Screening mammography was assessed in 9 randomized trials initiated between 1963 and 1990, with breast cancer-specific mortality as the primary endpoint. In contrast, breast cancer detection has been ...the primary endpoint in most screening trials initiated during the past decade. These trials have evaluated digital breast tomosynthesis, magnetic resonance imaging, and ultrasound, and novel screening strategies have been recommended solely on the basis of improvements in breast cancer detection rates. Yet, the assumption that increases in tumor detection produce reductions in cancer mortality has not been validated, and tumor-detection endpoints may exacerbate the problem of overdiagnosis. Indeed, the detection of greater numbers of early stage breast cancers in the absence of a subsequent decline in rates of metastatic cancers and cancer-related mortality is the hallmark of overdiagnosis. There is now evidence to suggest that both ductal carcinoma in situ and invasive cancers are overdiagnosed as a consequence of screening. For each patient who is overdiagnosed with breast cancer, the adverse consequences include unnecessary anxiety, financial hardships, and a small risk of morbidity and mortality from unnecessary treatments. Moreover, the overtreatment of breast cancer, as a consequence of overdiagnosis, is costly and contributes to waste in health-care spending. In this article, we argue that there is a need to establish better endpoints in breast cancer screening trials, including quality of life and composite endpoints. Tumor-detection endpoints should be abandoned, because they may lead to the implementation of screening strategies that increase the risk of overdiagnosis.
Principles of Cancer Screening Pinsky, Paul F
The Surgical clinics of North America,
10/2015, Letnik:
95, Številka:
5
Journal Article
Recenzirano
Odprti dostop
Cancer screening has long been an important component of the struggle to reduce the burden of morbidity and mortality from cancer. Notwithstanding this history, many aspects of cancer screening ...remain poorly understood. This article presents a summary of basic principles of cancer screening that are relevant for researchers, clinicians, and public health officials alike.
IMPORTANCE: Individuals with adenomatous polyps are advised to undergo repeated colonoscopy surveillance to prevent subsequent colorectal cancer (CRC), but the relationship between adenomas at ...colonoscopy and long-term CRC incidence is unclear. OBJECTIVE: To compare long-term CRC incidence by colonoscopy adenoma findings. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, prospective cohort study of participants in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer randomized clinical trial of flexible sigmoidoscopy (FSG) beginning in 1993 with follow-up for CRC incidence to 2013 across the United States. Participants included 154 900 men and women aged 55 to 74 years enrolled in PLCO of whom 15 935 underwent colonoscopy following their first positive FSG screening result. The final day of follow-up was December 31, 2013. EXPOSURES: Enrolled participants had been randomized to FSG or usual care. Participants who underwent FSG and had abnormal findings were referred for follow-up. Subsequent colonoscopy findings were categorized as advanced adenoma (≥1 cm, high-grade dysplasia, or tubulovillous or villous histology), nonadvanced adenoma (<1 cm without advanced histology), or no adenoma. MAIN OUTCOMES AND MEASURES: The primary outcome was CRC incidence within 15 years of the baseline colonoscopy. The secondary outcome was CRC mortality. RESULTS: There were 15 935 participants who underwent colonoscopy (men, 59.7%; white, 90.7%; median age, 64 y IQR, 61-68). On initial colonoscopy, 2882 participants (18.1%) had an advanced adenoma, 5068 participants (31.8%) had a nonadvanced adenoma, and 7985 participants (50.1%) had no adenoma; median follow-up for CRC incidence was 12.9 years. CRC incidence rates per 10 000 person-years of observation were 20.0 (95% CI, 15.3-24.7; n = 70) for advanced adenoma, 9.1 (95% CI, 6.7-11.5; n = 55) for nonadvanced adenoma, and 7.5 (95% CI, 5.8-9.7; n = 71) for no adenoma. Participants with advanced adenoma were significantly more likely to develop CRC compared with participants with no adenoma (rate ratio RR, 2.7 95% CI, 1.9-3.7; P < .001). There was no significant difference in CRC risk between participants with nonadvanced adenoma compared with no adenoma (RR, 1.2 95% CI, 0.8-1.7; P = .30). Compared with participants with no adenoma, those with advanced adenoma were at significantly increased risk of CRC death (RR, 2.6 95% CI, 1.2-5.7, P = .01), but mortality risk in participants with nonadvanced adenoma was not significantly different (RR, 1.2 95% CI, 0.5-2.7, P = .68). CONCLUSIONS AND RELEVANCE: Over a median of 13 years of follow-up, participants with an advanced adenoma at diagnostic colonoscopy prompted by a positive flexible sigmoidoscopy result were at significantly increased risk of developing colorectal cancer compared with those with no adenoma. Identification of nonadvanced adenoma may not be associated with increased colorectal cancer risk. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00002540
