NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo

Table 3. Smoking History Eligibility Criteria for Low Dose CT Randomized Controlled Trials and Meta-AnalysesFirst Author, (year published) Study Acronym, Study DesignSmoking History Inclusion Criteria (pack-years)Smoking History Study Population Distribution in Intervention Arm (mean  SD; frequency, range, or percent; pack-years)Smoking Cessation Inclusion Criteria (years since quitting smoking)Smoking Cessation Duration Since Quitting: Distribution in Study Population Intervention Arm   (n, years since quitting)Timing: Follow up Duration (mean, median; years)Outcome: Lung Cancer Mortality: Low Dose CT Arm Compared Control Arm (HR, RR, or OR, 95% CI; p value)Becker (2020)  LUSI (RCT)At least 25 years smoking of at least 15 cigarettes per day, or at least 30 years smoking of at least 10 cigarettes per dayNo pack-years shownStopped smoking not more than 10 years before invitation to screeningNone shown8.8  yr (median)HR: 0.74 (0.46  1.19; p = 0.21) HR women: 0.31 (0.10 0.96, p = 0.04)de Koning (2020) NELSON (RCT)>15 cigarettes a day for > 25 years or >10 cigarettes a day for >30 yearsMedian pack-year: 38.0 Interquartile range: 29.7  49.5 Range of pack-years: 0.4 to 159.5Quit  10 years ago1.7% (49/2,908) quit smoking history of > 10 years since cessation of smoking10 yr (actual)RR: 0.76 (0.61 - 0.94; P = 0.01)RR men 50-54: 0.85 (0.48 - 1.50)Doroudi (2018) LSS (RCT)30 pack-year history of cigarette smokingNone shownQuit within the last 10 yearsNone shown5.2 yrRR: 1.24 (0.74 - 2.08)Field (May, 2016) UKLS (RCT)None shown93.4% smoking duration of 20+ years,5.8% smoking duration of 10-19 yearsNone shownNone shownNone shownNo lung cancer mortality Results: only lung cancer incidenceInfante (2015) DANTE (RCT)20+ pack-yearsMean pack-years: 47.3 (95% CI 45.7 - 49.0), standard error of mean: 0.8Median pack-years: 45.0 (IQR 28.5)Had quit less than 10 years before recruit-mentNone shown8.35 yr (median)HR: 0.993 (0.6881.433)Infante (Pooled, 2017) (pooled analysis DANTE and MILD)None shownNone shownNone shownNone shown8.2 yr (median)Pooled  HR: 0.83 (0.611.12)National Lung Screening Trial Research Team (2019) NLST (RCT)Minimum of 30 pack-years of cigarette smokingMedian pack-years = 48 (25th/75th percentile: 39/66)Had quit within the past 15 yearsNone shown12.3 yr (median)RR dilution-adjusted: 0.89 (0.800.997)Tanner (2016) NLST (secondary analysis of NLST)None shownNone shownNone shownNone shownNone shownHR, 0.62 (0.51  0.76).Paci (2017) ITALUNG (RCT)At least 20 pack-years in last 10 yearsMedian pack-years of smoking: 40 pack-yearsQuit more than 10 years ago excludedNone shown9.3 yrRR: 0.70 (0.47 to 1.03; p = 0.07)Paci (2021) ITALUNG (secondary analysis)None shownNone shownNone shownNone shown10 yr10 yr survival rates for lung cancer cases: 64% active arm vs 60% control arm (p = 0.689)Pastorino, Silva, (Prolonged, July, 2019) MILD (RCT) 20 pack- years< 30 pack-years of cigarette smoking: 21.9% (521/2,376); Median pack-years: 39 pack-years of smokingFormer smoker from < 10 years agoNone shown10 yrHR: 0.61 (0.39  0.95; p =0.02)Pastorino, Sverzellati (Ten Year, September 2019) MILD (secondary analysis of screening arm in RCT)None shownNone shownNone shownNone shown10 yrBiennial (low dose CT every 24 months) arm compared to annual arm: HR: 1.10 (0.59-2.05)Rampinelli (2017) COSMOS (secondary analysis of an observational screening trial) 20 pack-years of smokingNone shownNone shownNone shown10 yrNo lung cancer mortality, Results: lifetime attributable risk of cancer incidence and radiation exposure doseWille (2016) DLCST (RCT)Minimum of 20 pack-years of smokingMean (SD) pack-years: 36.4  13.4 pack-yearsHave quit after the age of 50 years and within the previous 10 yearsNone shown> 5 yrs after last screen, mean follow up duration not shownHR: 1.03 (0.661.6; p = 0.888)Meta-AnalysesHuang (2019) (9 RCTs)> 20 pack-years to > 30 pack-years, and included > 15 cigarettes a day for > 25 years or > 10 cigarettes per day for > 30 yearsMean  SD: 36.4  13.4,Median (IQR) ranged from 36 (IQR not reported) to 38.0 (19.8) to 45.0 (28.5) to 48 (27) to 54 (IQR not reported)From < 10 years since quitting to < 15 years since quittingNone shownHetero-geneousRR: 0.83 (0.760.90, I2= 1%)Sadate (2020) (7 RCTs)Average smoking history greater than 15 pack-yearsMedian pack-years: 39Mean (95% CI) ranged from 36.4 (95% CI 23  49.8) to 38.0 (95% CI 29.7  49.5) to 47.3 (95% CI 45.7  49) to 56.04 (no 95% CI reported)None shownNone shown3-10 yrRR: 0.83 (0.76 - 0.91; I2= 0%)Wang (2018) (4 RCTs)Minimum of 20 pack-years to more than 30 pack-yearsNone shownQuitting within 10 years of study enrollment to less than 15 years since quitting to quitting after age 50 years and within 10 years before trial enrollmentNone shownMedian 33.7 months to 6.5 yr; 4.8 person-yearsOR: 1.13 (0.781.64; I2> 75%)Yang (2019) (4 RCTs)None shownNone shownNone shownNone shownHetero-geneous: 6 yr 3.5 months to 9.47 yrPooled RR: 0.94 (0.74-1.19; p = 0.62; I2= 43.3%)