Active surveillance and African Americans with very low-risk disease

A new study in the Journal of Clinical Oncology has suggested that African American men with very low-risk disease (according to the National Comprehensive Cancer Network or NCCN definition) are at higher risk for disease progression than comparable Caucasian patients if they follow active surveillance protocols.

It is well understood that African American men are at higher risk for a diagnosis of prostate cancer and prostate cancer-specific mortality than comparable white men. However, we really still have no clear resolution about why this is the case. It could be diet; it could be genetics; it could be some combination of the two; and it is possible that other environmental and lifestyle factors are involved, along with poverty-related factors.

The new study by Sundi et al., just published on line, is based on a retrospective analysis of data from the Johns Hopkins longitudinal prostate cancer surgery database, and is focused on the outcomes, after surgery, of men who (considered in retrospect) met the standards for very low-risk disease as defined by the NCCN. And it needs to be pointed out immediately that this places limitations on the value of the data, because this was not a prospective study in which men were actively followed on active surveillance.

What Sundi et al. have shown is that, for the men in their surgery database who underwent immediate, first-line surgery as a treatment for localized, very low-risk prostate cancer, African American patients had a significantly higher risk for aggressive pathology and Gleason upgrading after surgery than did comparable white patients. As a consequence, they question whether Black males with very low-risk disease are actually appropriate candidates for active surveillance as a method to manage their prostate cancer.

In this study, the criteria for very low-risk disease required patients to have a PSA < 10 ng/ml, a PSA density of ≤ 0.15 ng/ml/cm3, clinical stage ≤ T1c, a Gleason score of ≤ 3 + 3 = 6, no more than two positive biopsy cores, and cancer involvement of no more than 50 percent in any positive core.

The data that Sundi et al. present are as follows:

  • Their database comprised 1,801 men with very low-risk disease (of the total of > 19,000 men in the Johns Hopkins database)
    • 256 African Americans
    • 1,473 Caucasians
    • 72 others
  • Compared to the Caucasian patients, the African American patients exhibited
    • Greater risk for disease upgrading at surgery (27.3 vs. 14.4 percent; P < 0.001)
    • Greater risk for positive surgical margins (9.8 vs. 5.9 percent; P = 0.02)
    • Higher CAPRA-S scores (Cancer of the Prostate Risk Assessment Post-surgical scores)
  • On multivariate analysis, African American race was an independent predictor of
    • Adverse surgical pathology (odds ratio [OR] = 3.23; P = 0.03)
    • Pathologic upgrading (OR = 2.26; P = 0.03)

It is clear from this data that there is a real increase in risk of worse pathology for African American patients compared to Caucasian patients in this series. What this does not tell us, however, is whether that pathological risk correlates to a real clinical risk if these patients follow active surveillance protocols until actual evidence of increased risk becomes apparent.

One other, admittedly smaller, surgical series did not show this increase in risk; and other even small series did show similar risk. It also needs to be recognized that the Johns Hopkins surgery database is atypical of the “real world” in many ways, and the patients treated in this subset of 1,801 patients were relatively young, with an average age of about 57 to 58 years, which is much younger than average for most men who are considering active surveillance.

The “New” Prostate Cancer InfoLink certainly believes that African American men who wish to consider active surveillance as a management option should be made aware of these data, but we think it should also be made clear to them that the clinical implications of these data are not well characterized as yet.

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