Lung cancer is the leading cause of cancer death worldwide, comprising almost 20% of all cancer deaths. The concept of screening for lung cancer using low-dose computed tomography (LDCT) dates back ...almost three decades. This paper reviews the randomized controlled trials and demonstration projects carried out world-wide on LDCT lung cancer screening. Most research has been carried out in North America, Europe and East Asia, regions where lung cancer mortality rates are generally the highest. There are currently no organized national or regional lung cancer screening programs with LDCT. A number of challenges exist to implementing such programs, including the fact that LDCT lung cancer screening generally targets only high risk ever-smokers, in contrast to screening programs for other cancers such as breast, cervical and colorectal, which target entire populations based only on age and sex. While tobacco control remains the most important tool in the long-term to decrease morbidity and mortality from lung cancer, LDCT screening, appropriately carried out, has the potential to modestly decrease lung cancer death rates for those countries whose overall resources and health care infrastructure are adequate for the task.
Screening for Prostate Cancer Pinsky, Paul F.; Parnes, Howard
The New England journal of medicine,
04/2023, Letnik:
388, Številka:
15
Journal Article
Recenzirano
PSA screening for prostate cancer should involve consideration of benefits and risks. Screening is associated with a small reduction in prostate cancer deaths; risks include overdiagnosis and ...unnecessary biopsy and treatment.
Relatively little is known about various aspects of low-dose CT (LDCT) scan lung cancer screening in US clinical practice, including characteristics of cases diagnosed after screening. We assessed ...this using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database.
What were the characteristics of patients with lung cancer, including stage and survival, whose disease was diagnosed after LDCT scan screenings?
We created an LDCT scan use cohort consisting of everyone in the 5% SEER-Medicare sample with ≥ 12 months of non-health maintenance organization (HMO) Part A and B coverage while 65 to 77 years of age from 2015 through 2019. LDCT scan use and lung cancer diagnosis rates were assessed in this cohort. Additionally, we created a lung cancer cohort consisting of patients who received a diagnosis between 2015 and 2017 at 65 to 78 years of age with complete (non-HMO Part A and B) coverage the year before diagnosis. The cases cohort comprised those screened or unscreened based on undergoing screening during that period; lung cancer characteristics and survival were compared between these groups.
In the LDCT scan use cohort (n = 414,358), use rates increased from 0.10 (per 100 person-years) in 2015 to 1.3 in 2019. Among those with first screenings, 39.2% underwent a subsequent screen within 18 months. The 1-year cumulative lung cancer diagnosis rate after initial screenings was 2.4%. Claims for prescreen counseling were infrequent (about 10%). Of 48,891 patients in the lung cancer cohort, 1,150 (2.4%) underwent screening. Among screened patients, 52.3%, 11.0%, 20.7%, and 16.0% received diagnoses of stages I, II, III, and IV disease, respectively. Lung cancer-specific survival through 3 years was significantly greater in screened versus unscreened patients overall and for all stages except stage II; 3-year lung cancer-specific survival was 89.0% in screened patients with stage I disease.
LDCT scan use was low but increased over time. The lung cancer yield was substantial; cases among those who underwent screening primarily were in the early stage with high survival rates. Although screening rates were unacceptably low, screening outcomes in those Medicare recipients undergoing screening were favorable.
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Background
Management of indeterminate pulmonary nodules (IPNs) is associated with redistribution of lung cancer to earlier stages, but most subjects with IPNs do not have lung cancer. The burden of ...IPN management in Medicare recipients was assessed.
