Consensus statement on pathologic factors and active surveillance

As previously mentioned earlier this week, a long statement that deals with the role of the pathologist in determining the suitability of patients for enrollment into active surveillance management protocols has been issued and endorsed by a number of organizations. We apologize to interested readers for taking a few days to address this important, recent publication. However, it is 19 pages long and extremely detailed, and we want to be clear up front that the only way to really understand this document is to read it in full for yourself. Every support group leader and other prostate cancer educator certainly needs to add a copy of this report to their “standard resource” files.

In what follows we shall provide just a short summary of what appears in this article by Amin et al., published in the Archives of Oncology and Laboratory Medicine. The full text of the article is available to all readers at no charge.

  • The consensus statement was developed cooperatively by four teams of experts and sought  to address “concerns … about the accuracy and consistency of pathologic information in prostatic needle biopsies and how that affected patient eligibility, patient management, and the success of the entire modality of active surveillance”. These concerns had initially been expressed at the state of the art conference on active surveillance held at the National Institutes of Health in December 2011.
  • The consensus statement and its recommendations are endorsed by the College of American Pathologists, the International Society of Urological Pathology, the Association of Directors of Anatomic and Surgical Pathology, the New Zealand Society of Pathologists, and the Prostate Cancer Foundation.
  • Taken as a whole, the document provides an extremely thorough overview of a wide range of factors relevant to the diagnosis and management of men who may or may not be eligible for management on active surveillance. From that perspective alone, this is a very useful review article. However, the recommendations provided are exclusively of a pathological nature.
  • “Team 1” was asked to review the “clinical perspective on active surveillance”, and this section of the report (see pp. 1338-1391) addresses, in detail, the epidemiology of prostate cancer, the rationale for active surveillance, and clinically relevant factors associated with the selection, surveillance, and treatment of men with prostate cancer who are on active surveillance.
  • “Team 1” makes no specific recommendations, but does carefully point out the following:
    • Prostate cancer-specific survival for men enrolled in established cohorts of active surveillance patients ranges from 97 to 100 percent. In other words, very few men on active surveillance appear to die from prostate cancer as a consequence of delays in the use of primary treatment.
    • Models currently suggest that the 20-year risk for prostate cancer-specific mortality is 2.8 percent for men on active surveillance (compared to a 20-year risk of 1.6 percent for comparable men who receive immediate therapy).
  • “Team 2” was asked to address “the influence of tumor extent measurements and other pathologic findings (except Gleason grading) in active surveillance protocols”. This they do (see pp. 1391-1395) in great detail by addressing such issues as tumor location, tumor extent measurements and methodologies, problems associated with tumor quantification in needle biopsies, histologic subtypes of carcinoma, perineural invasion, atypical small acinar proliferation (ASAP) in patients eligible for active surveillance, and a few other considerations. They also make three very specific recommendations of a pathologic nature (which we shall get to below).
  • “Team 3” addresses the role of Gleason grading in active surveillance (see pp. 1395-1398). In doing this they discuss, specifically, the issues related to the usefulness of the Gleason score in defining candidates for active surveillance, grade inflation, sampling errors, and definitions and detection thresholds for Gleason patterns 3, 4, and 5. They again make specific pathological recommendations which we will address below.
  • “Team 4” was asked to address the potential future role of personalized or “precision” medicine and  how currently available and developing molecular diagnostic tests may help to increase the safety and viability of active surveillance as a management strategy for some early-stage forms of prostate cancer. They do this under three headings on pp. 1398-1399: background, predictive instruments and prostate cancer outcomes, and the need for a precision medicine approach to active surveillance. They make no specific recommendations because “available data do not support a recommendation for any particular molecular tool or test for determining eligibility of patients into [active surveillance] protocols” at this time.

On pp. 1399-1402 of the text, the authors offer a “Summary and future perspectives” that pulls all of the relevant information together. Specifically, in Table 9 on p. 1400, there is a detailed set of pathologic recommendations that, it is suggested, should be followed by all clinicians in conducting biopsies on patients who may be candidates for active surveillance and by all pathologists in providing reports to other clinicians based on such biopsy specimens. This table is too large to reproduce here, but it contains nothing surprising. Also, in Table 10 on p. 1401, the authors provide a list of issues related to pathological factors affecting active surveillance that are either unresolved at this time or are in need of further study before any recommendations might become possible.

Overall, The “New” Prostate Cancer InfoLink finds this report to be a very thorough assessment of “where we are at” in the use of pathological information to help to define men who are good or less good candidates for active surveillance and in describing where either better information is needed or better tools might provide greater opportunity to assess the benefits and risks associated with active surveillance as a management strategy. It should be noted that this document is not designed to tell clinicians who should or should not be considered to be eligible for active surveillance. It is also not designed to tell clinicians when someone who is on active surveillance needs to receive treatment. Rather, the consensus statement defines and describes the use of pathologic information in helping to make such decisions.

6 Responses

  1. Excellent post. Thank you.

  2. If I read the study correctly, they recommend AS for those with no higher than 3 + 3 = 6 Gleason which is contrary to recommendations from some quarters that AS is also suitable for some with 3 + 4 = 7 patterns.

  3. Cliff:

    Actually you are not reading the article quite correctly. The team (largely of pathologists) asked to look at the issue of Gleason grading suggested that AS should be limited to men with a Gleason score of 3 + 3 = 6 or lower. However, the consensus group as a whole did not include that recommendation in the full set of recommendations; they carefully left the door open for some men with Gleason scores of 3 + 4 = 7.

  4. Mike, thanks for that clarification.

  5. Sitemaster,

    Thank you for all your excellent reviews of recent developments in prostate cancer diagnosis and treatment.

    One 2015 article you and your readers might like to hear about is the paper by Kates et al. entitled “Indications for intervention during active surveillance of prostate cancer: a comparison of the Johns Hopkins and Prostate Cancer Research International Active Surveillance (PRIAS) protocols”, which discusses the pros and cons of using the PSA doubling time and periodic but not yearly prostate biopsies for following patients with low-risk prostate cancer. The abstract and the full text of the article are readily available.

    Please keep up the good work!

  6. Thank you Walter. … We will see if we can put together some comments about this article within the next couple of days for our readers.

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