Post-surgical outcomes of a cohort of very low-risk patients


The LAPPRO cohort study is a Swedish trial, started in 2008, and designed to explore the differences in outcomes of men treated by robot-assisted laparoscopic prostatectomy (RALP) as opposed to open radical prostatectomy (ORP).

New data just reported by Carlsson et al. in BJU International has provided insights into the outcomes after radical surgery of a subset of men enrolled into the LAPPRO cohort who also met criteria for very low-risk prostate cancer. This subset of men elected to have surgery as their first-line treatment even though they were good candidates for active surveillance. Specifically, Carlsson et al. looked at data on the oncological and functional outcomes of these patients at 12 months post-treatment. However, these outcomes are not broken down (at least in the study abstract) by type of surgery.

The LAPPRO study enrolled a total of 4,003 men at 14 different Swedish treatment centers. Validated patient questionnaires were collected from all patients at baseline and after 12 months by independent healthcare researchers. Biochemical recurrence was defined by a PSA level ≥ 0.25 ng/ml or treatment with salvage radiotherapy or treatment with any form of androgen deprivation. Urinary continence was defined as “less than one pad changed per 24 hour”. Erectile function was defined as “erection hard enough for penetration more than half of the time after sexual stimulation”.

Here is a summary of the study findings:

  • 338/4,003 men in the LAPPRO cohort met preoperative Swedish criteria for very low-risk prostate cancer.
  • Adverse post-surgical oncologic outcomes included the following:
    • 115/333 patients (34.5 percent) exhibited either upstaging (i.e., pathological evidence of pT3 disease) or upgrading (pathological evidence of a Gleason score of ≥ 7).
    • 54/329 patients (16.4 percent) exhibited at least one positive surgical margin.
    • 7/329 men (2.1 percent) had a PSA level > 0.1 ng/ml at 6 to 12 weeks post-surgery.
  • 98/222 patients (44.1 percent) had adequate erectile function (as defined above) at 12 months post-surgery.
  • 264/315 patients (84 percent) had good urinary continence (as defined above) at 12 months post-surgery.
  • 84/221 patients (38 percent) had an acceptable “trifecta” outcome (preoperatively potent and continent men that remained potent and continent with no biochemical recurrence at 12 months).

Frankly, in our opinion, it is very difficult to know what to make of these data from a group of very low-risk men followed for only 1 year after radical surgery. The authors conclude that:

  • Favorable oncological outcomes occurred in about two-thirds of the patients.
  • Roughly 40 percent of the patients “did not suffer” from surgically induced urinary incontinence or erectile dysfunction.

They go on to state that:

These results provide additional support for the use of active surveillance in men with very low risk prostate cancer, however the group of men with risk of upgrading and upstaging is not negligible. Improved stratification is still an urgently needed.

However, what we don’t know really is critical.

  • Were these 338 patients much younger than the average patient in the LAPPRO cohort?
  • Does their age or some other factor help to justify why they were given surgery as opposed to active surveillance? In other words, is selection bias at play here in some way?

It is well understood that a percentage of men who are good candidates for active surveillance will turn out to have adverse pathological findings if they actually have surgery, but the finding of 34.5 percent being upgraded or upstaged in this study seems high for a set of men with very low-risk prostate cancer.

We don’t understand how the data from this study “provide additional support for the use of active surveillance in men with very low risk prostate cancer”. We do note that 72 percent of these men did not meet the trifecta criteria for a good outcome, so we suppose that is what the authors may be implying. One the other hand, we certainly agree with the authors that we need to find better ways to accurately identify the subset of men who present with apparently very low- or low-risk prostate cancer who may, in fact, not really have such low-risk forms of the disease. Such men can then either be monitored with great attention to their risk level or they can be offered treatment prior to any significant risk for disease progression.

Active surveillance as a first-line management tool for low- and very low-risk prostate cancer is not a treatment. It is a way to defer unnecessary treatment until it actually becomes necessary. For some patients, it may be possible to defer treatment for ever. For others it may only be appropriate to defer treatment for 12 to 24 months. What this study does not tell us is anything about how many of these 338 patients would have done just as well if they had not been treated immediately. We have no doubt that at least some of these patients got immediate treatment because they asked for it. But how many of them got immediate treatment because there may have been other indicators of risk?

 

One Response

  1. Mike,

    Sounds like they are not diagnosing the men in this cohort early enough. Could it be the low use of PSA testing in Sweden? But then, the experts know best …

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