For all the talk of overtreatment, what are your suggestions to curb it? Part 1

TC-LasVegas said...
Ralph,
We'll have to see what effects there are and hopefully with all the murmur about the USPSTF noise the last few years more focus on better testing will deliver better results. We're never going to see the "baseline at 40" results because that was in place just three years and it lacked enough science to support it. Before the USPSTF debacle we saw the 50/45 screening rules for 12 years and I think the new guidelines are no worse than that old and crusty guidelines that resulted in the USPSTF debacle. Beside you know as well as I do that the call to bring every man in at age 40 for a baseline was never likely to hit more than 10% of the 40yo population. We can improve education for men in their 30's but still if they ain't sick they likely ain't coming in to the doctors office! We start doing that as we get older than 40. Some guys will do it, but not a lot of young guys feel the need.

Tony

Tony,
The work by Vickers/Lilja on baseline PSA can be easily instituted as a men's health project and it will definitely reduce overdiagnosis and consequently overtreatment. It is one more men's health issue being ignored...

The movement to do more selective screening is equally strong in BCa. The reasons mentioned to reduce screening are all the same as with PCa, but women's health organizations have done a superb job in preventing being "railroaded" into submission when important research data such as the true number of diagnosis has been misreported and used to control screening.

RalphV

My sense is....if there was more literature comparing G7-G10 cancers with treatment vs. no treatment, there would be a significant benefit to treat. Too many studies have a large samples of G6 patients that skew the results away from treatment.

paul

Ralph,
You are one of the most respected advocate voices that has ever lived. The only real difference between you and I is that I see that data that contradicts the benefits in the advocate position to screen every asymptomatic man alive starting at age 40, 35 when high risk exists to get a baseline PSA. The plan on the surface is one that says we can save more lives but it totally neglects it's dark side. Some even write off that over treatment is only a minor issue.

Well is every man screened has a saved life the we screen 750,000-1,000,000 men per every year. We don't save that menu lives. Is the ERSPC data has the number of saves lives between 7,500 and 10,000. 200,000 men per year are treated for life saving benefit. So I don't think we are talking about an 8% over treatment number as that Austrian study attempts to paint.

We diagnose 250,000 men per year and every man diagnosed was saved then after you take 30,000 men off that list because they die over time annually and we treat 90% of patients diagnosed that too arrives at 200,000 men treated but not saved.

If we do what the USPSTF says to do then the PCSM would probably rise to 50,000 per year using your 40% reduction statistic (40% off the 50,000 is 30,000 and that's where we are). The institutions are not saying that the number saved is 200,000. They're saying that 120,000 men are reasonably treated knowing full well that 90,000 still won't die from the disease annually. The rest are ODOT ranging from 100,000 to 130,000 depending on which position you side with.

While it is true that the women's advocacy has done a better job at getting the industry to ignore the USPSTF and continue with aggressive mass screening, it's important to note that the women have better tools than the men do when it comes to screening. They also have higher odds of mortality due to breast cancer as well. But they too face a changing horizon as a result of newer data and I understand that new screening guidelines from their doctors are headed their way from the medical industry.

Stay tuned for that. My understanding it might be from Chicago this weekend.

Until we have better testing like the ladies do, in order to save as many lives as is possible, we have to trust all doctors will exercise restraint and every patient will understand this very complicated matter. That proposal puts 67.5 million men over the age of 40 at risk to morbid therapy and behavior.

Tony

Thanks for the perspective, TA. That's also the reason I put the word "proven" in there, and you picked right up on it. That's the distinct sense I get when I talk to my doctor, too (whose name appears on a number of the AUA documents). They're kind of professorial about the "level of proof".

As an engineer, there is a practice of accepting lower confidence levels if there are other corroborating factors. In other words, if the results are trending the expected direction based on solid theory, we'll accept confirming test results at lower confidence levels so we can move forward. 89% vs 95% confidence would never stop us from implementing a design change, for example. We're all about "close enough"!

At the same time, for it to take 12 years to *begin* to show a difference is rather amazing. I'll be living with likely significant side effects for a really long time, for a benefit that may begin to show after 12 years or more in somewhat extended overall survival. Of course, 12+ years from now an extra couple years of survival (hypothetically at least) then will be totally worth it!

Tony - My wife just read that they are recommending every other year on mammagrams.  Is that your understanding?  She was a bit surprised, especially now that her mother has breast cancer.

Southern Comfort,

I was addressing the issue of treatment vs no treatment for high risk men (see my revised statement above.

