Finasteride (Proscar) reduced the risk for prostate cancer by nearly 25% in the large Prostate Cancer Prevention Trial (PCPT), which was conducted in men 55 years and older.
But this finding begs the question of who to recommend the drug to, say the authors of a new analysis published online February 1 in the Journal of Clinical Oncology.
Despite the encouraging findings of the PCPT, the use of finasteride to prevent cancer in the community remains low and is not widely used, explained lead author Andrew Vickers, PhD, associate attending research methodologist at Memorial Sloan-Kettering Cancer Center in New York City.
"This suggests that, for the average man, the benefits of finasteride, in terms of reduced risk, do not outweigh the harms," he told Medscape Oncology.
The analysis conducted by Dr. Vickers and colleagues found that risk-group stratification for treatment with finasteride is "unlikely to be beneficial for preventing all prostate cancers detectable at biopsy." But if cancers found as a result of routine clinical care are used as an end point, then the optimal strategy would be to treat a subgroup of men at high risk rather than the whole at-risk population, they write.
The interpretation of these results, in relation to whether finasteride should be used as chemopreventive therapy for all men or for only for those at higher risk, depends on the relative clinical significance of cancers found during the end-of-study biopsy, the authors explain.
Basically, clinicians should recommend finasteride to all men if they want to reduce the risk for any biopsy-detectable prostate cancer.
However, "clinicians who believe that it is unnecessary to prevent all cancers, but that preventing those readily detectable by screening is desirable, would be best off recommending finasteride only to a high-risk subgroup," they write.
Balancing Benefit and Harms
The primary adverse effect associated with finasteride is decreased sexual function, the authors explain. Even though this effect is generally mild, the reduction in libido can be experienced immediately. Conversely, men at higher risk have a greater potential benefit from finasteride. Therefore, note the authors, a strategy that focuses on high-risk men might tip the balance between the benefits and harms of finasteride in favor of treatment.
"Along with many other groups, we have shown that the risk of getting prostate cancer over the course of next 5 to 10 years is strongly dependent on your PSA [prostate-specific antigen] level," said Dr. Vickers. "If you have a high PSA level, you are naturally a candidate for immediate biopsy. But even among those who are not candidates for biopsy, higher PSA means higher risk."
As an example, few clinicians would consider biopsying a man with a PSA of 0.8 ng/mL or one with a PSA of 1.6 ng/mL. "However, the man with the PSA of 1.6 ng/mL has a much higher risk of being diagnosed with prostate cancer over the next 5 to 10 years," he said.
Dr. Vickers explained that, in this study, he and his colleagues demonstrate that not only is the risk higher with increasing PSA, but the effects of finasteride are larger for men with a higher PSA level. "For example, the risk of cancer goes down by about 1% for the man with a PSA of 0.8 ng/mL but nearly 3% for the man with a PSA of 1.6 ng/mL," he said.
"We go on to show, using decision analysis, that it makes the most sense to offer finasteride not to all men at risk for prostate cancer, but only to men with a PSA above 1.3 ng/mL or those with a PSA above 2 ng/mL," Dr. Vickers continued. "Whether you choose 2 or 1.3 ng/mL for your cut-point depends on your views about the relative benefits and harms of taking finasteride."
A patient who is anxious about prostate cancer might be advised to take finasteride for a PSA of 1.5 ng/mL, for example, whereas one who prefers not to take drugs unless needed might be advised to take finasteride if his PSA is above 2 ng/mL, he added.
Study Details
In the current study, Dr. Vickers and colleagues used raw data from the PCPT to model chemopreventive treatment strategies to determine whether PSA levels can identify a high-risk subgroup in which the benefits of finasteride treatment outweigh the potential harm.
For their analysis, they weighed the benefits and harms for each strategy using number-needed-to-treat (NNT) thresholds, or the maximum number of patients that a clinician would need to treat with finasteride to prevent 1 cancer.
