AS success does not equal long term G6 indolence

Here is a a recently published European study of the long-term safety of AS.
www.europeanurology.com/article/S0302-2838(16)30026-4/abstract/long-term-results-of-active-surveillance-in-the-goteborg-randomized-population-based-prostate-cancer-screening-trial
The 10-yr and 15-yr treatment-free survival was 47% and 34%, respectively. The hazard ratio for the treatment for low- and intermediate-risk PCa, compared with very low risk, was 1.4 and 1.6 .
Conclusion by the study:
AS is safe for men with very low-risk PCa, but for men with low- and intermediate-risk PCa, AS carries a risk of missing the possibility of being able to cure the cancer. It is questionable whether men who are not in the lowest tumor risk group and who have a long remaining life expectancy are suitable candidates for this strategy.

JackH said...

John T said...
I don't know where the 28% mortality rate came from, but his data shows 1.5% mortality at 15 years, the same as low risk patients treated immediately.

JohnT, the referenced data is not relevant to this conversation. Dan0 mentioned, in another thread, a study by Popiolek about Watchful Waiting (importantly, something very different than Active Surveillance), and that the PC mortality there was 11% at 15 years and 28% at 20 years. Klotz mentions this study in some of his publications and highlights that men on WW are not offered delayed definitive interventions. Klotz emphasizes that the differences in WW and AS fully explain these deltas.

Hi JackH,
I said I was going back to lurking but feel the need to respond since I clearly did not make my main point. The data from Popiolek, mentioned also in my first post in this thread, is perhaps the most relevant thing I have said. That statistic illustrates the potential long term (15+ years) outcome of untreated, low risk PC. This is not about the efficiasy of Active Surveillance, it never was.

Be well.

HopingForTheBestinNJ recently asked about the differences in "Watchful Waiting" and "Active Surveillance." I pointed him to the "Newly diagnosed..." sticky thread.

There was also a recent (2 weeks ago) article at the PC Infolink site discussing (and defining) the differences. The article discussed the more broad term "expectant management" which does indeed encompass both of the more narrow terms. See here: /prostatecancerinfolink.net/2016/04/05/the-value-in-personalization-of-expectant-management-strategies/

An interesting quote in that article highlights the vast differences in the Klotz and Johns Hopkins AS studies, and specifically the "AS" data from the Göteborg study. The PC Infolink quote reads:

"Outcomes from [programs at Johns Hopkins, Göteborg, and Sunnybrook] help illustrate the reality that the outcomes of [active surveillance] reflect a complex interaction of cancer risk, surveillance approach, and overall patient health."

In a different PC Infolink article from a year ago, the specifics of the issue in referring to the Göteborg study as an "AS" study was spelled out more clearly and in detail:

"This paper looked at the outcomes of patients whose cancers were initially monitored (as opposed to immediately treated) after diagnosis as part of the Göteborg cohort in the European Randomized Screening for Prostate Cancer (ERSPC) trial. While these patients are referred to as “active surveillance” patients in the report, Dr. Matt Cooperberg of UCSF correctly observes that this is a somewhat misleading characterization of this group of patients:


• The Gotebörg study had no strict active surveillance protocol.
  
• Few if any patients would have received a repeat biopsy within 12 months of diagnosis to confirm their initial biopsy results.
  
• At the time of progression, at least some patients do not appear to have been offered (or maybe they refused) curative or palliative therapy (and may well have had incurable disease).
  
  Arguably, none of the patients in the Gotebörg study were ever on active surveillance at all, because what they were actually being managed by seems more like watchful waiting than active surveillance."

The Gotebörg study probably should not be compared, without these clarifications, to the Klotz (Sunnybrook) or Johns Hopkins AS data.

Post Edited (JackH) : 4/18/2016 4:19:26 PM (GMT-6)

Bozolidat said...
Is this thread horizontally elongated for anyone else??….or is it an omen specifically for me? Its kinda cool and I get to use swipes like the Magus does when performing a trick..quantum physics is so cool..

Just you, Boz. Or at least not me. You be special!

Macpro lap.. the only thread thats doing it.. no biggie… I do appreciate both your responses..

I read the extract from the Goteborg study, and wanted to copy and paste some parts of it, but I only have my iPhone with me, and that webpage is protected.

Anyway, both the selection criteria, monitoring protocols, and conclusions were very different from what has been recently published by Johns Hopkins regarding their program with more than twice as many men enrolled and followed over the same time period.

