U.S. Preventive Services Task Force

Rise in metastatic prostate cancer incidence coincides with screening guideline changes

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Increases in metastatic prostate cancer incidence may be temporally associated with changes in clinical policy following U.S. Preventive Services Task Force recommendations, according to a study in JAMA Network Open.

“This study is the first to document a continued rise in metastatic prostate cancer using the most up-to-date population data set. Our study of the recently released 2004-2018 SEER data set confirms a rising incidence rate of metastatic prostate cancer coinciding with the 2008 and 2012 USPSTF recommendations against PSA-based prostate cancer screening,” Giovanni E. Cacciamani, MSc, MD, assistant professor of research urology at Keck School of Medicine of University of Southern California, told Healio.

Rate of metastatic prostate cancer.
Data derived from Desai MM, et al. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.2246.

Background and methodology

In 2012, the USPSTF recommended against routine PSA-based prostate cancer screening for all men. In 2008, it made the same recommendations for men aged older than 75 years.

Cacciamani and colleagues said concern followed that the recommendation could contribute to an increase in the incidence of metastatic prostate cancer. To evaluate the potential impact, they investigated metastatic prostate cancer incidence before and after the USPSTF recommendations against routine screening.

The analysis included 836,282 men with prostate cancer recorded in the SEER database from 2004 to 2018.

Desai and colleagues examined annual age-adjusted incidence rates per 100,000 men with prostate cancer according to race and age, adjusting for age structure and reporting delay from 2004 to 2011. Then they calculated the annual percentage changes (APCs) to quantify the changes in annual incidence rates.

Key findings

Results showed 26,642 (56.5%) of the distant metastatic prostate cancer cases occurred in men aged 45 to 74 years and 20,507 (43.5%) in men aged 75 years or older.

Desai and colleagues found that, among men aged 45 to 74 years, the incidence rate of distant metastatic prostate cancer (SEER Summary staging) remained stable from 2004 to 2010 (APC, 0.4%; 95% CI, 1.7 to 1.1) but increased significantly during 2010 to 2018 (APC, 5.3%; 95% CI, 4.5-6).

Among men aged 75 years or older, the incidence rate of distant metastatic prostate cancer decreased from 2004 to 2011 (APC, 1.5%; 95% CI, 3 to 0) before increasing from 2011 to 2018 (APC, 6.5%; 95% CI, 5.1-7.8). Additionally, researchers found particularly significant increased trends in incidence among non-Hispanic white men (2010-2018 APC, 6.9%; 95% CI, 5.4-8.4).

“The increased metastatic prostate cancer incidence rates occurred despite a significant concurrent reduction in the overall incidence of prostate cancer diagnosis,” Cacciamani said. “Since SEER cannot provide data to assess causality, this trend should be carefully studied further to see if it continues beyond 2018 and whether it is associated with a similar rise in prostate cancer mortality.”

Implications

Cacciamani noted the stark contrast between the increased incidence rates observed in the study and the decreases prior to the USPSTF recommendations.

Giovanni Cacciamani, MD, MS

Giovanni E. Cacciamani

“Although the reasons behind this recent rising incidence are multifactorial, it is unlikely to be due to a true change in cancer biology in such a short period of time. Factors such as environmental exposures or germline mutations leading to changes in epidemiologic signatures of cancers take significantly longer,” Cacciamani said. “Rather, changes in clinical policy and/or practice such as screening strategies and use of diagnostic imaging are much more likely to explain such relatively short-term swings in cancer epidemiologic trends.”

An accompanying editorial also examined the relationship between screening practices and guidelines and prostate cancer incidence, emphasizing the need to strike a balance between early detection and overtreatment.

“Less screening reduces the risks [for] overdiagnosis and overtreatment, but there is a trade-off,” wrote Richard M. Hoffman, MD, MPH, professor of internal medicine, director in the division of general internal medicine, and co-leader of the cancer epidemiology population science program at Carver College of Medicine and University of Iowa Health Care.

“The harms of overtreatment could be mitigated if men with low-risk prostate cancer routinely engage in shared decision-making around treatment choices and are supported in considering active surveillance,” Hoffman concluded. “Although the overall number of cancer diagnoses might not rebound to the level seen before the guideline change, the number of men discussing screening and receiving diagnoses of clinically important treatable cancers could increase. Achieving these outcomes might further reduce morbidity and mortality from prostate cancer, reversing recent metastatic prostate cancer trends and minimizing the harms of overdiagnosis and overtreatment.”

References:

Desai MM, et al. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.2246.
Hoffman RM. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.2174.

Cryptogenic Stroke: Getting at the ‘Unknown Unknowns’

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The U.S. Preventive Services Task Force (USPSTF) finalized its grade A recommendations for blood pressure screening of adults with few changes, citing “substantial” net benefit in preventing stroke, heart failure, and other risks.

The one change in the final version, released online in the Annals of Internal Medicine, was a slight softening of the recommendation to use ambulatory blood pressure monitoring (ABPM) to confirm diagnosis of hypertension measured in-office.

“The USPSTF acknowledges the current barriers to implementation of its recommendation, including the availability and affordability of ABPM,” the task force wrote. “In response, it revised the final recommendation to include home blood pressure monitoring as an alternative method for confirmation of a diagnosis of hypertension when ABPM is not feasible.”

The USPSTF also offered details on how that diagnostic confirmation should be implemented and the industry standards for home blood pressure monitors.

The following is the MedPage Today story outlining the recommendations from when the draft was released on Dec. 22, 2014:

In a draft recommendation statement, the U.S. Preventive Services Task Force is calling for ambulatory blood pressure measurement to confirm hypertension before diagnosis in a draft statement that also advocated more frequent hypertension screening for many adults.

One exception to the grade A recommendation for out-of-office confirmation of hypertension: cases for which therapy should begin immediately.

People 40 and older as well as higher-risk groups should be re-screened every year after a normal blood pressure finding, while others can be screened every 3 to 5 years, the draft statement recommended.

Guidelines have generally advocated every 2 or 5 years for screening intervals, so the shift to annual screening for so many patients will be a major shift, John P. Higgins MD, MBA, MPhil, chief of cardiology at Lyndon B. Johnson General Hospital in Houston, toldMedPage Today.

Change for Practice

American College of Cardiology president-elect Kim A. Williams Sr., MD, chief of cardiology at Rush University Medical Center in Chicago, praised the change to ambulatory confirmation of hypertension.

“This will help solve problems of overestimation of blood pressure in the clinic with the ‘office hypertension’ phenomenon and, in my experience, fully engages patients in the control of the blood pressure,” he told MedPage Today. “When you measure it, you don’t ignore it.”

But just how ambulatory monitoring can be operationalized on a large scale remains to be seen, he noted.

Most physician offices don’t actually have the equipment for ambulatory monitoring,John Bisognano, MD, PhD, director of outpatient cardiology services at the University of Rochester Medical Center in Rochester, N.Y., and president-elect of the American Society of Hypertension, told MedPage Today.

“The guidelines, if put into play, will really have a big change on this because there will be an expectation that every physician’s office, every hypertension specialist’s office, will have one of these devices or many of these devices to confirm the diagnosis of hypertension,” he said.

American Heart Association president Elliott Antman, MD, of Brigham and Women’s Hospital and Harvard University, agreed that the change could present a challenge, although perhaps less so than in the past.

“It makes great sense to perform ambulatory blood pressure monitoring,” he toldMedPage Today. “This has been known for quite a while. The problem was that it has been difficult to implement because of the lack of equipment to do this.”

“Now it’s easier to do,” he said, pointing to the increasing availability of smartphone and table-connected digital wrist or arm-cuff blood pressure devices that patients can use at home and simply email the results to their physician.

Ambulatory monitoring hasn’t been prominent in joint guidelines from the organizations, Antman noted. But he predicted that could change, too.

“It’s quite likely we will see revision to the definition of what constitutes hypertension and of whether treatment has been effective in controlling hypertension,” he suggested in an interview, adding “the hypertension guideline is in the process of being updated. So I know that there will be interest in evaluating ambulatory blood pressure monitoring as part of those recommendations.”

