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Active surveillance should be standard for favorable-risk prostate cancer
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Long-term follow-up data supports the use of active surveillance for men with favorable-risk prostate cancer, according to prospective study results.
These men should be informed of the the low likelihood of harm from their diagnosis and encouraged to consider active surveillance over a curative approach, according to researchers.
H. Ballentine Carter, MD, director of the division of adult urology at the Brady Urological Institute and the Bernard L. Schwartz distinguished professor of urologic oncology at Johns Hopkins Medicine, and colleagues sought to assess the long-term outcomes for men with favorable-risk prostate cancer in a prospective, active surveillance program.
OS, cancer-specific survival and metastasis-free survival served as the primary outcomes.
Secondary outcomes focused on reclassification of disease and curative intervention, as well as biochemical recurrence among men who underwent treatment.
“Overtreatment of low-risk disease is common and problematic, especially among older men for whom treatment is not likely to improve health outcomes,” Carter and colleagues wrote. “With concurrent goals of reducing overtreatment and identifying lethal tumors while curable, active surveillance has evolved into a well-accepted management strategy for appropriately selected men.”
Carter and colleagues evaluated data 1,298 men (median age, 66 years; range, 41-92 years) with favorable-risk prostate cancer — or low risk or very low risk — who enrolled onto active surveillance between 1995 and 2014.
Median follow-up was 4 years (range, 0.01-18 years) for patients who remained at risk and 5 years (0.01-18 years) for all patients from time of enrollment to their most recent follow-up.
As of June 2014, 50% of the cohort was still active in the program. Thirty-six percent of the men eventually had a curative intervention, whereas the other 14% were undecided about their treatment modality, withdrew from the study, were lost to follow-up or died. Forty-nine patients died; however, only two patients died as a result of their prostate cancer.
At 10 years, the rate of OS was 93%, cancer-specific survival was 99.9% and metastasis-free survival was 99.4% for the entire cohort.
At 15 years, OS was 69%, cancer-specific survival was 99.9% and metastasis-free survival was 99.4%.
Tumor grade reclassification occurred in 26% of the cohort at 10 years and 31% at 15 years, leading to a 50% incidence of curative intervention at 10 years and 57% incidence at 15 years. The median treatment-free survival was 8.5 years (range, 0.01-18 years).
Factors associated with the reclassification of tumor grade included older age (HR = 1.03 for each additional year; 95% CI, 1.01-1.06), PSA density (HR = 1.21 per 0.1 unit increase; 95% CI, 1.12-1.46) and a higher number of biopsy cores (HR = 1.47 for each additional positive core; 955 CI, 1.26-1.69).
Factors associated with intervention included PSA density (HR = 1.38 per 0.1 unit increase; 95% CI, 1.22-1.56) and a higher amount of biopsy cores (HR = 1.35 for 1 additional positive core; 95% CI, 1.19-1.53).
Despite its prospective nature, there were some study limitations. Follow-up was incomplete, meaning the reported 15-year rates were based on a small sample size of men who remained at risk. However, researchers noted the 10-year rates may be considered a valid endpoint.
Secondly, the cohort was made up of mostly white men (88.4%), meaning the results may not be applicable to other ethnicities. These is important because other studies have found that black men may have more aggressive tumor biology in prostate cancer than whites, according to the researchers.
Finally, active surveillance was not offered to men with a Gleason score greater than 6, so the findings do not apply to men with more extensive low-grade disease.
“Our data suggest that, for men with favorable-risk prostate cancer, the paradigm of immediate intervention must be replaced by one of immediate contemplation — a thoughtful assessment of prognostic risk, life expectancy, and the relative risks and benefits of available management options considered in the context of personal preferences,” Carter and colleagues concluded.
The concept of active surveillance for prostate cancer requires personalization for each individual patient, as certain subgroups who may be lumped in to larger group data may have different outcomes, Anthony V. D’Amico, MD, PhD, chief of the division of genitourinary radiation oncology at Dana-Farber Cancer Institute and professor of radiation oncology at Harvard Medical School, wrote in an accompanying editorial.
“I offer a suggestion that our attention should shift away from establishing that long-term rates of metastasis and death as a result of prostate cancer are low for a population of men diagnosed with favorable-risk prostate cancer who are observed on an active surveillance protocol or who are randomly assigned to active surveillance versus intervention,” D’Amico wrote.
“Rather, we should focus on defining a validated risk assessment scheme that is based on a panel of cancer and patient factors capable of determining whether an individual man of a given age, health and ethnicity and with specific tumor characteristics, family history and perhaps multiparametric MRI imaging characteristics, is best served by being observed on an active surveillance protocol.” – by Anthony SanFilippo
Disclosure: Carter and D’Amico report no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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