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Old 06-13-2009, 04:42 PM   #1
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Thumbs up Effectively preserving curative options - Active Surveillance for Prostate Cancer

Active Surveillance (AS) is growing in popularity among men with truly low-risk prostate cancer, but a recent article from Johns Hopkins suggests that only about 10% of eligible men take this approach. One likely reason is that many men still seem very concerned that their prostate cancers may jump from low-risk to higher risk suddenly and without much warning, despite research to the contrary!

Well aware of this concern, and no doubt wanting to check the facts for themselves, some of the major AS programs are carefully checking and publishing their results for the minority of their AS patients for whom their diligent monitoring reveals a need for radiation, surgery or other such major therapy to attempt to cure the cancer. The programs want to confirm their expectations that their AS patients will do about as well as their patients with similar truly low-risk cases who decide to have immediate therapy.

(These major centers, as I understand it as a layman, include at least the U. of Toronto - Sunnybrook (Dr. Laurence Klotz and others), Johns Hopkins (Drs. H. Ballentine Carter, Patrick Walsh, Jonathan Epstein and others), Memorial Sloan Kettering (Dr. Peter Scardino and others), Erasmus Medical Center (Netherlands, Dr. Fritz Schröder and others), MD Anderson (Dr. Babaian and others), and the University of California at San Francisco (Dr. Peter Carroll and others).

I thought this thread would be a good place to describe and discuss the research that is being published, including questions and doubts.

To lead off, here's one important study from Johns Hopkins, including comments from a 2005 talk by the renowned leader of the Johns Hopkins AS program, Dr. H. Ballentine Carter; renowned pathologist Jonathan Epstein, MD is the co-leader, as I understand it. (Here's the citation for the study: J Natl Cancer Inst.2006 Mar 1;98(5):355-7. Delayed versus immediate surgical intervention and prostate cancer outcome. Warlick C, Trock BJ, Landis P, Epstein JL, Carter HB. PubMed, at www.pubmed.gov, a site we can use on this board because it is Government sponsored, has a free link to the complete study.

They looked at 38 patients in their AS program who underwent surgery at an average of 27 months after diagnosis and compared them with 150 similar patients who had surgery within an average of 3 months after diagnosis. After reading the complete paper on June 14 after posting this, I would like to add that the groups compared looked highly comparable to me, as asserted in the study. The only difference that caught my attention was the maximum percent of cancer in a core: an average (mean) of 10.8% in the AS group versus 23.5% in the immediate surgery group. However, both percentages are fairly low, and in their analysis the authors found that these figures were not associated with the risk of incurable cancer; I'm thinking that men with substantially higher core percentages that were looked at in this study could be at higher risk of noncurable cancer.

What they were comparing was the number in each group estimated to have "noncurable cancer," which they defined as pathology characteristics that indicated a less than 75% chance of remaining disease-free for 10 years after surgery. As observed below, it appears that almost all of these surgeries were due to progression but that a few were elective. While "noncurable" cancer was determined in 23% (9 of 38) of the minority of AS patients who had surgery versus only 16% (24 of 150) in the comparison group that had more or less immediate surgery, after making adjustments to better match for age and PSA density, the Johns Hopkins researchers found strong statistical evidence that the risk of non-curable cancer was not different between the two groups. They concluded: "Thus, delayed prostate cancer surgery for patients with small, lower-grade prostate cancers does not appear to compromise curability."

Here's some more information about the Johns Hopkins AS program, which they refer to as "Expectant Management of Prostate Cancer," from a talk by Dr. H. Ballentine Carter at the National Conference on Prostate Cancer 2005 in Washington, DC. Their standards for eligibility - how they identify truly low risk disease - include, on the favorable, small-volume side, a PSA density of less than .1 (meaning the PSA divided by the volume of the prostate determined by ultrasound), and only 1 or 2 cores with cancer (probably out of 12 to 14 cores, based on other information), and less than ("not more than" in another publication) 50% of any core with cancer, and no high grade disease, meaning Gleason Score 7 or higher, and (not from the paper but published by Johns Hopkins elsewhere) stage T1c (can't be felt on DRE) as well as a free PSA percentage of consistently greater than 15 and a preference for older age men in their 60s, or men with other health problems that make active treatment less attractive.

