Comparative Ignorance on Prostate Cancer Screening

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  • 03/19/2009
In case you missed it, here is what the Fritz Schroder who ran the European Randomized Study of Screening for Prostate Cancer said about the results of the study published today in the New England Journal of Medicine:
By initially screening men 55 to 69 years with the PSA marker and offering regular follow up, this led to an increase in early detection. Deaths due to metastasized disease were then reduced. Exact data showedthat on average for every 1,408 men screened, 48 had cancer diagnosed and received treatment, resulting in saving one life. Screening took place on average every four years with a mean follow-up over nine years. The cut-off value was a PSA level of 3.0 ng/ml or more. Men with this reading were then offered a biopsy.

The study shows that PSA screening delivers a 20% reduction in mortality from prostate cancer. This provides decision makers on screening policies with important new data on the effectiveness of PSA testing in preventing deaths.
Did you miss that? I sure did. I am sure you did too. Know why? Because the New England Journal of Medicine, the New York Times, USA Today, etc, all ignored the findings and ran with this:

"The PSA blood test, used to screen for prostate cancer, saves few lives and leads to risky and unnecessary treatments for large numbers of men, two large studies have found."

Mortality Results from a Randomized Prostate-Cancer Screening Trial  (The New England Journal of Medicine)

"The findings, the first based on rigorous, randomized studies, confirm some longstanding concerns about the wisdom of widespread prostate cancer screening. Although the studies are continuing, results so far are considered significant and the most definitive to date ..."

Continued Here

"What the European study tells us is that, if you are a man who chooses screening, you are 47 times more likely to be harmed by screening than to have your life saved," said Dr. Otis W. Brawley, chief medical officer of the American Cancer Society.

Where to begin?

Unnecessary and harmed by screening?

What is Brawley thinking? Does the ACS really pay him to say things to reduce prostate cancer survival rates? Does he realize that urological oncology has learned how to segment and stage prostate cancers based on risk and PSA velocity? That the number of cancers detected that undergo watchful waiting have increased even as the more dangerous tumors can be removed successfully to increase overall life expectancy at ever age and that this is possible because of the increase in early and widespread detection in combination of better treatment?

Oh, and did he read the methodology section of the study which controlled for mortality caused by treatment? Guess not.

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Now let's turn to Kolata who's article is as balanced as the Dreyfus Affair. The American study likely understates the impact of screening because the design is biased against minorities who would have higher detection rates of cancers that progress faster and have an oversampling of asymptomatic patients whose slow growing tumors are likely to have a a good prognosis. This bias was further compounded in the American study because the treatment rates in the untreated group were about the same as those in the treatment group:

The other half of the men on the trial were offered “usual care” - meaning ‘whatever their health insurers considered appropriate’. Crucially, this meant that the control group for the study contained men who could also potentially be screened for prostate cancer.

"According to this analysis, over half of men in the ‘unscreened’ group actually received some form of prostate cancer screening (compared to over eight-out-of-ten men in the ’screened’ group)."

In the US trial, some men who were in the unscreened group actually ended up having a PSA test - probably as part of their health insurance or because of suspected prostate cancer symptoms.This may have significantly affected the results, by cutting deaths from prostate cancer in this group, and reducing any differences the trial was designed to show."

Finally, both studies took a one size fits all approach to screening and to PSA levels. In fact, PSA use and levels in the real world are tailored to family history, age and race. Increasingly, algorithms that combine clinical data, PSA levels and other markers such as fusion genes and sarcosine, a metabolite found in urine can be used to more precisely determine whether prostate cancers were benign, localized or agressive.

Read More

Here is info on the PSA Test

So the take away is this: to make policy or impose reimbursement from one clinical trial or even several is fool hardy. To dictate clinical practice and ration screening based on press releases or sound bites is irresponsible.

Then again both the NY TImes and the American Cancer Society are desperately seeking to show the flag on comparative effectiveness. They have done the job well on prostate cancer screening. At the expense of cancer patients and medical progress.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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