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New Research Reveals Positive Therapies and Methods for Treating Prostate Cancer

New Research Reveals Positive Therapies and Methods for Treating Prostate Cancer Recent research suggests physicians treating patients with prostate cancer may soon have more tools in their armamentarium and clearer guidance on how to use some of them. But how effective these tools will be remains unclear. More therapies will be welcomed, as prostate cancer is the second leading cause of cancer death in men in the United States, lagging behind only lung cancer. The American Cancer Society estimates that in 2012, about 240 000 new US cases of prostate cancer will be diagnosed, and about 28 000 men will die from the disease. (Photo credit: David McCarthy/www.sciencesource.com) New therapies being developed in clinical trials could give physicians new options when treating men with prostate cancer. The recent research, presented in June at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, focused on the use of radiation therapy for patients with bone metastases, 2 different hormonal therapies, and the timing of hormonal therapy. Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, welcomed the findings but cautioned that they need to be used appropriately. “A number of years ago we had no real treatment options for prostate cancer, but now we have something. It's not enough, but they are steps in the right direction,” Lichtenfeld said. “If we have a problem today, it's because we have to learn how to take all this new knowledge and put it together in novel ways to get the maximum benefit and do so in a coordinated fashion to best manage prostate cancer.” Radiopharmacological At the ASCO meeting, researchers from Europe and the United States presented findings suggesting that radium-223 dichloride (Alpharadin), an investigational α-particle–emitting pharmaceutical administered intravenously, increased overall survival (median of 14.9 months compared with 11.3 months for patients taking placebo) in men with castration-resistant prostate cancer and symptomatic bone metastases. The phase 3, randomized, double-blind international trial enrolled 809 men and was stopped early when a planned interim analysis found the therapy was significantly outperforming placebo. Guru Sonpavde, MD, an assistant professor of medicine at Baylor College of Medicine in Houston, said he is impressed with the radium-223 results. “This is the first radiopharmacological to improve survival,” Sonpavde said. Bayer HealthCare said in a release that it plans to file radium-223 dichloride with the US Food and Drug Administration (FDA), the European Medicines Agency, and other health authorities in the second half of 2012. Inhibiting androgens Attendees at the ASCO meeting also heard about advances in androgen-inhibiting therapies, including a presentation of positive findings for abiraterone acetate, an androgen biosynthesis inhibitor that already has FDA approval for treating prostate cancer in postdocetaxel castration-resistant patients. The new study involved 1088 patients with castration-resistant prostate cancer at 151 medical centers in 12 countries. The patients had yet to receive chemotherapy and were asymptomatic or mildly symptomatic. Half were randomized to receive abiraterone acetate plus prednisone, and the others received placebo plus prednisone. The study was stopped early when its independent data monitoring committee concluded overall survival, progression-free survival, and secondary end points all favored the abiraterone acetate care. The stopping of the trial led to some raised eyebrows because the increase in overall survival did not reach statistical significance. Bruce J. Roth, MD, ASCO spokesman and a professor of medicine at Washington University School of Medicine in St Louis, said he was comfortable with the decision. “From a statistical viewpoint, you could have waited a little while longer to have overall survival reach significance, but if I was on the monitoring committee and looking at the results, the question would be, ‘Would I want some member of my family on a placebo?’” Roth said. “This would have been a positive study and confirmed if they wanted to wait.” In another study of androgen-suppressing therapy that was stopped early by an independent data monitoring committee, an international team of researchers found that MDV3100, an androgen-receptor–signaling inhibitor, increased overall survival to 18.4 months for patients taking the drug compared with 13.6 months for those taking placebo. The randomized, double-blind, placebo-controlled, multinational phase 3 study involved 1199 patients with castration-resistant prostate cancer who had received up to 2 regimens of docetaxel-based chemotherapy. Meanwhile, a 17-year study begun in 1995 comparing intermittent androgen deprivation therapy with continuous androgen deprivation therapy came up with an answer that did not sit well with some researchers and treating physicians. In this study, 1535 patients with hormone-sensitive metastatic prostate cancer were randomized to receive intermittent or continuous androgen deprivation therapy. After a median follow-up of 9.2 years, the researchers found that intermittent therapy was not proven to be noninferior to continuous therapy and may have even increased risk for shorter survival. The findings were questioned by proponents of intermittent therapy, which has become the standard of care in many communities. Roth said he was accepting of the results. “We're not going to redo this trial or have a confirmation trial, so we're stuck with the results,” Roth said. “My question to those in favor of intermittent therapy is, ‘What are you going to tell the next patient you see that you offer intermittent therapy?’ Are you going to argue that this is a statistical fluke? How can you defend that? The data are the data.” http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

New Research Reveals Positive Therapies and Methods for Treating Prostate Cancer

JAMA , Volume 308 (5) – Aug 1, 2012

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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.7960
Publisher site
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Abstract

Recent research suggests physicians treating patients with prostate cancer may soon have more tools in their armamentarium and clearer guidance on how to use some of them. But how effective these tools will be remains unclear. More therapies will be welcomed, as prostate cancer is the second leading cause of cancer death in men in the United States, lagging behind only lung cancer. The American Cancer Society estimates that in 2012, about 240 000 new US cases of prostate cancer will be diagnosed, and about 28 000 men will die from the disease. (Photo credit: David McCarthy/www.sciencesource.com) New therapies being developed in clinical trials could give physicians new options when treating men with prostate cancer. The recent research, presented in June at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, focused on the use of radiation therapy for patients with bone metastases, 2 different hormonal therapies, and the timing of hormonal therapy. Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, welcomed the findings but cautioned that they need to be used appropriately. “A number of years ago we had no real treatment options for prostate cancer, but now we have something. It's not enough, but they are steps in the right direction,” Lichtenfeld said. “If we have a problem today, it's because we have to learn how to take all this new knowledge and put it together in novel ways to get the maximum benefit and do so in a coordinated fashion to best manage prostate cancer.” Radiopharmacological At the ASCO meeting, researchers from Europe and the United States presented findings suggesting that radium-223 dichloride (Alpharadin), an investigational α-particle–emitting pharmaceutical administered intravenously, increased overall survival (median of 14.9 months compared with 11.3 months for patients taking placebo) in men with castration-resistant prostate cancer and symptomatic bone metastases. The phase 3, randomized, double-blind international trial enrolled 809 men and was stopped early when a planned interim analysis found the therapy was significantly outperforming placebo. Guru Sonpavde, MD, an assistant professor of medicine at Baylor College of Medicine in Houston, said he is impressed with the radium-223 results. “This is the first radiopharmacological to improve survival,” Sonpavde said. Bayer HealthCare said in a release that it plans to file radium-223 dichloride with the US Food and Drug Administration (FDA), the European Medicines Agency, and other health authorities in the second half of 2012. Inhibiting androgens Attendees at the ASCO meeting also heard about advances in androgen-inhibiting therapies, including a presentation of positive findings for abiraterone acetate, an androgen biosynthesis inhibitor that already has FDA approval for treating prostate cancer in postdocetaxel castration-resistant patients. The new study involved 1088 patients with castration-resistant prostate cancer at 151 medical centers in 12 countries. The patients had yet to receive chemotherapy and were asymptomatic or mildly symptomatic. Half were randomized to receive abiraterone acetate plus prednisone, and the others received placebo plus prednisone. The study was stopped early when its independent data monitoring committee concluded overall survival, progression-free survival, and secondary end points all favored the abiraterone acetate care. The stopping of the trial led to some raised eyebrows because the increase in overall survival did not reach statistical significance. Bruce J. Roth, MD, ASCO spokesman and a professor of medicine at Washington University School of Medicine in St Louis, said he was comfortable with the decision. “From a statistical viewpoint, you could have waited a little while longer to have overall survival reach significance, but if I was on the monitoring committee and looking at the results, the question would be, ‘Would I want some member of my family on a placebo?’” Roth said. “This would have been a positive study and confirmed if they wanted to wait.” In another study of androgen-suppressing therapy that was stopped early by an independent data monitoring committee, an international team of researchers found that MDV3100, an androgen-receptor–signaling inhibitor, increased overall survival to 18.4 months for patients taking the drug compared with 13.6 months for those taking placebo. The randomized, double-blind, placebo-controlled, multinational phase 3 study involved 1199 patients with castration-resistant prostate cancer who had received up to 2 regimens of docetaxel-based chemotherapy. Meanwhile, a 17-year study begun in 1995 comparing intermittent androgen deprivation therapy with continuous androgen deprivation therapy came up with an answer that did not sit well with some researchers and treating physicians. In this study, 1535 patients with hormone-sensitive metastatic prostate cancer were randomized to receive intermittent or continuous androgen deprivation therapy. After a median follow-up of 9.2 years, the researchers found that intermittent therapy was not proven to be noninferior to continuous therapy and may have even increased risk for shorter survival. The findings were questioned by proponents of intermittent therapy, which has become the standard of care in many communities. Roth said he was accepting of the results. “We're not going to redo this trial or have a confirmation trial, so we're stuck with the results,” Roth said. “My question to those in favor of intermittent therapy is, ‘What are you going to tell the next patient you see that you offer intermittent therapy?’ Are you going to argue that this is a statistical fluke? How can you defend that? The data are the data.”

Journal

JAMAAmerican Medical Association

Published: Aug 1, 2012

Keywords: prostate cancer

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