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STAMPEDE trial. LATITUDE trial came out about
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Hormone naive metastatic PC :
CHICAGO — The addition of abiraterone acetate with prednisone to standard hormonal therapy led to a 38% lower risk for death in men with high-risk, metastatic prostate cancer, according to results of the phase 3 LATITUDE trial presented at the ASCO Annual Meeting.
Abiraterone acetate (Zytiga, Janssen) also more than doubled the median time to prostate cancer worsening, from 14.8 months to 33 months, researchers reported.
“There is a large unmet need to improve treatment for men with newly diagnosed metastatic cancer, who die of the disease within less than 5 years on average,” Karim Fizazi MD, PhD, head of the department of cancer medicine at Gustave Roussy, University Paris-Sud in Villejuif, France, said during a press briefing. “The benefit from early use of abiraterone we saw in this study is at least comparable to the benefit from docetaxel chemotherapy, which was observed in prior clinical trials, but abiraterone is much easier to tolerate, with many patients reporting no side effects.”
Prostate cancer growth is fueled by testosterone. Abiraterone stops the production of testosterone throughout the body by blocking an enzyme that converts other hormones to testosterone. The FDA previously approved abiraterone for patients with metastatic prostate cancer that worsened despite androgen deprivation therapy (ADT).
LATITUDE is a multinational, randomized placebo-controlled phase 3 clinical trial of 1,200 men with newly diagnosed, high-risk metastatic prostate cancer who had not previously received ADT. All trial participants had at least two of three risk factors:
Gleason score of 8 or more;
three or more bone metastases; or
three or more visceral metastases
Researchers randomly assigned patients to receive ADT plus abiraterone and prednisone, or ADT plus placebo. Patients routinely receive corticosteroid prednisone along with abiraterone to manage its side effects, such as low potassium or high blood pressure.
OS and radiographic PFS served as primary endpoints.
After median follow-up of 30.4 months, 406 deaths (48%) and 593 radiographic PFS events had occurred.
Men who received abiraterone demonstrated a 38% lower risk for death than those who received placebo (HR = 0.62; 95% CI, 0.51-0.76).
Median OS had not yet been reached in the abiraterone group, as more than 50% of men in that group remained alive at the time of analysis. Researchers reported median OS of 34.7 months in the placebo group.
Abiraterone conferred a 53% lower risk for radiographic PFS (HR = 0.47; 95% CI, 0.39-0.55) and resulted in cancer growth being delayed by a median of 18.2 months.
Post Edited (RobertC) : 6/3/2017 1:01:13 PM (GMT-6)