On the flip side, considering unfavorable, not-small volume cancer, indicators included a PSA density of 0.1 or greater, or 3 cores or more with cancer, probably based on 12 to 14 cores based on other information, or 50% or more of any one core with cancer, or any high grade cancer (Gleason Score 7 or higher).

As of June 2005 talk to us, the Johns Hopkins program included 253 men. The program had been started in 1995, with confirmational biopsies to reduce the risk of undetected cancer started in 1998, and in its eleventh year in 2005 the program had more than 1 year of follow-up on 220 (87%) of the 253 men. The average age of men in the program was 65 years. Men with suspected small volume cancer as described above counted 178, and there were 42 men who classed in a group described as "comorbidity or other), indicating to me that they were somewhat higher in risk but with a life expectancy short enough that AS was deemed a reasonable option. The Johns Hopkins AS monitoring approach features PSAs and DREs every six months, with biopsies annually (with 12 to 14 core area-sampling biopsies recommended). (Note that at least one other major AS program, Toronto, does biopsies on all patients only for the first two years - baseline plus two years, with later biopsies based on judgment, by my recollection.) The program recommends curative treatment if there is "progression" of the cancer, defined as more than two positive cores found in a follow-up annual biopsy, or cancer involvement of 50% or more of any one biopsy core, or a Gleason Score of 7 or higher, or a change in the DRE. I suspect a suspiciously rising PSA would also trigger concern, but Johns Hopkins does not rely on that.

As of the 2005 talk, 213 confirmation biopsies revealed 31% unfavorable cancers (65 men), an equal percent and number revealed cancer with favorable characteristics (31%, 65 men), and 38% (83 men) resulted in no cancer found in follow-up biopsies (though it had, of course, been found in the initial biopsy). That means that 69% of patients remained eligible to stay in the AS program, consisting of the 31% with favorable follow-up but cancerous biopsies plus the 38% with no cancer found in subsequent biopsies. All of the work, I believe, was done at Johns Hopkins, known for its excellence in prostate cancer.

Let's look at the men whose follow-up biopsies were unfavorable. Regarding these 65 men, 48 (74% of 65) had Gleason Score 6 cancer found, which would be considered favorable except that the cancer was more extensive than originally found, 14 (22% of 65) were found to have Gleason Score 7 cancer, and only 3 (4%) were found to have Gleason Score 8 cancer. Thus, while the follow-up suggested a need for treatment, it would be quite unlikely for the cancer to turn out to be Gleason Score 7, and even far less likely for it to turn out to be Gleason Score 8. We should also keep in mind, in my view, that some of these higher risk cancers probably existed at the time of the original biopsy but were simply missed; that's significant, because it means that not all "unfavorable" cancers had turned unfavorable during AS: they were that way from the start. Dr. Carter also provided a chart showing that confirmation biopsies were very effective in reducing the risk of future unfavorable biopsy findings, with a miniscule percentage of unfavorable biopsies by the third biopsy, the first two having pretty much weeded out any detectable "unfavorable" cancer.

In another Johns Hopkins publication in 2005 to inform those interested in AS about the follow-up biopsies, they said this about their biopsy results:
- 12% of men whose first follow-up biopsy showed no cancer eventually experienced cancer progression, contrasted with just 5% of men whose first and second follow-up biopsies showed no cancer. That means you are entitled at least to a small celebration if that second follow-up biopsy is negative: you have a 95% chance that your cancer will not progress.
- 29% of men whose first follow-up biopsy showed cancer that was favorable eventually experienced cancer progression (flipping it, 71% did not progress!), while 22% of men eventually had the cancer progress despite showing only cancer that was favorable on both the first and second follow-up.
From these numbers, it's easy to see the importance of follow-up biopsies, not only to check for progression, but to get a handle of the likelihood of progression later on.

He also showed a chart with the percentages of men with non-curable disease by their years in the Johns Hopkins AS program, through the 7th year. A very encouraging finding was that the percentage with non-curable disease does not increase as men stay in the program.

