Abstract:If RP efficacy and prostate cancer survival in the absence of screening are similar to that in the SPCG-4 trial, then overdiagnosis and lead time largely explain the lower AMD in PIVOT. If these artifacts of screening are the correct explanation, then there is a subset of case subjects that should not be treated with RP, and identifying this subset should lead to a clearer understanding of the benefit of RP in the remaining cases.
“…Thus, even though the two trials produced similar results in terms of relative hazards, the NNT for the PIVOT trial was considerably higher; the lower baseline risk of death in that trial meant that there were fewer lives to save even under a hazard ratio that was almost the same as in the SPCG-4 trial. A recent study that examined these results and attempted to reconcile them 4 concluded that differences in the prevalence of PSA screening in the two case populations largely explained the discrepancies between the trials in the observed frequency of prostate cancer deaths and survival.…”
Section: Comparisons Of All-cause Mortalitymentioning
The investigator comparing outcomes across arms of a drug development trial has available a variety of measures of survival benefit. In this article we systematically review the most common measures of comparative survival used in published studies. We distinguish between relative and absolute survival differences, and measures of instantaneous and cumulative risk. We consider settings in which the endpoint is overall survival as well as those in which disease-specific endpoints are of primary interest. We note that different measures capture different aspects of benefit and some may be more reliable than others or more representative of clinically relevant benefit. Rather than simply using procedures that have become standard, analyses should identify the most clinically relevant measures of impact and apply procedures that reliably estimate these.
“…Thus, even though the two trials produced similar results in terms of relative hazards, the NNT for the PIVOT trial was considerably higher; the lower baseline risk of death in that trial meant that there were fewer lives to save even under a hazard ratio that was almost the same as in the SPCG-4 trial. A recent study that examined these results and attempted to reconcile them 4 concluded that differences in the prevalence of PSA screening in the two case populations largely explained the discrepancies between the trials in the observed frequency of prostate cancer deaths and survival.…”
Section: Comparisons Of All-cause Mortalitymentioning
The investigator comparing outcomes across arms of a drug development trial has available a variety of measures of survival benefit. In this article we systematically review the most common measures of comparative survival used in published studies. We distinguish between relative and absolute survival differences, and measures of instantaneous and cumulative risk. We consider settings in which the endpoint is overall survival as well as those in which disease-specific endpoints are of primary interest. We note that different measures capture different aspects of benefit and some may be more reliable than others or more representative of clinically relevant benefit. Rather than simply using procedures that have become standard, analyses should identify the most clinically relevant measures of impact and apply procedures that reliably estimate these.
“…The insignificance of mortality reductions by radical intervention observed in the Prostate Cancer Intervention versus Observation Trial (PIVOT) study reflect in part the more favorable prognosis of patients with tumors detected by PSA screening. The resulting lead time and increased rates of overdiagnosis have led to a greater number of low risk, clinically insignificant tumors that naturally yield better outcomes [16,30].…”
“…In fact, many CaPs would never have become clinically significant or caused any impairment to the quality or quantity of life if they remained undetected, and are thus said to be overdiagnosed [19,20]. It is estimated that 32% of screen-detected cancers were overdiagnosed and that the mean lead time defined as the time between the screening and subsequent diagnosis and the time the disease would have been diagnosed without screening was 7.7 years among nonoverdiagnosed men [21]. A multiplicity of CaP risk assessment instruments have been designed to classify the patients and predict disease outcomes, all of which include PSA level [22][23][24][25][26][27][28].…”
Section: Cap Stage Migration and Overtreatmentmentioning
Prostate cancer screening had led to the diagnosis of a large proportion of localized and low-risk disease. Many of these cancer cases are believed to be indolent and would not be clinically perceived in the absence of screening. In addition to that, the wide use of active treatment has exposed these patients to treatment-related quality-of-life impact. In this setting active surveillance as a way of deferring active treatment and reserving such treatment to cases of disease progression only has gained interest. PSA has been widely used to identify patients eligible for active surveillance and also for disease monitoring. The goal of this review was to describe the place of PSA in the monitoring of patients under active surveillance based on the existing studies and to discuss the importance of PSA in light of other existing or emerging tools to monitor prostate cancer in active surveillance.
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