Originally published as JCO Early Release 10.1200/JCO.2009.23.1167 on September 8 2009

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Guideline for 5--Reductase Inhibitors in the Prevention of Prostate Cancer Is Premature

Division of Biostatistics, City of Hope National Medical Center, Duarte, CA

Przemyslaw Twardowski

Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, CA

To the Editor:

It is well-recognized that researchers can examine the same data and yet have divergent opinions.¹ In our view, the evidence-based guideline² for use of 5--reductase inhibitors (5-ARIs) in the prevention of prostate cancer should more clearly recommend against use of 5-ARIs in otherwise healthy men at this time. There is no evidence that healthy men live longer with use of 5-ARIs, nor is there any evidence of improved quality of life, the two measures that are most relevant for healthy individuals. In fact, the guideline states that studies have reported higher all-cause mortality in patients receiving finasteride when compared with control groups, as well as "a consistently higher frequency of adverse events."

Aside from the empirical observation of more deaths among patients receiving finasteride than in the placebo group in the PCPT (Prostate Cancer Prevention Trial) study,³ the guideline reports that the upper 95% CI for relative risk of death from any cause is 1.18, suggesting that the evidence to date cannot rule out an 18% increase in risk of death resulting from finasteride. In addition, the prostate-specific benefit is quite small, requiring 1,000 men treated for 7 years to prevent just 15 cases of prostate cancer. The guideline notes the possibility of an increase of three cases of high-grade prostate cancer in those 1,000 men. In more general terms, the prostate-specific mortality rates for finasteride and placebo were identical.

When considering a healthy person, one should not focus on a single gland, single disease, or even single potential cause of death. The trend of specialization in medicine exemplified by organ-centric analysis sometimes obscures the consideration of overall health of the individual. From that perspective, the recommendation that healthy, asymptomatic men with low PSA values "may benefit from a discussion"² about use of 5-ARIs may be interpreted as an implicit endorsement of a drug for prostate cancer prevention, which we believe is, at this point, premature.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.

REFERENCES

1. Wiley S: The problem of perception. Scientist 23:31; 2009.

2. Kramer BS, Hagerty KL, Justman S, et al: Use of 5--reductase inhibitors for prostate cancer chemoprevention: American Society for Clinical Oncology/American Urologic Association 2008 Clinical Practice Guideline. J Clin Oncol 27:1502–1516, 2009.[Abstract/Free Full Text]

3. Thompson IM, Goodman PJ, Tangen CM, et al: The influence of finasteride on the development of prostate cancer. N Engl J Med 349:215–224, 2003.[Abstract/Free Full Text]

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