"11 October 2010
The Prostate Cancer Charity comments on latest research into abiraterone
The Prostate Cancer Charity comments on the interim results of a phase III trial into the prostate cancer drug abiraterone, which has been shown to extend the lives of men living with advanced disease by an average of almost four months.
John Neate, Chief Executive at The Prostate Cancer Charity, explains: “These initial findings are particularly important as they offer new hope to men diagnosed with an advanced form of prostate cancer who can quickly run out of treatment options once their tumour stops responding to the existing methods of controlling its progression.
“The results of the trial conducted in over 1,000 men across 13 countries, indicate that abiraterone is able to prolong the lives of men living with the most advanced stages of the disease by an average of almost four months. What is particularly encouraging is that men taking the drug did not generally experience significant side effects, such as those normally associated with chemotherapy treatment.”
He continued: “Abiraterone represents a significant move forward in the treatment of advanced prostate cancer for some time. To date, the full results of this study are yet to be published and reviewed. We look forward to seeing these results and hope that they will provide the robust evidence necessary for abiraterone to be licensed and made generally available on the NHS to all men who need it.”"
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"Abiraterone acetate extends median survival by 3.9 months in mCRPC
Posted on October 11, 2010 by Sitemaster
The results of a randomized, double-blind, placebo-controlled, multi-center, Phase III clinical trial comparing abiraterone actetate + prednisone to a placebo + prednisone in men with metastatic castration-resistant prostate cancer (mCRPC) were presented today at the annual meeting of the European Society for Medical Oncology in Milan, Italy.
This first Phase III trial of abiraterone acetate, initiated in early 2008, enrolled 1,195 men with mCRPC who had progressive prostate cancer following one or two courses of chemotherapy, including one course of docetaxel-based chemotherapy.
Patients could not have received prior treatment with ketoconazole, abiraterone acetate, any other drug that acts as a CYP17 inhibitor, or any other investigational drug that targets the androgen receptor. They also had to have an ECOG performance status of 0 to 2. Eligible patients were enrolled at 147 clinical sites in Australia, Europe, the USA, and Canada.
The key data presented by Dr. de Bono on behalf of the investigators are as follows:
•Patients were randomized in a 2:1 fashion, with 797 patients randomized to abiraterone acetate + prednisone and 398 patients randomized to a placebo + prednisone.
•Patients treated with abiraterone + prednisone had a 35 percent reduction in their risk of death (hazard ratio [HR] = 0.65) compared to those receiving a placebo + prednisone.
•Median survival of patients receiving abiraterone was 14.8 months compared to 10.9 months for those receiving the placebo.
•Time to disease progression was 10.2 months among those on abiraterone and 6.6 months for the placebo patients.
•The two most evident adverse effects of abiraterone acetate + prednisone were fluid retention and hypokalemia (elevated potassium levels).
•Most adverse events of abiraterone acetate + prednisone appear to be manageable and do not include any of the classic side effects of chemotherapy.
Marketing applications for abiraterone in the U.S. and Europe are scheduled to be filed by the end of this year. Additional details about the results of the trial are available in a media release from subsidiaries of Johnson & Johnson.
Abiraterone acetate becomes the second drug this year to demonstrate a clear median survival benefit in men with mCRPC and with progressive disease after treatment with docetaxel-based chemotherapy, representing a practice-changing advance in the management of late-stage prostate cancer."
The "New" Prostate Cancer InfoLink
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