Prostate cancer trial stuns researchers: 'It's a once in a career feeling'

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Half of the group was assigned to standard cancer care protocols.

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. And if traditional antihormonal treatments were able to contain the disease for many months, cancer could eventually develop resistance to drugs and invade the bones, causing pain and fractures.

Additionally, the rates of grade ≥2 neurotoxicity were approximately 30% less with the shorter duration of chemotherapy.

CHICAGO, June 3 Adding Johnson & Johnson's Zytiga to standard hormone therapy reduced by almost 40 percent the risk of death for men newly diagnosed with prostate cancer that had spread to other parts of the body, according to new trial results.

Prof Johann de Bono said they showed that when used at the start of treatment, abiraterone had "clear benefits for patients".

"We wanted this to be simple", Saltz said.

The IDEA (International Duration Evaluation of Adjuvant chemotherapy) collaboration, involving more than 12,000 patients in six parallel clinical trials, was meant to see if shorter - and therefore less toxic - courses of post-surgical oxaliplatin-based chemotherapy are as effective as the current standard, according to Axel Grothey, MD, of the Mayo Clinic in Rochester, Minn. Since the risk of neuropathy is dose-dependent, it made sense to see if shortening the duration of therapy might also cut the adverse events. Researchers also evaluated potential differences with FOLFOX chemotherapy (5-fluorouracil and oxaliplatin) compared with CAPOX (capecitabine and oxaliplatin).

"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".

The results of these trials are "pretty likely to change clinical practice overnight", said ASCO Chief Medical Officer Dr. Richard Schilsky.

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The second successful trial, still based on the same drug combination, was conducted by Dr. Nicholas James, a clinical oncology professor at the Queen Elisabeth Hospital in Birmingham, UK, and of about 2,000 men British and Swiss.

About 3 percent of USA men newly diagnosed with prostate cancer have metastatic cancer, or cancer that has spread beyond the original tumor, said Dr. Karim Fizazi, head of cancer medicine at Gustave Roussy, University Paris-Sud in Villejiuf, France. It compared patients treated with standard hormone therapy to those treated with hormone therapy plus abiraterone and the steroid prednisone. Only FOLFOX was administered in the United States, where patients participated through the Alliance/SWOG 80702 trial.

Participation was continued until cancer treatment was stopped. Approximately 60% had low-risk disease (T-1 N1) and 40% had high-risk (T4 or N2).

The goal of the study was to determine whether 3 months of adjuvant chemotherapy would be as effective as 6 months.

Fizazi said a trial to see if Zytiga has a benefit when added to hormonal therapy and chemotherapy is still under way.

Under that definition, the DFS findings for the overall patient population favored the 3-month regimen but did not meet the threshold for statistically significant noninferiority (HR, 1.07; 95% CI, 1.00-1.15).

Collaborative Effort Highlighted Grothey pointed out that the IDEA research was funded through the National Institutes of Health (NIH), public agencies in other countries, and philanthropies. "The pharmaceutical industry is not interested in giving less treatment". You have encouraged us in our mission - to provide quality news and watchdog journalism.

Shi Q, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Survival results from an adaptive, multiarm, multistage, platform randomized controlled trial.

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