Methods
Surveillance, Epidemiology, and End Results–Medicare data were analyzed for IPNs, diagnostic procedures, and lung cancer status. IPNs were defined as chest computed tomography (CT) scans with accompanying International Classification of Diseases (ICD) codes of 793.11 (ICD‐9) or R91.1 (ICD‐10). Two cohorts were defined: persons with IPNs during 2014–2017 comprised the IPN cohort, whereas those with chest CT scans without IPNs during 2014–2017 comprised the control cohort. Excess rates of various procedures due to reported IPNs over 2 years of follow‐up (chest CT, positron emission tomography PET/PET‐CT, bronchoscopy, needle biopsy, and surgical procedures) were estimated using multivariable Poisson regression models comparing the cohorts adjusted for covariates. Prior data on stage redistribution associated with IPN management were then used to define a metric of excess procedures per late‐stage case avoided.
Results
Totals of 19,009 and 60,985 subjects were included in the IPN and control cohorts, respectively; 3.6% and 0.8% had lung cancer during follow‐up. Excess procedures per 100 persons with IPNs over a 2‐year follow‐up were 63, 8.2, 1.4, 1.9, and 0.9 for chest CT, PET/PET‐CT, bronchoscopy, needle biopsy, and surgery, respectively. Corresponding excess procedures per late‐stage case avoided were 48, 6.3, 1.1, 1.5, and 0.7 based on an estimated 1.3 late‐stage cases avoided per 100 IPN cohort subjects.
Conclusions
The metric of excess procedures per late‐stage case avoided can be used to measure the benefits‐to‐harms tradeoff of IPN management.
A metric was developed to assess the burden of diagnostic follow‐up of indeterminate pulmonary nodules (IPNs). The metric—excess procedures per late‐stage case avoided—can be used to measure the benefits‐to‐harms tradeoff of IPN management.
Controversy continues to roil around the role of PSA screening in prostate cancer. The authors review the available data and its quality and conclude that the evidence does not indicate that the ...benefits outweigh the harms.
After a quarter century of extensive screening for prostate cancer with prostate-specific antigen (PSA) in the United States, and after the completion of two major trials examining the effects of such screening, the medical community is still divided with regard to its effectiveness and its benefits-to-harms ratio. Here, we review the current status of PSA screening and examine emerging trends.
In 2012, after publication of the findings from the major randomized trials of PSA-based screening for prostate cancer — the European Randomized Study of Screening for Prostate Cancer (ERSPC) and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) . . .
Screening for Prostate Cancer. Reply Pinsky, Paul F; Parnes, Howard
The New England journal of medicine,
2023-Jul-06, 20230706, Letnik:
389, Številka:
1
Journal Article
Lung cancer screening with low-dose computed tomography (LDCT) has been recommended, based primarily on the results of the NLST (National Lung Screening Trial). The American College of Radiology ...recently released Lung-RADS, a classification system for LDCT lung cancer screening.
To retrospectively apply the Lung-RADS criteria to the NLST.
Secondary analysis of a group from a randomized trial.
33 U.S. screening centers.
Participants were randomly assigned to the LDCT group of the NLST, were aged 55 to 74 years, had at least a 30-pack-year history of smoking, and were current smokers or had quit within the past 15 years.
3 annual LDCT lung cancer screenings.
Lung-RADS classifications for LDCT screenings. Lung-RADS categories 1 to 2 constitute negative screening results, and categories 3 to 4 constitute positive results.
Of 26 722 LDCT group participants, 26 455 received a baseline screening; 48 671 screenings were done after baseline. At baseline, the false-positive result rate (1 minus the specificity rate) for Lung-RADS was 12.8% (95% CI, 12.4% to 13.2%) versus 26.6% (CI, 26.1% to 27.1%) for the NLST; after baseline, the false-positive result rate was 5.3% (CI, 5.1% to 5.5%) for Lung-RADS versus 21.8% (CI, 21.4% to 22.2%) for the NLST. Baseline sensitivity was 84.9% (CI, 80.8% to 89.0%) for Lung-RADS versus 93.5% (CI, 90.7% to 96.3%) for the NLST, and sensitivity after baseline was 78.6% (CI, 74.6% to 82.6%) for Lung-RADS versus 93.8% (CI, 91.4% to 96.1%) for the NLST.
Lung-RADS criteria were applied retrospectively.
Lung-RADS may substantially reduce the false-positive result rate; however, sensitivity is also decreased. The effect of using Lung-RADS criteria in clinical practice must be carefully studied.
National Institutes of Health.