Their analysis consisted of 9058 men, 1957 of whom were diagnosed with prostate cancer during the 7-year study period: 798 (18.3%) men were in the finasteride group and 1159 (24.7%) were in the placebo group. Demographic characteristics such as baseline PSA, age, race, and family history were similar in both groups.
The overall risk of being diagnosed with cancer was 21.6% and, in both groups, approximately half of all cancers were detected by a biopsy that followed an elevated PSA level and/or an abnormal digital rectal exam result.
The authors observed that PSA levels were significantly associated with the outcome of all cancers and for-cause cancers (P < .001 for both). The data were divided into approximate quintiles according to baseline PSA, and then the clinical net benefit of treating by each of these cut points was determined.
They note that for the outcome of detecting all cancers, it is difficult to justify stratifying the population into risk groups and treating only men who are at high risk. For an extremely conservative clinician, such as one who would treat no more than 10 men to prevent 1 cancer, the highest clinical net benefit would be obtained from treating only the highest quintile of the population. But for the other NNT threshold, they write, the optimal strategy would be to treat either all men at risk or all but the lowest-risk quintile.
If only cancers that are detected by a for-cause biopsy are considered, "there is a clear case for recommending finasteride to some, but not all, men," they write. The optimal strategy, across all NNT thresholds, is to treat either 20% or 40% of those with the highest PSA levels. If only men with a PSA of 1.3 ng/mL or greater are given finasteride, the treatment rate would be reduced by 62%, with only a small increase in the event rate (from 9.6% to 9.9%).
Restricting the use of finasteride to men with a PSA of greater than 2 ng/mL would reduce the treatment rate by 83% and result in a cancer rate only 1.1% higher than treating all men, they note.
The study was supported in part by funds from David H. Koch provided through the Prostate Cancer Foundation, the Sidney Kimmel Center for Prostate and Urologic Cancers, and a SPORE grant from the National Cancer Institute. Dr. Vickers and coauthor Hans Lilja, MD, PhD, also from Memorial Sloan-Kettering Cancer Center, report receiving honoraria from GlaxoSmithKline. Hans Lilja also reports owning stock in Arctic Partners Oy.
But this finding begs the question of who to recommend the drug to, say the authors of a new analysis published online February 1 in the Journal of Clinical Oncology.
Despite the encouraging findings of the PCPT, the use of finasteride to prevent cancer in the community remains low and is not widely used, explained lead author Andrew Vickers, PhD, associate attending research methodologist at Memorial Sloan-Kettering Cancer Center in New York City.
"This suggests that, for the average man, the benefits of finasteride, in terms of reduced risk, do not outweigh the harms," he told Medscape Oncology.
The analysis conducted by Dr. Vickers and colleagues found that risk-group stratification for treatment with finasteride is "unlikely to be beneficial for preventing all prostate cancers detectable at biopsy." But if cancers found as a result of routine clinical care are used as an end point, then the optimal strategy would be to treat a subgroup of men at high risk rather than the whole at-risk population, they write.
The interpretation of these results, in relation to whether finasteride should be used as chemopreventive therapy for all men or for only for those at higher risk, depends on the relative clinical significance of cancers found during the end-of-study biopsy, the authors explain.
Basically, clinicians should recommend finasteride to all men if they want to reduce the risk for any biopsy-detectable prostate cancer.
However, "clinicians who believe that it is unnecessary to prevent all cancers, but that preventing those readily detectable by screening is desirable, would be best off recommending finasteride only to a high-risk subgroup," they write.
Balancing Benefit and Harms
The primary adverse effect associated with finasteride is decreased sexual function, the authors explain. Even though this effect is generally mild, the reduction in libido can be experienced immediately. Conversely, men at higher risk have a greater potential benefit from finasteride. Therefore, note the authors, a strategy that focuses on high-risk men might tip the balance between the benefits and harms of finasteride in favor of treatment.
"Along with many other groups, we have shown that the risk of getting prostate cancer over the course of next 5 to 10 years is strongly dependent on your PSA [prostate-specific antigen] level," said Dr. Vickers. "If you have a high PSA level, you are naturally a candidate for immediate biopsy. But even among those who are not candidates for biopsy, higher PSA means higher risk."
As an example, few clinicians would consider biopsying a man with a PSA of 0.8 ng/mL or one with a PSA of 1.6 ng/mL. "However, the man with the PSA of 1.6 ng/mL has a much higher risk of being diagnosed with prostate cancer over the next 5 to 10 years," he said.
Dr. Vickers explained that, in this study, he and his colleagues demonstrate that not only is the risk higher with increasing PSA, but the effects of finasteride are larger for men with a higher PSA level. "For example, the risk of cancer goes down by about 1% for the man with a PSA of 0.8 ng/mL but nearly 3% for the man with a PSA of 1.6 ng/mL," he said.
"We go on to show, using decision analysis, that it makes the most sense to offer finasteride not to all men at risk for prostate cancer, but only to men with a PSA above 1.3 ng/mL or those with a PSA above 2 ng/mL," Dr. Vickers continued. "Whether you choose 2 or 1.3 ng/mL for your cut-point depends on your views about the relative benefits and harms of taking finasteride."
A patient who is anxious about prostate cancer might be advised to take finasteride for a PSA of 1.5 ng/mL, for example, whereas one who prefers not to take drugs unless needed might be advised to take finasteride if his PSA is above 2 ng/mL, he added.
Study Details
In the current study, Dr. Vickers and colleagues used raw data from the PCPT to model chemopreventive treatment strategies to determine whether PSA levels can identify a high-risk subgroup in which the benefits of finasteride treatment outweigh the potential harm.
For their analysis, they weighed the benefits and harms for each strategy using number-needed-to-treat (NNT) thresholds, or the maximum number of patients that a clinician would need to treat with finasteride to prevent 1 cancer.
Their analysis consisted of 9058 men, 1957 of whom were diagnosed with prostate cancer during the 7-year study period: 798 (18.3%) men were in the finasteride group and 1159 (24.7%) were in the placebo group. Demographic characteristics such as baseline PSA, age, race, and family history were similar in both groups.
The overall risk of being diagnosed with cancer was 21.6% and, in both groups, approximately half of all cancers were detected by a biopsy that followed an elevated PSA level and/or an abnormal digital rectal exam result.
The authors observed that PSA levels were significantly associated with the outcome of all cancers and for-cause cancers (P < .001 for both). The data were divided into approximate quintiles according to baseline PSA, and then the clinical net benefit of treating by each of these cut points was determined.
They note that for the outcome of detecting all cancers, it is difficult to justify stratifying the population into risk groups and treating only men who are at high risk. For an extremely conservative clinician, such as one who would treat no more than 10 men to prevent 1 cancer, the highest clinical net benefit would be obtained from treating only the highest quintile of the population. But for the other NNT threshold, they write, the optimal strategy would be to treat either all men at risk or all but the lowest-risk quintile.
If only cancers that are detected by a for-cause biopsy are considered, "there is a clear case for recommending finasteride to some, but not all, men," they write. The optimal strategy, across all NNT thresholds, is to treat either 20% or 40% of those with the highest PSA levels. If only men with a PSA of 1.3 ng/mL or greater are given finasteride, the treatment rate would be reduced by 62%, with only a small increase in the event rate (from 9.6% to 9.9%).
Restricting the use of finasteride to men with a PSA of greater than 2 ng/mL would reduce the treatment rate by 83% and result in a cancer rate only 1.1% higher than treating all men, they note.
The study was supported in part by funds from David H. Koch provided through the Prostate Cancer Foundation, the Sidney Kimmel Center for Prostate and Urologic Cancers, and a SPORE grant from the National Cancer Institute. Dr. Vickers and coauthor Hans Lilja, MD, PhD, also from Memorial Sloan-Kettering Cancer Center, report receiving honoraria from GlaxoSmithKline. Hans Lilja also reports owning stock in Arctic Partners Oy.
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