February 17, 2011 — When screening for prostate cancer, a prostate-specific antigen (PSA) level below 3.0 ng/mL might be an appropriate minimum cutoff to determine the need for biopsy, according to the results from a European study.
Findings from the study also show that the higher the initial PSA level, the greater the risk of developing prostate cancer, having more aggressive disease, and dying from prostate cancer.
These findings were discussed at a press conference held ahead of the 2011 Genitourinary Cancers Symposium in Orlando, Florida. One of the conclusions suggested by these data is that — for men with low initial PSA levels — the interval between PSA screens could be greatly increased, maybe to every 8 years, journalists were told.
The results come from a large subset of participants enrolled in the landmark population-based European Randomized Study of Screening for Prostate Cancer. The main results from that study have been reported previously.
Now, the investigators are reporting on the 15,758 (79%) of 19,950 screened men (55 to 74 years) who had an initial PSA level below 3.0 ng/mL.
Meelan Bul, MD, PhD candidate, from the Department of Urology at Erasmus University Medical Center in Rotterdam, the Netherlands, explained that these men underwent rescreens every 4 years. During that time, 915 men were diagnosed with prostate cancer — but there were only 23 disease-related deaths over the median follow-up of 11 years, Dr. Bul reported. The risk for death from prostate cancer when an initial PSA level is below 3.0 ng/mL is "extremely low," she said.
Among the 23 prostate-cancer-related deaths, an initial PSA level of 2.0 to 2.9 ng/mL was 7.6 times more likely to result in death than an initial level below 1.0 ng/mL, and was 4 times more likely to result in death than an initial level of 1.0 to 1.9 ng/mL.
In short, the higher the initial PSA level, the greater the likelihood of a man dying from prostate-cancer-related death, Dr. Bul explained.
New Trigger for Biopsy?
These data suggest that a PSA level of 3.0 ng/mL should trigger a biopsy, whereas various American organizations currently recommend a biopsy at a PSA level of 4 ng/mL, said Nicholas Vogelzang, MD, from US Oncology, who moderated the press conference.
Dr. Vogelzang's comment about the PSA cutoff level also referred to the data from the study on the likelihood of prostate cancer developing and being aggressive.
Among the 915 men with an initial PSA level below 3.0 ng/mL who were found to have prostate cancer over the course of the study, the investigators found that an initial PSA level of 2.0 to 2.9 ng/mL was a resounding 10.3 times more likely to result in prostate cancer than an initial level below 1.0 ng/mL, and 4 times more likely than a level of 1.0 to 1.9 ng/mL, reported Dr. Bul.
Again, the higher the initial PSA level, the greater the likelihood of a problem — in this case, prostate cancer — being found over time.
Of the 915 prostate cancers found, 138 were "aggressive." Dr. Bul added. These aggressive cancers were 6.24 times more likely to occur in men with a higher initial PSA level (2.0 to 2.9 ng/mL) than in those with a lower level (below 1.0 ng/mL), she told reporters.
The median time to diagnosis revealed that a higher initial PSA level indicates the need for more frequent monitoring, and that men with lower levels could have much longer intervals between screens.
Of the 915 prostate cancers found, the median time to diagnosis was 4.2 years for men with an initial level of 2.0 to 2.9 ng/mL — which is much shorter than the 8.3 years for an initial level of 1.0 to 1.9 ng/mL and the 8.1 years for an initial level below 1 ng/mL.
"Personalization" of PSA Screening
"The favorable outcome in men with initial PSA values less than 1.0 ng/mL, which was 45% of the men, supports prolongation of the screening interval," said Dr. Bul, adding that the interval could be up to 8 years.
"The personalization of PSA screening is underway," said Dr. Vogelzang about these findings and others. "Annual screening is going to become a thing of the past."
"It's like colonoscopy," he said, adding that patients with a negative colon exam "don't need another for 10 years."
This study is "quite helpful," Dr. Vogelzang said, in the effort to "reduce the intensity and frequency of screening" for prostate cancer.
"We now know more about prostate cancer detected by PSA screening in men with initial PSA scores of less than 3.0," summarized Dr. Bul in a press statement. "Our results strengthen the justification of the use of PSA in risk stratification for screening purposes. This means that we can possibly avoid unnecessary testing, diagnosis, and treatment of less aggressive disease, with the accompanying side effects, by focusing biopsies and other follow-up on men with initial PSA levels above 3.0 ng/mL."
Dr. Vogelzang reports a leadership position at US Oncology; serving as a consultant for Amgen, Aveo, Bayer, Celgene, Dendreon, Eisai, GE Healthcare, Genentech, GlaxoSmithKline, Medscape, Novartis, Pfizer, Sanofi-Aventis, and Wilex; and receiving honoraria from Amgen, ArQule, Bayer, Clinical Care Options, Cougar Biotechnology, Genentech, Imedex, Lilly Lippincott, Williams and Wilkins, Medscape, Novartis, Onyx, Pfizer, and Veridex.