He showed a chart in this talk that showed where all 220 men of the total of 253 in the AS program were who had at least one year of follow-up:

- 50% (109 men) then still active in the program with an average follow-up of 2.7 years;
- 7% (17 men) who decided to have treatment, despite having no cancer progression, after an average of 2.7 years in the program, 4 of them choosing RRPs (surgery) and 13 of them choosing radiation);
- 35% (77 men) experiencing cancer progression as caught in the diligent monitoring program, at an average follow-up time in the program of 2.7 years (26 men had RRPs, 32 had radiation, 7 were just watchfully waiting, and 12 were undecided);
- 2% (4 men) died from something other than prostate cancers (clear winners in one sense - lived their lives without any burden from prostate cancer treatment); and
- 6% (14 men) were lost to follow-up or withdrew from the program.
- ? (1 man) more than the 220, as the above numbers total 221 - I don't know why. I'm basing this on the printed slides for Dr. Carter's talk.

A thought - while the average follow-up figures are short, 2.7 years for example, quite a few men have much longer follow-up since the programs beginning in 1995. That enables the researchers to give longer term projections with confidence.

One of Dr. Carter's final slides from his 2005 talk gives us another cut at the curability comparison for those who choose AS instead of immediate treatment: 76% curability for men who got surgical treatment after having been in the AS program, versus 80% curability for all men treated surgically at Johns Hopkins who could have met all eligibility requirements for the AS program. Considering that the AS program has been improving, such as by adding follow-up biopsies in 1998, those numbers strongly suggest equivalence to me (and to Dr. Carter). (Here are the details for these percentages: for AS - of 94 men in the AS program who were treated - 77 with progression plus 17 who elected treatment, 30 were treated surgically - 26 after progression and 4 after deciding to have surgery, and curability was deemed 76%; for 11,600 men treated surgically at Johns Hopkins since 1983, 691 had T1 disease and otherwise would have qualified for the AS program, and 80% were deemed curable.)

Note that we are taking two looks at somewhat different times at the same AS program here. In the published 2006 paper, there are 38 patients from the AS program who had surgery, versus 30 in the 2005 talk. I'm thinking the difference is due to passage of time from the date of the statistics in the 2005 talk to the date of the 2006 paper. I'm not sure why there were 150 "similar" comparison patients in the paper versus 691 "T1c disease patients [who] met all criteria for expectant management.

In its information for AS patients Johns Hopkins addresses dietary changes but is tentative. Here are a couple of key lines. "The bottom line is that there is an association between intake of animal fat and the incidence of prostate cancer, and that fruits and vegetables can reduce the risk of many cancers. Thus, a diet that is mostly made up of food from plant sources (fruits, vegetables, soy) and that limits the intake of high fat foods makes sense for now." They also mention various vitamins. As of the 2005 document I have, their AS program did not mention the wisdom of taking a statin drug and either finasteride or Avodart.

As the Johns Hopkins AS "Expectant Management" program puts it in information for patients, "... Recent studies suggest that 30-50% of men over the age of 60 years diagnosed with prostate cancer today by PSA screening would never have known they had prostate cancer during their life if a prostate biopsy had not been performed. For these men, the news that they have prostate cancer will not be beneficial and their treatment will not add years to life.... The key is to be able to identify those older men who for now can safely forego treatment." The Johns Hopkins publication added this: "Thus, it would appear that when men are carefully selected for expectant management [meaning Active Surveillance], the window of opportunity for cure is unlikely to close with monitoring."

There's more published information about the AS program at Johns Hopkins and curability, but this is enough for now.

Take care,

Jim

Last edited by IADT3since2000; 06-14-2009 at 02:27 PM. Reason: Brief added information after reading complete paper by Warlick ..., Carter. No change to main points of post.

 
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Old 06-13-2009, 10:02 PM   #2
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Thanks Jim for the informatiion.

Vegasduffer

 
Old 06-14-2009, 02:33 PM   #3
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Quote:
Originally Posted by vegasduffer View Post
Thanks Jim for the informatiion.

Vegasduffer
Hi Vegasduffer and welcome to the board! You're welcome! I've read your previous posts, and it's great to have someone pursuing Active Surveillance who is actively posting. I've been very interested in AS, but it's not my own therapy (I wish!), and it really helps to have survivors sharing their first hand experiences.

Good luck on finding the cause of that rise in PSA; I too have a strong hunch, as a layman, that infection is the cause. Hope that's the case.

Take care,

Jim

 
Old 06-15-2009, 10:10 AM   #4
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Hi Jim:
Very comprehensive summary of the J.H. data and advocasy of the A.S. option. As everyone knows I'm still the skeptic and non-believer having had the experience of having consulted H.B. Carter and hhaving Peter Scardino as my surgeon 8 years ago.
All of the statistics underlying their studies have little relevance to each individual since the decision whether to defer therapy or not is more directly related to the individual's temperment, level of anxiety, degree of risk averseness and biasses of the Dr's he's seen.
H.Ballentine Carter (and Patrick Walsh, his boss)were pushing "Expectant Management"
back in 2001 when there were very few studies and stats supporting it. This was in large part due to John Hopkins, actually Patrick Walsh;s desire to cherry pick their surgery candidates and avoid operating on men over 60 so as to publish the best outcome and impotence/incontinence statistics in the country. I have little doubt that their underlying agenda has changed.
H.Ballentine Carter told me personally when I came for a surgical consultation that I was a poor candidate for surgery due to my age (69) and should consider A.S. since I was a low risk case. When I refused he said I obviuosly wasn't a risk taker and probably wasn't investing heavily in the NASDAC (before the crash). He suggested I go elsewhere if I persisted in seeking a surgeon and I ended up at Sloan-Kettering with Peter Scardino who had no such qualms or concerns about cherry picking to minimize their side effect profile.
I know how sincerely you believe in the case for A.S. , but even with the latest evidence and with Johns Hopkins' H.B. Carter leading the charge and Scardino and others withdrawing their earlier reservations, I remain skeptical and continue to support aggressive therapy for younger healthy men when curative treatment is within reach as I see little to gain by postponing the inevitable for one or two years, current studies not withstanding.
Bob

Last edited by shs50; 06-15-2009 at 10:15 AM.

 
Old 06-15-2009, 01:10 PM   #5
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Quote:
Originally Posted by shs50 View Post
Hi Jim:
...I remain skeptical and continue to support aggressive therapy for younger healthy men when curative treatment is within reach...
Bob
I was under the impression that "younger healthy men" were generally not the target population for Active Surveillance...in other words, I'm confused by your statement, Bob, because I didn't think anyone was advocating AS for this segment. I suppose, however, that different people will define "young" differently and this may be the basis of this comment. I am NOT extremely well-versed in AS, but as I understand it in broader terms, all decisions to treat prostate cancer should be made with careful assessment of the clinical agressiveness of the cancer, plus their overall health and comorbitity (chance of dying of some other disease or disorder) which are both impacted by age and health.

While AS is no longer an option for me personally (nor did I consider it because of my relatively young age), I am interested in learning more about it so that I might better advise others on the broadest range of options in the future. This being said, it does appear that the medical community is gaining greater consensus on differentiating more clearly between treatment and overtreatment of PC patients. My understanding is that one goal of AS is to avoid un-necessary overtreatment. It's also my perception that AS is sometimes continues to be misunderstood as passively waiting for PC to overtake the patient...certainly not the case (thus the "A" in AS).

Comments?

Last edited by kcon; 06-15-2009 at 08:35 PM. Reason: added green text clarification

 
Old 06-15-2009, 10:31 PM   #6
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

In my case I am 65 and am in the early stage of PC. My view is 20 years ago my
PC would not have been detected as PSA was not being done. My life would have been
cancer free until the Doctor picked it up on a digital exam, which had a high probability
of not being detected for 10-15 years or even longer. I do not have a acute fear of
cancer, probably because I was in the Funeral Business until retiring and have been
exposed to worse deaths. My biggest fear is end up bedridden in a nursing home
for years slowly withering away.

If I can live another 15 years without having worrying about incontinence or loss
of sexual activity, I think it will be worth the risk. Of course when I reach 80, I could
change my mind.

Meanwhile a new treatment for PC will hopefully be found where surgery or radiation
will not be necessary.

I appreciate your opinions concerning AC, hopefully new members using AC will
participate.