But, we will all pick and choose to interpret data in different lights. I had an exchange last year with the moderator of another forum about how much certainty you needed to trust choosing AS. I cited a data point claiming the new MRI's are detecting >=97 percent for areas suspicious for PCa. He responded that anything under 100 percent certainty of indolence would cause him to choose surgery. I respect him, but his mindset and mine are never going to converge. That's life. Let's enjoy it. Lhasa, Tibet is outside my window.

Paul65 said...
I'll take 1,3,5,10 years of no SE's and when Ballentine Carter looks me in the eye and says "Dude, it's time"... then act decisively.

Very solid.

ASAdvocate said...
Paul65, Did Dr. Carter or one of his assistants enroll you in JH's AS program?

That would interest me, as he recently wrote:

"Surveillance would be the preferred option for these (very low risk) men) if life expectancy is less than 20 years, which would include most men over age 65 years."

So, your being part of the study at 50 is intriguing. What were you advised for your expectations?

BTW, best wishes to you for a long period of indolence and enjoying life:

My work-up was initially with Dr Schaeffer but when he (thankfully) moved to Northwestern Dr Carter took me on as his patient. He and I had the diagnosis discussion face to face and he signed me up for AS. I missed a couple of criteria - age (too young) and PSA Density (too nasty), but that was based on a rollercoaster PSA. His conclusion was "can't trust that".

I think he saw that I was a million miles from considering surgery, he looked at me, my wife and concluded "we gotta watch this one closely and see what shakes out". Which is a testament to the fact that one size does not fit all and he is fine and keenly intuitive Doctor.

That's what I'm working on anyway. Expectations-wise it was simple... we watch and wait for the needle to twitch. 6 monthly PSA, 12 monthly mpMRI, biopsy if his eyebrow goes up.

Frankly if he said "you can have 20 years of no side effects and drop dead at 70, or 30 years of side effects and drop dead at 80... I'd likely take the former and enjoy every minute of it.

ASAdvocate said...
Paul 65, Good stuff. Great advice and outlook. I see Dr. Ross, who works closely with Dr. Carter. A great team to be with.

Yep, I'm following your tracks dude... for as long as I can!

I kinda got lucky, when Schaeffer left I got to take my pick.

This speculative comment is probably not correct...

Gemlin said...
The best possible results in terms of side effects is lost if one deselect treatment early.

Dr Ian Thompson (who treats PC for many members here at HW/PC) probably had the best comment to address this point:

"If you have a choice of a dollar today or a dollar 10 years from now, take the dollar today. But if you have a choice of a curative treatment for prostate cancer today or a curative treatment for prostate cancer 10 years from now, choose it 10 years from now.

In a posting several days ago (4/18/2016) above, I was critical of the “Göteborg study” and challenged it’s inclusion by HW/PC member Gemlin in the category of being an “Active Surveillance study.” For the various reasons I listed, it should NOT be considered on the same plane as the Klotz/Sunnybrook studies or the Johns Hopkins studies. The Göteborg study is so poorly executed that it is really closer to a study on Watchful Waiting than AS.

The main failure of the Göteborg study was that they did not adhere to the fundamentals of Active Surveillance…specifically AS Fundamental #3, which I will copy/paste here:

AS FUNDAMENTAL #3: Some men who originally qualify for AS end up moving onward at a later date to a deferred treatment if signs indicate degradation in case characteristics. These men with deferred treatment are also “AS success stories!” (Please study and understand this PC Infolink article if you are confused by that statement: prostatecancerinfolink.net/2010/10/19/understanding-your-clinicians-mindset-about-active-surveillance/) The program worked for them, too, by showing them if and when treatment was appropriate. Complementary research has demonstrated that men on AS who move to deferred treatments have essentially the same outcome as those who sought immediate treatment.

Despite that shortcoming, there IS good data being extracted from the Göteborg study which CAN be useful for the continually expanding base of data about AS cases.

An article published today at the PC Infolink site about the Göteborg study, titled Active surveillance studies can have highly informative results—even when poorly executed!.

Good reading, if you are interested in expanding your knowledge of AS:
https://prostatecancerinfolink.net/2016/04/22/active-surveillance-studies-can-have-highly-informative-results-even-when-poorly-executed/

Platy said...
Another advantage of deferring treatment is the possibility of holding out for less invasive future options as they come on line, e.g. thermal ablation.

Excellent point, Platy. Surgery and radiation treatment options today are far different than 10 or 15 years ago. Who knows? In 10 years, a vaccine pill or an injection of our own genetically-modified cells may be the choices. If we can buy time, we allow for more possibilities. Those new options could offer greater cure rates with less (or no) side effects. That is our greatest hope.