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Medical Forum / Diseases and Disorders / Prostate Cancer / February 2008Watchful waiting report
Some Older Men May Delay Prostate Cancer Treatment; Study Shows Most Survive Without It Wednesday, February 13, 2008 18:55 EST Older men with early-stage prostate cancer are not taking a big risk if they keep an eye on the disease instead of treating it right away, suggests the largest study to look at this issue since PSA tests became popular. Only 10 percent of the 9,000 men in the study who chose to delay or skip treatment had died of prostate cancer a decade later. The vast majority were alive without significantly worsening symptoms or had died of other causes. Even the 30 percent who eventually sought treatment were able to delay it for an average of 11 years. "It is important news," said Dr. Otis Brawley, chief medical officer of the American Cancer Society. "It may persuade some middle-of-the-roaders that we are overtreating this disease," and that PSA testing may be amplifying the problem, he said. The PSA blood test to help detect tumors has been widely used since the 1990s. Grace Lu-Yao of Robert Wood Johnson Medical School in New Jersey led the study and will report results at a cancer conference later this week in San Francisco. Whether to treat prostate cancer is one of the biggest medical dilemmas today. The disease is the most common cancer in American men _ about 220,000 cases will be diagnosed this year _ but most tumors grow so slowly they never threaten lives. There is no sure way to tell which tumors will. PSA tests can help find tumors many years before they cause symptoms, but routine screening of men at average risk of the disease is not recommended, because there is no proof it saves lives. Prostate cancer treatments are tough, especially on older men. Many men are left with sexual or bladder control problems. Some doctors instead recommend "watchful waiting" to monitor signs of the disease and treat only if they worsen, but smaller studies have given conflicting views of the safety of that approach. The new study looked at the natural course of the disease in men who chose that option. It is the first involving so many older men _ half were over 75 _ and so many whose tumors were found through PSA tests. Using the federal government's cancer database, researchers studied 9,018 men diagnosed from 1992-2002 with early-stage prostate cancer who did not get surgery, radiation or hormone therapy for at least six months. Most never got any treatment at all. A decade later, 3 percent to 7 percent of those with low- or moderate-grade tumors (rated by how aggressive the cells appear) had died of prostate cancer, versus 23 percent of those with high-grade tumors. Overall, prostate cancer killed 10 percent of them. "The great majority of patients ... are going to die of something else," so most older men with early-stage tumors could delay treatment, Lu-Yao said. "If people are younger or have more advanced disease, I wouldn't say this is a safe option," but most cases are diagnosed in men 68 or older, and most are early stage, she noted. The National Cancer Institute paid for the study. It is not the final word _ that usually comes from studies where similar groups of patients are randomly assigned to get one treatment or another, and the results compared. But absent that kind of evidence, this large study "does show that a large number of men do well with no initial treatment and indeed with no treatment long term," Brawley said. Dr. Howard Sandler, a radiation and prostate specialist at the University of Michigan, agreed, but cautioned, "there are exceptions to every rule," and some very active, healthy older men may do better having treatment right away, along with older men who have higher-grade tumors. Earlier this month, a scientific review published in the Annals of Internal Medicine concluded that evidence was too thin to recommend treatment over watchful waiting, or one treatment over another. Studies do show that prostate cancer surgery mostly helps men under 65, said Dr. Timothy Wilt of the Minneapolis VA Center for Chronic Disease Outcomes Research, who led the review. The new study shows that for men older than that, "observation is a very reasonable approach," he said. "Many men do quite well for a long period of time with no treatment." The cancer conference is sponsored by the American Society of Clinical Oncology and several other groups. Although routine PSA testing is not recommended for all men, the cancer society does advise giving men information and the option to have it starting at age 50. Screening is recommended starting at age 45 for men with a family history of prostate cancer and for black men, because of their higher risk of the disease. ___ On the Net: Cancer meeting: http://www.asco.org National Cancer Institute: http://www.cancer.gov American Cancer Society: http://www.cancer.org ___ Blue Wave/QWK v2.12 > Some Older Men May Delay Prostate Cancer Treatment; > PSA tests can help find tumors many years before they cause symptoms, > but routine screening of men at average risk of the disease is not recommended, > because there is no proof it saves lives. It is important to distinguish between "proof" and "evidence" in this context. It is of course impossible to prove anything at all in medicine in the sense that mathematicians and logicians use that term. What people usually mean is that there has been no prospective randomized