PROVENGE® FOR HORMONE-REFRACTORY PROSTATE CANCER
CancerConsultants.com, 08/11/2010
Among men with metastatic, hormone-refractory prostate cancer, the immunotherapy agent Provenge® (sipuleucel-T) improves survival by roughly four months. The findings from this Phase III study were recently published in The New England Journal of Medicine
Friday, August 13, 2010
Duodart Treats E larged Prostate
March 31, 2010
LONDON - Pharmaceutical company GlaxoSmithKline PLC said Wednesday it has received European approval for Duodart, a two-in-one drug for the treatment of the symptoms of an enlarged prostate. The drug is a combination of dutasteride, currently marketed as Avodart, and tamsulosin, a generic drug marketed by Astellas Pharma as Flomax. Glaxo received backing for the drug from Germany under the European Union's decentralized approval procedure, meaning it is applicable across the 27-member bloc. The company said national licenses are expected to be granted throughout the year
LONDON - Pharmaceutical company GlaxoSmithKline PLC said Wednesday it has received European approval for Duodart, a two-in-one drug for the treatment of the symptoms of an enlarged prostate. The drug is a combination of dutasteride, currently marketed as Avodart, and tamsulosin, a generic drug marketed by Astellas Pharma as Flomax. Glaxo received backing for the drug from Germany under the European Union's decentralized approval procedure, meaning it is applicable across the 27-member bloc. The company said national licenses are expected to be granted throughout the year
Canines May Smell Prostate Cancer
Dogs May Be Able to Smell Prostate Cancer
Dogs may be able to smell the presence of prostate cancer in patient urine samples, according to data presented at the 2010 Annual Scientific Meeting of the American Urological Association (AUA).
Volatile organic compounds (VOCs) are organic chemical compounds that are derived from a number of man-made and biologic sources, including cancer cells. Data have indicated that concentrations of VOCs differ according to age and produce a scent to which animals may be particularly sensitive. Researchers have been evaluating the capability among dogs to detect cancer by scent; previous research has focused on breast, lung, and bladder cancers.
To investigate whether prostate cancer tumors may excrete certain VOCs through urine that dogs can detect by scent, researchers in Paris trained dogs to recognize the scent of VOCs from prostate cancer cells. The dogs were then trained to distinguish between urine from prostate cancer patients and urine from individuals without cancer. Following this training, the dogs were presented with five urine samples, only one of which came from a patient with confirmed cancer. The animals were instructed to identify the samples from cancer patients.
A total of 66 urine samples were used in the study; of these, the dogs correctly classified 63—meaning in 63 of the 66 samples, they accurately identified which samples were from prostate cancer patients and which were not. The dogs correctly identified 100% of urine samples from cancer patients and correctly classified 91% of samples from people without cancer.
According to the AUA Public Media Committee Chair Anthony Y. Smith, MD, “These data suggest that prostate cancer tumors may excrete certain VOCs that turn up in a patient’s urine and that this ‘scent’ may be specific to prostate cancer.” The next step will be to determine what those VOCs are and to develop a test that can identify them. Further development of accurate screening tests for prostate cancer is an important area of research, as the accuracy of the current primary screening method—the prostate-specific antigen (PSA) test—remains suboptimal.
Reference: Cornu J-N, Girardet C, Cancel-Tassin G et al. The use of canines for prostate cancer detection: towards a non-invasive alternative screening tool. Presented at the 2010 annual meeting of the American Urological Association. May 29-June 3, 2010. San Francisco, CA. Abstract 2159.
Dogs may be able to smell the presence of prostate cancer in patient urine samples, according to data presented at the 2010 Annual Scientific Meeting of the American Urological Association (AUA).
Volatile organic compounds (VOCs) are organic chemical compounds that are derived from a number of man-made and biologic sources, including cancer cells. Data have indicated that concentrations of VOCs differ according to age and produce a scent to which animals may be particularly sensitive. Researchers have been evaluating the capability among dogs to detect cancer by scent; previous research has focused on breast, lung, and bladder cancers.
To investigate whether prostate cancer tumors may excrete certain VOCs through urine that dogs can detect by scent, researchers in Paris trained dogs to recognize the scent of VOCs from prostate cancer cells. The dogs were then trained to distinguish between urine from prostate cancer patients and urine from individuals without cancer. Following this training, the dogs were presented with five urine samples, only one of which came from a patient with confirmed cancer. The animals were instructed to identify the samples from cancer patients.
A total of 66 urine samples were used in the study; of these, the dogs correctly classified 63—meaning in 63 of the 66 samples, they accurately identified which samples were from prostate cancer patients and which were not. The dogs correctly identified 100% of urine samples from cancer patients and correctly classified 91% of samples from people without cancer.
According to the AUA Public Media Committee Chair Anthony Y. Smith, MD, “These data suggest that prostate cancer tumors may excrete certain VOCs that turn up in a patient’s urine and that this ‘scent’ may be specific to prostate cancer.” The next step will be to determine what those VOCs are and to develop a test that can identify them. Further development of accurate screening tests for prostate cancer is an important area of research, as the accuracy of the current primary screening method—the prostate-specific antigen (PSA) test—remains suboptimal.
Reference: Cornu J-N, Girardet C, Cancel-Tassin G et al. The use of canines for prostate cancer detection: towards a non-invasive alternative screening tool. Presented at the 2010 annual meeting of the American Urological Association. May 29-June 3, 2010. San Francisco, CA. Abstract 2159.
Medivation, a New Treatment for Prostate Cancer
DATA FROM PHASE 1-2 TRIAL OF MDV3100 IN ADVANCED...
NewsRx.com,
April 22, 2010
Medivation, Inc. (NASDAQ:MDVN) and Astellas Pharma Inc. announced publication of positive results from their previously reported Phase 1-2 trial of the novel triple-acting oral androgen receptor antagonist MDV3100 in men with progressive, metastatic castration-resistant prostate cancer in the April 15 online version of The Lancet. According to the published results, MDV3100 demonstrated anti-tumor activity in patients with late-stage prostate cancer as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. Anti-tumor effects were observed in patients who were resistant to standard anti- androgen treatments, as well as in patients who had progressed following chemotherapy. MDV3100 is currently in Phase 3 development for the treatment of advanced prostate cancer (see also Medivation, Inc.; Astellas Pharma Inc.). "MDV3100, with its unique mechanism of action, could offer an important new treatment option to men with prostate cancer that is resistant to currently available anti-androgens," said Howard Scher, M.D., lead author of The Lancet article and chief of the Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center in New York. "It is particularly encouraging that antitumor activity was seen on all outcomes assessed in patients who had failed chemotherapy because their survival times are one year or less, on average, and their treatment options are limited."
ASTRO PRESIDENT SPEAKS ON PROSTATE CANCER
NewsRx.com,
April 22, 2010
Medivation, Inc. (NASDAQ:MDVN) and Astellas Pharma Inc. announced publication of positive results from their previously reported Phase 1-2 trial of the novel triple-acting oral androgen receptor antagonist MDV3100 in men with progressive, metastatic castration-resistant prostate cancer in the April 15 online version of The Lancet. According to the published results, MDV3100 demonstrated anti-tumor activity in patients with late-stage prostate cancer as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. Anti-tumor effects were observed in patients who were resistant to standard anti- androgen treatments, as well as in patients who had progressed following chemotherapy. MDV3100 is currently in Phase 3 development for the treatment of advanced prostate cancer (see also Medivation, Inc.; Astellas Pharma Inc.). "MDV3100, with its unique mechanism of action, could offer an important new treatment option to men with prostate cancer that is resistant to currently available anti-androgens," said Howard Scher, M.D., lead author of The Lancet article and chief of the Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center in New York. "It is particularly encouraging that antitumor activity was seen on all outcomes assessed in patients who had failed chemotherapy because their survival times are one year or less, on average, and their treatment options are limited."
ASTRO PRESIDENT SPEAKS ON PROSTATE CANCER
Tuesday, August 10, 2010
FDA Criticizes Dendreon's Claims for Provenge
ERSSTOREABOUT US
FDA Objects to Dendreon Promotions for Provenge
Reuters | 08.06.2010
Dendreon Corp. exaggerated the benefits of its novel prostate cancer vaccine and downplayed risks in some sales materials for the product, U.S. regulators said in a letter released on Friday.
