March 16, 2010 — Two ongoing controversies in prostate cancer — the value of screening with prostate-specific antigen (PSA) and the role of active surveillance — are highlighted and discussed in depth in the just-released 2010 Annual Report on Prostate Disease from Harvard Medical School.
"This report will be useful for all physicians who are discussing these issues with their patients," editor-in-chief Marc Garnick, MD, clinical professor of medicine at Harvard Medical School, in Boston, Massachusetts, told Medscape Oncology. Although it is primarily aimed at patients, the wealth of detail included will make it a useful resource for physicians and related health professionals, he said. As well as summaries of the latest research with full citations, it reports on indepth discussions among Harvard experts in medical oncology, urology, surgery, and radiology.
"Getting screened for prostate cancer, which seems like it would be a no-brainer, requires thoughtful consideration," Dr. Garnick writes in the introduction to the report.
There has been a shift away from widespread screening with the PSA test among medical experts, the report notes, explaining that "the shift comes on the heels of a growing body of evidence that PSA screening may not outweigh the potential harm of unnecessary treatment."
In an interview with Medscape Oncology, Dr. Garnick said the data for the PSA test do not support its use for population screening. The new data on PSA screening and survival from 2 large studies published last year (N Engl J Med. 2009;360:1310-1319, 1320-1328) "fell short of everyone's expectations," he said. "There is no overall survival benefit, and there is no benefit for prostate-cancer-specific survival from the [American] study and only a benefit in a subset of patients in the European study."
"There are no data to support PSA testing for screening. If this was a drug, it wouldn't be approved," he said.
In a round-table discussion detailed in the report, other experts agree.
"Many cancers are slow-growing and never spread. Yet treatments for prostate cancer can cause life-altering side effects, such as erectile dysfunction and incontinence," Anthony Komaroff, MD, senior physician at Brigham and Women's Hospital in Boston, and professor of medicine at Harvard Medical School, pointed out.
This has not yet been shown for the PSA test.
"To have value, a screening test must be shown to reduce a patient's risk of death and suffering (both from the disease and treatment side effects)," he said. "This has not yet been shown for the PSA test, based on these 2 long-awaited recent studies."
Kevin Loughlin, MD, professor of surgery/urology at Harvard, added that it is hard for the public, and even for physicians, to realize that "cancer screening has not generally been as successful as we had hoped it would be."
Dr. Komaroff said he had a lot of patients asking about the 2 studies, and noticed a change in the sorts of questions that patients are now asking him.
Conservations about PSA screening can be overwhelming for the patient and very time-consuming for the doctor, said Howard LeWine, MD, a practicing internist at Brigham and Women's Hospital. "Some patients ask me, 'Doc, what would you do?"
Dr. LeWine said he answers honestly, telling patients, "I don't get PSA screening because personally I won't be reassured by a normal PSA and would only worry if it was abnormal."
"This is not the case for other diseases that I do believe might shorten my life," Dr. LeWine added. "For example, I do get regular screening for colon cancer and control my risk factors for coronary artery disease."
All the experts emphasized the need for detailed discussions before deciding whether or not to have a PSA test — which does not appear to be always happening in practice; a recent survey found that one third of men underwent the test with no prior discussion.
"A man should know that a PSA test may very well lead to a biopsy, and that a biopsy could show cancerous cells under the microscope," Dr. LeWine explained.
"Knowing that these cells may never pose a problem and could lead to a treatment with side effects, a man may want to consider what to he might do with this knowledge," he continued. "Would he be comfortable with active surveillance? Would he want to remove the cancer at all costs? Or would he do nothing, wishing that he did not know?"
There has been a change in attitude toward biopsies, the report notes. Whereas in the past, most abnormal PSA test results would commonly lead to a biopsy, "I think that we are taking biopsies from far fewer patients than we did 5 or 10 years ago," said Dr. Loughlin.
