An Easier Colonoscopy Prep

Overall, the lifetime risk of developing colorectal cancer is about 1 in 20 (5.1%). The American Cancer Society estimates that there will be almost 150,000 colorectal cancers diagnosed in the United States annually and that approximately 50,000 deaths will result.

What makes this particularly disturbing is that colon cancer is almost entirely preventable when appropriate screening tests are done. Guidelines from professional societies vary but they generally recommend that average-risk adults should begin colorectal cancer screening at age 50 years, utilizing one of several options for screening, among which is colonoscopy. For patients with relatives who have had colon cancer or polyps, earlier screening is recommended.

We have reviewed the data regarding colorectal cancer and screening risks and benefits and we strongly recommend screening using colonoscopy beginning at age 40 rather than 50. Colonoscopy is a very safe procedure and complications are very rare. When polyps are found, they can almost always be removed immediately (during the colonoscopy procedure).

In our experience, the largest barrier to colon cancer screening with colonoscopy is the preparation required. The traditional colonoscopy prep requires that you drink 64 ounces of liquid in two hours and while most patients have no trouble with this, some find it difficult. Fortunately, there is a new product called Suprep which is a much smaller volume to drink.   So, for those of you who've been putting this off (and you know who you are), it's time to act!

If you’ve questions about this, please contact us. We’re happy to discuss this important issue further and to help make arrangements to protect you from this devastating disease.

Written by: Scott W. Yates, MD, MBA, MS, FACP 

More Controversy about PSA Screening for Prostate Cancer

The Wall Street Journal (and others) report that the U.S. Preventive Services Task Force will recommend against screening for prostate cancer using the PSA blood test having apparently concluded that more harm than benefit results from testing.

This recommendation will certainly be controversial.  This is the same panel that recently recommended that women not do breast self examination and that screening mammography not be offered to women between ages 40 and 50.  Those recommendations have not been widely adopted.

Here are a few of the articles discussing this change:

Panel Faults Widely Used Prostate-Cancer Test
By JENNIFER CORBETT DOOREN And THOMAS M. BURTON
Published: October 7, 2011 - Wall Street Journal online

A key federal advisory panel is poised to recommend that healthy men shouldn't be screened with a widely used blood test for prostate cancer, indicating that the test offers more harm than benefit.

The U.S. Preventive Services Task Force will recommend a "D" rating for prostate specific antigen, or PSA, testing, said a person familiar with the draft document. A "D" rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. It also is a recommendation to "discourage use" of test or treatment.

The task force is set to make its proposal Tuesday, and then allow for a four-week comment period before issuing a final recommendation.

The task force is an influential group whose recommendations can influence coverage decisions by the federal Medicare program and other insurers.

The scientific findings behind the recommendation are scheduled to be published Monday by the Annals of Internal Medicine. A copy of the paper was obtained by the newsletter Cancer Letter, which posted the paper on its website Thursday night.

The paper concluded that after about 10 years, PSA screening "results in small or no reduction" in death from prostate cancer but is "associated with harms," including biopsies, other tests and treatments, "some of which may be unnecessary."

Virginia A. Moyer, who chairs the task force,declined to comment on what the updated advisory would be. She noted that the current guidance is that the evidence is insufficient to recommend for or against screening in men younger than 75. That recommendation was last updated in August 2008. "New evidence has become available, and we had to reconsider our statement," Dr. Moyer said.

The new report is the latest in a long-running controversy over the value of PSA screening. Advocates say the test, when given regularly to men age 50 and over, facilitates the discovery of the cancer at an early stage, improving the chances of successful treatment. Critics say the test has a significant rate of false positives—apparent detection of cancer that isn't confirmed with further tests—or that it identifies so-called indolent tumors that are ultimately of little health consequence. This leads to unnecessary biopsies and cancer treatments.

Because such interventions can lead to infections, impotence and incontinence, critics say the risks of testing often outweigh the benefit.

