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  • Pc conference 2011 highlight: Active surveillance (AS)

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    Old 09-30-2011, 02:25 PM   #1
    IADT3since2000
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    Cool Pc conference 2011 highlight: Active surveillance (AS)

    Active Surveillance (AS) - Dr. Klotz, a surgeon/researcher with a worldwide reputation from Toronto, Canada, gave a major presentation. He is generally regarded as the lead guru for Active Surveillance. I was once again impressed with the large proportion of patients on AS who experience long-term success, and I was also impressed with the extremely low mortality rate.

    I've learned that Dr. Laurence Klotz is a highly regarded surgeon practicing at the University of Toronto, Sunnybrook. He is also an amazingly prolific researcher with a wide range of interests in prostate cancer. I believe he is also the first physician to set up a program of AS, enrolling patients in the Toronto program as early as late 1995. He has published numerous articles on aspects of the program, including results that have been updated since 2003. Now we are seeing the fruits of that research with substantial periods of average (median) follow-up as well as longer-term "actuarial" projections that benefit from the experience of the earlier patients in the program who now have follow-up as long as sixteen years.

    I have been fortunate to see him present in person twice, and I have also spoken to him twice as a representative of prostate cancer survivors. As with some other presenters at this conference, I've come away knowing I have been in the presence of genius and dedication. One point he made at one of those earlier encounters was that active surveillance was suitable for appropriate patients at any age!

    Active Surveillance (AS) involves deferring major treatment of prostate cancer, hopefully forever, while diligently monitoring the cancer to make sure that a stealthy aggressive cancer does not harm the patient; if surveillance reveals that a cancer is really aggressive, then the patient is treated in a timely way. Unfortunately, the term "watchful waiting" (WW) is sometimes used synonymously with "active surveillance," but the two approaches are radically different: WW essentially involves deferring treatment until symptoms develop, which usually does not happen until the cancer is well advanced, a stage which precludes effective local therapy and which even greatly compromises systemic therapy, with current technology. In sharp contrast, AS requires diligent monitoring of the patient to ensure that he does not have a stealthy cancer that is aggressive; if he does, he gets timely and effective treatment.

    In the 1990s no one knew whether AS would work. No one knew whether a substantial proportion of patients would benefit. No one knew if patients would significantly increase their risk of side effects or death by deferring therapy. There were fears that "just one cancer cell could escape" and cause the patient to die. Based on his clinical experience, Dr. Klotz was among the first to feel that some patients had insignificant prostate cancer that would never be a threat to their well being or survival.

    Dr. Klotz said that in the mid-1990s he noticed a lack of consistency in treatment of low-risk prostate cancer, cancer in men, for example, in their sixties with Gleason 6 cancer in just 2 of 12 biopsy samples and a rising PSA. He estimated that 150,000 men in just the US and Canada fall into the AS eligible category, and I believe he was talking about patients newly diagnosed each year. That means a large proportion of newly diagnosed men are eligible for AS. As part of his introductory comments, he made the key observation that, even if active treatment gave such a man with low-risk prostate cancer additional life, it was often very little additional life and came at the expense of side effects that were typically burdensome such as incontentence and impotence. He also emphasized that he was not including men with any Gleason grade 4 cancer, stating there was a "world of difference" between Gleason grade 3 and grade 4 prostate cancer.

    The key question is impact on survival from chosing AS instead of treatment. Based on his experience, he said that he was projecting just 2 deaths out of 1,000, .2%, from AS at the 20 year point for patients diagnosed with Gleason 6 cancer at biopsy! Moreover, based on reanalysis of the cases of the few men who had died of PC, all had some true Gleason grade 4 disease in their biopsy samples! In other words, the rate of death for true Gleason score 6 and lower cancer was zero! (It's important to remember that the GS 6 and lower patients in the Toronto program also have several other key case characteristics; his comment would not apply to any GS 6 patient without those other characteristics.)

    He included a slide with statistics of success from seven different AS programs. I hope someone will comment on that slide, but I haven't had a chance to review it. I recall that it showed remarkably consistent success of AS across different major programs. The average success for patients staying on AS in all programs was 66%, slightly higher than for the Toronto program, but follow-up in the Toronto program is significantly longer.

    He addressed how to monitor the patient's case under AS, emphasizing the point that PSA doubling time (PSADT) was quite important. Among other interesting points, he noted that his team had found a seasonal variation in PSA, with PSA tending to be lower in the summer in Toronto.

    Okay, with all this preamble, here's his key point: with a median (average) follow-up of 9 years, involving 450 patients, his team projects that 62% of AS patients are free of major treatment intervention at the 10 year point! Awesome! He noted that about one third of patients in the Toronto series do get treated, but he added that his program continued to evolve, especially with ever improving selection of better candidates for AS while moving other patients to earlier treatment, and he expected that 62% figure to rise. (There are now more than 800 men in the Toronto AS program.)

    As to death, only 5 out of 452 patients died from prostate cancer in the series. The team carefully looked at those 5, and they found that 3 actually had undiscovered metastases at the time they were diagnosed or GS 7 cancer on a repeat biopsy. One patient refused treatment the team recommended. Only one patient with what appeared to be true low-risk disease might have been helped by getting treatment shortly after his diagnosis! (I doubt that low-risk patients getting surgery or radiation would do better.) Dr. Klotz had looked at some other published research and estimated that the risk of dying from other causes outweighed death from prostate cancer for low-risk patients by 19 to 1! (Published research, not mentioned by Dr. Klotz as I recall, has indicated that men who prove to need treatment after surveillance have virtually the same success as men who get treatment without a period of surveillance.)

    Dr. Klotz also made a key point about the location of prostate cancer: cancers that are missed in biopsies are usually anterior. If such a cancer is missed, it can make a higher-risk case seem lower-risk. Therefore, a key goal is to detect such anterior cancers. He stated that 100% of men in his series with a tumor volume greater than 1.0 ccm had anterior cancers. He then gave several solutions: transperineal template biopsies (I believe this involves many cores taken in a highly disciplined way.), "multiparametric imaging (I'm not sure what that is.), diffusion weighted imaging that observes the rapidity of water diffusion, and dynamic contrast enhanced imaging. (Allen, can you help here?) Dr. Klotz was convinced that such advanced techniques would enable doctors to detect the bad actor cancers that would otherwise be stealthy threats to success under active surveillance, contributing to the one third who would turn out to need treatment. He also favorably mentioned the PCA3 test. He believes that imaging and possibly better biomarkers will transform AS, making it even much more effective. (In answer to the moderator's later question, Dr. Klotz said the technology for multiparametric MRI imaging was widely available but the expertise was not. However, he said this was a "hot area" with a lot of training in progress; he felt that use of multiparametric MRI imaging would expand rapidly.)

    Dr. Klotz also spoke favorably about using 5-ARI drugs (f i n a s t e r i d e and Avodart) for AS patients. He did not think much of the FDA's recent guidance that was negative about the usefulness of these drugs for prostate cancer patients. He stated he would take a 5-ARI drug if he were a patient with BPH, but, due to the controversy, he would hold off on taking a 5-ARI drug purely for prevention.

    Dr. Mark Moyad, as moderator, asked him several questions. He asked if men on AS suffered from high anxiety by deferring treatment. Dr. Klotz responded that their anxiety in the early years was about the same as anxiety for patients undergoing treatment, but that men on AS frequently were "ebullient" after being on AS for a few years: they looked at the side effects their friends were enduring who had had active treatment, and they were delighted they had not gone that route.

    Regarding monitoring, PSA monitoring, especially analysis of PSADT is key in the Toronto program. Follow-up biopsies are also key, but his program tries to minimize them while maintaining fine predictive information. They give a follow-up biopsy at one year after diagnosis; then, depending on overall results, they give biopsies at intervals up to three years to five years. The program involves office visits every six months, but a man often has only three to four biopsies. For example, a 65 year old man will have his diagnostic biopsy at age 65, a follow-up at age 66, one at age 75 and one at 80. I now see a gap of ten years between 66 and 75; I may have misheard him. Dr. Klotz also emphasized the need to have an expert perform pathology for the biopsy samples. Dr. Klotz was concerned that each biopsy carried some risk of serious infection; while key biopsies were well worth the small risk, it was a risk that should be avoided where possible. He also mentioned resarch from the Carter program at Johns Hopkins, where annual biopsies for AS patients are the norm, that documented an increased risk of erectile dysfunction after the third biopsy.

    Answering Dr. Moyad's question about prostatitis and other influences on PSA, Dr. Klotz mentioned a case of a bike rider whose PSA was 1,000; after he got a test when he had suspended riding, his PSA was just 3!

    While he said he took a lot of heat from fellow physicians in the early years, Dr. Klotz is now enjoying the fruits of vindication: both the National Comprehensive Cancer Network (NCCN) and the American Urological Association, both premier US medical organizations which publish guidelines to physicians, have strongly endorsed active surveillance for low-risk prostate cancer patients. In fact the NCCN has endorsed AS as the only approach that should be used for patients with "very low-risk" prostate cancer, adding that it should be a leading option those at slightly higher risk classified as "low-risk" prostate cancer. What a striking change from guidance from just a few years ago!

    I was so glad to see that Dr. Klotz was a presenter at this conference. Leaders in active surveillance who were presenters at previous conferences included Dr. H. Ballentine Carter from Johns Hopkins, Dr. Babaian from MD Anderson in Texas, and Dr. Peter Carroll from the University of California, San Francisco.

    Jim

    Last edited by IADT3since2000; 10-02-2011 at 05:48 PM. Reason: Spelled out f i n a s t e r i d e as a an apparent glitch in the Board's software substitutes asterisks for this drug. Added words about "each year" for the 150,000 newly diagnosed men.

     
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    Old 10-03-2011, 06:27 PM   #2
    mrmike2009
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    Re: Pc conference 2011 highlight: Active surveillance (AS)

    Jim,

    Excellent report. I remember when I had my surgery (RP) that the doctor listed the statistics on WW and it seemed back then (2-years ago) that after about 4 years 50% of the men had stopped their WW. I know you say (or the doctor does) that AS is very different from WW but I wonder what the drop out rate would be from men not in this type of study. It would seem to me that being in a study you already have a greater sense of following it through. If AS was sampled throughout all practices, I wonder what the drop-out rate would be. I am not tossing "cold water" on AS - just interested in how many men would continue with this type of treatment as the years went on.

    By the way - this past September was 2-years post op and I feel great.

    Again, thanks for all your great posts.

    Mike

     
    Old 10-04-2011, 02:39 PM   #3
    Tall Allen
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    Re: Pc conference 2011 highlight: Active surveillance (AS)

    In Klotz's study of 453 patients on AS, the ten-year actuarial rate of intervention with radiation or surgery was 38%, including 3 of only 5 patients who died (99% cause-specific survival). Radical treatment was offered if their PSA doubling time slipped to less than 3 years or their Gleason Score rose to 3+4. So 62% stayed on AS for at least ten years.
    http://www.ncbi.nlm.nih.gov/pubmed/20478589

    - Allen

     
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