Trial drug extends life of men with advanced prostate cancer
Friday 1 June 2012
An experimental hormone treatment called enzalutamide extended the lives of men with advanced prostate cancer taking part in a UK clinical trial.
The initial findings were presented at the American Society of Clinical Oncology's annual conference.
Researchers running the trial, from The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust, say that the promising results are "very pleasing" as there are few treatments available for advanced prostate cancer.
Professor Johann de Bono from the ICR and The Royal Marsden, said: "The trial showed that enzalutamide was not only keeping men alive for longer, but for some it was also improving their quality of life."
The Phase III trials involved 1,199 men with an advanced form of disease called metastatic castration-resistant prostate cancer that had stopped responding to chemotherapy. The men were split into two groups, those taking a course of enzalutamide and those given placebos.
The results showed that patients taking enzalutamide lived an average of 18.4 months, compared with 13.6 months for the placebo group.
The men's quality of life was also assessed, including measures of their energy levels, ability to cope with their illness and levels of pain. 43 per cent of men in the enzalutamide group had an improved quality of life, compared with 18 per cent of men taking a placebo.
Elizabeth Woolf, head of Cancer Research UK's information website, CancerHelp UK, said: "It's really encouraging to see such positive results for a new drug to treat advanced prostate cancer.
"Before NICE approved abiraterone - a drug that Cancer Research UK helped develop - last month, there were no other treatments available for men with this type of cancer that has come back after chemotherapy.
"Enzalutamide appears to extend life by around five months, as well as improving quality of life for the patient. So although this isn't a cure, it could offer men crucial extra months to spend with their loved ones.
"We look forward to seeing the results of this trial when it's completed, which will tell us for sure how effective enzalutamide is."
Prostate cancer relies on testosterone to grow. Enzalutamide, the first in a new class of medicines called androgen receptor signaling inhibitors, has been designed to block the interaction between prostate cancer cells and testosterone.
In November last year, the trial's Independent Data Monitoring Committee recommended that the trial be stopped early and men who received the placebo be offered enzalutamide.
The drug's developers, Medivation and Astellas, have since submitted a New Drug Application for enzalutamide to the US FDA and plan to submit for regulatory approval in Europe.
Copyright Press Association 2012
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