ASCO generally endorses Canadian guidelines on role of active surveillance

We continue to see movement toward consensus on the appropriate selection of patients for active surveillance and how those patients need to be managed on active surveillance over time.

In the most recent step toward such consensus, the American Society for Clinical Oncology (ASCO) has generally — but not completely — endorsed active surveillance guidelines previously issued by Cancer Care Ontario in Canada. For the complete text of the ASCO endorsement, see this full-text article by Chen et al. in the Journal of Clinical Oncology.

The four key ASCO recommendations have been reproduced below:

(1) For most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, AS is the recommended disease management strategy.

ASCO qualifying statement: It is known that there is heterogeneity within this population and therefore factors such as younger age, high-volume Gleason 6 cancer, patient preference, and/or African American ethnicity should be taken into account in this recommendation. Young patients (younger than age 55 years) with high-volume Gleason 6 cancer should be closely scrutinized for the presence of higher-grade cancer, and definitive therapy may be warranted for select patients. For patients with limited life expectancy (< 5 years) and low-risk cancer, watchful waiting may be more appropriate than active surveillance.

(2) Active treatment (RP or RT) is recommended for most patients with intermediate-risk (Gleason score 7) localized prostate cancer. For select patients with low-volume, intermediate-risk (Gleason 3 + 4 = 7) localized prostate cancer, AS may be offered.

ASCO qualifying statement: Patients with Gleason score 7 (3 + 4) being considered for AS should include only those men with low-volume Gleason pattern 4 pathology and/or age older than 75 years. Because of known interobserver variability associated with the identification of minor Gleason pattern 4 elements, prospective intradepartmental consultation with colleagues should be considered a cornerstone of quality assurance in this area. For patients with limited life expectancy (< 5 years), watchful waiting may be more appropriate than AS.

(3) The AS protocol should include the following tests: a PSA test every 3 to 6 months; a DRE at least every year; and at least a 12-core confirmatory transrectal ultrasound guided biopsy (including anterior directed cores) within 6 to 12 months, and then serial biopsy every 2 to 5 years thereafter or more frequently if clinically warranted. Men with limited life expectancy may transition to watchful waiting and avoid further biopsies.

The AS protocol may include ancillary tests that are still under investigation. These could include multiparametric MRI (mpMRI) and/or genomic testing. mpMRI and genomic testing may be indicated when a patient’s clinical findings are discordant with the pathologic findings and could be useful in identifying occult cancers or changes indicative of tumor progression in patients at risk. These tests may also be helpful when the decision regarding AS versus active treatment is uncertain (e.g., in cases of low-volume Gleason 3 + 4). mpMRI should not be used as a replacement for rebiopsy.

(4) For patients undergoing AS who are reclassified to a higher-risk category, defined by repeat biopsy showing Gleason score ≥ 7 and/or significant increases in the volume of Gleason 6 tumor, consideration should be given to active therapy (e.g., RP or RT).

It is worth noting that this set of guidance for US-based oncologists is very close to the current recommendations issued by the National Comprehensive Cancer Network (NCCN) in the prostate cancer management guidelines earlier this year.

The one piece of guidance from the Ontario guidelines not endorsed by ASCO was the recommendation that daily treatment with 5α-alpha reductase inhibitors may have a role in management of men on AS. Since this use of 5α-alpha reductase inhibitors is not approved by the U.S. Food and Drug Administration, it would have been almost impossible for ASCO to go along with this particular recommendation.

While The “New” Prostate Cancer InfoLink might quibble gently with some of this wording, we consider this to be a generally good set of standardized guidance for the time being, and we would hope to see the American Urological Association (AUA) and perhaps the American Society of Radiation Oncology (ASTRO) also endorse very similar wording in the near future.

2 Responses

  1. ASCO has taken a very bold step in endorsing AS as “the recommended disease management strategy” for most patients with low-risk PC. I hope clinicians will follow suit.

    I would have liked to see them endorse use of 5-ARIs, at least in those patients who are are also diagnosed with BPH. There are several good reasons for doing so:

    Fleschner et al. found that 5-ARI use reduced 3-year progression by 38% in low volume, low-risk patients on AS.

    • 5-ARIs also render PSA a more sensitive and specific tool for monitoring progression while on AS (see Thompson et al.).

    UCLA recently reported that LUTS symptoms increased anxiety that contributed to patient decisions to forgo AS.

    I suspect that it’s probably a good idea to add Cialis to the mix as well because it reduces LUTS and will help with any sexual symptoms associated with 5-ARI therapy.

  2. Collapsing of Previous Criteria Into Just Gleason Score and Localization

    I am glad to see what looks like good progress toward a consensus on eligibility for and monitoring active surveillance.

    It is interesting that some of the earlier criteria are no longer there. Age has been receding for a good number of years now, with AS being confidently offered to men of any age. More recently, PSA < 10, PSA velocity < 2 ng/ml/year, PSA density < 0.15, and percentage of positive biopsy cores less than 34% were also getting a lot of play as sound criteria, but these seem to have been largely dropped. I'm curious why that is, though I suspect the studies on survival are showing that these added details don't make that much of a difference beyond Gleason score and disease that is local. (As of this point I have given the Canadian guidelines a pretty thorough scanning but have not looked at the evidence part.)

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