Determining the cause of death in randomized screening trial(s) for prostate cancer

Koning, Harry J. de; Blom, J.; Merkelbach, J.W.; Raaijmakers, René; Verhaegen, H.; Vliet, Peter Van de; Nelen, Vera; Coebergh, Jan Willem; Hermans, Annemie; Ciatto, Stefano; Mäkinen, Tuukka

doi:10.1111/j.1465-5101.2003.04402.x

Cited by 75 publications

(68 citation statements)

References 10 publications

(9 reference statements)

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“…Similar principles are also used for cause-of-death determination in the PLCO trial in the United States, 5 The early experiences in applying the flowchart in the ERSPC have been illustrated by de Koning et al 10 The difficulties encountered here were similar to those previously reported, and were mainly due to the presence of multiple malignancies or other concurrent severe medical conditions (usually cardiovascular disease). 16,18,24 There is a concern over potential misclassification of the cause of death, especially in elderly men with several other medical conditions in addition to prostate cancer.…”

Section: Discussionsupporting

confidence: 64%

“…7,14,15 However, previous studies have indicated several sources of potential error, particularly in assigning the cause of death in elderly prostate cancer patients with considerable comorbidity. 5,10,[16][17][18] In fact, more than half of the deaths in patients with prostate cancer are due to causes other than prostate cancer. 19 In England and Wales, nearly a half of the noted increase in prostate cancer mortality from 1970 to 1990 for men 75-84 years old was accounted for by inaccuracies in death certification.…”

Section: Discussionmentioning

confidence: 99%

“…First, all cases were reviewed independently by each member with a predetermined algorithm, a detailed description of which has been published elsewhere. 10 In principle, a flowchart was used to classify the role of prostate cancer in causing death depending on the extent of the disease (metastatic vs. local), disease progression and possible complications of diagnostic measures and treatment. Disease extent and progression were assessed on the basis of several criteria including clinical picture, PSA (and other relevant laboratory tests), X-rays, histological findings, therapy and autopsy data.…”

Section: Methodsmentioning

confidence: 99%

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Assessment of causes of death in a prostate cancer screening trial

Mäkinen

Karhunen

Aro

et al. 2007

Intl Journal of Cancer

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Accurate assessment of the causes of death is crucial for a conclusive evaluation of the ongoing prostate cancer screening trials. Here, we report the validity of the official causes of death as compared with an independent expert review in the Finnish prostate cancer screening trial. Because nearly 80,000 men were involved, death-cause evaluation was restricted to men diagnosed for prostate cancer. Medical charts were retrieved and the cause of death was assigned by an expert review panel for all deaths among men with prostate cancer during the study period, 1996-2003. The panel decision was compared with both death certificates and the official causes of death as assigned by Statistics Finland. Of a total of 315 deaths, the review panel attributed 127 (41%) to prostate cancer and 184 (59%) to other causes, the corresponding figures in death certificates being 124 (40%) and 187 (60%). Four cases were excluded because of insufficient information. The death-certificate data were in agreement with the panel's assessment in 305 out of 311 cases (overall agreement 97.7%, j 5 0.95). The overall agreement between the official causes of death and the panel's decision was 97.4% (304/311, j 5 0.95). The sensitivity of the certificates in identifying prostate cancer deaths was 96.1% (panel as golden standard). Correspondingly, specificity was 98.9%. The official causes of death thus provide an accurate means for evaluating disease-specific mortality in a large population-based prostatecancer screening trial in Finland. ' 2007 Wiley-Liss, Inc.Key words: prostate cancer; prostate-specific antigen; mass screening; cause of death; mortality; randomized trials Prostate cancer mortality is declining in some parts of the world, e.g., in the United States.1 Widespread debate has prevailed as to the extent to which the decrease may be a consequence of prostate-specific antigen (PSA)-based screening. The only valid means of settling the issue is through large randomized screening trials. Such trials are currently under way in both the United States (Prostate, Lung, Colorectal and Ovary screening trial, PLCO) and Europe (European Randomized Study of Prostate Cancer Screening, ERSPC), and the first mortality results are expected within a few years.2 Nevertheless the value of these ongoing trials has been questioned by suggesting that it would be almost impossible to demonstrate (or rule out) the value of PSA screening on account of possible misdiagnosis of the cause of death in elderly men with multiple comorbidities.3 Accurate assessment of the underlying cause of death is thus crucial for a conclusive evaluation of the possible benefits of prostate cancer screening. For several chronic conditions, a panel of experts has been regarded as the preferred strategy to establish cause-specific mortality for research purposes. [4][5][6] However, the use of death certificates has also been advocated to avoid labor-intensive and costly death reviews in large epidemiological studies. 7The Finnish prostate cancer screening trial is a part of ...

