evekhm/cms_iom_500 huggingface dataset:
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
In the National Comprehensive Cancer Network (NCCN), Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Lung Cancer Screening Version 1.2022, the NCCN Lung Cancer Screening Panel defined the risk status of high risk as age  50 years and  20 pack-year history of smoking with these high-risk persons candidates for low dose CT (LDCT) screening (category 1) where shared patient/provider decision-making is recommended, including a discussion of benefits/risks (Wood, NCCN; 2021). Further, in the discussion of extending low dose CT screening beyond 77 years that is being updated in the most recent NCCN guidelines Version 1. 2022 (Wood, NCCN; 2021), no randomized controlled trial data were presented that showed whether low dose CT screening in persons age 77 or more years had an effect on lung cancer mortality, and so the evidence base for extending the eligibility criterion for low dose CT screening beyond 77 years does not appear to have randomized controlled trial evidence. Thus, in the updated National Comprehensive Cancer Network (NCCN) guidelines Version 1.2022, the eligibility criterion for age has no upper age limit in the low dose CT screening algorithm, and therefore, does not include a stopping age for low dose CT screening.In summary of their recommendations, the American College of Radiology Appropriateness Criteria expert panel concluded that for Variant 1: Lung cancer screening with low-dose CT chest without IV contrast is usually appropriate in patients 55 to 80 years of age and 30 or more packs per year smoking history and currently smoke or have quit within the past 15 years. Variant 2: The panel did not agree on recommending lung cancer screening with low dose CT chest without IV contrast in patients 50 years of age or older and 20 or more packs per year history of smoking plus one additional risk factor. There is insufficient medical literature to conclude whether or not these patients would benefit from CT screening for lung cancer. Screening in this patient population is controversial but may be appropriate. Variant 3: Lung cancer screening is usually not appropriate in patients younger than 50 years of age or older than 80 years of age or in patients of any age with less than 20 packs per year history of smoking and no additional risk factors (Donnelly, 2018). Thus, the American College of Radiology recommends stopping screening at age 80 years.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Similarly, the American Academy of Family Physicians gives the clinical preventive services recommendation for lung cancer screening in adults a B grade recommendation. The AAFP supports the United States Preventive Services Task Force (USPSTF) recommendation for annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years (AAFP, 2021). Thus, the American Academy of Family Physicians recommends stopping screening at age 80 years.The American Cancer Society 2013 guideline recommends that clinicians with access to high-volume, high-quality lung cancer screening and treatment centers should initiate a discussion about screening with apparently healthy patients aged 55 years to 74 years who have at least a 30 [or more]pack-year smoking history and who currently smoke or have quit within the past 15 years. (Wender, 2013). However, the 2013 American Cancer Society guideline is being updated and, in the meantime, the American Cancer Society recommends yearly lung cancer screening with low dose CT scans for people who: are 50 to 80 years old and in fairly good health, currently smoke or have quit in the past 15 years, and have at least a 20 pack-year smoking history.We find that the human clinical evidence is not sufficient to conclude that lung cancer screening with low dose CT is reasonable and necessary for Medicare beneficiaries with the specific eligibility criterion for stopping low dose CT screening at age 80 years. The Medicare beneficiary eligibility criterion for stopping age will not be changed and will remain at 77 years-old.Lowering Pack-Year Smoking History From 30 Pack-Years to 20 Pack-Years
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Lowering Pack-Year Smoking History From 30 Pack-Years to 20 Pack-YearsThe 2021 USPSTF lung cancer screening statement recommends annual lung cancer screening with low dose CT for adults who have a 20 pack-year smoking history (USPSTF, Krist; 2021). The current updated 2021 USPSTF recommendation reduces the pack-years of smoking history that makes someone eligible for screening from 30 pack-years to 20 pack-years. Thus, the pack-year eligibility criterion was lowered from 30 pack-years in the previous 2013 USPSTF recommendation (Moyer, USPSTF; 2014) to 20 pack-year smoking history in the current updated recommendation. For this reconsideration, we will assess the recently updated trial data published from 2014 to the present for evidence on the beneficial effect of screening with low dose CT among persons who have a smoking history of 20 to 29 pack-years.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
