Prostate cancer mortality reduction by screening: Power and time frame with complete enrollment in the European randomised screening for prostate cancer (ERSPC) trial

Koning, Harry J. de; Liem, Michael; Baan, Caroline A.; Boer, R. de; Schröder, Fritz H.

doi:10.1002/ijc.10188

Cited by 146 publications

(76 citation statements)

References 23 publications

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“…Using the same formulas as in the American PLCO (prostate, lung, colorectal and ovarian) screening trial and the European Randomised Screening Trial on Prostate Cancer, required sample sizes to be able to demonstrate a lung cancer mortality reduction of 20%, 25% or 30% were calculated for the various selection scenarios (Appendix 24,25 ). A 1:1 randomisation, a power of 80%, a one-sided a significance level of 0.05, a 95% compliance in the screen group, a 5% contamination rate in the control group and 10 years of follow up after randomisation were assumed.…”

Section: Required Sample Sizementioning

confidence: 99%

“…A 1:1 randomisation, a power of 80%, a one-sided a significance level of 0.05, a 95% compliance in the screen group, a 5% contamination rate in the control group and 10 years of follow up after randomisation were assumed. 25 …”

Section: Required Sample Sizementioning

confidence: 99%

“…Appendix: Sample size calculations 24,25 The power (1 2 b) is the probability of detecting a statistically significant difference in lung cancer mortality if screening does have a reducing effect on lung cancer mortality. The total number of lung cancer deaths needed to detect a lung cancer mortality difference is:…”

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confidence: 99%

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Risk‐based selection from the general population in a screening trial: Selection criteria, recruitment and power for the Dutch‐Belgian randomised lung cancer multi‐slice CT screening trial (NELSON)

Iersel

Koning

Draisma

et al. 2006

Intl Journal of Cancer

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442

357

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A method to obtain the optimal selection criteria, taking into account available resources and capacity and the impact on power, is presented for the Dutch-Belgian randomised lung cancer screening trial (NELSON). NELSON investigates whether 16-detector multi-slice computed tomography screening will decrease lung cancer mortality compared to no screening. A questionnaire was sent to 335,441 (mainly) men, aged 50-75. Smoking exposure (years smoked, cigarettes/day, years quit) was determined, and expected lung cancer mortality was estimated for different selection scenarios for the 106,931 respondents, using lung cancer mortality data by level of smoking exposure (US Cancer Prevention Study I and II). Selection criteria were chosen so that the required response among eligible subjects to reach sufficient sample size was minimised and the required sample size was within our capacity. Inviting current and former smokers (quit 10 years ago) who smoked >15 cigarettes/day during >25 years or >10 cigarettes/day during >30 years was most optimal. With a power of 80%, 17,300-27,900 participants are needed to show a 20-25% lung cancer mortality reduction 10 years after randomisation. Until October 18, 2005 11,103 (first recruitment round) and 4,325 (second recruitment round) (total 5 15,428) participants have been randomised. Selecting participants for lung cancer screening trials based on risk estimates is feasible and helpful to minimize sample size and costs. When pooling with Danish trial data (n 5 64,000) NELSON is the only trial without screening in controls that is expected to have 80% power to show a lung cancer mortality reduction of at least 25% 10 years after randomisation. ' 2006 Wiley-Liss, Inc.Key words: lung cancer; screening; computed tomography; power; risk estimation Lung cancer is the most common cause of cancer-related death in men and the second most common cause of cancer-related death in women in Europe. 1 Because lung cancer is often in an advanced stage at the time of diagnosis, 5-year-survival is only 15% or less. 2 Japanese studies and the US Early Lung Cancer Action Project (ELCAP) showed that in a high-risk population more lung cancers can be detected by spiral computed tomography (CT) screening than by chest X-ray screening. 3,4 These and other observational studies with spiral CT screening showed that 55-85% of CTdetected lung cancers at baseline screening in a high-risk population of current and former smokers are at a surgically removable stage (stage I). 5 Although these results seem promising, observational studies are prone to lead-time, length-time and overdiagnosis bias. Only in a randomised design, disease-specific mortality between the screened and the unscreened population, instead of survival, can be compared. Lead-time, length-time and overdiagnosis do not bias the analysis in such comparisons. 6 Therefore, in the United States the National Lung Screening Trial (NLST) was launched in 2002 7 and in the Netherlands and Belgium, the NEL-SON trial, a Dutch acronym for ÔDutch-Belgian lu...

