A new chemotherapy drug that The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust helped develop extends the life of men with advanced prostate cancer, according to final results of a large-scale trial published in the journal The Lancet today.
The drug cabazitaxel, developed by sanofi-aventis under the brand name Jevtana, has already been approved by the US Food and Drug Administration (FDA) for use in combination with the steroid prednisone. The decision was based largely on results from the Phase III trial jointly led by Johann de Bono from the ICR and The Royal Marsden.
“We are proud to have been involved in the development of this drug, which will offer new hope to men with advanced prostate cancer who have exhausted other treatment options,” Dr de Bono says. “This is one of only a small handful of drugs shown to prolong the life of men with advanced prostate cancer.”
Men whose cancer has spread beyond the prostate are normally treated with drugs that block the body’s production of testosterone, which feeds cancer growth. Patients often become resistant to hormone therapy and move on to the chemotherapy drug docetaxel. Once men develop resistance to docetaxel they are often given mitoxantrone to maintain quality of life, but until now no other treatments have been available to prolong survival.
Cabazitaxel was tested in men with metastatic advanced prostate cancer who had developed resistance to hormone treatment and docetaxel. The study, known as TROPIC and funded by sanofi-aventis, was conducted in 146 trial sites in 26 countries around the world. Patients were randomly assigned to receive an injection of cabazitaxel plus prednisone or another chemotherapy drug mitoxantrone plus prednisone (378 and 377 patients, respectively), for up to a maximum of 10 cycles. The study found that patients in the cabazitaxel treatment group lived on average 15.1 months compared to 12.7 months for men in the mitoxantrone group.
Cabazitaxel blocked cancer growth for twice as long as mitoxantrone (1.4 months compared to 2.8 months), and men’s levels of prostate specific antigen (PSA), the standard measure of tumour activity, stayed down for longer.
During the study, which ran from January 2007 until September 2009, men taking cabazitaxel in combination with prednisone were 30 per cent less likely to die than men in the mitoxantrone treatment group.
The FDA considered cabazitaxel under its priority review programme for drugs that may offer a major advance in treatment. The regulatory body suggested the human growth factor G-CSF could be given alongside cabazitaxel to reduce the risk of neutropenia, or low white blood cell count, which was a recognised and potentially serious side-effect of treatment. Other side-effects included fatigue, nausea and vomiting.
Dr de Bono says the next step is to test cabazitaxel in patients with earlier stage disease including those who have not yet received any chemotherapy.
Prostate cancer has overtaken lung cancer to become the most common cancer in men. One man dies of prostate cancer in the UK every hour, and more than 35,000 men are diagnosed with the disease every year.
The Institute of Cancer Research (ICR)
www.icr.ac.uk
