GUIDELINES FOR PULMONARY NODULE MANAGEMENT : RECENT CHANGES AND UPDATES

Venice 2017 GUIDELINES FOR PULMONARY NODULE MANAGEMENT : RECENT CHANGES AND UPDATES Heber MacMahon MB, BCh Department of Radiology The University of Chicago

Disclosures Consultant for Riverain Medical Minor stockholder in Hologic, Inc. Consultant for GE Healthcare Research Support from Philips Healthcare License and royalty fees from University of Chicago (UC Tech)

What is a Pulmonary Nodule?

Pulmonary Nodule A rounded opacity, well or poorly defined, measuring up to 3 cm in diameter

Nodule Size and Probability of Malignancy Size ELCAP Mayo <3mm 0.1% 2-5mm 1% 4-7mm 0.7% 6-10mm 24% 8-20mm 18.7% 21-30mm 33.3% 21-45mm 80%

Diagnostic Features of Nodules Size Morphology Texture Solid, Part solid, Ground glass Calcification Shape Margins Location Growth rate

Spectrum of NoduleTexture GGO Part Solid Solid

Part-Solid and Non-Solid Nodules in a Screening Program Henschke et al. AJR 2002 ;178:1053-1057 Part-solid: 63% malignant Non-solid: 18% malignant Solid: 7% malignant

Persistent Non-Solid nodules 53 NS nodules in 49 pts Persisted or grew for > 1 month 75% were adenoca/ BAC 6% AAH 19% Nodular fibrosis/organizing pna Kim et al. Radiology 2007 245,1 p267

Atypical Adenomatous Hyperplasia (AAH) Typically GGO <5mm Precursor of adenoca Found in 20% + of lobes resected for lung ca

Ground Glass (Non-Solid) Nodule 7-07 12-08 4-09

Adenocarcinoma Progression 12-2009 6-2010 1-2011 3-2012 10-2013 3-2014

Diagnostic Features of Nodules Size Morphology Texture Attenuation Solid, Part solid, Ground glass Calcium, Fat Shape Margins Location Growth rate

Benign Features Laminar Calc. Central Calc. Fat

Patterns of Calcification Central Laminated Eccentric Popcorn Diffuse Stippled

Calcified Lung Carcinoma Calcium detectable by CT in 10% Usually 2 dystrophic ca++ or engulfed granulomatous ca++ Most calcified carcinomas are 5cm.+ Diffuse, speckled or irregular

Diagnostic Features of Nodules Size Morphology Texture Attenuation Shape Margins Solid, Part solid, Ground glass Calcium, Fat Spherical, elliptical, linear Spiculated, lobulated, smooth Location Growth rate

Nodule Margins Smooth Lobulated Spiculated

Non Solid and Part Solid Nodules Benign Malignant Benign Malignant

Malignant (17) versus Benign (12) Non-solid (GGO) Nodules Margins Malignant Benign Rounded 85% 15% Straight 0 100% Li F, Sone S, Abe H, MacMahon H, Doi K: Radiology (3):233, November, 2004.Pages 793-798

Incidentally detected 5x6mm nodule in a 52 year old never smoker. The most appropriate action would be: 1. 6-12, 18-24 mos CT FU 2. No follow-up 3. PET scan 4. Needle biopsy 5. VATS resection

Diagnostic Features of Nodules Size Morphology Texture Calcification Shape Margins Solid, Part solid, Ground glass Central, Laminar, Popcorn Diffuse Spherical, elliptical, linear Spiculated, lobulated, smooth Location Growth rate

Small Perifissural Solid Nodules De Hoop B, et al.pulmonary perifissural nodules on CT scans: rapid growth is not a predictor of malignancy. Radiology` 2012;265(2):611-16. Myeong I. Ahn MD et al. Perifissural Nodules Seen at CT Screening for Lung Cancer. Radiology: 2010; 254 (3): 949-956.

Diagnostic Features of Nodules Size Morphology Texture Attenuation Shape Margins Location Solid, Part solid, Ground glass Calcium, Fat Spherical, elliptical, linear Spiculated, lobulated, smooth Perifissural, subpleural, upper lobe Growth rate

Growth rate of nodules Volume doubling time (VDT): 26% diameter increase = One volume doubling Typical lung ca. VDT = 100 200 days Range = 30 400 + days

Growth rate of Small Cancers (Hasegawa BJR 2000) Parameter Mean VDT (Days) <10mm 536 >20mm 299 Smoker 292 Non-smoker 607 Adenoca 533 Squamous 129 Small cell 97 GGO 813 Mixed Solid 457 149

Fleischner Society Guidelines 2005 Nodule Size (mm) Low-Risk Patient High-Risk Patient 0-4 None 12 mos >4-6 12 mos 6-12, 18-24mos >6-8 6-12, 18-24mos 3-6, 9-12, 24mos >8 Follow-up CT at around 3, 9, and 24mo, dynamic contrast-enhanced CT, PET, and/or bx

Fleischner Society Guidelines Solitary Subsolid Nodules (2013): Nodule type Management recommendations Solitary pure GGNs: <5mm >5mm No CT FU required 3 mos, then annual for at least 3 yrs Solitary part-solid nodules: 3 mos FU CT, then annual LDCT if solid part <5mm. If solid part >5mm then consider Bx or surg.

Fleischner Society Guidelines Multiple Subsolid Nodules (2013): Nodule type Management recommendations Pure GGNs: <5mm >5mm No CT FU required 3 mos, then annual for at least 3 yrs Dominant Nodules with Part-Solid/Solid Component: 3 mos FU CT, then bx or surgery, especially if solid part <5mm.

Incidental Nodules Exclusions: Patients with unexplained fever Patients with known or suspected metastases Patients < 35 years of age Lung Cancer Screening

Screening Detected vs Incidental Nodules Screen Detected Nodule Limited age range & high cancer risk Surgical candidate Understand risks and benefits Incidental Nodule Wide age range Comorbid conditions Variable motivation & understanding

Screening Detected vs Incidental Nodules Screen Detected Nodule Limited age range & high cancer risk Surgical candidate Understand risks and benefits Negative report > 12 month CT Incidental Nodule Wide age range Comorbid conditions Variable motivation & understanding Negative report > no follow up

New Evidence International Early Lung Cancer Action Program (ielcap) National Lung Cancer Screening Trial (NLST) Pan-Canadian Early Detection of Lung Cancer Study (PanCan) & British Columbia Cancer Agency Trial (BCCA) Nederlans-Leuvens Longkanker Screenings Onderzoek (NELSON) UKLS (UK), MILD (Italy), DANTE (Italy), DLCST (Denmark), LUSI (Germany), DEPISCAN (France)

Fleischner Guidelines 2017 : Threshold Size Relationship between Nodule Size and Probability That a Nodule Is Lung Cancer. McWilliams A et al. N Engl J Med 2013;369:910-919.

New Evidence McWilliams A et al. N Engl J Med 2013;369:910-919 Factors Odds Ratio Age, per year 1.03 Sex, female vs male 1.82 Family History 1.34 Emphysema 1.34 Nodule Type GGN 0.88 PS 1.46 Solid Reference Nodule Location, upper lobe 1.93 Nodule Count, per extra nodule 0.92

Revised Guidelines 2017: Purpose Apply new evidence to determine optimal management strategy Reduce number of unnecessary CT scans

Revised Guidelines 2017: Purpose Apply new evidence to determine optimal management strategy Reduce number of unnecessary CT scans Allow greater discretion to radiologists, clinicians and patients in management decisions - Consider morphology - Comorbid conditions - Patient preference

Fleischner Guidelines 2017 General recommendations: Contiguous thin section CT technique (1mm) Coronal & sagittal recons Low radiation technique for follow up scans

Revised Fleischner Guidelines 2017 General recommendations: Contiguous thin section CT technique (1mm) Coronal & sagittal recons Low radiation technique for follow up scans

3mm 1mm Calcified granuloma

? Nodule

Axial Coronal Sagittal

Revised Fleischner Guidelines 2017 General recommendations: Contiguous thin section CT technique (1mm) Coronal & sagittal recons Low radiation technique for follow up scans