The MILD study (Pastorino, Silva, Sestini; 2019) defined the enrollment eligibility criterion for current smokers as  20 pack-years (Pastorino, Silva, Sestini; 2019). In the intervention arm, 21.9% (521/2,376) had < 30 pack-years of cigarette smoking and the median pack-years was 39 pack-years of smoking (Pastorino, 2019). Taking into account the minimum enrollment criterion for smokers of at least 20 pack-years, 21.9% of the intervention arm smoked 20 to 29 pack-years. In the MILD study, the low dose CT arm showed a significant 39% reduced risk of lung cancer mortality at 10 years compared to the control arm (hazard ratio = 0.61; 95% CI 0.39  0.95; p = 0.02) with adjustment for age and pack-years (Pastorino, Silva, Sestini; 2019). Even though there was no stratified lung cancer mortality analysis by smoking history subgroups in the number of pack-years, such as 20 to 29 pack-years of smoking cigarettes, the overall study results demonstrated statistically significant reduced lung cancer mortality, 39%, in the low dose CT arm which included persons who smoked between 20 to 29 pack-years with the large subgroup comprising 21.9% of the overall study population. Thus, there is evidence from the MILD study that lowering the smoking history from 30 pack-years to 20 pack-years would likely continue to reduce lung cancer deaths among persons who are screened for lung cancer with low dose CT.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
In the good quality NELSON study, the eligibility inclusion criterion for smoking history was persons who had smoked >15 cigarettes a day for > 25 years or >10 cigarettes a day for >30 years (de Koning, 2020). In pack-years, >15 cigarettes a day for > 25 years is equivalent to > 19 pack-years, and >10 cigarettes a day for >30 years is equivalent to >15 pack-years. Persons who smoked 20 to 29 pack-years were included in the NELSON study. Among the male participants in the screening group for the NELSON study, the median pack-year of smoking was 38.0 (interquartile range: 29.7  49.5) with a range of pack-years from 0.4 to 159.5 (de Koning, 2020). The specific number of pack-years smoked by the male participants is not shown in the NELSON study results. However, the NELSON study reported on the number of cigarettes smoked per day and the duration of smoking in years for the male participants.Because the number of pack-years smoked by participants in the NELSON study was not used to define smoking history, it is necessary to show how to convert the number of cigarettes smoked per day and the duration of smoking to pack-years smoked. Pack-years, or packs per years, are calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked, with a pack equal to 20 cigarettes. If a person has smoked a pack a day for the last 20 years, or two packs a day for the last 10 years, the person has a smoking history of 20 pack-years. Equivalently, if a person has smoked 20 cigarettes a day, which is one pack a day, for the last 20 years; or 40 cigarettes a day, which is two packs a day, for the last 10 years, the person has a smoking history of 20 pack-years.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Among the male participants in the screening group (n = 6,583) for the NELSON study, 28.3% (1,859/6,565) smoked 16 to 20 cigarettes a day, which is about one pack a day, and 0.4% (25/6,563)had a duration of smoking of  25 years which includes an unspecified number of persons smoking for the last 20 years which is below 0.4%, meaning that an undetermined but likely small but non zero number of men smoked about one pack per day for perhaps 20 years which approximates a 20 pack-year smoking history. Equivalently to a 20 pack-year history, 6.9% (454/6,565) smoked 31 to 40 cigarettes a day, which is about two packs a day, and 0.4% (25/6,563) had a duration of smoking of  25 years which includes an unspecified number of persons smoking for the last 10 years which is below 0.4% (de Koning, 2020). Because the NELSON study results did not include the pack-year smoking history stratified by the number of pack-years, it is not known exactly how many men had a smoking history of 20 to 29 pack-years. However, the NELSON study included men who smoked about one pack per day (28.3%) and about two packs per day (6.9%), and those men smoked for  25 years (0.4%) with some of them, less than 0.4%, likely smoking for the last 20 years at one pack per day or 10 years at two packs per day, which would amount to a 20 pack-year smoking history. In addition, the lower limit of the range of pack-years of smoking was 0.4, so the range of pack-years of smoking encompasses 20 to 29 pack-years. Thus, while the exact number of men smoking 20 to 29 pack-years is not known, men with a smoking history of 20 to 29 pack-years would very likely have been included in the NELSON study, though the precise number is likely to be small but not zero. Additionally, the eligibility criterion for smoking history permitted persons who smoked 20 to 29 pack-years to be included in the NELSON study.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
For the NELSON study at 10 years of follow up among men, the cumulative rate ratio for death from lung cancer was significantly lower (rate ratio [RR] = 0.76, 95% CI: 0.61 to 0.94; p = 0.01) among those in the screening group who underwent low dose CT as compared with the control group who underwent no screening (de Koning, 2020). Among the small subsample of women, the non-significant rate ratio was 0.67 (95% CI: 0.38 to 1.14) at 10 years of follow up for lung cancer mortality comparing the low dose CT group to the control group, though the rate ratios were statistically significant at 7, 8, and 9 years of follow up (at 7 years: rate ratio = 0.46; 95% CI: 0.21  0.96; de Koning, 2020). There were no stratified analyses of lung cancer mortality by number of pack-years smoked as a subgroup that were shown in the NELSON study results. The authors concluded that in this trial involving high-risk persons, lung cancer mortality was significantly lower among those who underwent volume CT screening than among those who underwent no screening (de Koning, 2020). Additionally, the eligibility criterion for smoking history permitted persons who smoked 20 to 29 pack-years to be included in the NELSON study.Because the NELSON study showed a statistically significantly lower lung cancer death rate among men of all ages who underwent low dose CT and included persons who smoked 20 to 29 pack-years of cigarettes, the NELSON study provides convincing evidence for the discussion of lowering the smoking history eligibility criterion.