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Watchful waiting for low-risk disease

DR MAGRINAT: Before the lawyers get in there and start suing doctors because they didn’t treat someone with a good prognosis, I think we need to develop some guidelines for watchful waiting. For example, if you have a Gleason 4 or 5, do you really need any treatment? Clear guidelines on that would be very helpful at this point. Five years from now, or even three years from now, we might not have the luxury to do that.

DR MOUL: In the CALGB, we’ve been trying to design a watchful waiting prospective trial. We’re having a lot of difficulty agreeing on how to design the study and we’re having issues with the National Cancer Institute, because even though it’s a treatment, C-TEP is having difficulty deciding whether they’re going to fund it because it’s not a treatment we normally associate as a treatment. It’s not surgery or radiation or some kind of medication.

Nevertheless, we, as urologists and clinicians, are doing watchful waiting in a haphazard manner. No standard way to do it has been established.

We published a paper about two years ago in JCO evaluating a group of patients from the military for whom clinicians had recommended watchful waiting. These men were age 70 or less. We found that 80 percent of those patients dropped out of watchful waiting by four years.

Imagine presenting data like that on surgery or radiation. They would throw us out of the room, saying we were charlatans who did not know how to do this treatment. Yet we published these data on watchful waiting.

It goes to show you that we don’t know how to pick patients properly for watchful waiting. It demonstrated that everyone gets scared off when the PSA rises, both the doctors and the patients, and we jump the gun and put the guy on treatment.

None of the physicians here would be willing to go on watchful waiting because of the “C” word and the worry of cancer, even though probably everyone in here has a better chance of dying of a heart attack than of prostate cancer.

DR LOVE: Computerized web-based models have been used in breast cancer to assist with this type of situation. If you go to the Adjuvant! Online website, which is run by Peter Ravdin, one of the fascinating things they incorporate is non-cancer causes of mortality. This is very helpful in older women with low-risk tumors.

I wonder if we really need more research on watchful waiting in prostate cancer, or whether we just need a closer look at the whole health situation of these patients.

DR SCHELLHAMMER: An algorithm like that does not exist for prostate cancer. You might think it would be easy enough to construct, and some pretty thoughtful people are working on it, but it doesn’t exist yet.

We look at the tumor and make some estimations, and then we kind of get this gestalt about the host, and then we try to put this together for a reasonable conclusion. It’s individualized and, I dare say, from month to month, it’s different even for the same physician.

DR LANGE: All these nomograms are good for helping to educate us and for enrolling patients in trials, but I don’t know whether it really helps patients. It gives them a false sense of control, which may be good, but does it really make any difference? If your chances of extracapsular extension are 40 percent versus 10 percent versus 80 percent, what is the difference in terms of what you would pick for therapy?

This concept has been over-sold to the patient because they come in with their nomograms and they feel great about having a nomogram, but they’re more confused than ever. I think we need to find something that works for the patient — and for the doctor.

DR LOVE: One of the things that must be factored into this is the toxicity of the therapy. When you hear a story like Alan’s and he says, “I’d rather die than be treated with this again,” you know you need something better.

In breast cancer these nomograms are mainly used to decide about chemotherapy, not hormonal therapy. We don’t even use these with hormone therapy because the treatment side effects are so benign.

DR SHIMM: To be an oncologist, you have to have the ability to deceive yourself. We do a good job of minimizing side effects to patients.

The work that you’ve talked about and other people have done, looking at women with the response buzzer, saying, “I’d be willing to have this treatment for a one percent improvement in survival,” I think that’s really because people don’t understand the toxicity of the treatment.

In a sense, they’re saying, “Am I willing to take a one percent improvement in survival for free?” And of course, the answer is, “Yes.” But I don’t think they really understand the toxicity.

Although I’m a radiation oncologist, I practice with a bunch of busy medical oncologists and sometimes they don’t always do their work in terms of explaining chemotherapy to their patients. I find these nomograms to be extremely useful for patients.Adjuvant! provides a much more userfriendly printout than, for example, the Parton tables.

Nothing is intellectually more complicated about prostate cancer than about breast cancer, and I suspect that at some point, some smart person is going to come up with a similar sort of nomogram for prostate cancer that will be very useful to patients.

DR LOVE: Lots of assumptions are made in these programs. Adjuvant! contains hundreds of pages explaining why these are just guesses, although the model was recently validated and is very accurate. But getting back to your point, our group asked breast cancer patients, “Would you go through chemotherapy for a one percent improvement?”

It’s all well and good to say, “55 percent of these women said they would,” but 45 percent said they wouldn’t. That’s a lot, and that means that people see these tradeoffs differently. If the information is placed in their hands, they can make that kind of a decision. I think that the information is out there, it just might not be getting to the patient right now.

In terms of looking at the health threats to a patient, we need to consider the whole milieu that the patient is functioning in, not just specifically the side effects of a therapy.

What else is going on in that person’s life? What’s their lifestyle like? What’s their relationship with their loved ones? All these things affect quality of life, not just the drug and its side effects.

 

 
   

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Editor’s Note:
Visiting professors

The initial reaction to the diagnosis of prostate cancer
Discussing treatment options for localized disease
Treatment side effects and complications
Case discussion: Maximal androgen blockade and radiation therapy for PSA relapse
Psychosocial issues in prostate cancer
Case discussion: PSA progression after intolerable side effects from chemical castration
Case discussion: Androgen deprivation for metastatic
Case discussion: Open versus laparoscopic prostatectomy
Case discussion: In search of a radiation oncologist
Watchful waiting for low-risk disease
Complementary medicine and supportive care
Select publications

CME Information

Faculty Disclosures

Editor’s Office

 
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