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Section: Required Sample Sizementioning

confidence: 99%

Section: Required Sample Sizementioning

confidence: 99%

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Risk‐based selection from the general population in a screening trial: Selection criteria, recruitment and power for the Dutch‐Belgian randomised lung cancer multi‐slice CT screening trial (NELSON)

Iersel

Koning

Draisma

et al. 2006

Intl Journal of Cancer

Self Cite

442

357

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“…23,27 It has yet to be proven in large randomized control studies that PSA screening significantly reduces mortality from PCa; however two studies are anticipated to answer this question in the near future. 28,29 Detecting cancer at lower stages and volumes has led to improved survival for other malignancies. 30 The American Urologic Association (AUA) recommends beginning PSA screening in all men aged 50 years or more with a life expectancy of more than 10 years.…”

Section: Prostate Cancermentioning

confidence: 99%

HIV and prostate cancer: a systematic review of the literature

Silberstein

Downs

Lakin

et al. 2008

Prostate Cancer Prostatic Dis

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Malignancy occurs with increased frequency in the HIV-positive population. The true incidence of prostate cancer in this population is unknown. In the few cases that have been presented in the literature, prostate cancer in HIV-positive men appears to behave much like it does in HIV-negative men. Prostate cancer is the most common malignancy in men and the second leading cause of cancer death. Approximately 800 000 men in the United States are HIV positive, and innovative therapies have dramatically improved survival. HIV disproportionately impacts ethnic groups with increased risk of prostate cancer and has been associated with increases in the incidence of certain malignancies. Despite the high prevalence of both diseases, there is relatively little literature about prostate cancer in HIV-positive patients. There is no consensus on how to screen or treat this patient population. We review the literature with regards to incidence, screening, treatment, and outcomes of this poorly characterized population. We briefly discuss the impact of highly active antiretroviral therapy and testosterone supplementation in the development of prostate cancer. A systematic review of the literature was conducted using MEDLINE key words 'HIV,' 'prostate,' 'prostate cancer' and 'AIDS.' Manual bibliographic review of cross-referenced items was also performed. A total of 176 unique abstracts and publications were reviewed; many authors provided data on the incidence of HIV and various malignancies including prostate cancer. Twelve unique publications providing detailed information on 60 patients with HIV and prostate cancer were identified. Prostate cancer is a common malignancy in HIV-positive men. With improved therapies for HIV and increasing survival, the importance for screening and treating prostate cancer is increasing. Acute outcomes of treatment do not demonstrate increased acute morbidity; however long-term outcomes have not been reported.

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“…10,14 In the ERSPC study, after initial screening, screening was only offered every 4 years or once after 4 years. 25 As a result, after 11 years of follow-up, PSA testing had been done on average only 2.27 times per man over the 11-year period, including first screening for a median interval of 4.02 years between screenings 12 ( Table 1). With such a long interval between screenings, it is remarkable that a 21% reduction in deaths from prostate cancer could be observed, thus demonstrating the high efficacy of screening, even when performed so intermittently at a clearly suboptimal rate.…”

Section: Psa Screening Intervalmentioning

confidence: 99%

PSA screening for prostate cancer: why so much controversy?

Labrie

2013

Asian J Androl

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Since prostate cancer reaches the advanced and non curable stage in the absence of any specific symptom or sign, it seems reasonable to diagnose this cancer at an early and curable stage. Screening by prostate-specific antigen (PSA) has been the common technology used. The last follow-up of the first two prospective and randomized screening studies for prostate cancer, namely the Quebec and ERSPC (European Randomized Study of Screening for Prostate Cancer) clinical trials started in 1988 and 1991, respectively, have shown reductions of prostate cancer death of 62% (P,0.002) and 21% (P,0.001) (38% in the tenth and eleventh years of follow-up, P,0.003), respectively, while the PLCO (Prostate Lung Colorectal and Ovarian Cancer) screening trial reported no benefit. It has been estimated, however, that 85% of men in the planned 'non-screened' group of the US study have been screened. With such a serious flaw, the PLCO study does not have the statistical power to reach any valid conclusion. In the Quebec study, only 7.3% of men were screened in the control arm. The important benefit observed in the ERSPC study was achieved using a less than optimal 4-year PSA screening interval which misses a significant number of cancers while the Quebec study used the optimal 1-year interval. With proper information obtained from their physicians or otherwise using data collected only from the clinical trials having the required statistical power, men should be in a good position to decide about being or not being screened for prostate cancer.

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Prostate cancer mortality reduction by screening: Power and time frame with complete enrollment in the European randomised screening for prostate cancer (ERSPC) trial

Cited by 146 publications

References 23 publications

Risk‐based selection from the general population in a screening trial: Selection criteria, recruitment and power for the Dutch‐Belgian randomised lung cancer multi‐slice CT screening trial (NELSON)

Risk‐based selection from the general population in a screening trial: Selection criteria, recruitment and power for the Dutch‐Belgian randomised lung cancer multi‐slice CT screening trial (NELSON)

HIV and prostate cancer: a systematic review of the literature

PSA screening for prostate cancer: why so much controversy?

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