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Other small European studies, such as the LUSI and ITALUNG studies, had data on smokers with a 20 to 29 pack-year smoking history, but had differing results on lung cancer mortality. In the LUSI study, current smokers were described as long-term smokers but the study authors did not define long-term smokers (Becker, 2020). Eligibility for the LUSI study by smoking history criterion was defined by at least 25 years of smoking of at least 15 cigarettes per day, which is equivalent to at least 19 pack-years; or at least 30 years smoking of at least 10 cigarettes per day, which is at least equivalent to 15 pack-years (Becker, 2020). In the low dose CT intervention arm of the LUSI study, 50.2% were current smokers and 49.8% were ex-smokers (Becker, 2020). No definition of current smoker or ex-smoker was given in the study results. There were no data presented on the distribution of smoking history by subgroup of the number of pack-years smoked for the study population in the LUSI study results.Over an average observation time of 8.8 years after randomization, modeling by sex, however, showed a statistically significant reduction in lung cancer mortality among women (HR [hazard ratio] = 0.31 [95% CI: 0.10-0.96], p = 0.04), but not among men (HR = 0.94 [95% CI: 0.54-1.61], p = 0.81) screened by LDCT.. and this heterogeneity was close to statistical significance ([Pheterogeneity = 0.09) (Becker, 2020). There were no stratified analyses by smoking history for number of pack-years of smoking for lung cancer mortality in the LUSI study results. Because the smoking history eligibility criterion was defined as having at least 15 or 19 pack-years of smoking, it appears that the study population for the LUSI trial is likely to include smokers with a 20 to 25 pack-year smoking history. Thus, the LUSI study showed that low dose CT screening among persons with a 20 to 29 pack-year history reduces lung cancer mortality, especially among women.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Several studies, the ITALUNG, the DANTE, and the DLCST studies, had data on smokers with a smoking history of at least 20 pack-years but did not show a statistically significant effect on lung cancer mortality. The ITALUNG study, one of several small European randomized controlled clinical trials of low dose CT, randomized eligible persons to receive an annual invitation for low dose CT screening for four years, the active group (n = 1,613), or to usual care, the control group, in three screening centers in Italy (Paci, 2017). The ITALUNG study (Paci, 2017) defined the enrollment eligibility criterion for smokers as a smoking history of at least 20 pack-years in the last 10 years (Paci, 2017). Persons with a 20 to 29 pack-year history of smoking were included in the ITALUNG study. In the active group that received low dose CT, the median pack-years of smoking was 40 pack-years. The active group consisted of 66% current smokers (Paci, 2017). There was no data shown on the distribution of the number of pack-years smoked in the ITALUNG study results. After a median follow up of 9.3 years, study results showed a non-significant reduction of 30% (RR = 0.70; 95% CI 0.47 to1.03; p = 0.07) for lung cancer mortality in the active LDCT group compared to the usual care control group (Paci, 2017). However, the study authors reported that none of these published outcome studies alone (DANTE, MILD, and DLCST), including the ITALUNG, has sufficient statistical power to detect a real benefit and, for specific analyses, as those assessing benefit for risk profile subgroups (Paci, 2017). In the ITALUNG study results, there were no stratified analyses by pack-year smoking history for lung cancer mortality. While the ITALUNG study included smokers with a smoking history of at least 20 pack-years, the results showed a non-statistically significant reduction for lung cancer mortality in the low dose CT intervention group compared to the control group.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
The DANTE study (Infante, 2015) defined the enrollment eligibility criterion for smokers of at least 20 pack-years, defined as 20+ pack-years (Infante, 2015). Persons with a 20 to 29 pack-year history of smoking were included in the DANTE study. In the low dose CT group, the mean pack-years was 47.3 (95% confidence interval 45.7 - 49.0) with a standard error of the mean of 0.8, and a median pack-years of 45.0 (interquartile range 28.5) (Infante, 2015). There was no stratified distribution of smoking history by number of pack-years subgroups shown in the DANTE baseline study results. For lung cancer mortality, the hazard ratio was 0.993 with a 95% CI of 0.688 to 1.433 (Infante, 2015). Lung cancer mortality did not differ significantly between the two arms of LDCT screening compared to annual clinical review (Infante, 2015). There were no stratified analyses of lung cancer mortality by pack-years of smoking history subgroup shown in the DANTE study results. The authors concluded that given the limited statistical power of the DANTE [Detection And screening of early lung cancer with Novel imaging TEchnology] trial, our data do not allow making a definitive statement about whether or not LDCT screening is effective in reducing lung cancer mortality (Infante, 2015). While the DANTE study included smokers with a smoking history of at least 20 pack-years, the results showed a non-statistically significant reduction for lung cancer mortality in the low dose CT intervention group compared to the control group.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