study which shows a statistical advantage for men who have had regular PSA tests. In such a study, a large group of men would be randomly assigned to two groups, one of which regularly received PSA tests, and the other of which didn't. These men would be followed for a period of time and death rates and other relevant statistical information corrected. There is such a study in process in the US, but it is not complete. So it is also true that we cannot say, in this limited sense, that the benefits of PSA testing has been disproved. But this doesn't mean there is an absence of such evidence. One factor commonly quoted is that in more than one instance, when PSA testing has been introduced, prostate cancer death rates have declined. In the US the actual number of such deaths declined despite an increase in the size of the vulnerable population. Such evidence is not considered definitive because there may be other reasons which could explain it. Prospective randomized studies are preferred because they can better avoid confounding factors; the assumption being that any confounders would affect the two groups equally. Unfortunately, such studies may have problems of their own. One such is that they almost never proceed to a logical end, in this case when all the participants have died. There is a time limit. Such is the case for the current study, so whatever its results, they must be read with caution. Specifically, all you can conclude from is that for the specific circumstances of the study, including any restrictions on time, the results are valid. A good example of this is the recent Swedish study, which compared Swedish men who had been diagnosed with prostate cancer. They were divided randomly into two groups, one of which was treated by RP and the other by WW. After an average wait of six years, the men in the RP group had a statistically significant advantage in prostate cancer mortality, but there was no significant difference in overall mortality. The critics of aggressive treatment of prostate cancer seized on this and told us the result was that there was no reason to prefer RP over WW. But they should have added that such was the case for (Swedish) men expecting to live only six years. When the results were tabulated after an additon four years, it turned out that the RP men also had a stistically significant edge in total mortality. In fact suggestions that such might be the case were already apparent in the earlier study which has shown the the RP men had fewer cases of metastasis. Let me add that this study, while suggestive, may not "prove" anything about prostate cancer for men in the US. Namely, it applied to Swdish men who by and large had not had a record PSA testing, while many men in the US do. But at least it might be fair to conjecture that should American men cease having routine PSA testing, then a prospective randomized study comparing aggressive treatment to WW many years later might show a benefit from RP. > Prostate cancer treatments are tough, especially on older men. Many men > are left with sexual or bladder control problems. Some doctors instead recommend [quoted text clipped - 9 lines] > hormone therapy for at least six months. Most never got any treatment at all. > .... Note that this also was not a prospective randomized study. So it also doesn't "prove" anything. So, to be consistent, those who demand "proof' that PSA testing is effective, should not use such evidence to argue their case. Personally, I am in favor of using all the evidence available, so I think studies like this are useful. But, as I remarked in another post, the results are not startling. We already know that aggressive treatment is not appropriate for older men, and so it follows that PSA testing for such men may not be valuable. For example, Patrick Walsh, hardly an opponent of PSA testing, questions whether or not it is appropriate for most older men. PSA testing, it seems to me is mostly valuable for men under 65 or older men in good health with an expected lifespan of at least 10-15 years. This is of course closely linked to what one might do with evidence of prostate cancer should it be detected. When I considered my choices, when diagnosed at age 67 through biopsy following suspicious PSA results, I took that into consideration. My health, except for the prostate cancer was excellent and remains so as I approach 75. I am convinced that without PSA testing, my Gleason 7 tumor might easily have metastasized within five to ten years and not only shortened my life span but also subjected me to the effects of metastatic cancer and HT, the only available treatment. I remain recurrence free without significant life altering side effects from my RP. On the other hand, if my PSA tests had remained normal until age 75, I might very well have decided to stop having them because it would be questionable whether I would choose aggressive treatment if cancer was detected. I probably would have continued with the tests but rejected treatment in favor of watchful waiting if the testing led to a a diagnosis of PC. > Although routine PSA testing is not recommended for all men, the cancer > society does advise giving men information and the option to have it > starting at age 50. Screening is recommended starting at age 45 for men > with a family history of prostate cancer and for black men, because of > their higher risk of the disease. I am having a hard time imagining such a discussion between a physician and his 50 year old