"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the U.S. Food and Drug Administration said in a letter to the company.
Some of Dendreon's promotions included a chart that "does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of" the company's main study, the FDA said.
The materials also left out some information about sterility testing, the agency said.
The FDA asked Dendreon to immediately stop using the promotions and any others with similar claims.
Dendreon spokeswoman Katherine Stueland said the company "has spoken with the FDA and intends to comply with the request."
The FDA approved Provenge in April for treating advanced prostate cancer.
Unlike traditional vaccines that prevent a disease, Provenge treats prostate cancer by stimulating the body's own immune system to attack malignant cells. It is produced by taking cells from a patient's tumor and incorporating them into a vaccine that is injected back into the patient.
Dendreon shares fell slightly after the FDA letter was released, but recovered to close 1.5 percent higher at $39.05 on Nasdaq.
The FDA posted the letter here:
PROVENGE (sipuleucel-T) - Untitled Letter
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448
August 3, 2010
Helen Kim
Director of Regulatory Affairs
Dendreon Corporation
3005 First Avenue
Seattle, WA 98121
Re: PROVENGE® (sipuleucel-T)
BLA STN# 125197
Dear Ms. Kim:
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has reviewed an In Service Kit (P-A-04.10-007.00) (kit) and PROVENGE Detail Aid (P-A-04.10.009.00) (detail aid) for PROVENGE® (sipuleucel-T). Dendreon Corporation (Dendreon) submitted the kit and detail aid under cover of Form FDA 2253 on May 4 and May 27, 2010, respectively.
These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of PROVENGE. Therefore, this material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).
Background
According to the FDA-approved prescribing information (PI), PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
The Warnings and Precautions section of the PI includes, but is not limited to, the following risks for PROVENGE:
PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.
According to the Clinical Studies section of the PI, the effectiveness of PROVENGE was studied in 512 patients, “randomized in a 2:1 ratio to receive PROVENGE (n=341) or control (n=171).” This study “was a randomized, double-blind, placebo-controlled, multicenter trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.” As shown in Table 2, the observed median survival time for patients randomized to the PROVENGE arm was 25.8 months and for patients randomized to placebo was 21.7 months. The Hazard Ratio was 0.775 (95% Confidence Interval: 0.614, 0.979). The study achieved a p-value of 0.032 based on a log-rank test (not pre-specified).
Omission and Minimization of Risk Information
Promotional materials are misleading if they fail to reveal facts that are material in light of representations made with respect to consequences that may result from the use of the product as recommended or suggested by the materials.
Specifically, the kit presents a misleading product timeline on the slide entitled, “Is PROVENGE therapy approved for infusion?” The timeline includes “Test Results Complete” before the product arrives at the office, which is contrary to the Warnings and Precautions section of the PI which states that the final (7-day incubation) sterility test results are not available at the time of infusion. Furthermore, the kit omits the Warning and Precaution that the final sterility test results are not available at the time of infusion.
Overstatement of Efficacy
Promotional materials are misleading if they contain a representation or suggestion, not approved or permitted for use in the labeling, that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.
Page seven of the professional detail aid includes a chart entitled, “Kaplan-Meier Survival Rate Estimates.” This chart presents the percentage of patients alive at 12, 24, 36 and 48 months. This information is misleading because it does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of the study. For example, the chart does not include a measure of variability, such as the 95% confidence intervals, when presenting the survival rate estimates.
Conclusion and Requested Actions
For the reasons discussed above, your promotional material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).
We request that Dendreon immediately cease the dissemination of these violative promotional materials for PROVENGE, as well as promotional materials with the same or similar representations. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative promotional materials for PROVENGE and explaining your plan for discontinuing use of such materials. Please direct your response to Lisa Stockbridge, PhD, Acting Branch Chief at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN number. We remind you that only written communications are considered official responses.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for PROVENGE comply with each applicable requirement of the Act and FDA implementing regulations.
If you choose to revise your promotional materials, APLB is willing to assist you in assuring that your revised materials comply with applicable provisions of the Act by reviewing your revisions before you use them in promotion.
Sincerely,
Robert A. Sausville
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
FDA Objects to Dendreon Promotions for Provenge
Reuters | 08.06.2010
Dendreon Corp. exaggerated the benefits of its novel prostate cancer vaccine and downplayed risks in some sales materials for the product, U.S. regulators said in a letter released on Friday.
"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the U.S. Food and Drug Administration said in a letter to the company.
Some of Dendreon's promotions included a chart that "does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of" the company's main study, the FDA said.
The materials also left out some information about sterility testing, the agency said.
The FDA asked Dendreon to immediately stop using the promotions and any others with similar claims.
Dendreon spokeswoman Katherine Stueland said the company "has spoken with the FDA and intends to comply with the request."
The FDA approved Provenge in April for treating advanced prostate cancer.
Unlike traditional vaccines that prevent a disease, Provenge treats prostate cancer by stimulating the body's own immune system to attack malignant cells. It is produced by taking cells from a patient's tumor and incorporating them into a vaccine that is injected back into the patient.
Dendreon shares fell slightly after the FDA letter was released, but recovered to close 1.5 percent higher at $39.05 on Nasdaq.
The FDA posted the letter here:
PROVENGE (sipuleucel-T) - Untitled Letter
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448
August 3, 2010
Helen Kim
Director of Regulatory Affairs
Dendreon Corporation
3005 First Avenue
Seattle, WA 98121
Re: PROVENGE® (sipuleucel-T)
BLA STN# 125197
Dear Ms. Kim:
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has reviewed an In Service Kit (P-A-04.10-007.00) (kit) and PROVENGE Detail Aid (P-A-04.10.009.00) (detail aid) for PROVENGE® (sipuleucel-T). Dendreon Corporation (Dendreon) submitted the kit and detail aid under cover of Form FDA 2253 on May 4 and May 27, 2010, respectively.
These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of PROVENGE. Therefore, this material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).
Background
According to the FDA-approved prescribing information (PI), PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
The Warnings and Precautions section of the PI includes, but is not limited to, the following risks for PROVENGE:
PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.
According to the Clinical Studies section of the PI, the effectiveness of PROVENGE was studied in 512 patients, “randomized in a 2:1 ratio to receive PROVENGE (n=341) or control (n=171).” This study “was a randomized, double-blind, placebo-controlled, multicenter trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.” As shown in Table 2, the observed median survival time for patients randomized to the PROVENGE arm was 25.8 months and for patients randomized to placebo was 21.7 months. The Hazard Ratio was 0.775 (95% Confidence Interval: 0.614, 0.979). The study achieved a p-value of 0.032 based on a log-rank test (not pre-specified).
Omission and Minimization of Risk Information
Promotional materials are misleading if they fail to reveal facts that are material in light of representations made with respect to consequences that may result from the use of the product as recommended or suggested by the materials.
Specifically, the kit presents a misleading product timeline on the slide entitled, “Is PROVENGE therapy approved for infusion?” The timeline includes “Test Results Complete” before the product arrives at the office, which is contrary to the Warnings and Precautions section of the PI which states that the final (7-day incubation) sterility test results are not available at the time of infusion. Furthermore, the kit omits the Warning and Precaution that the final sterility test results are not available at the time of infusion.
Overstatement of Efficacy
Promotional materials are misleading if they contain a representation or suggestion, not approved or permitted for use in the labeling, that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.
Page seven of the professional detail aid includes a chart entitled, “Kaplan-Meier Survival Rate Estimates.” This chart presents the percentage of patients alive at 12, 24, 36 and 48 months. This information is misleading because it does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of the study. For example, the chart does not include a measure of variability, such as the 95% confidence intervals, when presenting the survival rate estimates.
Conclusion and Requested Actions
For the reasons discussed above, your promotional material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).
We request that Dendreon immediately cease the dissemination of these violative promotional materials for PROVENGE, as well as promotional materials with the same or similar representations. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative promotional materials for PROVENGE and explaining your plan for discontinuing use of such materials. Please direct your response to Lisa Stockbridge, PhD, Acting Branch Chief at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN number. We remind you that only written communications are considered official responses.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for PROVENGE comply with each applicable requirement of the Act and FDA implementing regulations.
If you choose to revise your promotional materials, APLB is willing to assist you in assuring that your revised materials comply with applicable provisions of the Act by reviewing your revisions before you use them in promotion.
Sincerely,
Robert A. Sausville
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Statins &Painkillers May Skew PCaScreening Results
Statins, Painkillers May Upset PSA Test Results
Common medications might affect prostate cancer diagnoses, researchers say
by Amanda Gardner | HealthDay | 08.06.2010
Some of the most widely prescribed drugs in the United States may skew results of prostate cancer screening tests, possibly causing errors in diagnoses, a new study finds.
A prostate cancer diagnosis is typically based on an elevated PSA (prostate-specific antigen) level, but new research shows that common drugs, including cholesterol-lowering statins and certain painkillers, may lower PSA levels.
"Our study reveals that men regularly consuming NSAIDs [non-steroidal anti-inflammatory drugs], statins, and thiazide diuretics may have lower serum PSA levels compared to men who are not taking these medications," said Dr. Steven L. Chang, lead author of a paper published online Aug. 2 in the Journal of Clinical Oncology.
"This could be a confounder when you're trying to screen for prostate cancer," added Dr. Lionel L. Bañez, assistant professor of urologic surgery at Duke University Medical Center in Durham, N.C. "We should exercise caution in interpreting PSA results from patients who are taking any of these medications, especially those who are taking these medications for a long time."
But for now, men shouldn't worry unduly that their health is being compromised, said another expert.
"One PSA reading does not give accurate information," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "You want to follow the trend over a number of years. It's time that makes a difference."
Other studies have suggested that these drugs as well as others used to treat enlarged prostate can lower PSA levels, but those studies suffered from various limitations, the authors reported.
Chang and his colleagues studied the effect of 10 common medications on PSA test readings in 1,864 men age 40 and older with no history of prostate cancer.
One year of using NSAIDs, statins or thiazide diuretics gave PSA readings 1 percent, 3 percent and 6 percent lower, respectively, than those for men not on one of these drugs.
The numbers were significantly higher after five years: 6 percent, 13 percent and 26 percent lower PSA levels, respectively.
When statins were combined with the diuretics over five years, PSA levels were lowered 36 percent, the researchers found. (But taking calcium channel blockers -- often prescribed for high blood pressure -- neutralized that effect.)
It's not known why these three classes of medications have this effect, but the finding merits further study, the researchers said.
"The reason why these medications are associated with a lower PSA are unclear, and therefore it is impossible at this time to determine the true implications of our findings," said Chang, who conducted the study while at the Stanford University School of Medicine but is now affiliated with Brigham and Women's Hospital and Harvard Medical School in Boston.
Given how many older men take one or more medications, and often take NSAIDs, statins, or thiazide diuretics, the findings could affect a vast number of people, the authors stated. (The American Urological Association recommends offering prostate cancer screening to men starting at age 40.)
"If future studies show that the difference in PSA has no bearing on the development of prostate cancer, then it may be necessary to lower the PSA threshold for recommending prostate needle biopsies in men who are taking NSAIDs, statins and thiazide diuretics," Chang said.
Another possibility is that these drugs may actually have a protective effect against cancer, researchers speculated.
"Should studies demonstrate that these medications reduce the risk of developing prostate cancer, then there may be some role for NSAIDs, statins and thiazide diuretics in prostate cancer prevention," said Chang.
NSAIDs and statins are already being studied as a means of preventing prostate cancer or its progression, Bañez said.
"There may be another story here," he said.
Common medications might affect prostate cancer diagnoses, researchers say
by Amanda Gardner | HealthDay | 08.06.2010
Some of the most widely prescribed drugs in the United States may skew results of prostate cancer screening tests, possibly causing errors in diagnoses, a new study finds.
A prostate cancer diagnosis is typically based on an elevated PSA (prostate-specific antigen) level, but new research shows that common drugs, including cholesterol-lowering statins and certain painkillers, may lower PSA levels.
"Our study reveals that men regularly consuming NSAIDs [non-steroidal anti-inflammatory drugs], statins, and thiazide diuretics may have lower serum PSA levels compared to men who are not taking these medications," said Dr. Steven L. Chang, lead author of a paper published online Aug. 2 in the Journal of Clinical Oncology.
"This could be a confounder when you're trying to screen for prostate cancer," added Dr. Lionel L. Bañez, assistant professor of urologic surgery at Duke University Medical Center in Durham, N.C. "We should exercise caution in interpreting PSA results from patients who are taking any of these medications, especially those who are taking these medications for a long time."
But for now, men shouldn't worry unduly that their health is being compromised, said another expert.
"One PSA reading does not give accurate information," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "You want to follow the trend over a number of years. It's time that makes a difference."
Other studies have suggested that these drugs as well as others used to treat enlarged prostate can lower PSA levels, but those studies suffered from various limitations, the authors reported.
Chang and his colleagues studied the effect of 10 common medications on PSA test readings in 1,864 men age 40 and older with no history of prostate cancer.
One year of using NSAIDs, statins or thiazide diuretics gave PSA readings 1 percent, 3 percent and 6 percent lower, respectively, than those for men not on one of these drugs.
The numbers were significantly higher after five years: 6 percent, 13 percent and 26 percent lower PSA levels, respectively.
When statins were combined with the diuretics over five years, PSA levels were lowered 36 percent, the researchers found. (But taking calcium channel blockers -- often prescribed for high blood pressure -- neutralized that effect.)
It's not known why these three classes of medications have this effect, but the finding merits further study, the researchers said.
"The reason why these medications are associated with a lower PSA are unclear, and therefore it is impossible at this time to determine the true implications of our findings," said Chang, who conducted the study while at the Stanford University School of Medicine but is now affiliated with Brigham and Women's Hospital and Harvard Medical School in Boston.
Given how many older men take one or more medications, and often take NSAIDs, statins, or thiazide diuretics, the findings could affect a vast number of people, the authors stated. (The American Urological Association recommends offering prostate cancer screening to men starting at age 40.)
"If future studies show that the difference in PSA has no bearing on the development of prostate cancer, then it may be necessary to lower the PSA threshold for recommending prostate needle biopsies in men who are taking NSAIDs, statins and thiazide diuretics," Chang said.
Another possibility is that these drugs may actually have a protective effect against cancer, researchers speculated.
"Should studies demonstrate that these medications reduce the risk of developing prostate cancer, then there may be some role for NSAIDs, statins and thiazide diuretics in prostate cancer prevention," said Chang.
NSAIDs and statins are already being studied as a means of preventing prostate cancer or its progression, Bañez said.
"There may be another story here," he said.
Saturday, August 7, 2010
Nat'l Comprehense Cancer Network Intoduces Proventys
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News and Updates from the National Comprehensive Cancer Network® (NCCN®) July 26, 2010 | Volume 2 • Issue 15
Sign up for this Newsletter | Search Past NCCN eBulletins
Featured Articles
ADVERTISEMENT
NCCN and Proventys to Launch Novel Decision Support System
NCCN has entered into an exclusive collaboration with Proventys, a leader in advanced decision support technologies, to introduce the Proventys CDS Oncology™ system, a first-of-its-kind Web platform designed to arm oncologists with the information and evidence necessary to deliver high-quality patient care. Through this novel, point-of-care platform, Proventys and NCCN are integrating the standard in oncology practice guidelines with technologies that enable clinicians to assess individual patient factors and make decisions along cancer treatment paths more effectively.
NC
News and Updates from the National Comprehensive Cancer Network® (NCCN®) July 26, 2010 | Volume 2 • Issue 15
Sign up for this Newsletter | Search Past NCCN eBulletins
Featured Articles
ADVERTISEMENT
NCCN and Proventys to Launch Novel Decision Support System
NCCN has entered into an exclusive collaboration with Proventys, a leader in advanced decision support technologies, to introduce the Proventys CDS Oncology™ system, a first-of-its-kind Web platform designed to arm oncologists with the information and evidence necessary to deliver high-quality patient care. Through this novel, point-of-care platform, Proventys and NCCN are integrating the standard in oncology practice guidelines with technologies that enable clinicians to assess individual patient factors and make decisions along cancer treatment paths more effectively.
NC
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