Vegas Duffer

 
Old 06-16-2009, 07:39 AM   #7
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Good question KCon:
A.S. has been recommended for younger healthier men since the criteria used was chronological rather physiological age. I was 69 chronologically but closer to 55 physiologically at the time H. Ballentine Carter advised me that this was my best course of action with a low risk diagnosis.
I ski aggressively, play tennis regularly and have (had) no other health issues. My argument has always been that A.S. isn't an appropriate alternative for men with more than 10 years life expectancy and without co-morbidities that would preclude aggressive local treatment for Prostate Cancer.
Dr. Peter Scardino agreed with me on this. I believe his current position supporting A.S. as a reasonable option still is qualified by this criteria.
Age 70-75 should be the entry level age group for considering A.S. depending on the patient's overall state of health and vigor in that age group or older in my opinion. Regardless of J.H statistics it is still generally conceded that a low risk P.C. case can become aggressive or spread in a 6 month interval and the cancer may have been present for some time before diagnosis.
Bob
Bob

 
Old 06-16-2009, 09:42 AM   #8
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Quote:
Originally Posted by vegasduffer View Post
My biggest fear is end up bedridden in a nursing home for years slowly withering away.
Vegas Duffer,

If you don’t mind me saying, with re-assuring intent, that this is also probably not the outcome your medical advisor(s) have in mind either when advising you on an AS strategy.

It is probably quite natural, despite portrayed confidence, that we all probably harbor some unanswerable doubt about our own personal choice of treatment paths (“did I make the right decision for 10-, 20-years from now?”). But I suspect that your “biggest fear” may be a remnant of the misperception that AS means “passive waiting for PC to overtake the patient” (quoted from my post #5, below).

As long as you don’t go “in-Active” in your AS approach, then I envision your doctor has advised that you will be continually and “actively” monitoring whether cancer has turned acutely more aggressive, or not. If it has not, then you will likely continue to stay-the-course with ongoing “active” monitoring of the trends. You might be actively monitoring for the rest of your life.

On the other hand, if in a year, or 5-years, or 10-years, or 20-years the trend indicators change, then it might be time to re-assess all of your “updated” multi-dimensional personal circumstances of age, health, etc. and to look at the curative options that you have preserved. Depending on your new set of circumstances at that future date, the list of options may have been re-arranged. For example, in a year, the options would likely be the same. However, hypothetically, surgery might have dropped down the list and while hormone treatment might have risen for someone who “actively surveyed” their PC for 10 or 15 years. Every single set of individual circumstances is different, so blanket statements about any single personal dimension may or may not apply.

It seems that the key to AS success is the “active” part; staying continually on-top of regularly scheduled testing…don’t go “in-Active.”

This is how I envision a doc would convey an AS strategy to a patient like you. Is this (roughly) correct in your experience?

 
Old 06-16-2009, 02:18 PM   #9
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

I would agree that AC for anyone with my exact age and exact PC exposure should not be a blanket treatment. Everyone is different, I admit AC is a form of Russian Roulette.
not be a blanket treatment. To some people the Cancer word is a death sentence and they will do anything immediately to get rid of it.

My Doctor is young and if my situation become acute in the near future I will be going to the Surgeon who gave me the second opinion because of the number of robotic surgeries he has completed. My questions to both were direct, and my question was to the second surgeon was "If you were in my situation and had to have the surgery, would be have Dr. _________ do the surgery." His answer "no I would in a few years but right now he has not done enough using the robotics".

Getting back to your question about Doctor #1, I kinda new the program i felt was right for me after he told me the biopsy results. He reaffirmed my feelilngs and so did the second doctor, both feel new treatments are on the horizon.

Again I agree with all of you that no one program fits all and its important to keep ones mind open and do as much research as possible.

VegasDuffer

 
Old 06-16-2009, 04:27 PM   #10
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Quote:
Originally Posted by vegasduffer View Post
I

If I can live another 15 years without having worrying about incontinence or loss of sexual activity, I think it will be worth the risk.
Just wondered if you've checked on proton beam radiation- either for now or later-- likelihood of incontinence close to zero and most don't have a major impact re: sexual activity. If you haven't learned about it, you might want to read Robert Marckini's book, You Can Beat Prostate Cancer.

 
Old 06-17-2009, 04:42 PM   #11
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Thanks, I will look into it. I think the closest one is in California, I am in Oregon.
Will be researching it. What I have read is its expensive, does Medicare cover
most of it??