The study you cited deals with Radiation+ADT vs Radiation alone, which is a different issue.
BTW, the radiation dose they used in that study (70 Gy) is now considered inadequate, so that research is outdated. Retrospective studies have given conflicting results, so this is very much in question. For example:

Retrospective Evaluation Reveals That Long-term Androgen Deprivation Therapy Improves Cause-Specific and Overall Survival in the Setting of Dose-Escalated Radiation for High-Risk Prostate Cancer.

Lack of Benefit for the Addition of Androgen Deprivation Therapy to Dose-Escalated Radiotherapy in the Treatment of Intermediate- and High-Risk Prostate Cancer

We await the results of prospective studies to clarify whether ADT is beneficial along with dose-escalated radiation. The timing and length of ADT co-treatment are at issue too. It so far seems that ADT is of no benefit when used with hypofractionated radiation (HDR brachy or SBRT).

- Allen

Where are the studies that can point the way to some treatment guidelines? For example, for men who went on AS, what were their stats prior and what happened to them over the next 15 years? In other words, relative to their numbers, how likely were they to eventually "need" treatment and then how likely were they to get any PC-specific benefit from it? I guess PIVOT was supposed to have demonstrated no benefit for any treatment to anybody, so if that holds up the guidelines would be real simple: no treatment, period. Now, what about the advanced cases, of which there will certainly be more following the new guidelines? Any information on what, if anything, treatment has accomplished for the various stages of that? Has it extended life, and if so, how much on average? What's the cost in terms of money and QOL? Although it would have no scientific value, I would love to see a long questionnaire presenting all variables of treatment, results, side effects, etc., sent to every urologist with more than 15 years experience to find out how they feel about all this from what they've been through. After all, they're the ones that have done the "experimenting," as it seems to come down to, on their patients all this time. What's their intuitive feeling about benefits and costs?

Post Edited (Phenom) : 5/27/2013 5:18:38 PM (GMT-6)

Phenom,
Be very careful about reading study data. The PIVOT trial did not show no benefit, it showed the best benefits are in high risk men to be early in therapy.

It showed and I quote "Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter" but it had no benefit for men with lower PSA's and G sums. Thus the argument for RP versus observation in low risk patients from 1994 to 2002 is very weak.

That is a benefit for high risk men and a statically insignificant benefit in low risk men.

Now those guys were treated as long as 19 years ago. What it lacks is stratifications for low risk Age 40 baseline tested men. We have zero data there yet the advocacies, and briefly the AUA, were pushing hard for that to be a standard that exposed every 40yo man to ODOT without scientific proof that it would do anything at all to curb ODOT or provide life saving benefits.

Tony

So are we at a point where we can say, generally, who are the most likely to make up the million and a half overtreated? All G6s? G7s with lower PSAs? All lower PSAs? Low core counts? low core volumes? location of cores? Can we start to put together some guidelines that might at least serve as a warning to those diagnosed with PC that they could very well fall into this vast cohort of patients not likely to get any benefit from treatment? In other words, that they might be "at risk" of overtreatment?

Phenom.
I'll start your list and I'm aware there will be some disagreement.

1. All men in the "very low risk category" should be treated only when progression has been identified either through a repeat biopsy, scan, or rising PSA.
2. "Low risk" men over 65 with a G6 and a PSA less than 10.
3. Anyone with a life expectancy < 5 years.

I think these are pretty safe criteria that most would agree on and that statistics support. Once we get beyond this there will be a lot of disagreements and the data is much more sketchy.

TC-LasVegas said...
Phenom,
Be very careful about reading study data. The PIVOT trial did not show no benefit, it showed the best benefits are in high risk men to be early in therapy.

It showed and I quote "Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter" but it had no benefit for men with lower PSA's and G sums. Thus the argument for RP versus observation in low risk patients from 1994 to 2002 is very weak.

That is a benefit for high risk men and a statically insignificant benefit in low risk men.

Now those guys were treated as long as 19 years ago. What it lacks is stratifications for low risk Age 40 baseline tested men. We have zero data there yet the advocacies, and briefly the AUA, were pushing hard for that to be a standard that exposed every 40yo man to ODOT without scientific proof that it would do anything at all to curb ODOT or provide life saving benefits.

Tony

Wasn't the Pivot study severely lacking when it came to young guys, number of participants and type of participant? That's what I've read online about it.

BTW,
Davidg are you in the Tuscany region yet? I just suffered through the best Italian Tuscan food today and lost my old heritage!


Tony

Well you take care an get rest. You've got a tough road here and my thoughts and prayers are with you all the way...

But I am a bit jealous about your restaurant choices. But not today. I tuscaned out my Italian side with my wife...



Tony