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Investigational PCa agent improves survival in patients with bone mets
An investigational alpha-pharmaceutical appears to significantly prolong survival in patients with bone metastases from advanced prostate cancer, British researchers reported at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden.
An investigational alpha-pharmaceutical appears to significantly prolong survival in patients with bone metastases from advanced prostate cancer, British researchers reported at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden.
Chris Parker, MD, of the Royal Marsden Hospital, London, and colleagues studied 922 prostate cancer patients who were resistant to hormone treatment and treated with radium-223 chloride (Alpharadin). The international phase III study was stopped early when an interim analysis by the Independent Data Monitoring Committee in June 2011 revealed that patients receiving the best standard treatment plus radium-223 were living longer than those who were receiving the same standard treatment plus placebo.
Patients taking radium-223 had a 30% lower rate of death compared with patients taking placebo (HR 0.695 [p=.00185]). Median overall survival was 14 months compared with 11.2 months in the placebo group.
"Compared with chemotherapy, radium-223 is highly targeted to the bone metastases, and it has a completely different safety profile," Dr. Parker said. "Although it has never been rigorously compared with chemotherapy, from observing patients in the clinic, it is clear that patients tolerate it much better than they do chemotherapy."
The researchers now intend to submit the data for regulatory approval.
"I have no doubt that there will be further trials looking at a combination of radium-223 with other drugs that are currently used in prostate cancer, and that there will also be studies using radium earlier in the disease," Dr. Parker said. "In particular, our research was restricted to those men who were not going to receive chemotherapy for prostate cancer. It would be interesting to use radium-223 chloride before chemotherapy since it might be even more effective in that setting."
The trial was sponsored by Algeta ASA and Bayer Healthcare Pharmaceuticals.
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