VegasDuffer

 
Old 06-17-2009, 05:04 PM   #12
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Quote:
Originally Posted by vegasduffer View Post
Thanks, I will look into it. I think the closest one is in California, I am in Oregon.
Will be researching it. What I have read is its expensive, does Medicare cover
most of it??
You are correct- Loma Linda has been using proton beam therapy since 1990, with over 10,000 patients treated. Improvements have been made over the years, with even more precise targeting and higher doses, safely administered. The Marckini book describes what happens at Loma Linda.

Medicare, as well as many private insurance companies, covers proton treatment. More info on that is also discussed in Marckini's book. There is often a backlog to get into the program, so if you do want to consider this, at least get on the schedule for a consultation. But reading the book should come first. I know that Univ of Florida Proton Therapy Institute in Jacksonville now provides a copy with its informational packet. Don't know if Loma Linda does too.

 
Old 12-02-2009, 08:08 PM   #13
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

This thread has already spotlighted the Active Surveillance (AS) work at Johns Hopkins, and there is a recently published paper updating that research, in line with the original idea behind the thread:

Quote:
Originally Posted by IADT3since2000 View Post
...

(These major centers, as I understand it as a layman, include at least the U. of Toronto - Sunnybrook (Dr. Laurence Klotz and others), Johns Hopkins (Drs. H. Ballentine Carter, Patrick Walsh, Jonathan Epstein and others), Memorial Sloan Kettering (Dr. Peter Scardino and others), Erasmus Medical Center (Netherlands, Dr. Fritz Schröder and others), MD Anderson (Dr. Babaian and others), and the University of California at San Francisco (Dr. Peter Carroll and others).

I thought this thread would be a good place to describe and discuss the research that is being published, including questions and doubts.

...
[COLOR="darkgreen"]Here's an update from perhaps the most mature of the AS programs, the one led by Dr. Laurence Klotz, MD, at the University of Toronto, Sunnybrook. This is the most recent paper (November 30)published on the program, but there have been many, many others, covering a great many facets of AS. I'll put the abstract of the paper in blue and make comments in green.

J Clin Oncol. 2009 Nov 30.
COLOR="DarkGreen"]With the great interest in this pioneering series, we will probably see updates almost every year. Each one will extend the average follow-up time for men who remain on AS in the program.


[Clinical Results of Long-Term Follow-Up of a Large, Active Surveillance Cohort With Localized Prostate Cancer.
Klotz L, Zhang L, Lam A, Nam R, Mamedov A, Loblaw A.

Divisions of Urology, Biostatistics, Epidemiology, and Clinical Epidemiology, Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

PURPOSE: We assessed the outcome of a watchful-waiting protocol with selective delayed intervention by using clinical prostate-specific antigen (PSA), or histologic progression as treatment indications for clinically localized prostate cancer.
Back at the start in late 1995, "watchful-waiting" (WW) was the term in use. But the concept in this program was already quite different from WW. The intent was to carefully select men who were thought to have a good chance to do well long-term without therapy, to then monitor them carefully to catch any aggressive disease early, and to do curative therapy at that time. As you can see from the title, the term Active Surveillance has gradually become the common term for this newer approach.