U.S. Panel Says No to Prostate Screening for Healthy Men
By GARDINER HARRIS
Published: October 6, 2011 - New York Times online
Healthy men should no longer receive a P.S.A. blood test to screen for prostate cancer because the test does not save lives over all and often leads to more tests and treatments that needlessly cause pain, impotence and incontinence in many, a key government health panel has decided.

The draft recommendation, by the United States Preventive Services Task Force and due for official release next week, is based on the results of five well-controlled clinical trials and could substantially change the care given to men 50 and older. There are 44 million such men in the United States, and 33 million of them have already had a P.S.A. test — sometimes without their knowledge — during routine physicals.

The task force’s recommendations are followed by most medical groups. Two years ago the task force recommended that women in their 40s should no longer get routine mammograms, setting off a firestorm of controversy. The recommendation to avoid the P.S.A. test is even more forceful and applies to healthy men of all ages.

“Unfortunately, the evidence now shows that this test does not save men’s lives,” said Dr. Virginia Moyer, a professor of pediatrics at Baylor College of Medicine and chairwoman of the task force. “This test cannot tell the difference between cancers that will and will not affect a man during his natural lifetime. We need to find one that does.”

But advocates for those with prostate cancer promised to fight the recommendation. Baseball’s Joe Torre, the financier Michael Milken and Rudolph W. Giuliani, the former New York City mayor, are among tens of thousands of men who believe a P.S.A. test saved their lives.

The task force can also expect resistance from some drug makers and doctors. Treating men with high P.S.A. levels has become a lucrative business. Some in Congress have criticized previous decisions by the task force as akin to rationing, although the task force does not consider cost in its recommendations.

“We’re disappointed,” said Thomas Kirk, of Us TOO, the nation’s largest advocacy group for prostate cancer survivors. “The bottom line is that this is the best test we have, and the answer can’t be, ‘Don’t get tested.’ ”

But that is exactly what the task force is recommending. There is no evidence that a digital rectal exam or ultrasound are effective, either. “There are no reliable signs or symptoms of prostate cancer,” said Dr. Timothy J. Wilt, a member of the task force and a professor of medicine at the University of Minnesota. Frequency and urgency of urinating are poor indicators of disease, since the cause is often benign.

The P.S.A. test, routinely given to men 50 and older, measures a protein — prostate-specific antigen — that is released by prostate cells, and there is little doubt that it helps identify the presence of cancerous cells in the prostate. But a vast majority of men with such cells never suffer ill effects because their cancer is usually slow-growing. Even for men who do have fast-growing cancer, the P.S.A. test may not save them since there is no proven benefit to earlier treatment of such invasive disease.

As the P.S.A. test has grown in popularity, the devastating consequences of the biopsies and treatments that often flow from the test have become increasingly apparent. From 1986 through 2005, one million men received surgery, radiation therapy or both who would not have been treated without a P.S.A. test, according to the task force. Among them, at least 5,000 died soon after surgery and 10,000 to 70,000 suffered serious complications. Half had persistent blood in their semen, and 200,000 to 300,000 suffered impotence, incontinence or both. As a result of these complications, the man who developed the test, Dr. Richard J. Ablin, has called its widespread use a “public health disaster.”

One in six men in the United States will eventually be found to have prostate cancer, making it the second most common form of cancer in men after skin cancer. An estimated 32,050 men died of prostate cancer last year and 217,730 men received the diagnosis. The disease is rare before age 50, and most deaths occur after age 75.

Not knowing what is going on with one’s prostate may be the best course, since few men live happily with the knowledge that one of their organs is cancerous. Autopsy studies show that a third of men ages 40 to 60 have prostate cancer, a share that grows to three-fourths after age 85.

P.S.A. testing is most common in men over 70, and it is in that group that it is the most dangerous since such men usually have cancerous prostate cells but benefit the least from surgery and radiation. Some doctors treat patients who have high P.S.A. levels with drugs that block male hormones, although there is no convincing evidence that these drugs are helpful in localized prostate cancer and they often result in impotence, breast enlargement and hot flashes.

Of the trials conducted to assess the value of P.S.A. testing, the two largest were conducted in Europe and the United States. Both “demonstrate that if any benefit does exist, it is very small after 10 years,” according to the task force’s draft recommendation statement.

The European trial had 182,000 men from seven countries who either got P.S.A. testing or did not. When measured across all of the men in the study, P.S.A. testing did not cut death rates in nine years of follow-up. But in men ages 55 to 69, there was a very slight improvement in mortality. The American trial, with 76,693 men, found that P.S.A. testing did not cut death rates after 10 years.

Dr. Eric Klein of the Cleveland Clinic, an expert in prostate cancer, said he disagreed with the task force’s recommendations. Citing the European trial, he said “I think there’s a substantial amount of evidence from randomized clinical trials that show that among younger men, under 65, screening saves lives.”

The task force’s recommendations apply only to healthy men without symptoms. The group did not consider whether the test is appropriate in men who already have suspicious symptoms or those who have already been treated for the disease. The recommendations will be open to public comment next week before they are finalized.

Recommendations of the task force often determine whether federal health programs like Medicare and private health plans envisioned under the health reform law pay fully for a test. But legislation already requires Medicare to pay for P.S.A. testing no matter what the task force recommends.

Still, the recommendations will most likely be greeted with trepidation by the Obama administration, which has faced charges from Republicans that it supports rationing of health care services, which have been politically effective, regardless of the facts.

After the task force’s recommendation against routine mammograms for women under 50, Health and Human Services Secretary Kathleen Sibelius announced that the government would continue to pay for the test for women in their 40s. On Thursday, the administration announced with great fanfare that as a result of the health reform law, more people with Medicare were getting free preventive services like mammograms.

Dr. Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence in Britain, said he was given a P.S.A. test several years ago without his knowledge. He then had a biopsy, which turned out to be negative. But if cancer had been detected, he would have faced an awful choice, he said: “Would I want to have it removed, or would I have gone for watchful waiting with all the anxieties of that?” He said he no longer gets the test.

But Dan Zenka, a spokesman for the Prostate Cancer Foundation, said a high P.S.A. test result eventually led him to have his prostate removed, a procedure that led to the discovery that cancer had spread to his lymph nodes. His organization supports widespread P.S.A. testing. “I can tell you it saved my life,” he said. 

Answering Questions About the P.S.A. Test
By TARA PARKER-POPE
Published: October 6, 2011 - New York Times online

News that an influential panel of experts is advising healthy men not to be screened for prostate cancer with a widely used test is certain to cause confusion and anxiety among men and their doctors, and reignites a debate about the benefits and risks of screening tests.

The recommendations, to be officially announced on Tuesday by the United States Preventive Services Task Force, affect more than 44 million men age 50 and older who typically are candidates for a simple blood screen call the prostate-specific antigen (P.S.A.) test.

The panel, which already recommends against P.S.A. screening for men age 75 and older, will cite recent research suggesting that the testing does not save lives but does lead to unnecessary treatments that can cause impotence, incontinence and a number of other complications.

Here are some answers to common questions about P.S.A. testing and what the task force recommendations mean for men.

Will the new recommendations prevent me from getting a P.S.A. test if I want one?

No. Whether to be screened for prostate cancer is still a decision that each man must make for himself with the advice of a doctor he trusts. But now that the independent panel has taken a stand, many doctors who were ambivalent or opposed to P.S.A. testing may be more willing to express their own doubts about the test and to advise patients against it.

What if I have a family history of prostate cancer or worrisome symptoms? Should I still be checked for cancer?

The panel’s advice is based on studies of healthy men. Men who have symptoms related to prostate health should always be seen by a doctor; the task force did not address whether P.S.A. testing is appropriate for them. And men with a strong family history of prostate cancer may have more to gain from screening than men at low risk, so they also should discuss the issue with their physician.

In addition, a man who already has prostate cancer that has been diagnosed or treated is likely to continue to undergo P.S.A. testing, which can help doctors determine whether cancer has returned or is spreading.

What do other groups say about P.S.A. testing?

Most major medical groups have not taken a stand against routine P.S.A. screening and say it is a decision a man should discuss with his doctor. The American Cancer Society suggests that the conversation start at age 50 for most men, earlier for African-Americans and men with a strong family history of prostate cancer.

The American Urological Association recommends that P.S.A. screening be offered to men 40 or older. Most organizations discourage prostate cancer screening for men with less than 10 years life expectancy.

Why not get screened? Isn’t it always better to find cancer early?

The argument against P.S.A. testing is that prostate cancer is typically so slow growing that most men would be just fine if they never knew it was there. But once cancer is detected, it is psychologically difficult for a man to do nothing.

As a result, tens of thousands of men each year are left impotent and incontinent as a result of aggressive treatment for a cancer that would never have caused them harm. But it is impossible to tell which men have comparatively benign cancer and which men have aggressive cancer. As a result, many doctors believe the overall benefits of screening outweigh the negatives.

How much weight do the task force recommendations carry?

The task force is an independent panel of experts in prevention and primary care appointed by the federal Department of Health and Human Services. While the group only makes recommendations, a change by the task force often prompts other organizations to review their guidelines and can influence how insurance companies reimburse for certain services.

But the influence of the panel is often determined by how controversial its recommendations are. Two years ago, for instance, the task force concluded that healthy women under age 50 should no longer get annual mammograms. That recommendation was met with strong resistance by many cancer organizations, women and their doctors, many of whom continue to ignore it.

And even though the panel has already recommended that men over age 75 not undergo P.S.A. testing, many men and their doctors continue the practice. Earlier this year, the Journal of Clinical Oncology reported that men ages 80 to 85 are being screened as often as those 30 years younger. The task force’s advice is not necessarily the final word.

Radiation Risks Prompt Push to Curb CT Scans

For millions of patients, a CT scan can mean the difference between life and death, detecting a brain tumor, blood clot or burst appendix in seconds.

But federal regulators, radiology groups and hospitals are launching efforts to scale back use of the scans, also called CAT scans, amid growing evidence that they are exposing millions of patients to radiation that may elevate the risk of cancer in the future. A third or more of scans may be unnecessary or repetitive, studies show, and in scans that are medically appropriate, radiation doses could be dramatically reduced without hurting the quality of images.

Combining special X-ray equipment with sophisticated computers, CT-for computed tomography-produces vivid cross-sectional pictures of organs, bone, soft tissue and blood vessels with far greater clarity and detail than regular X-ray exams-but at 50 to 500 times the radiation dose. The number of CT scans in the U.S. has skyrocketed to about 70 million a year from just three million annually in 1980. A study in the Archives of Internal Medicine estimated that 29,000 future cancers could be related to CT scans performed in the U.S. in 2007 alone.

The Food and Drug Administration recently announced a broad initiative to reduce unnecessary radiation exposure from all medical imaging, and is developing new safety requirements for manufacturers of CT devices. It also said it will support "informed clinical decision making" programs that prompt doctors to think twice before ordering a scan whose risk may outweigh its benefit.

"If a CT scan is medically warranted, the benefit is going to completely outweigh the risk," says David Brenner, director of Columbia University's Center for Radiological Research in New York. Too often scans are ordered because they are quick and easy, because a doctor fears a lawsuit from a missed diagnosis, or owns a scanner and directly benefits from its use, he says. Moreover, "patients may put the pressure on to get a CT scan," Dr. Brenner says.

Dr. Brenner co-authored a study in the New England Journal of Medicine in 2007 estimating that 20 million adults and one million children are being irradiated unnecessarily and up to 2% of all cancers in the U.S. at present may be caused by radiation from CT scans, based on data extrapolated from atomic bomb survivors in Japan.

The American College of Radiology says equating the CT scans and atomic exposure is faulty, and that there is still no direct evidence linking CT scan radiation to cancer.

"Someone who comes in with a stroke could die today, but if they are worried about a cancer 30 years from now they may refuse a life-saving scan," says James Thrall, chairman of the American College of Radiology's Board of Chancellors and chief radiologist at Massachusetts General Hospital in Boston.

That said, Dr. Thrall says patients should ask doctors whether a scan is necessary, what the risks and benefits are, and whether there is an alternative test that doesn't use radiation such as ultrasound, which relies on sound waves, or magnetic resonance imaging, which uses powerful magnets and radio-frequency waves. The College is working on a national registry to the track the radiation dose that patients receive from CT scans nationwide, which will allow facilities to compare their rates to others.

Experts say that the best way to reduce the use of CT scans is to encourage doctors to follow guidelines developed by the American College of Radiology and others. Massachusetts General Hospital incorporated thousands of the guidelines into a program that requires doctors to enter information about a patient in the hospital's electronic medical records system before ordering a scan. If the need is questionable or another test might be more appropriate, doctors will get a yellow light. If a scan isn't recommended, it comes up red. A study of the program's use from 2004 to 2009 found that the rate of growth in outpatient scans fell to 1% a year from 12%, even though outpatient visits grew at a compound annual rate of nearly 5% over the same period.

"We will allow a doctor's clinical judgment and instinct to override the system but if they are overriding it consistently, we will let them know we are watching and have a conversation about why," says Jeffrey Weilburg, the hospital's director of clinical psychology. Mass General licensed the program to Nuance Healthcare, which provides software for health plans and hospitals.

Six medical groups and five health plans in Minnesota completed a two-year pilot test of the system in 2007. The number of CT scans was reduced to 385,660 from a projected 416,974 for the year, saving insurers nearly $18 million. Typically, costs for a CT procedure range from $600 to more than $3,000.

Barry Bershow, vice president of quality at Fairview Health Services in Minneapolis, says many CT scans are ordered for patients with sinus infections, but the guidelines indicate a scan isn't appropriate if a patient has a headache with no nasal discharge or a fever of less than 10 days' duration. In the pilot, Dr. Bershow says, insurance companies agreed that if doctors got a yellow or red alert and decided the scan was necessary anyway, they would "trust them to do the right thing in their clinical judgment" as long as they went through the program.

Although there is no evidence on how many scans are too many, hospitals are also acting to reduce the number of scans patients receive over time, especially younger patients and those who have repeat problems such as kidney stones. When Rachel Johnson suffered her second kidney-stone attack at 17 last summer, her mother Robin took her to the same emergency room near their home in Dacula, Ga., where Rachel had received a CT scan to diagnose the first attack. Ms. Johnson, an ultrasound technician, was prepared to voice her concerns about the possibility of additional radiation from a second scan, but says that before she had a chance, the doctor said he was foregoing a scan for the same reasons. "Doctors usually want to run so many tests so I was pleasantly surprised," she says.

Southern New Hampshire Medical Center developed a Patient Protection Program that sends letters to doctors when their patients under 40 have had between five and 10 scans, and sends them directly to patients who have had more than 10 scans. While one CT scan has a minimal risk for any patient, "the damage from radiation is thought to be additive over time," says Steven Birnbaum, a radiologist affiliated with the center and developer of the program. In 2008, 15% of scans were canceled and 15% switched to an MRI or ultrasound as a result of the program.

Health-care providers are also taking steps to lower the radiation dose in tests that are deemed necessary by changing the speed of the scan or the intensity of the radiation. Using scans on cadavers, for example, researchers at Loma Linda University Medical Center reported in December that they were able to reduce radiation exposure by 95% and still detect kidney stones.

