Drug Extends Lives of Patients With Advanced Prostate Cancer

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Of the 15,000 diagnosed when the disease is confined to the pelvic area, most could expect to live as long as they would if they were cancer-free.

The clinical trial, run by Cancer Research UK and believed to be the biggest cancer trial in the world, including about 1,900 men diagnosed with advanced prostate cancer which had not spread.

J&J $JNJ has been duking it out with Pfizer's Xtandi - recently acquired in the $14 billion Medivation deal - in the area of prostate cancer, where both drugs are credited with a major improvement in the standard of care for prostate cancer.

Late previous year Pfizer and its partners at Astellas conceded that Xtandi combined with Zytiga and prednisone failed to bend the curve on progression-free survival for chemo-naïve patients whose disease had progressed following treatment with Xtandi, compared with a group of patients treated with Zytiga and prednisone alone.

"We think this is one of the biggest survival gains ever reported in a trial in adults with solid tumor", he said.

Usually, abiraterone is given to men who have stopped responding to ADT but the study found that giving it much earlier, and in combination with ADT, reduced the risk of dying by 37 percent.

The drug, abiraterone (Zytiga), lowered patients' risk of death by almost 40 percent when added to standard androgen deprivation therapy, both studies found.

Study findings indicated abiraterone acetate plus prednisone, in combination with ADT, reduced the risk of death by 38% compared to placebo plus ADT (Hazard Ratio [HR]=0.62; 95 percent CI [0.51 to 0.76], P 0.0001).

Overall, the treatment appears to mark a step forward against advanced prostate cancer, said Sumanta Kumar Pal, an ASCO expert who was not involved in the study.

He said: "It felt like my world fell apart overnight". "The doctors explained that surgery wasn't an option for me because cancer had spread beyond my prostate".

According to Dr. Fizazi, all secondary endpoints for the trial were met, including improvements in time to prostate-specific antigen progression, time to pain progression, and time to next symptomatic skeletal event.

"There is a large unmet need to improve treatment for men with newly diagnosed metastatic cancer, who die of the disease within less than five years on average", said Karim Fizazi, head of cancer medicine at Gustave Roussy, University Paris-Sud, in Villejuif, France, who led the other study.

Abiraterone is already approved for use on the NHS in men whose prostate cancer has become resistant to hormone treatment.

Abiraterone, a pill taken once daily, blocks an enzyme that converts other hormones to testosterone, essentially halting production of testosterone throughout the body.

The studies, published in the New England Journal of Medicine, were funded by J&J. "During the first six months, tests showed that the treatment was working. As part of the trial, I started taking abiraterone four times a day and had a hormone injection every eight weeks", said Samuels, according to The Institute of Cancer Research.

"Now, the new results tell us that patients just starting hormone therapy can also benefit from this drug, which was discovered here at the ICR".

Workman added that the drug is a highly innovative treatment that not only improves survival rates but has lower rates of side-effects, compared to conventional therapies. "Abiraterone is already now being used before chemotherapy, at an earlier stage than initially had been the case, and it's really exciting to see that it could start benefiting patients as soon as they are diagnosed".

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