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Assessment of causes of death in a prostate cancer screening trial

Mäkinen

Karhunen

Aro

et al. 2007

Intl Journal of Cancer

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“…The cause of death was evaluated by an independent cause-of-death committee, where deaths due to causes related to screening were also counted as prostate cancer deaths. 16 Although data on the occurrence of distant metastases were available, we did not include this end point in our study, as these events largely overlapped with the number of disease-specific deaths.…”

Section: Clinical Follow-upmentioning

confidence: 99%

Disease-specific survival of patients with invasive cribriform and intraductal prostate cancer at diagnostic biopsy

et al. 2016

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Invasive cribriform and intraductal carcinoma in radical prostatectomy specimens have been associated with an adverse clinical outcome. Our objective was to determine the prognostic value of invasive cribriform and intraductal carcinoma in pre-treatment biopsies on time to disease-specific death. We pathologically revised the diagnostic biopsies of 1031 patients from the first screening round of the European Randomized Study of Screening for Prostate Cancer (1993Cancer ( -2000. Ninety percent of all patients (n = 923) had received active treatment, whereas 10% (n = 108) had been followed by watchful waiting. The median follow-up was 13 years. Patients who either had invasive cribriform growth pattern or intraductal carcinoma were categorized as CR/IDC+. The outcome was disease-specific survival. Relationships with outcome were analyzed using multivariable Cox regression and log-rank analysis. In total, 486 patients had Gleason score 6 (47%) and 545 had ≥ 7 (53%). The 15-year disease-specific-survival probabilities were 99% in Gleason score 6 (n = 486), 94% in CR/IDC − Gleason score ≥ 7 (n = 356) and 67% in CR/IDC+ Gleason score ≥ 7 (n = 189). CR/IDC − Gleason score 3+4 = 7 patients did not have statistically different survival probabilities from those with Gleason score 6 (P = 0.30), while CR/IDC+ Gleason score 3+4 = 7 patients did (P o0.001). In multivariable analysis, CR/IDC+ status was independently associated with a poorer disease-specific survival (HR 2.6, 95% CI 1.4-4.8, P = 0.002). We conclude that CR/IDC+ status in prostate cancer biopsies is associated with a worse disease-specific survival. Our findings indicate that men with biopsy CR/IDC − Gleason score 3+4 = 7 prostate cancer could be candidates for active surveillance, as these patients have similar survival probabilities to those with Gleason score 6.

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“…Three reviewers (a surgeon, a urologist, and a medical epidemiologist) separately judged the anonymized patient charts without knowledge of the randomization arm. The methods described by De Koning et al 10 were used for judgment of metastatic disease as well. Additionally, all men with a PSA of 150 ng/mL or more at diagnosis or during follow-up were assumed to have metastatic disease.…”

Section: Endpointmentioning

confidence: 99%

Metastatic disease of screen‐detected prostate cancer

Roemeling

Kranse

Vis

et al. 2006

Cancer

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BACKGROUND.Screening for prostate cancer has not only led to a stage migration, but also to a higher incidence of the disease. A decrease in mortality has occurred in several countries during the same time period. Risk stratification of screen‐detected cancers at diagnosis has become more important for the anticipation and interpretation of changing incidence/mortality ratios.METHODS.From 1993 to 1998, 633 men were diagnosed with nonmetastatic prostate cancer in the prevalence screen of the Rotterdam section of the European Randomized study of Screening for Prostate Cancer (ERSPC). The characteristics at diagnosis of men who developed metastatic disease were compared with men without evidence of metastases during follow‐up.RESULTS.During the median follow‐up of 7.5 years, 41 men developed metastatic disease. After 10 years the metastasis‐free survival rate was 89.6%, the overall survival 64.7%. In a Cox‐model 2logPSA (prostate‐specific antigen), biopsy Gleason score and the number of biopsy cores with prostate cancer were independent predictors for the development of metastases; the latter only predicted metastases that presented within 60 months of follow‐up.CONCLUSIONS.The metastasis‐free survival of men with prostate cancer detected in a prevalence screening was very high. Whether this was related to the beneficial effects of screening or to overdiagnosis due to screening (or both) remains unclear. The prognostic factors known for clinically diagnosed disease also hold for screen‐detected disease. Cancer 2006. © 2006 American Cancer Society.

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Determining the cause of death in randomized screening trial(s) for prostate cancer

Cited by 75 publications

References 10 publications

Assessment of causes of death in a prostate cancer screening trial

Assessment of causes of death in a prostate cancer screening trial

Disease-specific survival of patients with invasive cribriform and intraductal prostate cancer at diagnostic biopsy

Metastatic disease of screen‐detected prostate cancer

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