Decades ago, as a busy surgeon, Peter Carroll, MD, MPH, was "becoming increasingly uncomfortable" with issues related to overdetection and overtreatment of prostate cancer.
In the years since, Carroll has helped pioneer the shift towards active surveillance and has developed one of the largest research and clinical programs focused on active surveillance for early stage prostate cancer at the University of California San Francisco.
Pointing to the most recent research on active surveillance, Carroll told Medpage Today, "I think we can say now that in properly-selected men active surveillance appears to be very safe."
In a recently published study in The Journal of Urology, Carroll's team at UCSF reported that active surveillance "seems to preserve favorable long-term prognosis, as metastases and prostate cancer specific death are rare."
In this study they evaluated 1,450 men on active surveillance at UCSF from 1990 to 2018. These were patients with low or intermediate risk disease -- i.e., stage cT1-2, prostate specific antigen less than 20 ng/ml, and biopsy Grade Group (GG) 1-2.
Carroll and his colleagues determined that among this cohort of patients the 7-year metastasis-free survival rate was 99%. They also reported that men with GG2 had poorer metastasis-free survival compared to those with GG1 disease, and that GG2, prostate specific antigen (PSA) velocity, and PI-RADS 4-5 lesions on multiparametric MRI were associated with higher risk of metastases – factors that "should be considered when selecting and counseling patients for active surveillance."
"Relatively long-term data from the surveillance series at UCSF, Johns Hopkins, Toronto, and the European groups, suggest that for properly selected patients -- limited volume, Gleason 3+3 disease -- these men do quite well and they don't seem to need immediate treatment, and active surveillance appears to be safe," Carroll said.
Carroll's team also just published another study in The Journal of Urology looking at the clinical significance of multiple negative surveillance prostate biopsies on men on active surveillance.
A total of 514 men were included in this study, with 112 (22%) men having one negative biopsy and 78 (15%) with a series of them. Carroll's team found that both groups had roughly 80%-90% lower odds of subsequent cancer detection compared with those having positive biopsy findings.
"I've had patients bring up this idea – can my cancer go away?" said Carroll. "These cancers generally don't go away or vanish. They do 'hide.' They are generally small volume tumors, and on some biopsies you pick them up and on others you don't. And having a negative biopsy is a very favorable prognostic sign – so men who have negative biopsies generally have a lower risk of progression over time."
In fact, the study found that unadjusted 10-year treatment-free survival was highest for patients with consecutively negative biopsies (84%) and one negative biopsy (74%) than those who had none (66%).
Another recent study published in JAMA addressed the issue of active surveillance in African-American men.
Research has shown that African-American men are more likely to die from prostate cancer, suggesting that these men may harbor more aggressive disease than non-Hispanic white men (possibly leading to lower active surveillance adoption rates in this population).
The JAMA study, led by Brent Rose, MD, of the University of California San Diego, found that African-American men, compared with non-Hispanic white men, had higher 10-year cumulative incidence of disease progression (59.9% vs 48.3%) and definitive treatment (54.8% vs 41.4%), but no increased risk of metastasis (1.5% vs 1.4%), prostate cancer–specific mortality (1.1% vs 1.0%), or all-cause mortality (22.4% vs 23.5%).
Looking ahead, Carroll said two issues the field should address are making active surveillance less burdensome, as well as expanding the number of patients who may be eligible for the active surveillance approach.
"Early on, in some centers the number of patients who were considered eligible for surveillance were very small numbers, and we thought those numbers could be higher," said Carroll. "I think we know now that some patients, who in the past may not have been considered a good candidate for surveillance, may be good candidates based on the knowledge we have today. A good example of this is patients with low volume, Gleason 3+4 cancer may have not been suitable for surveillance in the past, but may be acceptable now."
Carroll added that the availability of new technology should also expand the number of men who can safely be managed on active surveillance. "With the use of MRI and genomic testing we can make surveillance safer," he said. "One of the big impediments to choosing surveillance – for both patients and physicians – is the thought of missing something. We know now that MRI allows for a refined biopsy and lower risk of missing clinically significant disease. And genomic testing does the same thing. So, both these tests tell us who is more likely to harbor higher risk disease that could have been missed on standard systematic biopsy."
As for decreasing the burden associated with active surveillance, the major goal should be decreasing the frequency of biopsy, Carroll said. For example, he pointed out that men who are at very low risk of progression – patients with low volume, Gleason 3+3 disease, favorable MRIs or genomic profiling, and PSA densities (PSA level in ng/mL divided by prostate gland volume in mL) below 0.15 – have a lower risk of progression and shouldn't necessarily be followed intensively.
"These are patients who may require biopsies at more infrequent intervals, whereas a patient who has average genomics or MRIs may require early confirmatory biopsies and more careful surveillance," he said.
And there are still areas of controversy, Carroll noted, such as the widespread variation in the use of active surveillance in the U.S., and across the world, as well as the best way to define patient risk and follow patients.
"Active surveillance is certainly being refined," said Carroll. "And it is certainly in the mainstream now, where 10 years ago you had considerable resistance to surveillance. And in some parts of the country and the world that is still the case, but I think we are moving towards some level of consensus. We do need more uniform adoption. and a more uniform approach to risk assessment and follow-up."
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