Of particular concern, some researchers say, is coronary angiography, which scans the heart at levels up to 1,000 times of a normal chest X-ray to diagnose coronary artery disease. The Archives of Internal Medicine study on radiation risk estimated that one in 270 women who underwent CT coronary angiography at age 40 and one in 600 men will develop cancer from that CT scan. A study published last week in the journal Radiology found that the radiation dose can be reduced by 91% using a volume scanning technique- which takes a picture of the heart in one piece as opposed to traditional scanning over intervals of time-without reducing the quality of the image markedly.

Montefiore Medical Center in the Bronx, N.Y., meanwhile, reduced the number of CT pulmonary angiography scans and radiation dose delivered to emergency room patients with a suspected blood clot in the lungs by routing some of those with a normal chest X-ray to an older technology known as a ventilation perfusion, or V/Q scan. A V/Q scan evaluates air flow and blood supply to the lungs. Radiation from a CT scan is five times greater than a V/Q scan; the dose is 20 to 40 times greater to the female breast says Linda Haramati, lead author of the study. "We found we can decrease radiation exposure without compromising patient care," she says.

Sources: Laura Landro, Wall Street Journal
Reviewed / Posted by: Scott W Yates, MD, MBA, MS, FACP

Don't Cancel Your Mammogram Yet

As you’ve certainly heard or read, the USPSTF (United States Preventive Services Task Force) has issued updated guidelines for breast cancer screening. Here’s a summary of those recommendations and our comments.

Summary of USPSTF Recommendations

• The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. The USPSTF recommends against routinely providing the service. There may be considerations that support providing the service in an individual patient. There is at least moderate certainty that the net benefit is small.

• The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.

• The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

• The USPSTF recommends against teaching breast self-examination (BSE). The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.

• The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

• The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

Summary of American Cancer Society Recommendations

• Yearly mammograms are recommended starting at age 40 and continuing for as long as a woman is in good health.

• Clinical breast exam (CBE) should be part of a periodic health exam, about every 3 years for women in their 20s and 30s and every year for women 40 and over.

• Women should know how their breasts normally feel and report any breast change promptly to their health care providers. Breast self-exam (BSE) is an option for women starting in their 20s.

• Women at high risk (greater than 20% lifetime risk) should get an MRI and a mammogram every year. Women at moderately increased risk (15% to 20% lifetime risk) should talk with their doctors about the benefits and limitations of adding MRI screening to their yearly mammogram. Yearly MRI screening is not recommended for women whose lifetime risk of breast cancer is less than 15%.

Phil Evans, a professor of radiology at the University of Texas Southwestern Medical Center and president of the Society for Breast Imaging, says he was "shocked" by the changes. "There's a ton of scientific data in this country and others on screening that shows a significant benefit for women between 40 and 49 to be screened," he says. (Quoted in the Wall Street Journal)

It is important to note that the American Cancer Society and other groups have not changed their recommendations (which uniformly include teaching breast self examination and routine mammography). Dr. Schrader, Dr. Bond and I will review the evidence supporting these changes as it becomes available, but for now we believe that it is premature to change screening procedures.

Comments / Posted by Scott W. Yates, MD, MBA, MS, FACP

PSA screens need more discussion

Physicians need to involve men more in the decision to undergo prostate-specific antigen (PSA) tests, concluded two studies and two editorials in Archives of Internal Medicine.

Clinicians strongly influence men's decisions to undergo PSA screening, but the conversations about screening fail to qualify as shared decision making because patients received more information about the pros than the cons, had limited knowledge of their importance, and were not routinely asked for their preferences.

In one study, researchers conducted a telephone survey of 375 men who had either undergone or discussed with clinicians PSA testing in the previous two years. Researchers assessed the character of the discussion, the patient's knowledge of prostate cancer and the importance of decision factors.

Almost 70% of patients discussed screening beforehand. Clinicians most often raised the idea of screening (64.6%), and 73.4% recommended PSA testing. Clinicians emphasized the pros of testing in 71.4% of discussions but addressed the cons in 32% of talks.

Researchers then asked the patients three questions to test their knowledge:

"Of every 100 men, about how many do you think will die of prostate cancer?"

"Of 100 men, about how many will be diagnosed as having prostate cancer at some time in their lives?"