PATIENTS AND METHODS: This was a prospective, single-arm, cohort study. [That means that the researchers were collecting new data as they went along per their plan rather than looking backward at historical data; it also means that they were not comparing their approach to another approach ("arm") that would have been progressing at the same time.] Patients were managed with an initial expectant approach. That means they expected to intervene with therapy if the cancer was revealed as aggressive at any point.] Definitive intervention was offered to those patients with a PSA doubling time of less than 3 years, Gleason score progression (to 4 + 3 or greater), or unequivocal clinical progression. Survival analysis and Cox proportional hazard model were applied to the data. RESULTS: A total of 450 patients have been observed with active surveillance. [That's a lot of patients; this group is growing substantially larger as time goes on, which increases confidence in the results.] Median follow-up was 6.8 years (range, 1 to 13 years). Overall survival was 78.6%. [That means that about 20% of the group has died from all causes over the 13 years of the program up to the time the paper was drafted.] The 10-year prostate cancer actuarial survival was 97.2%. [That means the researchers are projecting the ten year figure rather than basing it on an actual average, but, with the size of the group and the nearly 7 years of average follow-up, that projection should be quite accurate. Overall, 30% of patients have been reclassified as higher risk and have been offered definitive therapy. [That means that the remainder, minus a few men who chose to leave the program and get therapy, were still in the program; the percentage is likely between 60% (as suggested by previous reports) and 70% (max), and that is with nearly 7 years of average follow-up - impressive! ]Of 117 patients treated radically, the PSA failure rate was 50%, which was 13% of the total cohort. [I'll put a comment on the 50% rate below; at first glance it looks disturbingly high, but on second glance I don't thik it is. That 13% failure rate for the entire group at nearly the 7 year follow-up point stands up well in comparison to failure rates for radical surgery and radiation on low-risk patients at around 7 years, even though around 70% of these patients have not been treated.] PSA doubling time of 3 years or less was associated with an 8.5-times higher risk of biochemical failure after definitive treatment compared with a doubling time of more than 3 year (P < .0001). [PSA doubling time will probably become an added clue in deciding whether a patient is a good prospect for AS. PSA velocity is similar and is already used in some programs.] The hazard ratio for nonprostate cancer to prostate cancer mortality was 18.6 at 10 years. [That's very important. It means that, these men - most of them untreated, were nearly 19 times more likely to die of something other than prostate cancer at ten years. If you viewed this group as gamblers, those who died overwhelming won their bet that it was better not to have treatment! ] CONCLUSION: We observed a low rate of prostate cancer mortality. Among the patients who were reclassified as higher risk and who were treated, PSA failure was relatively common. Other-cause mortality accounted for almost all of the deaths. Additional studies are warranted to improve the identification of patients who harbor more aggressive disease despite favorable clinical parameters at diagnosis.


Let's look again at this sentence: "Of 117 patients treated radically, the PSA failure rate was 50%, which was 13% of the total cohort." My first reaction was that 50% was high, especially at 7 year of follow-up. But then I realized that studies of treatments like surgery and radiation typically are in settings where virtually all patients coming in are treated. That means, I think, it's not right to focus just on the group that turned out to need treatment in the AS program; it's more realistic to look at that figure of 13% for the whole group, just as a study for, say, surgery, will look at the whole group. I think I'm seeing this right, but it's getting late.

I'm growing more impressed with the Klotz series of AS patients with each new annual report.

Jim

 
Old 12-02-2009, 08:52 PM   #14
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

I think you are correct, Jim, that the 13% failure rate of the total cohort is the correct number to compare…because the other roughly 70% in the cohort not treated radically have also not had a PSA failure.

Thanks for continuing to educate us all in this area.

 
Old 12-15-2009, 06:24 AM   #15
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Re: Effectively preserving curative options - Active Surveillance for Prostate Cancer

Quote:
Originally Posted by IADT3since2000 View Post
Let's look again at this sentence: "Of 117 patients treated radically, the PSA failure rate was 50%, which was 13% of the total cohort." My first reaction was that 50% was high, especially at 7 year of follow-up. But then I realized that studies of treatments like surgery and radiation typically are in settings where virtually all patients coming in are treated. That means, I think, it's not right to focus just on the group that turned out to need treatment in the AS program; it's more realistic to look at that figure of 13% for the whole group, just as a study for, say, surgery, will look at the whole group. I think I'm seeing this right, but it's getting late. Jim
I agree that for the overall AS group a 13% PSA failure rate is good. Considering the 117 patients who were treated, and who overall had a biochemical failure rate of 50%, it appears that many of them ended up in the high or intermediate risk category before treatment. If the goal of AS is to identify and treat only people who progress to high/intermediate risk out of the entire AS population, it seems to be working. If the goal of AS is to identify and treat people in a low-risk population before their risk gets high, perhaps it isn't working as well as hoped. From the standpoint of the 117 people who progressed, they may feel that they waited too long. Clearly the situation still cries out for better diagnostic methods for low versus high risk, but that was known all along.

I'm wondering how the risk for the 117 compares with the risk for people who are diagnosed with PC, make their own decisions through non-AS routes, and are treated. My feeling is that the non-AS risk is lower. Of course this includes many low-risk patients who may have received "too much" treatment.

 
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