2011 Genitourinary Cancers Symposium (GUCS). Oral abstract session. Presented February 17, 2011.
Findings from the study also show that the higher the initial PSA level, the greater the risk of developing prostate cancer, having more aggressive disease, and dying from prostate cancer.
These findings were discussed at a press conference held ahead of the 2011 Genitourinary Cancers Symposium in Orlando, Florida. One of the conclusions suggested by these data is that — for men with low initial PSA levels — the interval between PSA screens could be greatly increased, maybe to every 8 years, journalists were told.
The results come from a large subset of participants enrolled in the landmark population-based European Randomized Study of Screening for Prostate Cancer. The main results from that study have been reported previously.
Now, the investigators are reporting on the 15,758 (79%) of 19,950 screened men (55 to 74 years) who had an initial PSA level below 3.0 ng/mL.
Meelan Bul, MD, PhD candidate, from the Department of Urology at Erasmus University Medical Center in Rotterdam, the Netherlands, explained that these men underwent rescreens every 4 years. During that time, 915 men were diagnosed with prostate cancer — but there were only 23 disease-related deaths over the median follow-up of 11 years, Dr. Bul reported. The risk for death from prostate cancer when an initial PSA level is below 3.0 ng/mL is "extremely low," she said.
Among the 23 prostate-cancer-related deaths, an initial PSA level of 2.0 to 2.9 ng/mL was 7.6 times more likely to result in death than an initial level below 1.0 ng/mL, and was 4 times more likely to result in death than an initial level of 1.0 to 1.9 ng/mL.
In short, the higher the initial PSA level, the greater the likelihood of a man dying from prostate-cancer-related death, Dr. Bul explained.
New Trigger for Biopsy?
These data suggest that a PSA level of 3.0 ng/mL should trigger a biopsy, whereas various American organizations currently recommend a biopsy at a PSA level of 4 ng/mL, said Nicholas Vogelzang, MD, from US Oncology, who moderated the press conference.
Dr. Vogelzang's comment about the PSA cutoff level also referred to the data from the study on the likelihood of prostate cancer developing and being aggressive.
Among the 915 men with an initial PSA level below 3.0 ng/mL who were found to have prostate cancer over the course of the study, the investigators found that an initial PSA level of 2.0 to 2.9 ng/mL was a resounding 10.3 times more likely to result in prostate cancer than an initial level below 1.0 ng/mL, and 4 times more likely than a level of 1.0 to 1.9 ng/mL, reported Dr. Bul.
Again, the higher the initial PSA level, the greater the likelihood of a problem — in this case, prostate cancer — being found over time.
Of the 915 prostate cancers found, 138 were "aggressive." Dr. Bul added. These aggressive cancers were 6.24 times more likely to occur in men with a higher initial PSA level (2.0 to 2.9 ng/mL) than in those with a lower level (below 1.0 ng/mL), she told reporters.
The median time to diagnosis revealed that a higher initial PSA level indicates the need for more frequent monitoring, and that men with lower levels could have much longer intervals between screens.
Of the 915 prostate cancers found, the median time to diagnosis was 4.2 years for men with an initial level of 2.0 to 2.9 ng/mL — which is much shorter than the 8.3 years for an initial level of 1.0 to 1.9 ng/mL and the 8.1 years for an initial level below 1 ng/mL.
"Personalization" of PSA Screening
"The favorable outcome in men with initial PSA values less than 1.0 ng/mL, which was 45% of the men, supports prolongation of the screening interval," said Dr. Bul, adding that the interval could be up to 8 years.
"The personalization of PSA screening is underway," said Dr. Vogelzang about these findings and others. "Annual screening is going to become a thing of the past."
"It's like colonoscopy," he said, adding that patients with a negative colon exam "don't need another for 10 years."
This study is "quite helpful," Dr. Vogelzang said, in the effort to "reduce the intensity and frequency of screening" for prostate cancer.
"We now know more about prostate cancer detected by PSA screening in men with initial PSA scores of less than 3.0," summarized Dr. Bul in a press statement. "Our results strengthen the justification of the use of PSA in risk stratification for screening purposes. This means that we can possibly avoid unnecessary testing, diagnosis, and treatment of less aggressive disease, with the accompanying side effects, by focusing biopsies and other follow-up on men with initial PSA levels above 3.0 ng/mL."
Dr. Vogelzang reports a leadership position at US Oncology; serving as a consultant for Amgen, Aveo, Bayer, Celgene, Dendreon, Eisai, GE Healthcare, Genentech, GlaxoSmithKline, Medscape, Novartis, Pfizer, Sanofi-Aventis, and Wilex; and receiving honoraria from Amgen, ArQule, Bayer, Clinical Care Options, Cougar Biotechnology, Genentech, Imedex, Lilly Lippincott, Williams and Wilkins, Medscape, Novartis, Onyx, Pfizer, and Veridex.
2011 Genitourinary Cancers Symposium (GUCS). Oral abstract session. Presented February 17, 2011.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου