The “right” ways to treat TxN1M0 disease today

Really sound guidance on “the best” way to treat men who are initially diagnosed with lymph node-positive (TxN1M0) prostate cancer — or are found to have such cancer at the time of first-line surgery — is not as readily available as one might like.

As a consequence, Zareba et al. set out to describe contemporary patterns of care and outcomes for a cohort of men with pN1 prostate cancer (i.e., men found to have pathological TxN1M0 prostate cancer at the time of radical prostatectomy) and to use this to initiate a process of consensus-building about the appropriate management of such patients.

The authors used data from the National Cancer Data Base (NCDB) to identify 7,791 men recently identified with TxN1M0 disease at the time of surgery. They then used the available data to identify patient, tumor, and facility characteristics associated with choice of post-surgical management strategy and overall survival.

Here is what they found:

  • Of the total of 7,791 patients
    • 63 percent were managed with observation alone
    • 20 percent were managed with androgen deprivation therapy (ADT) alone
    • 5 percent were managed with radiation therapy alone
    • 13 percent were managed with ADT + radiation therapy
  • The following patient characteristics were all associated with a higher likelihood of receiving combination therapy:
    • Younger age
    • Lower comorbidity burden
    • Higher grade and stage
    • The presence of positive surgical margins
  • Independent predictors of worse overall survival included
    • ISUP grade group 4 or 5 disease (i.e., Gleason score 8, 9, or 10)
    • Pathologic stage T3bN1M0 or T4N1M0 disease
    • Positive surgical margins
    • A higher number of positive lymph nodes
  • Probabilities of adjusted 10-year probabilities of overall survival decreased from 84 to 32 percent with the presence of an increasing number of adverse prognostic factors.
  • Treatment with the combination of ADT + radiation therapy was associated with superior overall survival (multivariable hazard ratio = 0.69 for combination therapy vs. observation).

Zareba et al. conclude that, in men with pTxN1M0 prostate cancer:

  • Patient and tumor characteristics are associated with both
    • Choice of post-surgical management strategy
    • Overall survival
  • Multimodal therapy may be of benefit in this patient population.

These are hardly revolutionary ideas, but notice again what it says above … that 63 percent of men recently diagnosed with these characteristics were being treated with observation alone (which may, to be fair, be a perfectly reasonable decision for some of them, but probably not all of the 63 percent).

4 Responses

  1. Sitemaster:

    Underscoring your final observation is the fact that this is a group judged young and healthy enough for surgery, yet nearly two in three were treated only with observation. At first glance this seems a sad state of practice indeed! I wish the full paper were available, as it would be interesting if the observation period on average was long or fairly short, and the paper might have provided some data on that.

    Do we know how “contemporary” this cohort was? Perhaps the average treatment years predated most of the recent advances in imaging and genetic testing that have now reached the clinic — advances that could aid decision making for such patients.

  2. Dear Jim:

    I have seen what you have seen … the abstract. I have reached out to get a copy of the full text but don’t have this yet.

  3. The overall survival for these patients is complex. Prognostically bad characteristics lead to worse survival compared with good characteristics. At the same time, more intensive treatment improves survival. If two dimensions were dichotomized, we’d have four groups from nice pathology given intense treatment to bad pathology given observation. It would be helpful if the paper gave such four survival curves.

    Finn Edler von Eyben
    Odense. Denmark

  4. Here is a report of one (1): 2006 surgery, pT2N1Mx, margins -ve, Gleason 4 + 4 {+ 5}, two nodes +ve (intraoperative) {5 +ve per pathology}. PSA 2.7 ng/ml 6 weeks post-surgery. 3D-RT 4 years later to bed + nodes, per scans. On/off ADT (varying) throughout. Current PSA <0.02 on one Xtandi/day 5 days/week, plus Avodart, metformin, atorvastatin. Planning to continue to taper Xtandi dose to zero. serum T = 535 ng/dl.

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