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Logo of nihpaAbout Author manuscriptsSubmit a manuscriptHHS Public Access; Author Manuscript; Accepted for publication in peer reviewed journal;
 
N Engl J Med. Author manuscript; available in PMC 2016 June 29.
Published in final edited form as:
PMCID: PMC4927191
NIHMSID: NIHMS622203

Survival in the Prostate Cancer Prevention Trial

TO THE EDITOR

In their article on long-term survival in the Prostate Cancer Prevention Trial (PCPT), Thompson et al. (Aug. 15 issue)1 comment on the aggressiveness of high-grade disease (which they defined as a tumor having a Gleason score of 7 to 10). These authors have always argued that the increase in high-grade disease in men receiving finasteride was an artifact.2 If this were true, men with high-grade disease who are treated with finasteride should have a better survival rate than men in the placebo group. However, the survival rates in these groups were virtually the same. This finding indicates that the increase in high-grade disease is not an artifact but is real. The Food and Drug Administration rejected the use of finasteride for the prevention of prostate cancer on the basis of a related increase in the most aggressive, potentially lethal form of high-grade disease (Gleason score, 8 to 10), excluding the less aggressive pattern of disease (Gleason score of 7).3,4 In another recent report, the PCPT investigators stated that tumors with a Gleason score of 8 to 10 may cause “a small increase in prostate cancer mortality.”5 In the study published in the Journal, which defined a high-grade tumor as one having a Gleason score of 7 to 10, there is no report on prevalence or mortality for cancers with Gleason scores of 8 to 10. What are they?

Footnotes

No potential conflict of interest relevant to this letter was reported.

References

1. Thompson IM, Jr, Goodman PJ, Tangen CM, et al. Long-term survival of participants in the Prostate Cancer Prevention Trial. N Engl J Med. 2013;369:603–10. [PMC free article] [PubMed]
2. Redman MW, Tangen CM, Goodman PJ, Lucia MS, Coltman CA, Jr, Thompson IM. Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach. Cancer Prev Res (Phila) 2008;1:174–81. [PMC free article] [PubMed]
3. Summary Minutes of the Oncologic Drugs Advisory Committee Meeting December 1, 2010. ( http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM239355.pdf)
4. Theoret MR, Ning Y-M, Zhang JJ, Justice R, Keegan P, Pazdur R. The risks and benefits of 5α-reductase inhibitors for prostate-cancer prevention. N Engl J Med. 2011;365:97–9. [PubMed]
5. Pinsky PF, Black A, Grubb R, et al. Projecting prostate cancer mortality in the PCPT and REDUCE chemoprevention trials. Cancer. 2013;119:593–601. [PMC free article] [PubMed]