National Lung Screening Trial Results
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1 National Lung Screening Trial Results Ella A. Kazerooni, M.D. Professor & Director Cardiothoracic Radiology Associate Chair for Clinical Affairs University of Michigan
2 NLST STOPPED! Lung cancer trial results show mortality benefit with low-dose CT 11/4/10 NCI Press Conference & Press Release The trials independent Data Safety Monitoring Board notified the NCI Director that the accumulated data provided statistically convincing answer to the study s primary question. This is the first time that we have seen clear evidence of a significant reduction in lung cancer mortality with a screening test in a randomized controlled trial. Christine Berg if low-dose helical CT screening is implemented responsibly and individuals with abnormalities are judiciously followed, we have the potential to save thousands of lives. Denise Aberle
3 NLST: Interim Primary Endpoint Analysis Reported by DSMB Oct. 20, 2010 Arm Person years (py) Lung cancer deaths Lung cancer mortality per 100,000 py Reduction in lung cancer mortality (%) Value of test statistic Efficacy boundary CT 144, CXR 143, Deficit of lung cancer deaths in CT arm exceeds that expected by chance, even allowing for multiple looks at the data
4 NLST: Interim Secondary Endpoint Analysis Reported by DSMB Oct. 20, 2010 Arm Person years (py) Deaths All-cause mortality per 100,000 py Reduction in all-cause mortality (%) Value of test statistic Value for significance CT 167, CXR 166, Deficit of deaths in CT arm exceeds that expected by chance.
5
6 NLST: Subjects Age & Gender
7 NLST: Subjects Race/Ethnicity
8 NLST: Subjects Smoking History
9 NLST: Family History of Lung Cancer CT CXR Total Any first degree relative 21.8 % 21.7 % 21.7 % Two or more first degree relatives 3.3 % 3.2 % 3.3 %
10 NLST Demographics vs. US Population U.S Census Department Tobacco Use Supplement of Continuing Population Survey for Information on 240,000 respondents Reviewed subset of respondents aged 55-74, with 30+ pack year smoking, either current smoker or former smoker who quit within the past 15 years Identified smoking status, age, sex, race, ethnicity, marital status, and education
11 NLST Demographics vs. US Population NLST US Census Male (%) Age (%) (%) (%) (%) Race/ethnicity Black (%) Hispanic (%)
12 NLST Demographics vs. US Population NLST US Census Married Education < HS College Current smoker Median pack years
13 NLST Demographics vs. US Population Compared with similar US population, NLST subjects have: similar gender distribution and smoking exposure are younger better educated less likely to be current smokers
14 Screening Exam Compliance & Crossover Study Year CT CXR Total Expected Screened Expected Screened Expected Screened T0 26, % 26, % 53, % T1 26, % 26, % 52, % T2 25, % 26, % 52, % Compliance: 95% CT arm & 93% CXR arm Crossover: 4.3% in LSS CXR arm underwent CT
15 NLST: Screen Positivity* Rate CT CXR Screening Round # screened # positive % positive # screened # positive % positive 1 26,309 7, ,035 2, ,715 6, ,089 1, ,102 4, ** 23,346 1, ** All 3 75,126 18, ,499 5, *A positive screen is one that may be suspicious for lung cancer. **A suspicious abnormality that has been stable for 3 rounds may be called negative according to protocol.
16 NLST: True and False Positive Screens CT CXR Round 1 N (%) Round 2 N (%) Round 3 N (%) Round 1 N (%) Round 2 N (%) Round 3 N (%) Total positives 7,193 (100) 6,902 (100) 4,054 (100) 2,387 (100) 1,482 (100) 1,175 (100) With lung cancer 270 (4) 168 (2) 211 (5) 136 (6) 65 (4) 78 (7) Without lung cancer 6,923 (96) 6,734 (98) 3,843 (95) 2,251 (94) 1,417 (96) 1,097 (93)
17 indeterminate lung nodule
18 NLST (+) CT screen & diagnostic tests 1.4% experienced a complication 28% among those determined to have lung cancer 0.35% determined to not have lung cancer 16 deaths due to medical interventions hastened the death of 16 people of the 16, 10 had lung cancer and 6 did not risk of death in non-cancer patients 0.024%
19 NLST: Clinically Significant Non Lung Cancer CT CXR Screening Round # screened # positive % positive # screened # positive % positive 1 26, , , , , , All 3 75, ,
20 NLST: Cumulative # of Lung Cancers
21 NLST: Cumulative # of Lung Cancer Deaths
22 Kaplan-Meier Curves for Lung Cancer Mortality
23 Kaplan-Meier Curves for All-Cause Mortality
24 Kaplan-Meier Curves for Lung Cancer Case Survival (Lung Cancer Cause of Death) Table d
25 National Lung Screening Trial Results Ella A. Kazerooni, M.D. Professor & Director Cardiothoracic Radiology Associate Chair for Clinical Affairs University of Michigan
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