THE "NEW" PROSTATE CANCER INFOLINK

Today’s news is focused on issues around prevention, screening, and active surveillance:

• The potential cost-effectiveness of widespread use of finasteride to prevent prostate cancer
• An update on data from the European Randomized Study of Screening for Prostate Cancer (ERSPC)
• The argument in favor of active surveillance as first-line management for men with low risk prostate cancer

The Prostate Cancer Prevention Trial (PCPT) demonstrated that finasteride reduces the prevalence of prostate cancer by 24.8 percent (risk reduction). A recent publication has now attempted to assess the cost-effectiveness of widespread utilization of finasteride for prostate cancer prevention, using a quality-of-life adjustment. The basic model was designed to determine the lifetime prostate health-related costs, beginning at age 50 years, for men treated with finasteride compared with placebo, and a significant number of assumptions are inevitably built into the model. The authors state that, based on their model, the quality-adjusted cost-effectiveness ratio for finasteride compared with men not receiving chemoprevention is $122,747 (in U.S. dollars) per quality-adjusted life-year  (QALY) saved. However, The “New” Prostate Cancer InfoLink suggests strongly that this is an inappropriate way to measure the value of chemoprevention with finasteride. The actual value should be based on the cost to prevent a diagnosis of prostate cancer, which then also saves significant costs associated with the probability of follow-up and treatment. Not surprisingly, the authors conclude that, “Finasteride is unlikely to be cost-effective when considering the impact on survival differences among treated vs. untreated groups.” By contrast, they do go on to state that “chemoprevention may be cost-effective in high-risk populations when taking into consideration adjustments for the impact on quality of life.”

Schröder has just published an update on the data currently available from the European Randomized Study of Screening for Prostate Cancer (ERSPC). This trial was initiated in 1993. It is a randomized, controlled trial running in eight European countries (Belgium, Finland, France, Italy, The Netherlands, Spain, Sweden, and Switzerland). A total of 267,994 men have been now randomized to screening vs. controls. Following an interim assessment of the available data in 2006, the Data Monitoring Committee recommended continuation the study. This was based on: 23,794 deaths in both study groups, 6,033 cases of prostate cancer detected in both groups (of whom about 1,200 had died). Lead-time and overdiagnosis with the screening regimen utilized in ERSPC Rotterdam were established to amount to 10.3 years and 54%. During the evolution of ERSPC, digital rectal examination was omitted and replaced by the inclusion of PSA 3-4 as a biopsy indication. The data on which this decision has been based were published and validated. Overdiagnosis and overtreatment have an adverse influence on quality of life, and an assessment of this issue will be included in the final evaluation of ERSPC. The recent development of a nomogram for the identification of indolent disease is a major step to improve on this outcome parameter. The application of this nomogram to screen-detected cases permits the active surveillance of about 30 percent of such patients. ERSPC was designed to evaluate the potential for a 25 percent reduction in prostate cancer mortality as a consequence of screening.

There appears to be a slowly increasing acceptance of the value of active surveillance as a management option for men with low-risk, early stage prostate cancer. Klotz has recently published his argument favoring active surveillance as the optimal therapy for screen-detected, low volume, low grade prostate cancer. His position is based on data from recent long-term studies of conservative management, the prostate cancer prevention trial (PCPT), the Swedish trial of radical prostatectomy vs. observation, and several large Phase II trials of active surveillance. In his opinion, these studies indicate convincingly that: (1) widespread screening results in a diagnosis of prostate cancer in many patients with clinically insignificant disease; (2) these patients can be identified with reasonable accuracy; (3) delayed intervention does not appear to put those patients who reclassify as higher risk over time at significant risk; and (4) the psychological burden of surveillance is acceptable.

Filed under: Diagnosis, Living with Prostate Cancer, Management, Prevention Tagged: | active, cost-effectiveness, finasteride. prevention, screening, surveillance