"For every 100 times a PSA test result suggests the need for further testing, about how many times does it turn out to be cancer?"

Although 58% of patients reported they felt well-informed about PSA testing, 47.8% failed to correctly answer any of the three questions, and only 7.2% of respondents could correctly answer more than one.

Only 54.8% of subjects reported being asked for their screening preferences. The clinicians' recommendations were the only discussion characteristic associated with testing (odds ratio, 2.67; 95% CI, 1.08-6.58). "Indeed, few subjects sought second opinions," researchers wrote.

An editorial concluded the research was an important step in prompting discussion about the tradeoffs between overdiagnosis and treatment complications versus the benefits of reduced risk of prostate cancer-related mortality.

A second editorial chided, "Today's practice environment presents few incentives or support tools for those clinicians and patients who prefer a discussion rather than simply marking a checkbox for PSA on a laboratory requisition form." It also noted some physicians may not ask to screen beforehand, but instead piggyback PSA tests onto other bloodwork.

A second study aimed to support individual decision making by creating a model of the likely benefits and harms.

Researchers in Australia created a model for men aged 40, 50, 60, and 70 years at low, moderate and high risk for prostate cancer. A Markov model compared patients with and without annual PSA screening using a 20% relative risk in prostate cancer mortality as a best-case scenario. The model estimated numbers of biopsies, prostate cancers and deaths from prostate cancer per 1,000 men over 10 years and cumulated to age 85 years.

Benefits and harms vary substantially with age and familial risk, the model found. As an example, among 1,000 60-year-old men with low risk screened annually, 115 would undergo biopsy triggered by an abnormal PSA screen. Among screened men, 53 would be diagnosed with prostate cancer over 10 years, compared with 23 men diagnosed as having prostate cancer among 1,000 unscreened men.

Among screened men, 3.5 would die of prostate cancer over 10 years compared with 4.4 deaths in unscreened men. For every 1,000 men screened from 40 to 69 years of age, there would be 27.9 prostate cancer deaths and 639.5 deaths overall by age 85 years compared with 29.9 prostate cancer deaths and 640.4 deaths overall in unscreened men. Higher-risk men have more prostate cancer deaths but also incurred more prostate cancers diagnosed and related harms.

References:

Richard M. Hoffman, MD, MPH; Mick P. Couper, PhD; Brian J. Zikmund-Fisher, PhD; Carrie A. Levin, PhD; Mary McNaughton-Collins, MD, MPH; Deborah L. Helitzer, ScD; John VanHoewyk, PhD; Michael J. Barry, MD. Prostate Cancer Screening Decisions. Arch Intern Med. 2009;169(17):1611-1618.

Steven H. Woolf, MD, MPH; Alex Krist, MD, MPH. Shared Decision Making for Prostate Cancer Screening. Arch Intern Med. 2009;169(17):1557-1559.

Kirsten Howard, BSc(Hons), MAppSc, MPH, MHealthEcon, PhD; Alex Barratt, MBBS, MPH, PhD; Graham J. Mann, MBBS, PhD;Manish I. Patel, MBBS, MMed, FRACS, PhD. A Model of Prostate-Specific Antigen Screening Outcomes for Low- to High-Risk Men. Arch Intern Med. 2009;169(17):1603-1610.

Michael Pignone, MD, MPH. Weighing the Benefits and Downsides of Prostate-Specific Antigen Screening. Arch Intern Med. 2009;169(17):1554-1556.

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

Patients Need Time

"Fifty to 75 percent of known preventive measures don't get done. This boils down to one thing -- time."

-- Dr. David DeAtkine Jr., internist and endocrinologist in Birmingham, Ala.

Posted by Scott W. Yates, MD, MBA, MS, FACP

New Debate on Prostate Cancer Screening

U.S. Study Shows PSA Test Doesn't Save Lives; European Study Shows Modest Benefit

Interim findings from an eagerly awaited ongoing government study show no evidence of a survival benefit associated with aggressive screening for prostate cancer using the prostate specific antigen (PSA) test.

