or surgical resection, especially for lesions with > 5mm solid component

22. Multiple subsolid lesions with single dominant focus. Naidich D P et al. Radiology 2013;266:304-317

23. PET Scans Erasmus, et al. Clinics in Chest Medicine 2008

24. PET Scans Sensitivity ~ 85% Specificity ~ 80% Less accurate for: – Smaller lesions – Subsolid nodlues

25. Establishing a Tissue Diagnosis Bronchoscopy vs. CT guided TTNA ModalitySensitivity Traditional bronchoscopy (screen detected)15% Navigational bronchoscopy70% CT guided TTNA90%

26. Establishing a Tissue Diagnosis Bronchoscopy vs. CT guided TTNA Data based on case series Risks of CT guided TTNA – Pneumothorax 15-27% ModalitySensitivity Traditional bronchoscopy (screen detected)15% Navigational bronchoscopy70% CT guided TTNA90%

27. Conclusions Lung nodules are increasingly common Important to elicit patient preferences Management should include – Estimation of cancer risk Nodules ≤ 8mm are infrequently malignant – CT scan surveillance is best option in most cases If high likelihood of malignancy and low surgical risk, consider surgical evaluation Emergence of peripheral blood biomarkers

28. THANK YOU