Active surveillance for men with low-risk prostate cancer has made it to prime time. That was the message of Stacy Loeb, MD, who moderated a press conference at the AUA annual meeting, where four studies documented the increasing popularity and safety of active surveillance in managing low-risk disease.
New Orleans-Active surveillance for men with low-risk prostate cancer has made it to prime time.
That was the message of Stacy Loeb, MD, who moderated a press conference at the AUA annual meeting, where four studies documented the increasing popularity and safety of active surveillance in managing low-risk disease. The panel included experts from Johns Hopkins University in Baltimore, the University of California, Los Angeles, and New York University, New York, where Dr. Loeb is assistant professor of urology.
For years, Dr. Loeb said prostate cancer has been over-diagnosed and over-treated, but recent data suggest that active surveillance is helping to address the problem.
“Active surveillance use is really expanding rapidly. It has finally hit the prime time and is not experimental treatment anymore. Now, this is really what we should be promoting for our patients,” Dr. Loeb told Urology Times.
Data presented by researchers from John Hopkins found active surveillance appears to be a safe management strategy in carefully selected men with favorable-risk prostate cancer.
“The cumulative risk of death in these favorable-risk men whom we were watching very closely was 24 times greater for non-prostate cancer death as compared to prostate cancer death or metastatic disease even,” said Jeffrey Tosoian, MD, a urology resident at Johns Hopkins working with H. Ballentine Carter, MD, and colleagues.
In this long-term study, favorable-risk patients were defined as those with a Gleason score ≤6 and a PSA level of ≤10.0 ng/mL. Dr. Tosoian and colleagues evaluated data from 1,298 men diagnosed since 1995 for overall survival, cancer-specific survival, and metastasis-free survival. At 10- and 15-year follow-up, overall survival was 93.2% and 68.7%, cancer-specific survival was 99.9% and 99.9%, and metastasis-free survival was 99.4% and 99.4%, respectively. The data suggest that for men with an extended life expectancy of more than 15 years, active surveillance may be the safest management strategy in men with very low-risk disease.
“Screening for prostate cancer is very important to find it at an early stage so men with life-threatening disease can get curative treatment, but for men with favorable-risk disease, there is now very strong data and excellent new data from John Hopkins showing that active surveillance is durable and safe even at 10 years and 15 years,” said Dr. Loeb.
Dr. Loeb says she believes this type of data shows significant improvement and gives hope to patients.
“At the John Hopkins active surveillance program at 10 years, 50% of the men were still on surveillance, which is huge,” she said. “That’s 50% of the men who avoided any kind of treatment at 10 years. This is really excellent news and hopefully gives more patients reassurance that this is a safe strategy. This is what we should be encouraging for patients with favorable cancers in order to reduce the harms [of treatment].”
Johns Hopkins researchers also presented data that suggest men on active surveillance with low-risk prostate cancer can expect the likelihood of disease reclassification to decline with each additional stable biopsy after 2 years. Low-risk prostate cancer can be defined as T1 or T2a disease with a Gleason score ≤6. Patients with low-risk prostate cancer have standard PSA levels of <10.0 ng/mL. The subcategory of very low-risk prostate cancer has the most favorable results. These men have clinical stage T1c disease with a Gleason score of ≤6. Patients with very low-risk prostate cancer a PSA density less than 0.15. On biopsy, these patients have no more than two cores with cancer, and the positive cores have no more than 50% cancer.
Among 808 men identified on active surveillance (557 with very-low-risk disease and 251 with low-risk disease), researchers found similar reclassification rates within the first 2 years. After this period, however, men in the low-risk group were twice as likely to be diagnosed with progressing disease (Gleason score >6) compared to those in the very low-risk group. For both, risk of lifetime reclassification beyond 2 years decreased by 30% and 35%, respectively, after each non-reclassifying biopsy.
“After 2 years, the reclassification rates were higher in men with low-risk as opposed to very-low-risk disease and the lifetime risk of reclassification declined substantially with each biopsy not showing any sort of disease reclassification,” said Ridwan Alam, a medical student at Johns Hopkins, who worked with Dr. Carter, Mufaddal Mamawala, MBBS, MPH, and colleagues. “These findings may help to reassure men and help reduce the dropout rate that we saw earlier, which was between 3% and 18%, by giving them this sense of security that we can really trust the data, trust the decisions that we offer.
“On top of that, they may also allow for an increased interval between biopsies in long-term compliant men. So even though prostate biopsies are relatively safe, they do have some sort of risk with them, in terms of infection, bleeding, and general discomfort.”
The increase in active surveillance adoption appears to be nationwide. In a study from UCLA and other institutions, of 1,401 men identified as meeting study inclusion criteria (a minimum of 6 months of documented follow-up from initial diagnosis), the average age was 63.6 years. In addition, based on data from community-based urology practices in California, Colorado, Indiana, North Carolina, Ohio, Oregon, and South Carolina, 17.3% had very low-, 36.1% had low- and 42.7% had intermediate-risk prostate cancer. Across all risk groups, the primary therapy choice was active surveillance (70.2% of men with very low, 39.2% of those with low, and 7.7% of those with intermediate risk of progression).
Risk level, age, and urology practice predicted choice of active surveillance, while race did not.
“We found that active surveillance appears to be adopted rapidly by urologists practicing in large community groups. The patterns of care delivery appear to be consistent with guidelines and principals of disease management and that variation by practice is an opportunity for additional education and quality improvement efforts, which are facilitated greatly by having this kind of data,” said first author Jeremy Shelton, MD, MSHS, a urologist at UCLA.
In a fourth study, however, Dr. Loeb and colleagues found that despite a global increase in active surveillance for men with low-risk prostate cancer, there is no consensus on the protocol to use when following men, and practice patterns vary widely. Reviewing records for 5,192 men from the SEER-Medicare linked dataset, NYU researchers found that although most men receive at least one PSA test per year, rates of imaging and biopsies declined over time, as did the number of patients adhering to active surveillance protocols. Younger men and those diagnosed in more recent years had a higher frequency of surveillance biopsies.
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