What’s being presented at ASCO this year: III

Another interesting presentation being made at the ASCO annual meeting this year will be the first report on a series of nearly 400 patients who did not conform to what would normally be considered a series of sound criteria for low risk disease. These patients all elected, as individuals, to go on actiuve surveillance despite their higher than average risk for progression.

Between 2006 and 2012, Davis et al. (abstract no. 5083) enrolled 572 men into a cohort of active surveillance patients at the M. D. Anderson Cancer Center. Of these 572 men, 369 (64.5 percent) met what the authors describe as “patient’s choice” criteria for active surveillance. Th only criteria for entry to this group was that

  • The patients had to have a life expectancy of > 10 years and
  • The patients must not meet “favorable risk” criteria for active surveillance.

To meet the “favorable risk” criteria for active surveillance according to the M. D. Anderson protocol, patients  had to have a single core of Gleason 3 + 3 = 6 that was < 3 mm in length or a single core  of Gleason  3 + 4 = 7 that was < 2 mm in length and a PSA level of  < 4 ng/ml; 191/572 patients in the M.D. Anderson series (33.4 percent) met all of these criteria.

All patients received a mandatory confirmatory biopsy at registration or within 6 months of their initial diagnostic biopsy and then repeat biopsies every 1 to 2 years. PSA tests and and digital rectal examinations were done every 6 months.

Here are the currently available outcomes data for the 369 patients in the “patient’s choice” group:

  • 317/369 men (86 percernt) were clinical stage cT1c .
  • The median PSA level for the group was 4.4 ng/ml.
  • Gleason scores were
    • 3 + 2 = 5 in 0.3 percent
    • 3 + 3 = 6 in 77.2 percent
    • 3 + 4 = 7 in 19.2 percent
    • 4 + 3 = 7 in 3.3 percent
  • At an average (median) follow-up of 3 years
    • 250/369 patients (67.8 percent) were still on active surveillance.
    • 119/369 patients (32.2 percent) had received some form of curative treatment.
      • 52/119 patients (43 percent) had received surgery.
      • 63/119 patients (53 percent) had received radiation therapy.
      • 4/119 patients (3 percent) had received cryotherapy.
    • One patient (with a PSA doubling time of < 2 years and a Gleason score of 6 to 7) had an anterior tumor and a positive pelvic lymph node at 1.5 years.
    • One patient with stage pT3bN0 at surgery at 9 months had a persistently elevated PSA post-surgery.
  • Among the 119 men who went on to have treatment, times on study pre-treatment were
    • < 6 months for 53 percent of patients
    •  6 to 11.9 months for 8 percent of patients
    • 12 to 23.9 months for 24 percent of patients
    • 24 to 35.9 months for 9 percent of patients
    • 36 to 47.9 months in 5% percent of patients
  • The following re-biopsy events were associated with recommendations/decisions for treatment
    • Increased tumor volume on biopsy in 106 patients
    • Gleason score upgrading in 74 patients
      • From Gleason 6 to ≥ 7 in 61 men
      • From Gleason 3 + 4 to 4 + 3 in 7 men
      • From Gleason 7 to > 7 in 6 men.

Davis et al. conclude that, in this prospective cohort of men with phenotypically heterogeneous tumors, all of whom elected to have active surveillance:

  • One third were eventually treated weith curative intent — mostly in the first year, after repeat biopsy results that indicated higher risk for clinically significant prostate cancer.
  • Biologically concerning treatment triggers (e.g., changes in Gleason score from 6 or 7 to 8 or 9) occurred in 12 percent of the treated patients.
  • “Despite limitations of selection criteria and monitoring tools, [active surveillance] is an important initial option in localized [prostate cancer].”

What The “New” Prostate Cancer InfoLink finds to be particularly interesting, however, are the similarities between the data from this group of patients and the data from the Sunnybrook series reported over time by Klotz and his colleagues, and particularly the facts that

  • A significant percentage of the patients who are not actually good candidates for active surveillance can be identified early on re-biopsy, and appropriately treated.
  • About two-thirds of the patients enrolled were still on active surveillance at a median of 3 years of follow-up.

It is becoming increasing clear that active surveillance may soon be seen as a very effective way to manage even lower levels of intermediate-risk disease, and not just men with “classic” low- and very low-risk disease.

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