More prostate cancers were detected over an average of seven years of follow-up among men who had regular PSA testing in addition to digital rectal exams compared to usual care, which could have included screening. But the increase in prostate cancers did not translate into fewer deaths from the disease.

The findings are certain to add to the controversy surrounding the value of PSA testing for prostate cancer screening, and the debate about whether current screening practices have led to overdiagnosis and overtreatment of prostate cancer.

The study, funded by the National Cancer Institute was published online ahead of publication in the March 26 issue of the New England Journal of Medicine.

"What this report tells us is that there may be some men who are diagnosed with prostate cancer and have the side effects of treatment, such as impotence and incontinence, with little chance of benefit," NCI director John E. Niederhuber, MD, says in a news release.

"Clearly, we need a better way of detecting prostate cancer at its earliest stages and as importantly, [we need] a method of determining which tumors will progress."

Screening Beneficial in European Study

To add to the confusion, findings from a major European trial appearing in the same issue of the New England Journal of Medicine did show a modest, 20% survival benefit associated with PSA screening in men followed for an average of nine years.

Both the U.S. and the European studies will be presented this week at the European Association of Urology annual meeting in Stockholm, Sweden.

For every 10,000 men screened with PSA over a nine-year period in the European trial, seven fewer deaths from prostate cancer were reported.

But the European researchers estimated that 48 additional men whose cancers were detected as a result of screening would need to be treated to avoid one prostate cancer death.

That compares with about 10 additional treatments among women screened with mammography needed to prevent one death from breast cancer, prostate cancer screening researcher Michael J. Barry, MD, of Harvard Medical School tells WebMD.

Barry, who wrote an editorial that appeared with the studies, adds that the new research helps to quantify the benefits and risks associated with PSA screening.

"When you look at the two trials together it becomes clear that the benefits, in terms of survival, are fairly modest," he says. "They are similar to what we see with mammography, but in my opinion it comes at a much higher price in terms of overdiagnosis and overtreatment."

Longer Follow-up May Be Needed

NCI researcher Christine D. Berg, MD, tells WebMD the failure of the U.S. trial to show a survival advantage associated with PSA testing could be due to the relatively short follow-up.

The researchers plan to follow the almost 77,000 men participating in the trial for a total of 17 years, and the men in the PSA arm of the trial will continue to have annual screenings.

Berg points out that in the European study the survival advantage was not seen until after seven years of follow-up.

But she echoed Barry's concerns that costs of PSA screening in terms of increased treatment may not be justified by the benefits.

"Personally, I think we should do some screening, but we really can't say what the optimal screening protocol should be at this time," she says. "The best we can do is counsel men to talk to their physicians."

Current Screening Recommendations

The U.S. Preventive Services Task Force, which makes recommendations about health care screenings, recently concluded that there is insufficient evidence to determine if the benefits of prostate cancer screening outweigh the risks in men younger than 75.

Prostate cancer screening is not recommended for older men.

The American Cancer Society does not support routine prostate cancer screening, but the group does urge men who have an average risk for the cancer, beginning at age 50, to talk with their physician about the pros and cons of screening. These discussions should take place at age 45 for men at higher risk.

"I think you will have a lot more men having this discussion with their health care providers as a result of these studies, and from our point of view that is a good thing," American Cancer Society Deputy Chief Medical Officer Len Lichtenfeld, MD, tells WebMD.

Lichtenfeld says the studies are likely to lead to vigorous debate within the medical community about the value of PSA screening.

"For years we've been saying wait for the trials, but so far the trials have not given us a definitive answer about whether prostate cancer screening is beneficial or harmful," he says.

"I suspect there will be a substantial amount of discussion over the next few weeks and months among the experts to try and put these findings into perspective and try and tease out what the message should be."

By Salynn Boyles, WebMD Health News

Posted by Scott W. Yates, MD, MBA, MS, FACP