patient. To be honest, (s)he has to tell the pateint that PSA testing may not be of much use for men over 70 since most cancers seem to grow slowly and most men that age won't live long enough to benefit from an early diagnosis of prostate cancer. (How does a man of 50 decide how long he might live after reaching the age of 70?) (S)he also has to tell the patient that if he is diagnosed through PSA testing, it is possible he may have serious side effects from treatment which he may not be able to resist. To be safe, (s)he also should get the patient to sign a statement saying that he understands all the risks and benefits for a man his age in his circumstances and he will not sue the doctor if he is later diagnosed with advanced prostate cancer because he chose not to be tested. If I were a physician, I would take the only safe course. I would recommend to such a man in favor of testing but explain that should the man be thereby diagnosed with prostate cancer, he may face a difficult decision about what to do next, so he should consider carefully whether he wants to begin testing. But no matter how the physician puts it, it is doubtful that many men of 50 would be able to make sense of such nuanced recommendations, and would go with what they thought the doctor was "really" saying. Law suits would be sure to follow. >> Although routine PSA testing is not recommended for all men, the >> cancer society does advise giving men information and the option to [quoted text clipped - 25 lines] > would go with what they thought the doctor was "really" saying. Law > suits would be sure to follow. This is hard to absorb. PSA does not in it's self provide a diagnoses as cancer of the prostate. This can only be provided by a biopsy.  SignatureBill P. >>> Although routine PSA testing is not recommended for all men, the >>> cancer society does advise giving men information and the option to [quoted text clipped - 29 lines] > This is hard to absorb. PSA does not in it's self provide a diagnoses > as cancer of the prostate. This can only be provided by a biopsy. That is the point often ignored by opponents of routine PSA testing. They treat such testing as a thing in itself isolated from anything else. Considered that way, you can design a prospective randomized study to determine if PSA testing reduces prostate cancer mortality, or, as some would argue is more important, overall mortality. The argument is then that if such a study shows no statistical advantage for PSA testing, then it is better to avoid it because such testing might have adverse consequences. But when examined, the supposed adverse consequences are not directly related to the testing. They follow from aggressive treatment of cancers detected by virtue of the testing. But, as you note, we don't go directly from one to the other. First, a decision has to be made about whether or not PSA results merit a biopsy, and that can depend on the patient's age among other things. Thus, for older men, PSA testing might be used primarily to determine if there was possibility of an aggressive cancer which should be treated immediately, but moderate increases ignored. Second, if a biopsy following PSA testing shows the patient has cancer, he then has to decide what to do. It is not axiomatic that all men have to choose aggressive treatment. Finally, if the decision is for treatment, the mode of treatment will depend on the man including the likelihood of serious side effects for that particular man. > Second, if a biopsy following PSA > testing shows the patient has cancer, he then has to decide what to do. > It is not axiomatic that all men have to choose aggressive treatment. > Finally, if the decision is for treatment, the mode of treatment will > depend on the man including the likelihood of serious side effects for > that particular man. As a theoretical matter you are entirely right. But as a practical matter surgeons want to operate, radiologists want to radiate and educated patients are not generally supported to decline treatment, even when generally accepted guidelines suggest that is entirely appropriate. This is well reflected on this newsgroup where the vocal conservative religious minority, i.e. IP, the two SStevess and their groupies Heather, Leah, RonJudas and Puerile Chief, cry that you should have "the beast" cut out even on a Gleason score of 1+1, no matter what side effects might occur. >> Second, if a biopsy following PSA testing shows the patient has >> cancer, he then has to decide what to do. It is not axiomatic that [quoted text clipped - 12 lines] > beast" cut out even on a Gleason score of 1+1, no matter what side > effects might occur. First, I think your description is a caricature of what those people say. Also, such recommendations are balanced by others who suggest a more conservative approach. Finally, I don't think you can generalize about what physicians do on the basis of what amateurs say in this newsgroup. I don't have a lot of experience with particular urologists or radiation therpaists. From my own experience and that of friends and also that related to us by posters here, physicians seem to explain pretty well to their patients what their alternatives are. Of course they may have inclinations based on what they do, but I think most of them recognize their obligation to their patients. On the other hand, it is not uncommon for primary care physicians to be pretty conservative about referring their patients to a urologist for biopsy. That tends to bias things in the opposite direction. In any event, it is unscientific to postulate that surgeons, et. al. are all ready to pursue aggressive therapy in all circumstances without strong evidence that such is actually the case. Moreover, even if one could establish such bias through well designed studies, the solution, it seems to me, would be better training of physicians, not guidelines based on the assumption that such things are inevitable in all places, for all men, and all times. There is a related point about this that has always concerned me. Often the argument is made that studies have to deal with what actual practice in the communityis rather than what the best practitioners do. For example, it may be argued that while the best surgeons may be able to avoid long term impotence for the great majority of their (younger) patients, it is better to look at the overall impotence rate when discussing such risks. This would make sense if the practice of medicine were static. There would always be a range of outcomes depending on the skill of the practitioners and other factors, and it would be a mistake to describe the typical outcome in terms of outliers. But medical practice is not static. In the early 80s, surgeons who were skilled in nerve sparing technique were pretty rare. But these days many urologest have trained in such surgery and are pretty competent at it. In deciding the likely success and side effects of some treatment, it is best to determine what it would be from the best trained practitioners and then see how it differs for average practitioners. That would give us a target to aim for in training of physicians as well as provide patients with useful information. >>> Second, if a biopsy following PSA testing shows the patient has >>> cancer, he then has to decide what to do. It is not axiomatic that [quoted text clipped - 15 lines] > First, I think your description is a caricature of what those people > say. "Caricature"? No, simply fiction. This is why he's been evicted by most of us. You're a very generous man for continuing to take your time with this person. I.P. Hey Len: Don't feed the trolls! That's what they crave. Steve J > There is a related point about this that has always concerned me. Often > the argument is made that studies have to deal with what actual practice [quoted text clipped - 14 lines] > practitioners. That would give us a target to aim for in training of > physicians as well as provide patients with useful information. If the "best practices" are not, or not yet, generally available, such studies would not be very useful for the average patient, would they? More importantly, existing studies differ widely in their definitions: "A notable study in 2005 showed that a year after surgery, 97 percent of patients were able to achieve an erection adequate for intercourse. But last month, researchers from George Washington University and New York University reviewed interim data from their own study showing that fewer than half of the men who had surgery felt their sex lives had returned to normal within a year. So which of the studies is right? Surprisingly, they both are." See http://www.nytimes.com/2008/01/15/health/15well.html In the same paper, interesting reviews of recent books about people like "IP Freely": http://www.nytimes.com/2008/02/14/books/14dumb.html I don't buy this approach across the board. It relies too much on broad-brush statistics and way too little on individual differences. As cheap and safe as a PSA test is, and as cheap and safe as a biopsy is if PSA warrants it, why would a healthy, vigorous, fit 70-something man not want to know whether his nearest alligator is a confined but very aggressive prostate cancer? I say even an 75-year-old athletic man should get the PSA, get the bx if warranted, than base his choices on his own reality, not on the fact that most 70-somethings are merely existing. I've had three idiot 95-pound doctors tell me to lose 25 pounds because their height-weight charts say I should weigh 25 pounds less. Sorry, dudes and dudette, but your stupid chart is a statistic, which none of your individual patients is. I.P. > I don't buy this approach across the board. > > I.P. Some of you folks need to learn how important it is to provide some context to your posts by including pertinent quotes, an option you can find in your toolbar right now. I have no idea what this post refers to, for example. A little philosophy on watchful waiting for you warriors, from my blog. In a message opposing what he perceives as the overaggressive treatment of prostate cancer in this country, Jim W. wrote in in one of the PC newsgroups: "It's kind of like a lot of us are shooting before we take aim. In the Revolutionary War, General Israel Putnam rallied his green colonial troops with this cry: 'Don't fire until you see the whites of their eyes. "Translated to our situation, that would be: 'Don't get treated until it's clear that you need treatment.' "I understand and support that some men will want to go ahead with treatment ASAP regardless of their chance of success with active surveillance. But those who make a choice of AS also deserve our support and respect. "After all, most of us are perfectly happy living with an appendix, yet an appendix can suddenly inflame and without treatment kill us in just a matter of days. That makes me think the problem is in what we think and feel rather than the actual situation. |
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