Ambulatory confirmation of hypertension before initiating treatment is already the standard in British practice, Jackson T. Wright Jr., MD, PhD, director of the Clinical Hypertension Program at University Hospitals Case Medical Center in Cleveland, noted in an editorial in the Annals of Internal Medicine.

“Availability of this diagnostic method in the U.S. is currently hindered by the reluctance of insurers to reimburse for it,” he noted. “This review for the U.S. Preventive Services Task Force will hopefully lead to greater availability of ambulatory blood pressure monitoring.”

The Rationale

A supporting evidence review published simultaneously online in the Annals showed that ambulatory blood pressure monitoring was better at predicting long-term cardiovascular outcomes.

Each 10-mmHg higher 24-hour ambulatory systolic blood pressure was associated with 28% to 40% higher risk of fatal or nonfatal events independent of in-office blood pressure measurements across 11 studies meta-analyzed.

The review found that 5% to as many as 65% of patients found to be hypertensive in the office across 27 studies fell in the normal range on confirmatory testing outside the office.

Those with so-called white-coat hypertension had cardiovascular outcomes similar to those normotensive on initial in-office screening, Margaret A. Piper, PhD, MPH, of the Kaiser Permanente Center for Health Research in Portland, and colleagues found.

While the review identified little risk of harm from ambulatory blood pressure monitoring — sleep disturbance, discomfort, and restrictions in daily activities during use of the device — there is potential harm of unnecessary treatment if it’s not used, they noted.

The review wasn’t able to determine a single best interval for repeat screening. The studies showed variably high incidence of hypertension using different intervals of up to 6 years, with higher yield at shorter intervals for those on the high end of the normal blood pressure range and those in certain higher-risk groups.

The USPSTF ended up recommending annual rescreening for the following groups:

  • People ages 40 and older
  • People with blood pressure in the 130/85 to 139/89 mmHg range on the initial screen
  • African Americans
  • Obese or overweight individuals

The screening interval for younger adults without such risk factors after an initial screening with normal blood pressure should be every 3 to 5 years, the draft recommendations said.

U.S. Preventive Services Task Force Revisits Prostate Cancer Screening

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On October 11, 2011, the U.S. Preventive Services Task Force (USPSTF) posted a draft recommendation statement on screening for prostate cancer. In its 2008 guideline on this topic, the USPSTF concluded that evidence was insufficient to make a recommendation in men younger than 75, but it recommended against screening older men (age, 75). Now, 3 years later, the USPSTF recommends against prostate-specific antigen (PSA)-based screening for prostate cancer in all age groups.
The impetus for the USPSTF’s revisiting of PSA screening is the recent publication of mortality results from two large randomized screening trials). A U.S. trial showed no benefit from screening but was tainted by substantial screening outside the trial in the control group. A European trial showed a small statistically significant reduction in prostate cancer mortality in screened men; however, substantial overtreatment occurred (i.e., a very small proportion of men who underwent surgery or radiation therapy ultimately benefited from these interventions), and critics have voiced concerns about certain methodologic issues in this trial, too. In reaching its decision, the USPSTF drew the following conclusions from its review of the evidence:
• The magnitude of harms from screening (e.g., falsely high PSA levels, psychological effects, unnecessary biopsies, overdiagnosis of indolent tumors) is “at least small.”
• The magnitude of treatment-associated harms (i.e., adverse effects of surgery, radiation, and hormonal therapy) is “at least moderate” — particularly because of overtreatment among men with low-grade disease.
• The 10-year mortality benefit of PSA-based prostate cancer screening is “small to none.”
• The overall balance of benefits and harms results in “moderate certainty that PSA-based screening . . . has no net benefit.”
I agree with this draft statement, which is a pre-release review and not the final recommendation. Public comment is invited through November 8, 2011, after which a final statement will be published. Nevertheless, the expected firestorm has erupted already. Advocates of screening have criticized the USPSTF analysis, and the American Urological Association issued a press release stating that “the USPSTF — by disparaging the [PSA] test — is doing a great disservice to the men worldwide who may benefit from the PSA test.” Journal Watch will cover the final recommendation when it is published.

Source:Journal Watch General Medicine