A drug already set to transform care for men with advanced prostate cancer has impressive benefits for men with earlier-stage disease too, a major new clinical trial shows.
Abiraterone, discovered at The Institute of Cancer Research, London*, was approved last May by NICE for use on the NHS to treat prostate cancer that has stopped responding to standard hormone therapies and docetaxel chemotherapy.
And the new Phase III trial, carried out with The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust, shows that when the drug is given to men with no or mild symptoms before chemotherapy it can double the time before tumour progression can be detected by a scan.
The benefits for men taking abiraterone were so striking that the trial was stopped early so that all patients in the study could receive it. The FDA yesterday approved abiraterone, in combination with prednisone, for use in patients before chemotherapy.
The findings are published online today in the New England Journal of Medicine and are set to pave the way for men to be treated with abiraterone much earlier in the course of their disease, without having to undergo toxic chemotherapy first.
Study author Professor Johann de Bono, leader of the prostate cancer targeted therapy team at The Institute of Cancer Research and honorary consultant at The Royal Marsden NHS Foundation Trust, said: “Abiraterone was initially approved for use in patients who had run out of standard treatment options, but this trial shows that if we can give patients the drug at an earlier stage we can slow their decline and block their cancer growth for longer. Abiraterone is not only keeping cancer in check and extending men’s lives, but it is also set to deliver substantial benefits to men’s quality of life, because its side-effects are so much milder than those of conventional chemotherapy.”
Some 1,088 men from the UK and elsewhere, who had stopped responding to standard hormone-suppressing drugs but had not received chemotherapy, took part in the randomised, double-blind study.
Men taking abiraterone went an average of 16.5 months before tumour growth was detected by a CT or MRI scan – twice as long as the 8.3 months among men taking a placebo. Men in the abiraterone group also reported less pain than those on placebo.
The drug’s benefits appeared greater than in the earlier trial in men with advanced prostate cancer, where men taking abiraterone went an average of 5.6 months before tumour growth was detected, compared with 3.6 months with placebo.
Professor Alan Ashworth, chief executive of The Institute of Cancer Research, said: “Abiraterone has provided men with advanced prostate cancer with a treatment option where previously they had none, and we were always optimistic that it would have even more dramatic benefits when tested in men with earlier-stage disease.
“The new findings show that abiraterone when given before chemotherapy can double the length of time before a patient’s cancer starts growing again, and are likely to herald even wider use of this important new drug. We are very pleased to see a drug that the ICR helped discover and take through clinical trials delivering benefits to so many men.”
Professor Martin Gore, medical director at The Royal Marsden, said: “Here at The Royal Marsden we have seen first hand the impact abiraterone has had on our patients with advanced prostate cancer. Patients are now living longer, and with fewer side-effects. To now see the positive effect this is having on patients with early-stage disease is an exciting development in prostate cancer research.”
Abiraterone was discovered at the ICR in what is now the Cancer Research UK Cancer Therapeutics Unit and further developed at the ICR and The Royal Marsden. Professor Johann de Bono, from the ICR and The Royal Marsden, led the Phase I and II clinical trials and pivotal phase III trial that led to the decision to make abiraterone available on the NHS. The new study was led in the US by Dr. Charles Ryan at the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, and funded by Janssen Research & Development, LLC.
“Abiraterone in Metastatic Prostate Cancer with No Prior Chemotherapy” , Charles J Ryan et al.
New England Journal of Medicine Online First on 10 December 2012Sources: The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust