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- 1. LUNG CANCER SCREENING Dr. Lokesh Lalwani
- 2. LungCancer Epidemiology Worldwide – predicted in 2018 • Incidence - 2.1 million newcases • Mortality - 1.8 milliondeaths MC cancer in India after India – predicted in 2018 • Incidence - 67,795 new cases (4th breast, oral cavity andcervix) • Mortality – 63,475 deaths (3rd MCcancer related deaths after breast and oral cavity) CACancer JClin.2018;68(6):394-424
- 3. Stage at presentation Localized, 16% Regional, 22% Distant, 57% Unknown, 5% SEERCancerStatistics Review, 2009-2015
- 4. 5-YearRelative Survival 56.3% 29.7% 7.8% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% Localized Unknown 4.7% Regional Distant 5-year survival rate Percent surviving 5 years –18.6% SEERCancerStatistics Review, 1975-2015
- 5. LungCancerScreening- CXR 1951-1975: 10 prospective studies, of which 4 are RCT s– • TheMemorial-Sloan Kettering LungProject (MSKLP) (sputum +CXR) • TheJohnHopkins lung project (JHLP)(Sputum +CXR) • TheMayo Lungproject (MLP) • TheCzechoslovakian study (CS)
- 6. 2013
- 9. CT scan v/s Chest X-ray Median delay in diagnosis wasfound to be >1year with cxr. Themiss-rate for lesions • ≤ 10mm was 70% • 10-20mm was30% • 21-30mm was25% • The overall accuracy of interpretation for lung cancer – 61%for CXR,Sensitivity – 23%, Specificity – 96%, when compared to CT scan Chest.1999 Mar;115(3):720-4
- 10. Low DoseCTscan • Non contrast study • Multi detector, helical CTscan • High resolution imagereconstruction • Estimated effective dose –1.4mSv • 7-8mSvfor CECTchest, 0.1mSvfor CXR AJRAm JRoentgenol.2011;197(5):1165
- 11. a- non solid nodule, b- partially solid nodule, c- solid nodule
- 13. Solid nodule on initial screening ≤5 mm Annual screening until patient is no longer a candidate for definitive treatment 6-7 mm LDCT in 6 months 8-14 mm LDCT in 3 months or consider PET/CT ≥ 15 mm Chest CT ± contrast and/or PET/CT Low suspicion of lung cancer LDCT in 3 months High suspicion of malignancy Biopsy or surgical excision No cancer Annual screening Cancer confirmed
- 14. Part solid nodule on initial screening ≤5 mm Annual screening until patient is no longer a candidate for definitive treatment ≥6 mm with solid component ≤5 mm LDCT in 6 months ≥6 mm with solid component 6-7 mm LDCT in 3 months or consider PET/CT Solid component ≥ 8 mm Chest CT ± contrast and/or PET/CT Low suspicion of lung cancer LDCT in 3 months High suspicion of malignancy Biopsy or surgical excision No cancer Annual screening Cancer confirmed
- 15. Non solid nodule on initial screening LDCT ≤ 19 mm Annual screening LDCT until patient is no longer candidate for definitive treatment ≥ 20 mm LDCT in 6 months
- 16. National LungScreeningTrial • Multicenter, RCT ,USA • 53,454 participants were enrolled between 2002 –2004 • LDCT(26,722) vsCXR(26,732) • 3 screenings –T0(at randomization), T1and T2at 1-year intervals Inclusion Criteria : • Age- 55 - 74 years • Cigarette smoking of at least 30 packyears • If former smokers - must have quit within the previous 15 years NEnglJMed 2011;365:395-409.
- 17. Positive test – “suspicious for” lungcancer • Any non calcified nodule measuring at least 4 mm in any diameter • Adenopathy • Effusion Minor abnormalities– • Clinically significant conditions other than lungcancer • After the third round of screening (T2), abnormalities suspicious for lung cancer that were stable across the three rounds NEnglJMed 2011;365:395-409.
- 20. Lungcancer specific mortality • 356 (LDCT)vs443 (CXR)deaths from lungcancer • 20.0% (95% CI, 6.8 to 26.7; P= 0.004) reduction in rate of death from lungcancer • total of 320 individuals with high risk factors needed to screen to prevent one death from lungcancer Overall mortality • 1877 (LDCT)vs 2000 (CXR)deaths • 6.7%reduction (95%CI,1.2 to 13.6; P=0.02) in the rate of death from anycause NEnglJMed 2011;365:395-409.
- 22. NELSONtrial Dutch-Belgian RandomizedLung CancerScreening Trial Hypothesis : • Lung cancer screening by LDCT will reduce 10-year lung cancer mortality by 25% in high-risk (ex-)smokers between 50 and 75 years of age. Inclusion Criteria : • Men aged50-75 years • Smokedcigarettes - >15/day for >25 years or >10/day for >30 years • Ifquit smoking then <10 years. CancerImaging (2011) 11, S79-S84
- 23. NELSONtrial • LDCTscreening at baseline (round 1), after 1 year (round2), after 3 years (round 3) and after 5.5 years after baseline (round 4) • 15,822 participants randomized in 1:1 ratio to screening LDCT (7915) vsno screening (7909) Thorax2017;72:48–56.
- 24. NELSONtrial CancerImaging (2011) 11, S79S84
- 25. NELSONtrial • Management wasdetermined based on the highest nodule category found • Growth was defined aschange in volume of at least25% between scans • NODCA T3 - indeterminate test result which required arepeat scan3-4 months later to assessgrowth CancerImaging (2011) 11, S79S84
- 27. Factors NLST NELSON Screening design LDCTvsCXR LDCTvsno screening Screening rounds 3 4 Length of screening interval (years) 1 1, 2 and 2.5 Yearof initiation 2002 2003 Enrolled participants 53,454 15,822 Positive result Maximum axial diameter ≥4mm Volume >500mm3 or Volume 50-500mm3 andVDT <400 days Negative result Maximal axial diameter <4mm Volume <50mm3 Entry criteria Age(yrs) 55-75 50-75 Smokingstatus Current and former smokers Current and former smokers Smokingcessation <15 years <10years Smokinghistory ≥30 pack years ≥15 per day for 25 yearsor ≥10 per day for 30years J.Compar.Effect. Res.(2013) 2(5)
- 28. Cumulativedata NLST NELSON Positive screening result 24.2% 1.9% Falsepositive rate after positive screening result 96.4% 59.4% Lungcancer detection rate 2.4% 3.2% %of StageI cancers detected 61.6% 69.4% LDCTsensitivity for LC 93.8% 94.6% LDCTspecificity for LC 73.4% 98.3% J.Compar.Effect. Res.(2013) 2(5) Thorax2017;72:48–56. • 26%reduction in lung cancerdeaths at 10yearsofstudy follow-up
- 29. Am JRespir Crit CareMed Vol 187, Iss.8, pp 848–854,Apr 15, 2013
- 30. Preventive Medicine 89 (2016) 301–314
- 31. Preventive Medicine 89 (2016) 301–314
- 32. Other benefits of L Cscreening • Improved QOL • Reduction in disease relatedmorbidity • Reduction in treatment relatedmorbidity • Reduction in anxiety and psychosocialburden • Increased smoking cessation rates • Other occult diseases: thyroid nodule, renal tumour, aortic aneurysm, breast cancer etc.
- 33. Risksof L Cscreening • Falsepositive results • Rangefrom 10-43% • Cumulative risk is 33%for aperson undergoing LCscreening with 2 sequential annualscans • Benign intrapulmonary LNand non calcified granulomas
- 35. • V olumetric analysis in NELSON trial – decreases the false positives Lung-RADS(Lung Imaging Reporting and Data System) • Increased sizethreshold from 4 mm greatesttransverse diameter to 6 mm transverse bi-dimensionalaverage • 20 mm for nonsolidnodules • Growth for preexisting nodules (>1.5mm)
- 36. Category No: Name Findings Management Probability of malignancy Negative 1 Nonodules Nodules with complete/central/popcorncalcification Fatcontaining nodules AnnualLDCT <1% Benign 2 SN:<6mm, New - <4mm AnnualLDCT <1% PSN:<6mm in baseline NSN:<20mm or ≥20 mm andunchanged Probably benign 3 SN:≥6 to <8mm at baselineor New – 4 mm to <6mm 6 monthLDCT 1-2% PSN:≥6 mm with solid component <6mmor New <6mm NSN:≥20 mm on baseline CTornew Suspicious 4A SN:≥8 to <15mm at baselineor Growing <8 mmor New 6 to <8mm PSN:≥6 mm with solid component ≥6 mm to <8mm or new or growing <4mm solidcomponent Endobronchial nodule 3 month LDCT; PET/CTmaybe usedwhen there is a≥8mm solid component 5-15% 4B SN:≥15 mm or New or growing, and ≥8 mm PSN:asolid component ≥8 mm or New or growing ≥4 mm solidcomponent CECTChest± PET/CTand tissue sampling. PET/CTmaybe usedwhen there is a≥8mm >15% 4X Category 3 or 4 nodules with additional findings thatincreasethe suspicion of malignancy
- 37. Application of Lung-RADSto NLST Lung-RADS at baseline NLSTat baseline Lung-RADS after baseline NLSTafter baseline Sensitivity 84.9% 93.5% 78.6% 93.8% Falsepositive result rate 12.8% 27.3% 5.3% 21.8% PPV 6.9% 3.8% 11.0% 3.5% NPV 99.81% 99.9% 99.81% 99.93% Ann Intern Med.2015;162:485-491
- 38. BRELT1:First Brazilian L CscreeningTrial • Single center study • Jan2013 to July2014 • Inclusion criteria similar toNLST • 790 participants were enrolled • Positive scans– pulmonary nodules >4mm (similar to NLST) Ann ThoracSurg 2016;101:481–8
- 39. BREL T1Protocol
- 40. BREL T1Results
- 41. China • Multicenter, RCT ,1:1 randomization • LDCT(3512) vsstandard care(3145) • Nov 2013 to Nov2014 Inclusion criteria : • Age- 45-70 years and at least one riskfactor • ≥20 pack year history • H/o any cancer in close family members • Prior h/o any cancer in theparticipant • Occupational exposure to carcinogens • Longh/o passivesmoking (>2 hr every day for at least 10years) • Longterm exposure to cooking oilfumes LungCancer117 (2018) 20–26
- 42. • Positive results – 22.9%(804/3512) • Lungcancer detection rate was1.5%(51/3512) • Falsepositive rate – 21.8%(753/3461)
- 43. SouthKorea • August 1999 – Sept 2003 • Single center, observational study • Age≥45 years and either ≥20 pack years (high risk group)or <20pack year smoking or non smokers (low riskgroup) • 6406 participants underwent LDCT JKoreanMed Sci2005; 20: 402-8
- 44. • For solid nodule and >10 mm – immediate intervention(tissue diagnosis) was done • For solid nodule <10 mm – follow up scan6 monthslater • For GGO>10 mm - immediate intervention (tissue diagnosis) was done • For GGO <10 mm – f/u scan after 2 months, then after 6 months and annually thereafter
- 45. • 35%(2,255 of 6,406) of screened subjects had at least one ormore non-calcified nodules (n=4,037) • 2,085 subjects had 3,783 solid nodules (mean- 1.8 nodulesper subject) • 170 subjects had 254 GGOnodules (mean- 1.5 nodules per subject) 23 lung cancerswere detected with an overall detection rateof • 0.36%(23 of 6,406) • 0.57%(23 of 4,037) of non calcifiednodules
- 47. PET/CT • Retrospective study from India • 191 patients with solitarypulmonary nodule undergoing FDG- PET/CT • Thefinal pathological diagnosis wasmalignancy in 75.3% (144/191) of nodules Indian JCancer2017;54:271-5.
- 50. • 24.7%(47/191) were benign • 64%(30/47) had afalse positive PET-CTat aSUVcut-off of 2.5
- 51. Solid nodule >8mm in diameter Determine pretest clinical probability of malignancy Low(<5%) Moderate (5-60%) High(>60%) Serial CT surveillance Non SurgicalBiopsy SurgicalResection ClearGrowth ? negative yes no suspicious SurgicalBiopsy positive PETscan Hypermetabolic ? intense CHESTrecommendations for SN-Asia CHEST2016; 150(4):877-893
- 52. • The expert panel recommends that regardless of whether clinical judgment or a calculation model is used, clinicians must decide if the clinical probability suggests further imaging studies, biopsy, and/or resection areneeded For benign nodules (low probability of malignancy), an accurate diagnosis is required in • TBor other infections requiring specifictreatment • Patients who are on high-doseimmunosuppression
- 53. Solid, indeterminate nodule >8 mm in diameter with moderate (5-60%) probability of malignancy (when - discordance between the clinical and radiologicfeatures) characterize the nodule before surgical resection • Consider functional imaging, preferably with PET, to or continued radiological surveillance limitations: • False-positive (e.g., TB,fungal and parasitic disease) and • False-negative slow-growing tumors (eg, adenocarcinoma in situ)
- 54. • In an individual with a solid, indeterminate nodule >8 mm in diameter with high (>60%) probability of malignancy, functional imaging has a greater role in preoperative staging than in characterizing thenodule • T o rule out previously undetected metastases before surgical intervention
- 55. Smokers were less likely to agree that early-stage survival is good (43% vs. 53%; OR: 0.64,0.46–0.88) or be willing to have surgery for an early stage, screen-detected cancer (84% vs. 94%; OR: 0.38, 0.21–0.68), compared with former smokers.
- 56. Liquid biopsies include circulating nucleic acids, circulating proteins and circulating tumour cells (CTCs)
- 57. Sensitivity of LCS according to adherence
- 58. Conclusion L Cscreening by LDCTscanreduces mortality (lungcancer specificandall cause mortality) Application of Lung-RAD Sandvolumetric analysis reduces falsepositive rates In amoderate risk patient, useof PET/CTscanislessreliable andemphasisshould beon non surgicalbiopsy Newermodilitiesarerequiredtodiagnoselungcancerwithlesssideeffects.