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The authors reported 20 (1.6 %) lung cancer deaths in the LDCT group and 20 (1.7 %) in the control group (p = 0.84) and 46 (3.6 %) total deaths in the LDCT group and 45 (3.8 %) in the control group (p = 0.83). They concluded: “possible overdiagnosis, false positives, hazards of downstream investigation procedures, and cost issues make the results of randomized studies critically important in establishing a proper public health policy, and the final results from all ongoing randomized trials are awaited. In the meantime, continued application of current policies is supported by our data, and screening for LC with LDCT should not be advertised or proposed to high-risk subjects outside research programs.”
National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID: 21714641
The NCI-sponsored NLST was a randomized trial “to determine whether screening with low-dose CT, as compared with chest radiography, would reduce mortality from lung cancer among high-risk persons.” From August 2002 to April 2004, 53,454 individuals who were “between 55 and 74 years of age at the time of randomization, had a history of cigarette smoking of at least 30 pack-years, and, if former smokers, had quit within the previous 15 years” were enrolled at 33 U.S. centers and randomized to screening with 3 annual LDCT (n = 26,722) or three annual chest radiography (n = 26,732). Individuals who “had previously received a diagnosis of lung cancer, had undergone chest CT within 18 months before enrollment, had hemoptysis, or had an unexplained weight loss of more than 6.8 kg (15 lb) in the preceding year were excluded.” All screening tests were performed and interpreted according to protocol (NLST study design, 2011). It was “estimated that each NLST low-dose CT resulted in an average effective dose of 1.5 mSv, whereas the effective dose from conventional chest CT varies considerably in clinical practice but is on the order of 8 mSv” (NLST study design, 2011). The primary outcome was lung cancer mortality. Secondary outcomes included all-cause mortality and lung cancer incidence. Median age was approximately 61 years with 26.6 % of participants being 65 years and older. Men comprised 59 % of the study. Ninety one percent were white. Forty eight percent were current smokers. Median follow-up was 6.5 years. Adherence to all three screenings was 95 % in the LDCT group and 93 % in the radiography group.
The authors reported “[t]here were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 person-years in the radiography group, representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0 % (95 % CI, 6.8 to 26.7; P = 0.004). The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiography group, by 6.7 % (95 % CI, 1.2 to 13.6; P = 0.02).”
Table 7. page 407. N Engl J Med. 2011 Aug 4;365(5):395-409.
The authors concluded “[s]creening with the use of low-dose CT reduces mortality from lung cancer.”
Pastorino U, Rossi M, Rosato V, Marchianò A, Sverzellati N, Morosi C, Fabbri A, Galeone C, Negri E, Sozzi G, Pelosi G, La Vecchia C. Annual or biennial CT screening versus observation in heavy smokers: 5-year results of the MILD trial. Eur J Cancer Prev. 2012 May;21(3):308-15. doi: 10.1097/CEJ.0b013e328351e1b6. PMID: 22465911
Pastorino and colleagues reported the results of the MILD randomized trial “to evaluate the impact on mortality of early lung cancer detection through LDCT at annual or biennial intervals versus no screening.” Individuals who were &#≥ 49 years of age with &#≥ 20 pack-year smoking history and no history of cancer within the past five years were included. No other exclusion criteria were reported. From September 2005 to January 2011, 4099 participants were enrolled and randomly assigned to annual LDCT screening (n = 1190), biennial LDCT screening (n = 1186) and no screening control group with smoking cessation interventions and pulmonary function tests (n = 1723) at one site in Italy (trial was initially designed to be conducted at multiple centers but limited to one site due to funding). Primary outcome was lung cancer mortality. Secondary outcomes included all-cause mortality and lung cancer incidence. Median age was 57 years. Men comprised 67 % of the study population. At baseline, there were more current smokers in the control group (89.7 %) compared to the LDCT screening groups (68.3 % annual and 68.9 % biennial). Median pack-years smoking was 39.
The authors reported: “The cumulative 5-year lung cancer incidence rate was 311/100 000 in the control group, 457 in the biennial, and 620 in the annual LDCT group (P = 0.036); lung cancer mortality rates were 109, 109, and 216/100 000 (P = 0.21), and total mortality rates were 310, 363, and 558/100 000, respectively (P = 0.13).” They concluded: “There was no evidence of a protective effect of annual or biennial LDCT screening. Furthermore, a meta-analysis of the four published randomized trials [DANTE (Infante), DLCST (Saghir), MILD, NLST] showed similar overall mortality in the LDCT arms compared with the control arm.” “The effect on lung cancer mortality remains significant (relative risk 0.82, 95 % CI 0.73 – 0.93) but the value of disease-specific mortality as the only endpoint appears questionable for two reasons: the assessment of the real cause of death can be very difficult in heavy smokers because of complex comorbidity; a shift in the cause of death from one disease to another is frequent in screened populations and hence potentially misleading.”
Saghir Z1, Dirksen A, Ashraf H, Bach KS, Brodersen J, Clementsen PF, Døssing M, Hansen H, Kofoed KF, Larsen KR, Mortensen J, Rasmussen JF, Seersholm N, Skov BG, Thorsen H, Tønnesen P, Pedersen JH. CT screening for lung cancer brings forward early disease. The randomised Danish Lung Cancer Screening Trial: status after five annual screening rounds with low-dose CT. Thorax. 2012 Apr;67(4):296-301. doi: 10.1136/thoraxjnl-2011-200736. Epub 2012 Jan 27.PMID: 22286927.
Saghir and colleagues reported the results of a randomized controlled trial “to evaluate if annual low dose CT screening [for 5 annual screenings] can reduce lung cancer mortality by more than 25 %” (Pederson, 2009). Inclusion criteria were age 50-70 years, current or former smokers with at least 20 pack-years of smoking history, ability to climb two flights of stairs (36 steps) without pausing. Exclusion criteria were “weight over 130 kg, history of cancer diagnosis and treatment, lung tuberculosis, illness that would shorten life expectancy to < 10 years and chest CT received during the last year for any reason.” Primary outcome was lung cancer mortality. Secondary outcomes included overall mortality, number of lung cancers, stage and health economic evaluations. From October 2004 to March 2006, 4104 participants were enrolled and randomly assigned to CT screening group (five annual LDCT; n = 2052) or control group (no screening) (n = 2052) at one site in Denmark. “All participants had an annual visit at the screening clinic, where lung function tests were performed, and questionnaires concerning health, lifestyle, smoking habits and psychosocial consequences of screening were completed.” Median age was not reported (peak number of patients were between 55-59 years). Men comprised 55 % of the study population. Median follow-up was 4.81 years.
The authors reported: “At the end of screening, 61 patients died in the screening group and 42 in the control group (p = 0.059). 15 and 11 died of lung cancer, respectively (p = 0.428).” They concluded: “CT screening for lung cancer brings forward early disease, and at this point no stage shift or reduction in mortality was observed. More lung cancers were diagnosed in the screening group, indicating some degree of over diagnosis and need for longer follow-up.”
3. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)
On April 30, 2014, a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting was convened to discuss the body of evidence, hear presentations, consider public comments, and make recommendations to CMS regarding the currently available evidence related to early detection (screening) of lung cancer with LDCT in asymptomatic adults with histories of significant smoking. A CMS representative presented a basic background of lung cancer screening; how Medicare's consideration of preventive services is statutorily different than CMS’ consideration of evaluation and management services; and read the voting and discussion questions that would be considered by the panel. The panel heard presentations from four invited guest speake
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