San Francisco, CA USA (UroToday.com) In 2012, the U.S. Preventive Services Task Force (USPSTF) issued a statement regarding screening for prostate cancer. After a review of new evidence on the benefits and harms of prostate-specific antigen (PSA)–based screening for prostate cancer, as well as the benefits and harms of treatment of
localized prostate cancer, the Task Force recommended against PSA-based screening for prostate cancer, giving it a “grade D” recommendation—defined as a determination that “...the service has no net benefit or the harms outweigh the benefits.” 1
Three years hence, Dr. Deepak Kapoor and colleagues from the Icahn School of Medicine in New York and the largest U.S. urology practices, conducted a study to assess trends in histology among newly diagnosed prostate cancer, and to quantify what they suspecting in their practice – that as fewer men were undergoing prostate cancer screening, the cancers they were diagnosing were higher grade.
Indeed, in the 3-year post-USPSTF period, the investigators found, patients had higher Gleason grades and more positive cores, part of a trend they say that, “...became readily apparent in 2013, grew significant in 2014 and “...seems to be continuing unabated in 2015.”
After the USPSTF published the Grade D recommendation against PSA screening, the investigators found, the rate of positive biopsies in Dr. Kapoor and colleagues’ sample increased significantly, from 39.7% to 45.4%. The percentage of positive cores/positive biopsies grew from 31.4% to 33.3%. Gleason patterns 4 and 5 scores per core were higher, reflected by the WPPI (Weighted Prostate Pattern Index), showing a significant rise from 12.98 to 15.24 and 15.05 in 2014 and 2015, respectively.
Dr. Kapoor spoke to UroToday about study data the and colleagues presented at the San Francisco 2016 ASCO Genitourinary Cancers Symposium, in San Francisco, recently.
For this study, a total of 3,707 prostate biopsies from men with a mean age o 65.8 years underwent review. Each cancer core was examined for primary and secondary Gleason grade, and each patient was given a Gleason score and a weighted prostate biopsy index (WPBI). (The WPBI (Weighted Prostate Biopsy Index), defined as the product of each positive core times its own Gleason score, resulting in a single number reflecting both Gleason score and the number of cores positive. (WPPI does the same for Gleason pattern and number of cores positive.)
“Anecdotally, we seem to be seeing more prostate cancer patients who are further along in their prostate cancer,” Dr. Kapoor explained. “We wanted to see whether there was a temporal relationship to when the USPSTF issued its Grade D recommendation on prostate cancer screening, which occurred in the middle of 2012, and was saying in essence “Don’t use PSA to look for prostate cancer.”
The USPSTF rationale was that “...physicians were performing biopsies on men with biologically inactive tumors and detecting cancers that did not warrant treatment. Patients were being exposed to the risk of therapy they wouldn’t need. We aimed to define a better way to do PSAs—a one-size blunt instrument approach that the urological and oncological community was really appalled at.”
This sentiment was widespread in the urology community. Many practitioners issued very grave concerns that, in an attempt to not treat people who may be candidates for surveillance, we were going to lose the opportunity to cure people who could be treated. Dr. Kapoor explained.
He pointed also to the strange timing of the USPSTF recommendation in relation to advances in detection sensitivity. In the subsequent few years since it was issued, our ability to stratify patients who need biopsy—to determine which cancers are biologically active—has improved along with better histological analysis along with “...molecular, genomic and genetic testing have enabled us to be a lot more precise in who we treat.”
The goals of the USPSTF and any urology practice—of any urologist—is to not to diagnose cancers that do not need to be treated. Dr. Kappoor asserted. “If you are proponent of the USPSTF recommendations, that is exactly what we wanted to do: we wanted not to diagnose cancers that did not need to be treated.”
But the problem, he said, was in the clinic. The percentage of patients they were seeing in their practice were presenting with higher-grade disease, Gleason 8, 9, and 10. From about 14% at baseline, he said, patients with higher Gleason score numbered “about 25% now,” he said.
To look at this trend more carefully, Dr. Kapoor and colleagues were advantaged by being a part of the largest urology group in the New York metropolitan area (and in the US). “We have a lot of volume, and a lot of physicians. Since we do our pathology in-house, we could eliminate a lot of the confounding variables that occur, by combining data from different institutions and looking at SEER data.
During their investigation, the group performed just over 12,000 biopsies. “What we did was that we aggregated the 2010 and 2011 data.” (The USPSTF recommendations were issued in 2012). We looked at 1014 and the first 10 months of 2015. “What we found was like what many other reports--that the number of patients with prostate biopsies has gone down dramatically.”
But the picture is much more complex. “A cynic might point out that if fewer prostate biopsies are being done, the denominator is decreasing, so your percentage is going to look bigger.”
That is not is what is happening however, Dr. Kapoor said. “What we saw in our data is that the overall percentage of Gleason 6 patients, those who are stayed relatively constant is at about 44% patients –those who are most appropriate for surveillance did not change much.”
What changed, he said, was the percentage of Gleason 7 patients. In particular, Dr. Kapoor said, “We saw that our Gleason 4 plus 3 had become 4 + 4 and 4+ 5. Intermediate risk cancers, patients with biologically active tumors, he said ”we are seeing later. [Thus,] the probably of curing these patients then goes down.”
“In 2010 and 2011, we had a combined 219 cases of Gleason 8, 9 and 10 patients.” Through 10 months of 2015, said Dr. Kapoor said, his practice had 228 patients, for more than a doubling of Gleason 8,9, and 10 patients.
“We expected to see a change, based on the recommendation and we were very nervous about it. But we did not expect it to happen so quickly.” The impact of the [recommendation] is expected to lag by 5 to 10 years. But, Dr. Kapoor said, estimates are that the death rate from prostate cancer is going to increase by about 5%.
This trend is “very troubling.” What is even more troubling, however, is that CMS (Centers for Medicare and Medicaid Services) has proposed an ECQM [Electronic Clinical Quality Measure] that will penalize doctors for doing PSA testing – in effect saying that “We are going to penalize you for looking for early stage prostate cancer.” Doctors will be fined.
Response from the urology community was unanimous in its objections, including a formal objection to CMS from the Large Urology Group Practice Association (LUGPA).
Written By: Barbara Jones
Olsson CA, Andreson AE, Kapoor DA, et al. Trends in histology of newly diagnosed prostate cancer subsequent to USPSTF screening recommendations. Available at: http://meetinglibrary.asco.org/print/2133626.
U.S. Preventive Services Task Force. Prostate Cancer Screening. Available at: http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/prostate-cancer-screening?ds=1&s=prostate%20cancer%20screening