Fleischner Guidelines 2005 vs 2017 Nodule Size (mm) * Low-Risk Patient High-Risk Patient 0-<4 None 12 mos < 6 None + 12 mos >4-6 12 mos 6-12, 18-24mos >6-8 6-12, 18-24mos 3-6, 9-12, 24mos 6-8 6-12, +18-24mos 6-12, 18-24mos >8 Follow-up CT at around 3, 9, and 24mo, dynamic contrast-enhanced CT, PET, and/or bx >8 Consider 3 mos CT, PET/CT or bx *Measure average diameter to nearest millimeter

Fleischner Guidelines 2005 vs 2017 Nodule Size (mm) * Low-Risk Patient High-Risk Patient 0-<4 None 12 mos < 6 1 mm change None + 12 mos Less FU >4-6 12 mos 6-12, 18-24mos >6-8 6-12, 18-24mos 3-6, 9-12, 24mos 6-8 Only 3 groups 6-12, +18-24mos 6-12, 18-24mos >8 Follow-up CT at around 3, 9, and 24mo, dynamic contrast-enhanced CT, PET, and/or bx >8 Consider 3 mos CT, PET/CT or bx *Measure average diameter to nearest millimeter

Fleischner Subsolid Guidelines 2013 vs 2017 Nodule Size (mm) * Management recommendations GGN < 5mm No FU < 6mm No FU >5mm 3 mos CT then annual for3 yrs > 6mm 6-12 mos CT then every 2 yrs until 5 yrs PSN < 5mm No FU < 6mm No FU > 5mm 3 mos then annual for 3 yrs > 6mm 3-6 mos CT then annual x 5 yrs

Fleischner Subsolid Guidelines 2013 vs 2017 Nodule Size (mm) * Management recommendations GGN < 5mm No FU < 6mm No FU >5mm 3 mos CT then annual for3 yrs > 6mm 6-12 mos CT then every 2 yrs until 5 yrs Same size threshold: < 5mm= <6 PSN when rounding < 5mm No FU < 6mm No FU > 5mm 3 mos then annual for 3 yrs > 6mm 3-6 mos CT then annual x 5 yrs

Fleischner Subsolid Guidelines 2013 vs 2017 Multiple Subsolid Nodules Nodule type Pure GGNs: <5mm >5mm <6mm Dominant Nodules with Part-Solid/Solid Component: >6mm Management recommendations No CT FU required 3 mos, then annual for at least 3 yrs 3-6 mos, then +2 and 4 yr CT FU 3 mos FU CT, then bx or surgery, especially if solid part <5mm. 3-6 mos CT, then based on most suspicious nodule

Fleischner Subsolid Guidelines 2013 vs 2017 Multiple Subsolid Nodules Nodule type Pure GGNs: <5mm >5mm <6mm Management recommendations No CT FU required 3 mos, then annual for at least 3 yrs 3-6 mos, then +2 and 4 yr CT FU Dominant Nodules with Part-Solid/Solid Component: Multiple Subsolid Nodules 3 mos FU CT, then bx or surgery, especially if solid part <5mm. 3-6 mos CT, then based on most suspicious nodule. If stable, consider 2 and 4 yr CT Optional later first FU, then longer FU

Fleischner Subsolid Guidelines 2013 vs 2017 Multiple Subsolid Nodules Nodule type Pure GGNs: <5mm >5mm Dominant Nodules with Part-Solid/Solid Component: Multiple Subsolid Nodules <6mm >6mm Management recommendations No CT FU required 3 mos, then annual for at least 3 yrs 3 mos FU CT, then bx or surgery, especially if solid part <5mm. 3-6 mos CT. If stable, consider 2 and 4 yr CT. 3-6 mos CT. Subsequent management based on the most suspicious nodule.

Revised Fleischner Guidelines 2017

Fleischner Guidelines 2017 Less routine follow-up for very small nodules More flexibility for follow up timing depending morphology and patient preference Longer follow up for suspicious sub-solid nodules