Σάββατο, 20 Μαΐου 2017

WATCHFUL WAITING SAFE FOR YOUNGER PATIENTS WITH LOW RISK PROSTATE CANCER

Active surveillance is a safe and effective treatment option for young men (<60 2017="" a="" according="" american="" annual="" association="" at="" cancer="" cohort="" here="" low-risk="" meeting.="" new="" p="" presented="" prostate="" study="" the="" to="" urological="" with="" years="">
However, judging by comments made at the meeting, that message may be hard to hear and accept, even at academic medical centers.
Men younger than 60 years have outcomes that are "comparable" to those reported in the literature for older men, said lead study author Keyan Salari, MD, chief resident in urologic surgery at Massachusetts General Hospital (MGH) in Boston.
The new study involved 432 young men with low-risk disease who were managed with surveillance between 1990 and 2016 at MGH (n = 181) and Sunnybrook Health Sciences Center in Toronto, Ontario, Canada (n = 251).
Metastasis-free survival was 99.7% and 97.5% at 5 and 10 years, respectively.
Five patients developed metastasis (two with positive lymph nodes at time of radical prostatectomy, three with distant metastasis). There were no prostate-cancer specific deaths. The median follow-up was 5.1 years.
Typically, men of this younger age are counseled into treatment, said Dr Salari. That is because of their longer life expectancy, fewer comorbidities (compared with older men), and perceived likelihood of eventually needing definitive treatment.
There also have not been many data to indicate that watching these younger men was okay.
However, the new retrospective data provide evidence that it is more than okay, suggested Dr Salari.
There is "no need for hesitancy," he said, adding that men younger than 60 years "shouldn't be excluded" from active surveillance. The criteria for active surveillance are "expanding," he commented.
But there is, and has been, hesitancy about including younger men, even at a pioneering active surveillance center like MGH, said another coauthor.
"The data for younger men are especially important. Even some of our colleagues at MGH are hesitant to place younger men on active surveillance," said Adam Feldman, MD, a urologist at MGH who also attended the news conference and spoke up from the audience.
The new data include the estimation that 74.3% of the men were free from treatment at 5 years, and 55.4% at 10 years.
"This is very compelling for young men who at least want to delay radical treatment for a period of years," said Stacy Loeb, MD, a urologist at New York University in New York City, who acted as the news conference moderator.
It is a durable option, with very few men developing metastases and more than half free from treatment at 10 years, she summarized.
It really is possible for young men to do this. Dr Stacy Loeb
In Sweden, among men 50 to 59 years old, 88% of very low risk patients and 68% of low-risk patients were managed with active surveillance in 2014, Dr Loeb also pointed out. "It really is possible for young men to do this," she said.

Who Is Likely to Progress to Treatment 

In a 432-patient study population, the median prostate-specific antigen (PSA) level was 4.6 ng/mL, with only 11 of the men having PSA levels of 10 ng/mL or higher. Almost all the patients had Gleason 6 or lower (97.7%) and clinical stage T1 (91.9%) disease.
Dr Salari reported that 84.3% of the men had a repeat biopsy, with 62.6% showing prostate cancer, 24.5% benign, 7.7% with prostatic intraepithelial neoplasia, and 5.2% with atypia. The high proportion of benign follow-up biopsies were a result of sampling errors that are to be expected because of the imprecision of ultrasound-guided biopsies and the presence of so many low-volume tumors, said Dr Salari.
Over time, 131 men (30.3%) progressed to treatment for the following reasons: pathologic progression (64.1%), PSA progression (18.3%), patient preference (11.5%), volume progression (3.1%), and other reasons (3.1%).
Dr Salari said there were only two predictors of progression to treatment, and both conferred about a doubling of risk compared with patients who did have the measures.
Namely, patients who had more than 20% tumor tissue in any one biopsy core (compared with those with 20% or less in all of their cores) were nearly twice as likely to move onto treatment (hazard ratio, 1.87; P = .0016), as were patients with PSA density of 0.15 or higher (compared with those with less; hazard ratio, 1.98; P = .01).
Among the 131 treated patients, 62.6% underwent radical prostatectomy, 13.0% underwent high-intensity focal ultrasound therapy, 12.2% underwent external beam radiation, and 10.7% had brachytherapy.
Among the surgery patients, pathologic review after surgery showed that 88.2% (60/68) were pT2, and 11.8% (8/68) were pT3.
Active surveillance of men younger than 60 years "spares most men from intervention," and allows "adequate time" for intervention for most, concluded Dr Salari.
Dr Salari and Dr Feldman have disclosed no relevant financial relationships. Dr Loeb has disclosed financial relationships with MDx Health, Armune BioScience, Minomic, Boehringer Ingelheim, GenomeDx Biosciences, and Astellas.

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