Published data on Klotz’s active surveillance series at c. 20 years

In a report published on line on Monday, in the Journal of Clinical Oncology, Klotz et al. have now provided peer-reviewed data from their nearly 20-year-long series of patients managed on active surveillance. These data are also discussed in a commentary on the American College of Surgery’s surgery news site.

Detailed editorial comment on this paper is also provided in the Journal of Clinical Oncology by Dr. Matthew Cooperberg. The full text of this editorial comment appears to be freely available on line.

As will be well known to many readers of the InfoLink news, the Sunnybrook series of patients is widely considered to be the least “academic” and arguably the most “clinical” series of active surveillance patients, including, as it does, men with small amounts of Gleason 3 + 4 = 7 disease and PSA levels up to 15 ng/ml at diagnosis. Klotz and his colleagues describe their series as being one made up of patients with “favorable-risk” and intermediate-risk prostate cancer.

The current report is based on the entire series of 993 men enrolled into the series based on having favorable- or intermediate-risk prostate cancer at time of initial diagnosis. The patients in the series could opt out at any time and seek treatment for their prostate cancer (at Sunnybrook or elsewhere). In addition, Klotz et al. list three occurrences which led, necessarily, to the patients being offered interventional therapy (which the patients were at liberty to accept or refuse):

  • A PSA doubling time of less than 3 years
  • Gleason score progression
  • Unequivocal clinical progression

Here are the results as reported in the most recent publication:

  • 844/993 patients (85.0 percent) were still living at the time of the analysis.
  • 149/993 patients (15.0 percent) had died of all causes.
  • 15/993 patients (1.5 percent) had died of prostate cancer.
  • Among the 819 surviving patients for whom precise data are available, median follow-up time from initial biopsy to date is 6.4 years (range, 0.2 to 19.8 years)
  • The 10-year actuarial prostate cancer-specific survival rate is 98.1 percent.
  • The 15-year actuarial prostate cancer-specific survival rate is 94.3 percent.
  • 13/978 additional patients (1.3 percent) who did not die of prostate cancer developed metastatic disease.
    • 9/13 patients are alive with confirmed metastases.
    • 4/13 patients died of other causes.
  • Over time, the percentages of patients who remain untreated and on active surveillance are
    • 75.7 percent at 5 years
    • 63.5 percent at 10 years
    • 55.0 percent at 15 years
  • The cumulative hazard ratio for non-prostate-cancer-specific to prostate cancer-specific mortality was slightly higher than 9 : 1.

Klotz et al. conclude that:

Active surveillance for favorable-risk prostate cancer is feasible and seems safe in the 15-year time frame. In our cohort, 2.8 percent of patients have developed metastatic disease, and 1.5 percent have died of prostate cancer. This mortality rate is consistent with expected mortality in favorable-risk patients managed with initial definitive intervention.

The “New” Prostate Cancer InfoLink would remind its readers that, as defined by Klotz and his colleagues, active surveillance is a management strategy designed to help patients avoid unnecessary treatment for as long as possible while allowing for treatment as and when it becomes necessary and can, if possible, still be carried out with curative intent. They do not tell their patients that active surveillance will necessarily allow them to avoid treatment forever, but rather that it allows patients to maintain their existing quality of life for as long as possible before the patient and his doctor (for whatever reason) come to the shared conclusion that some form of treatment is a wise idea. It should also be recognized that:

  • Many patients in the Sunnybrook series decided to switch from active surveillance to interventional treatment just because they felt uncomfortable with “doing nothing”, even though they continued to meet all relevant eligibility criteria for active surveillance.
  • Some patients in this series refused treatment after it was suggested to them and asked to remain on expectant management.

It is not clear from the abstract of this paper how many patients decided to have treatment despite the fact that they remained eligible for active surveillance. It is also not clear how many of the 28 patients who progressed to either metastatic disease or prostate cancer-specific death had decided to remain on expectant management as opposed to being given potentially curative therapy when it was offered to them for any one of the three pre-defined reasons.

2 Responses

  1. Dr. Klotz’ patients are lucky guys. He’s quite impressive, IMO.

  2. Thank for this post, including the link to the full text of original article (which can be downloaded for free by signing in as a patient at the publisher’s site) and full text of the editorial comment by Dr. Cooperberg, which is a must read. It expertly summarizes this article, as well as our current understanding of and future goals of “active surveillance”.

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