In the DLCST trial, the inclusion criterion for smoking history was a minimum of 20 pack-years of smoking (Wille, 2016). In the screening group (n = 2,052), the mean pack-years was 36.4  13.4 pack-years (standard deviation) (Wille, 2016). In the DLCST study, no difference between the low dose CT study group and the no screening control group in lung cancer mortality (hazard ratio = 1.03; 95% CI: 0.66  1.6; p = 0.888; Wille, 2016) was observed. The study results for lung cancer mortality were not stratified by the number of pack-years smoked for the subgroup of 20 to 29 pack-years smoked. The authors of the DLCST trial concluded that no statistically significant effects of CT screening on lung cancer mortality were found, but the results of post hoc high-risk subgroup analyses showed nonsignificant trends that seem to be in good agreement with the results of the National Lung Screening Trial [NLST] (Wille, 2016). The study authors also reported that the study was underpowered, and the results of the DLCST do not allow us to make definitive conclusions about the efficacy of screening (Wille, 2016). While the DLCST study included persons with a 20+ pack-year history of smoking, the results did not show that low dose CT screening lowers lung cancer deaths more so than in a no screening group. However, the study authors reported that the DLCST study may be underpowered and have a sample size that is too small to show a significant difference in lung cancer mortality among those receiving LDCT compared to no screening.Thus, the ITALUNG, the DANTE, and the DLCST studies had data on smokers with a smoking history of 20 to 29 pack-years, but the results did not show that low dose CT screening had a significant effect on lung cancer mortality.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
One study, the COSMOS study, had data on smokers with a smoking history of 20 to 29 pack-years but the study results did not have data on lung cancer mortality. In the secondary analysis of the COSMOS study, the eligibility criterion for smoking history was  20 pack-years of smoking (Rampinelli, 2017). No data on lung cancer mortality was presented in the secondary analysis of the COSMOS trial study results. The secondary analysis of the COSMOS study did not contribute data to the evaluation of the pack-year smoking history eligibility criterion.Several low-dose CT studies, such as the NLST, the LSS, and the UKLS, did not have data on persons who had a 20 to 29 pack-year history of smoking. For the extended follow up analysis of the good quality NLST (National Lung Screening Trial) trial, the pack-year smoking history criterion was a minimum of 30 pack-years of cigarette smoking (NLST Research Team, 2019). This eligibility criterion excluded persons with a 20 to 29 pack-year smoking history from enrolling in the NLST trial. For the low dose CT arm (n = 26,722), 48.1% were current smokers and the median pack-years was 48 (25th/75th percentile: 39/66) (NLST Research Team, 2019). In the NLST study results, no data was shown on the number of pack-years of cigarette smoking. Current smokers were not defined in the Methods of the NLST study. Because the NLST study does not have data on smokers with a 20 to 29 pack-year history of cigarette smoking, the NLST study results do not address the potential change in the pack-year smoking history eligibility criterion.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
For the LSS study, the eligibility criterion for smoking history was a 30 pack-year history of cigarette smoking (Doroudi, 2018). There were no data shown on the number of pack-years smoked for the study population in the LSS study results (Doroudi, 2018). Because the LSS study did not include persons with a 20 to 29 pack-year smoking history, the LSS study results did not contribute evidence to the discussion of lowering the pack-year smoking history criterion. In the UKLS study, who were current smokers was not defined. Among the 75,958 positive responders to the invitation letter to participate in the UKLS trial, 14.7% were current smokers. Among the 2,028 participants in the screening arm, 38.3% were current smokers (Field; May, 2016). No data on the number of pack-years smoked by current smokers were shown in the UKLS study results. Combining current and ex-smokers, 93.4% had a smoking duration of 20+ years and 5.8% had a smoking duration of 10 - 19 years (Field; May, 2016). The UKLS study did not have data on lung cancer mortality (Field; May, 2016). None of the analyses were stratified by pack-years of smoking. Because the UKLS study did not have the number of pack-years smoking history, the UKLS study did not have data that would affect the Analysis of lowering the pack-years smoking history.