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Finasteride And Dutasteride Raise Risk Of High-Grade Prostate Cancer, FDA Informs
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Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology; Regulatory Affairs / Drug Approvals
Article Date: 10 Jun 2011 - 7:00 PDT
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Although finasteride and dutasteride lower overall risk of developing prostate cancer, they raise the chances of developing high-grade prostate cancer, a more serious form of the disease, the FDA (Food and Drug Administration) has announced. The Agency adds that the risk is low; but doctors need to be aware of this.
The FDA announced that all 5-alpha reductase inhibitor (5-ARI) medications will now have new safety information about the risk of developing high-grade prostate in their labeling, in the Warnings and Precautions section.
Examples of 5-ARI class medications include finasteride (Proscar, Propecia), dutasteride (Avodart), turosteride, bexlosteride and izonsteride. They are drugs with antiandrogenic activity and are used to treat benign prostatic hyperplasia (prostate gland enlargement) and androgenic alopecia (hair loss, baldness).
The FDA evaluated two randomized controlled trials - PCPT (the Prostate Cancer Prevention Trial), which compared finasteride 5mg against placebo for 7 years, and REDUCE (Reduction by Dutasteride of Prostate Cancer Events trial), which compared dutasteride 0.5 mg against placebo for 4 years. Both trials were measuring prostate cancer risk reduction in males aged 50+ years.
Even though both studies demonstrated an overall reduction in prostate cancer risk with both drugs, they also showed a higher risk of high-grade prostate cancer.
High-grade prostate cancer (Gleason score between 8 and 10) is the most deadly form of prostate cancer. It is an aggressive cancer which grows and spreads into surrounding areas rapidly. The cancer cells are large, very difficult to treat, and frequently reappear.
The FDA stresses that patients should talk to their doctors first before deciding on whether to change or stop any prescription medication.
Finasteride is marketed by Merck. Dutasteride is marketed by GlaxoSmithKline.
Written by Christian Nordqvist
View drug information on dutasteride; Propecia; Proscar.
Copyright: Medical News Today
Sunday, June 12, 2011
Friday, June 10, 2011
Androgen Ablation &Bone Metastasis
Androgen Ablation
Androgen deprivation therapy (ADT) is commonly used in the treatment of prostate cancer.53 Survival in men with nonmetastatic prostate cancer treated with ADT is long, with a median survival of greater than 7 years.54 Hence, long-term effects on bones are of particular concern. At least one study has also suggested skeletal fractures as an adverse predictor of overall survival in men with prostate cancer.55
Even at baseline, men with prostate cancer who have not received ADT have a higher incidence of osteoporosis than the general age-matched population.56 Effects of hormone treatment most likely compound the problem.21
A Danish case-control registry study compared more than 15,000 men aged older than 50 years who had fractures with 45,000 men who did not. The authors found that a diagnosis of prostate cancer was associated with an increased odds ratio (OR) for fracture of 1.8 (95% CI, 1.6-2.1) and ADT was associated with an increased OR of 1.7 (95% CI, 1.2-2.5). It was noted that the increased risk became apparent soon after diagnosis and persisted even in long-term survivors.57
Retrospective cohort studies of men who have survived prostate cancer for many years have demonstrated that ADT therapy is associated with an increase in fracture risk (Table 2).58-65 Shahinian et al performed a Surveillance, Epidemiology, and End Results (SEER) database study of 50,613 men who were diagnosed with prostate cancer between 1992 and 1997. Five years after starting treatment, 19.4% of survivors who received ADT developed a fracture at any site, whereas only 12.6% of survivors not receiving ADT developed a fracture.58 Dickman et al studied almost 18,000 men who were treated for prostate cancer with bilateral orchiectomy, and compared their fracture risk with that of approximately 360,000 healthy controls. The authors found that those who had undergone orchiectomy had a fracture risk over 10 years of 12% at the femoral neck alone, compared with 5% in the general population.60 Smith et al conducted a claims-based retrospective cohort study of 3887 men with nonmetastatic prostate cancer receiving GnRH agonists compared with 7774 who did not receive these agents. GnRH agonists were associated with an increased clinical fracture risk (7.88 clinical fractures per 100 person-years in the GnRH group vs 6.51 per 100 person-years in controls; relative risk [RR], 1.21; 95% CI, 1.14-1.29 [P < .001]).59 However, these studies are limited in that fractures were not designated as osteoporotic versus pathologic, and no relation with BMD was performed.
Androgen deprivation therapy (ADT) is commonly used in the treatment of prostate cancer.53 Survival in men with nonmetastatic prostate cancer treated with ADT is long, with a median survival of greater than 7 years.54 Hence, long-term effects on bones are of particular concern. At least one study has also suggested skeletal fractures as an adverse predictor of overall survival in men with prostate cancer.55
Even at baseline, men with prostate cancer who have not received ADT have a higher incidence of osteoporosis than the general age-matched population.56 Effects of hormone treatment most likely compound the problem.21
A Danish case-control registry study compared more than 15,000 men aged older than 50 years who had fractures with 45,000 men who did not. The authors found that a diagnosis of prostate cancer was associated with an increased odds ratio (OR) for fracture of 1.8 (95% CI, 1.6-2.1) and ADT was associated with an increased OR of 1.7 (95% CI, 1.2-2.5). It was noted that the increased risk became apparent soon after diagnosis and persisted even in long-term survivors.57
Retrospective cohort studies of men who have survived prostate cancer for many years have demonstrated that ADT therapy is associated with an increase in fracture risk (Table 2).58-65 Shahinian et al performed a Surveillance, Epidemiology, and End Results (SEER) database study of 50,613 men who were diagnosed with prostate cancer between 1992 and 1997. Five years after starting treatment, 19.4% of survivors who received ADT developed a fracture at any site, whereas only 12.6% of survivors not receiving ADT developed a fracture.58 Dickman et al studied almost 18,000 men who were treated for prostate cancer with bilateral orchiectomy, and compared their fracture risk with that of approximately 360,000 healthy controls. The authors found that those who had undergone orchiectomy had a fracture risk over 10 years of 12% at the femoral neck alone, compared with 5% in the general population.60 Smith et al conducted a claims-based retrospective cohort study of 3887 men with nonmetastatic prostate cancer receiving GnRH agonists compared with 7774 who did not receive these agents. GnRH agonists were associated with an increased clinical fracture risk (7.88 clinical fractures per 100 person-years in the GnRH group vs 6.51 per 100 person-years in controls; relative risk [RR], 1.21; 95% CI, 1.14-1.29 [P < .001]).59 However, these studies are limited in that fractures were not designated as osteoporotic versus pathologic, and no relation with BMD was performed.
Tuesday, May 31, 2011
NCCN Annual Report
Support NCCN About NCCN
More Oncology Drug Shortages
By Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor
Recent news is plentiful with stories about how local hospitals and physician practices are struggling to provide their patients with drugs they critically need in today’s climate of drug shortages. In a previous eBulletin article, we described some ways to cope with the ever-expanding list of drugs that are in short supply. According to the FDA Drug Shortages website, three additional drugs (daunorubicin, thiotepa, and vincristine) have been added to the list of injectable drugs that are in short supply and used for the active treatment of cancer since that article was written. The shortage resolved for one drug previously on the list, which is carmustine. The list of oncology drugs currently experiencing a shortage stands as follows:
Bleomycin
Cisplatin
Cytarabine
Daunorubicin
Doxorubicin
Etoposide
Leucovorin/levoleucovorin
Mechlorethamine
Thiotepa
Vincristine.
As you can see, many of the drugs on this list are critical pieces of well-established chemotherapy regimens. In the short term, the US Food and Drug Administration (FDA) has some ability to help resolve some shortages. However, this ability is somewhat limited, especially if the cause of the shortage is due to circumstances beyond their control. Nonetheless, the FDA may be able to expedite the review of submissions by manufactures for a new product or manufacturing change that, if approved, may help to increase the supply of the drug that is currently experiencing a shortage. Additionally, the FDA works with manufacturers to identify sources of raw material or encourage others to increase production of the drug. Lastly, the FDA can utilize enforcement discretion to temporarily allow the importation of a drug from other countries, although the FDA has maintained that this practice is rare.1 Interestingly, it appears that the FDA is considering allowing the importation of certain oncology products (e.g., cytarabine, thiotepa).2, 3
Recently, legislation that may offer some long-term relief to this crisis was introduced to Congress. The “Preserving Access to Life Saving Medications Act (S. 296)” proposes to establish an early warning system so that manufacturers must report to the US Food and Drug Administration (FDA) on conditions that would likely result in a drug shortage. It also would provide the FDA with the power to impose financial penalties for manufacturers who fail to comply with this reporting.
As more drugs are added to the list of those in short supply, there is growing concern among the public regarding how patients are affected by these shortages. Hopefully, the actions of the FDA and Congress will relieve some of these problems and we will again see an adequate supply of these important medications.
Support NCCN About NCCN
More Oncology Drug Shortages
By Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor
Recent news is plentiful with stories about how local hospitals and physician practices are struggling to provide their patients with drugs they critically need in today’s climate of drug shortages. In a previous eBulletin article, we described some ways to cope with the ever-expanding list of drugs that are in short supply. According to the FDA Drug Shortages website, three additional drugs (daunorubicin, thiotepa, and vincristine) have been added to the list of injectable drugs that are in short supply and used for the active treatment of cancer since that article was written. The shortage resolved for one drug previously on the list, which is carmustine. The list of oncology drugs currently experiencing a shortage stands as follows:
Bleomycin
Cisplatin
Cytarabine
Daunorubicin
Doxorubicin
Etoposide
Leucovorin/levoleucovorin
Mechlorethamine
Thiotepa
Vincristine.
As you can see, many of the drugs on this list are critical pieces of well-established chemotherapy regimens. In the short term, the US Food and Drug Administration (FDA) has some ability to help resolve some shortages. However, this ability is somewhat limited, especially if the cause of the shortage is due to circumstances beyond their control. Nonetheless, the FDA may be able to expedite the review of submissions by manufactures for a new product or manufacturing change that, if approved, may help to increase the supply of the drug that is currently experiencing a shortage. Additionally, the FDA works with manufacturers to identify sources of raw material or encourage others to increase production of the drug. Lastly, the FDA can utilize enforcement discretion to temporarily allow the importation of a drug from other countries, although the FDA has maintained that this practice is rare.1 Interestingly, it appears that the FDA is considering allowing the importation of certain oncology products (e.g., cytarabine, thiotepa).2, 3
Recently, legislation that may offer some long-term relief to this crisis was introduced to Congress. The “Preserving Access to Life Saving Medications Act (S. 296)” proposes to establish an early warning system so that manufacturers must report to the US Food and Drug Administration (FDA) on conditions that would likely result in a drug shortage. It also would provide the FDA with the power to impose financial penalties for manufacturers who fail to comply with this reporting.
As more drugs are added to the list of those in short supply, there is growing concern among the public regarding how patients are affected by these shortages. Hopefully, the actions of the FDA and Congress will relieve some of these problems and we will again see an adequate supply of these important medications.
Sunday, May 1, 2011
Dick: have you seen this available in the US>????? A Pill that gives men with advanced prostrate cancer an extra 4 months of life has come a
A Pill that gives men with advanced prostrate cancer an extra 4 months of life has come a step closer to being approved for use in Britain. Zytiga is a hormonal drug that cuts of the source of testosterone, which makes prostrate cancer cells grow.
Standard hormone treatments for prostrate cancer blocks production of male hormone in the testes, but recent research shows that tumours can produce their own supply, as does the adrenal gland. Zytiga block all testosterone generation. It can be used in up to 80 per cent of patients with aggressive drug resistant prostrate cancer who have run out of options after exhausting a range of anti-hormonal therapies and chemotherapy. The drug is not available for use on the NHS, but makers Johnson and Johnson have applied for licensing approval in Europe that could be granted by the end of this year. That approval looks more likely after U.S. watchdogs at the Food and Drug Administration gave the green light to the drug there nearly 2 months earlier than expected, following its successful trial. A trial on almost 800 patients in 13 countries found those taking the drug combined with conventional steroid treatment survive ed for about 15 months compared with 11 months on steroid alone.
The study was cut short so all patients could be given Zytiga clinical name abiraterone acetate - after independent monitors determined a clear survival benefit.
Around 250,000 men in the UK are living with prostrate cancer, with 37,000 new cases diagnosed each year. It is the biggest cancer killer after lung cancer, with 10,000 men dying from the disease each year. Zytiga was discovered by British scientists at the institute of Cancer Research.
Professor Johann de Bono, of the ICR said "This news will be incredibly important ot prostrate cancer patients and their families"
Standard hormone treatments for prostrate cancer blocks production of male hormone in the testes, but recent research shows that tumours can produce their own supply, as does the adrenal gland. Zytiga block all testosterone generation. It can be used in up to 80 per cent of patients with aggressive drug resistant prostrate cancer who have run out of options after exhausting a range of anti-hormonal therapies and chemotherapy. The drug is not available for use on the NHS, but makers Johnson and Johnson have applied for licensing approval in Europe that could be granted by the end of this year. That approval looks more likely after U.S. watchdogs at the Food and Drug Administration gave the green light to the drug there nearly 2 months earlier than expected, following its successful trial. A trial on almost 800 patients in 13 countries found those taking the drug combined with conventional steroid treatment survive ed for about 15 months compared with 11 months on steroid alone.
The study was cut short so all patients could be given Zytiga clinical name abiraterone acetate - after independent monitors determined a clear survival benefit.
Around 250,000 men in the UK are living with prostrate cancer, with 37,000 new cases diagnosed each year. It is the biggest cancer killer after lung cancer, with 10,000 men dying from the disease each year. Zytiga was discovered by British scientists at the institute of Cancer Research.
Professor Johann de Bono, of the ICR said "This news will be incredibly important ot prostrate cancer patients and their families"
Wednesday, March 9, 2011
Rd Wine &Reveratrol. Good for Your Health
While the news about red wine might sound great if you enjoy a glass of red wine with your evening meal, doctors are wary of encouraging anyone to start drinking alcohol. That's because too much alcohol can have many harmful effects on your body.
Still, many doctors agree that something in red wine appears to help your heart. It's possible that antioxidants, such as flavonoids or a substance called resveratrol, have heart-healthy benefits.
How is red wine heart healthy?
Red wine seems to have even more heart-healthy benefits than other types of alcohol, but it's possible that red wine isn't any better than beer, white wine or liquor for heart health. There's still no clear evidence that red wine is better than other forms of alcohol when it comes to possible heart-healthy benefits.
Antioxidants in red wine called polyphenols may help protect the lining of blood vessels in your heart. A polyphenol called resveratrol is one substance in red wine that's gotten attention.
Resveratrol in red wine
Resveratrol might be a key ingredient in red wine that helps prevent damage to blood vessels, reduces "bad" cholesterol and prevents blood clots.
Most research on resveratrol has been done on animals, not people. Research in mice given resveratrol suggests that the antioxidant might also help protect them from obesity and diabetes, both of which are strong risk factors for heart disease. However, those findings were reported only in mice, not in people. In addition, to get the same dose of resveratrol used in the mice studies, a person would have to drink over 60 liters of red wine every day.
Some research shows that resveratrol could be linked to a reduced risk of inflammation and blood clotting, both of which can lead to heart disease. More research is needed before it's known whether resveratrol was the cause for the reduced risk.
Next page
(1 of 2)
Still, many doctors agree that something in red wine appears to help your heart. It's possible that antioxidants, such as flavonoids or a substance called resveratrol, have heart-healthy benefits.
How is red wine heart healthy?
Red wine seems to have even more heart-healthy benefits than other types of alcohol, but it's possible that red wine isn't any better than beer, white wine or liquor for heart health. There's still no clear evidence that red wine is better than other forms of alcohol when it comes to possible heart-healthy benefits.
Antioxidants in red wine called polyphenols may help protect the lining of blood vessels in your heart. A polyphenol called resveratrol is one substance in red wine that's gotten attention.
Resveratrol in red wine
Resveratrol might be a key ingredient in red wine that helps prevent damage to blood vessels, reduces "bad" cholesterol and prevents blood clots.
Most research on resveratrol has been done on animals, not people. Research in mice given resveratrol suggests that the antioxidant might also help protect them from obesity and diabetes, both of which are strong risk factors for heart disease. However, those findings were reported only in mice, not in people. In addition, to get the same dose of resveratrol used in the mice studies, a person would have to drink over 60 liters of red wine every day.
Some research shows that resveratrol could be linked to a reduced risk of inflammation and blood clotting, both of which can lead to heart disease. More research is needed before it's known whether resveratrol was the cause for the reduced risk.
Next page
(1 of 2)
Thursday, March 3, 2011
r Risk-based system to reduce unnecessary biopsies
OncologySTAT: How will we select men for biopsy in the future, and where are
we in terms of identifying molecular markers for aggressive prostate tumors?
Dr. Parker: I have no doubt that in the future we will be using risk
calculators based on multiple risk factors in order to decide who gets a
biopsy and who doesn't. Now, the adoption of these risk calculators has been
slow, partly because there are so many different risk calculators and no
consensus on which is better than any other, and partly because they have
not been extensively validated in separate cohorts. There is a pressing need
to validate these risk calculators and to see which of the currently
available risk calculators does the best job in different settings. I think
it is important that individual centers that do large numbers of prostate
biopsies should be auditing their results, seeking to validate these risk
calculators with a view to using them in future practice. So, in the very
near future, investigators should not be relying on PSA thresholds but
rather on the risk calculator that works best in their setting. There are a
large number of new markers that are coming through, which appear to predict
the risk of finding prostate cancer and, more importantly, the risk of
finding high-grade prostate cancer on biopsy. There is no doubt that some of
them will provide extra utility over and above the standard risk calculators
that are available today.
But, I'm also confident that none of these new markers is going to tell the
whole story. We should not expect any new marker to replace PSA and be used
on its own, to indicate who should get a biopsy and who shouldn't. Rather,
these new markers will need to be incorporated into existing risk
calculators. Among the novel markers, one of the best known is the urinary
PCA3 score, which looks promising. There are also a plethora of germline
genetic markers, which also appear to put men at increased risk of prostate
cancer, although, as yet, I'm not aware of any germline marker that is
associated with high-grade prostate cancer.
The fact that there are so many markers being evaluated underlines the need
for us to move from PSA-based decision-making to risk-based decision-making.
Right now, we have traditional risk factors, which I mentioned earlier, but
in 5 years' time, we are going to have a large number of new risk factors,
whether they are urinary markers, or blood markers, or germline genetic
markers. The only way we are going to make sense of all these new markers is
to use them as part of a risk-based approach.
So, again, the decision whether or not to have a prostate biopsy should be
made, in the future, not on a man's PSA level, but rather on the risk of
finding high-grade prostate cancer.
OncologySTAT: Then, aside from validating these different scoring systems
and validating more of the marker research, what are key, yet-unanswered
questions that need to be tested in clinical trials?
Dr. Parker: It will be important to know how effective these risk
calculators will be in avoiding unnecessary biopsies and reducing
over-diagnosis. Roobol et al have made a very nice first attempt at
estimating what the impact would be. They selected 10,000 men who took part
in the European randomized trial of prostate cancer screening, and described
what happened in the trial, given that biopsy was indicated for men with a
PSA level greater than 3 ng/mL. Then, they compared that with what would
have happened if they had used a risk threshold using the European risk
calculator.5
What they found was that about one-third of all the prostate biopsies would
have been avoided and that the number of indolent prostate cancers detected
would have been significantly reduced. Their work is a first step at showing
what could be gained from moving from a PSA-based system to a risk-based
system.
The other point to make is that while the immediate and obvious advantages
of using a risk-based system would be to reduce unnecessary biopsies and
reduce over-diagnosis, there is also a possible further benefit, because it
may be that we would be able to find harmful prostate cancers earlier,
before a man's PSA rises above the standard threshold, and finding it
earlier might improve the effectiveness of treatment. That is speculation,
but it is a further reason why we should be moving towards a risk
we in terms of identifying molecular markers for aggressive prostate tumors?
Dr. Parker: I have no doubt that in the future we will be using risk
calculators based on multiple risk factors in order to decide who gets a
biopsy and who doesn't. Now, the adoption of these risk calculators has been
slow, partly because there are so many different risk calculators and no
consensus on which is better than any other, and partly because they have
not been extensively validated in separate cohorts. There is a pressing need
to validate these risk calculators and to see which of the currently
available risk calculators does the best job in different settings. I think
it is important that individual centers that do large numbers of prostate
biopsies should be auditing their results, seeking to validate these risk
calculators with a view to using them in future practice. So, in the very
near future, investigators should not be relying on PSA thresholds but
rather on the risk calculator that works best in their setting. There are a
large number of new markers that are coming through, which appear to predict
the risk of finding prostate cancer and, more importantly, the risk of
finding high-grade prostate cancer on biopsy. There is no doubt that some of
them will provide extra utility over and above the standard risk calculators
that are available today.
But, I'm also confident that none of these new markers is going to tell the
whole story. We should not expect any new marker to replace PSA and be used
on its own, to indicate who should get a biopsy and who shouldn't. Rather,
these new markers will need to be incorporated into existing risk
calculators. Among the novel markers, one of the best known is the urinary
PCA3 score, which looks promising. There are also a plethora of germline
genetic markers, which also appear to put men at increased risk of prostate
cancer, although, as yet, I'm not aware of any germline marker that is
associated with high-grade prostate cancer.
The fact that there are so many markers being evaluated underlines the need
for us to move from PSA-based decision-making to risk-based decision-making.
Right now, we have traditional risk factors, which I mentioned earlier, but
in 5 years' time, we are going to have a large number of new risk factors,
whether they are urinary markers, or blood markers, or germline genetic
markers. The only way we are going to make sense of all these new markers is
to use them as part of a risk-based approach.
So, again, the decision whether or not to have a prostate biopsy should be
made, in the future, not on a man's PSA level, but rather on the risk of
finding high-grade prostate cancer.
OncologySTAT: Then, aside from validating these different scoring systems
and validating more of the marker research, what are key, yet-unanswered
questions that need to be tested in clinical trials?
Dr. Parker: It will be important to know how effective these risk
calculators will be in avoiding unnecessary biopsies and reducing
over-diagnosis. Roobol et al have made a very nice first attempt at
estimating what the impact would be. They selected 10,000 men who took part
in the European randomized trial of prostate cancer screening, and described
what happened in the trial, given that biopsy was indicated for men with a
PSA level greater than 3 ng/mL. Then, they compared that with what would
have happened if they had used a risk threshold using the European risk
calculator.5
What they found was that about one-third of all the prostate biopsies would
have been avoided and that the number of indolent prostate cancers detected
would have been significantly reduced. Their work is a first step at showing
what could be gained from moving from a PSA-based system to a risk-based
system.
The other point to make is that while the immediate and obvious advantages
of using a risk-based system would be to reduce unnecessary biopsies and
reduce over-diagnosis, there is also a possible further benefit, because it
may be that we would be able to find harmful prostate cancers earlier,
before a man's PSA rises above the standard threshold, and finding it
earlier might improve the effectiveness of treatment. That is speculation,
but it is a further reason why we should be moving towards a risk
Xgeva(denosumab)is more effective than Zometa® (
Xgeva Reduces Bone Complications From Prostate Cancer
Among men with bone metastases from prostate cancer, Xgeva™ (denosumab) was more effective than Zometa® (zoledronic acid) at delaying or preventing bone complications such as fracture. Results from this Phase III clinical trial were published in The Lancet.
Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including prostate cancer—have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression, and may require treatment with surgery or radiation therapy.
Bisphosphonate drugs such as Zometa have been commonly used to reduce the risk of complications from bone metastases. Xgeva is a newer type of drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Xgeva was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the prevention of bone complications in patients with bone metastases from solid (not blood-related) cancers, including prostate cancer.
To directly compare Xgeva to Zometa among prostate cancer patients with bone metastases, researchers conducted a Phase III clinical trial. The study enrolled 1,901 patients with metastatic, hormone-refractory prostate cancer. Study participants were assigned to receive either Xgeva or Zometa. Xgeva is given as a subcutaneous (under-the-skin) injection; Zometa is given intravenously (IV).
The objective of the study was to determine whether the occurrence of bone complications (“skeletal related events”) differed between the two study groups. The bone complications that were evaluated were fracture, radiation to the bone, surgery to the bone, and spinal cord compression.
The results of this study suggest that Xgeva is more effective than Zometa at delaying or preventing skeletal complications in prostate cancer patients with bone metastases.
Reference: Fizazi K, Carducci M, Smith M et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomized, double-blind study. The Lancet. Early online publication February 25, 2011.
Among men with bone metastases from prostate cancer, Xgeva™ (denosumab) was more effective than Zometa® (zoledronic acid) at delaying or preventing bone complications such as fracture. Results from this Phase III clinical trial were published in The Lancet.
Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including prostate cancer—have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression, and may require treatment with surgery or radiation therapy.
Bisphosphonate drugs such as Zometa have been commonly used to reduce the risk of complications from bone metastases. Xgeva is a newer type of drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Xgeva was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the prevention of bone complications in patients with bone metastases from solid (not blood-related) cancers, including prostate cancer.
To directly compare Xgeva to Zometa among prostate cancer patients with bone metastases, researchers conducted a Phase III clinical trial. The study enrolled 1,901 patients with metastatic, hormone-refractory prostate cancer. Study participants were assigned to receive either Xgeva or Zometa. Xgeva is given as a subcutaneous (under-the-skin) injection; Zometa is given intravenously (IV).
The objective of the study was to determine whether the occurrence of bone complications (“skeletal related events”) differed between the two study groups. The bone complications that were evaluated were fracture, radiation to the bone, surgery to the bone, and spinal cord compression.
The results of this study suggest that Xgeva is more effective than Zometa at delaying or preventing skeletal complications in prostate cancer patients with bone metastases.
Reference: Fizazi K, Carducci M, Smith M et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomized, double-blind study. The Lancet. Early online publication February 25, 2011.
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