"It's more and more apparent that prostate cancer is heterogeneous," he continued. "Some of the tumors that are diagnosed are not biologically significant and are not going to have an impact on the patient's overall survival. So I think there's been a rethinking on the part of primary care physicians, urologists, and medical oncologists."
"I don't think that there is an emergency, if you will, to treat prostate cancer," he said. "There is more and more evidence that's there's no urgency to treat indolent cancers early — if at all. In addition, there's a body of evidence that suggests that aggressive cancers remain aggressive and even early detection may not change the course of the disease. "
"I think it's still debatable whether early intervention truly makes a difference in higher-grade tumors, and if it does, how big a difference it makes," Dr. Loughlin stated. "It's a very difficult issue for physicians to deal with, let alone patients."
Active Surveillance Is the Way Forward
Widespread use of PSA tests for screening has led to both overdiagnosis and overtreatment of prostate cancer, Dr. Garnick said in the interview. "The way forward is to use more active surveillance," he maintained.
This was discussed by another set of experts in a second round-table discussion.
Ignacio San Francisco, MD, a urologist from Pontificia Universidad Catolica de Chile in Santiago, and a urologic oncology fellow at Beth Israel Deaconess Medical Center in Boston, clarified the distinction between active surveillance and watchful waiting.
"Watchful waiting is for patients who have a short life expectancy and for those who don't want to have treatment," he explained, whereas active surveillance is for patients who are candidates for curative treatment but who have low-risk cancers. "They can delay treatment — radical prostatectomy or any kind of radiation therapy — until their cancer shows signs of progression."
With active surveillance, there is a plan in place that involves PSA tests, digital rectal examinations, biopsy , and the realization that there might be some treatment at some point, added William DeWolf, MD, professor of surgery at Harvard Medical School and chief of urology at Beth Israel Deaconess Medical Center.
This is not an approach that is seen in any other type of cancer, he noted. There are low-risk skin cancers, but these are removed, and in some cases small masses in the kidney and thyroid tumors are followed with repeated imaging tests, but "in most cases, you treat the cancer right after it is diagnosed," Dr. DeWolf explained.
But this is not the case with prostate cancer, and this approach of not having treatment after a diagnosis of cancer is novel. Just hearing the word "cancer" can create a sense of panic in some patients, and it "throws them for a loop," Dr. Garnick said.
To counteract this, a new name has been proposed for low-risk prostate cancers — "indolent lesions of epithelial origin" or IDLE tumors.
But the Harvard experts were not enamored with this proposal.
"I don't think we know what is IDLE when it is diagnosed," Glenn Bubley, MD, director of genitourinary oncology at Beth Israel Deaconess Medical Center, pointed out. "We know retrospectively, after it's been treated."
That's too big an error rate.
"Altering the name is not a good idea because we just don't have enough of an understanding about what in the prostate [should be called an] IDLE," explained Dr. DeWolf. "When you correlate biopsy findings with surgical samples, we're wrong in about 10% to 20% of the time. . . . That's too big an error rate."
"With all the public education about prostate cancer — it has a long natural history and is really more like a chronic disease — more and more people are getting comfortable with the idea of deferred treatment without changing the name," he added.
However, Dr. DeWolf made the point that although active surveillance is accepted "here in Boston, around the country, it's not."
He is hopeful that, over the next 5 years, active surveillance will become "much more accepted and that patients will be more comfortable with the idea of holding off on treatment."
He is also hopeful that data from the patients being followed with active surveillance in Boston — now with 10 years of follow-up — as well as from those from other teams (groups from Johns Hopkins in Baltimore, Maryland, and from Toronto, Ontario, are both mentioned in the discussion) will advance our understanding of prostate cancer.
"Because we're not treating our active-surveillance group, this gives us the opportunity to look at the natural history of the disease — and for factors that might predict a more favorable outcome," Dr. DeWolf said.
The 2010 Annual Report on Prostate Diseases is available from the Harvard Medical School Web site.
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Cite this: Ongoing Controversies in Prostate Cancer Highlighted in Harvard Report - Medscape - Mar 16, 2010.
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