Active surveillance in Oz: a situation report

An interesting article published a couple of week’s ago in the Medical Journal of Australia reports on “real world issues” related to the implementation of active surveillance (AS) in Oz.

Evans et al. used patient outcomes and management data from the Prostate Cancer Outcomes Registry — Victoria (PCOR-Vic) to assess the management of 1,635 eligible men for whom there was relevant data. These patients were all diagnosed with prostate cancer at any one of 38 clinical centers; all aged ≤ 75 years; all apparently potential candidates for AS based on their diagnostic criteria; all said to have been followed on AS for a minimum of 2 years; and all enrolled in PCOR-Vic between August 2008 and December 2014. (The full text of this paper is accessible on line for interested readers.)

We would note, however, that this series of men included 20 men with an ISUP Grade Group of 3 or a Gleason score of 4 + 3 = 7. Many US-based physicians would argue that no patient with a Gleason score of 4 + 3 = 7 is an appropriate candidate for active surveillance. However, your sitemaster is certainly aware of a small number of patients who have insisted on taking such a course of action despite such a Gleason score.

What Evans and her colleagues set out to do was to see how many of these 1,635 men were actually being monitored using what might be considered to be a “reasonable” AS schedule, i.e., at least three follow-up PSA tests and at least one confirmatory follow-up biopsy over the first 2 years after initial diagnosis.

The basic findings of this study are reported to be as follows:

  • 433/1,635 men (26.5 percent) were managed — at a minimum — according to the proposed “reasonable” AS schedule.
  • The most significant predictor of adherence to the schedule was initial diagnosis in a private as opposed to a public hospital (adjusted odds ratio [aOR] = 1.83).
  • Significant predictors of non-adherence to the schedule included
    • Diagnosis by transurethral resection of the prostate (TUR) as opposed to TRUS-guided biopsy (OR = 0.54)
    • Diagnosis by transperineal biopsy pf the prostate as opposed to TRUS-guided biopsy (OR = 0.32)
    • Patient age of ≥ 66 years as opposed to < 55 years (OR = 0.65)

Evans et al. conclude, in part, that:

Almost three-quarters of men who had prostate cancer with low risk of disease progression did not have followup investigations consistent with standard AS protocols.

Your sitemaster (unfortunately) has to say that he is not exactly surprised by these data — although he is disappointed. There have been plenty of signals that many physicians have been willing to report that their patients are on AS protocols when the actual data suggest that they are not, in fact, being appropriately monitored if “active surveillance” is the intended form of management. In fact, the management of many such patients looks much more like “watchful waiting”.

We need to be clear that there are certainly subsets of patients for whom watchful waiting is a highly appropriate management strategy. The clearest examples are men diagnosed with low- and very low-risk prostate cancer who are 75 or more years of age with a life expectancy of < 10 years who are at very high risk for death from some other cause. It is highly unlikely that any such man would progress to have clinically significant prostate cancer within his remaining lifetime and so close active surveillance has little to no value for such a patient or his family (or indeed his doctor).

On the other hand, we need to get to the point, quickly, where there is a degree of consensus as to minimum management standards for monitoring of definable types of patient on AS and clarification of the differences between the application of AS and the application of watchful waiting in definable types of patient. It is your sitemaster’s personal opinion that such standards can and should be set internationally and built into management guidelines by appropriate authorities. He is currently working on an initiative that might be able to help with this.

Evans and her colleagues are careful to note — appropriately — that there are distinct limitations to their study (not least because the data collected by PCOR-Vic does not capture all potential predictors of non-adherence to an AS protocol). However, they also conclude that:

Despite these limitations, our findings have important implications for patients, health services, and, given the numbers of men affected, health policy. If they are not being followed appropriately according to AS protocols, men may miss the opportunity to be treated with curative intent.

And that is a distinctly worrisome set of findings that will need to be addressed.

Editorial note: We thank Dr. Declan Murphy of the Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia, for bringing this paper to our attention.

2 Responses

  1. Thanks Mike. I don’t think lack of compliance with AS is exclusive to Australia. It may also be true that such lack of compliance may not make much clinical difference to very many patients. However, part of the whole rationale for active surveillance is that patients avoid the likelihood of metastases and death from prostate cancer, and therefore some degree of compliance should be embraced. Another factor which we could not measured in this study is the use of MRI as a tool for patients on active surveillance. MRI has been in widespread use in Australia for many years both in the early detection (pre-biopsy) setting, and also in the active surveillance setting (despite not much evidence to support this). MRI scanning is now fully reimbursed in Australia for these indications and this is an important factor to consider.

  2. Thanks for your additional comments Dr. Murphy. I certainly wasn’t intending to imply that “lack of compliance with AS is exclusive to Australia”. We know this also occurs here in the US, and I am sure it is occurring elsewhere as well.

    One of the things that I think is critical as we move forward is clear distinction between when a man is on AS and when he is on WW and the appropriate recording of the reasoning (which shouldn’t be onerous) so that this can be clearly understood and communicated by all concerned.

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