A study published in The New England Journal of Medicine demonstrates significant improvements in survival in patients with advanced metastatic prostate cancer, prior chemotherapy, when given a novel treatment, the abiraterone acetate in combination with prednisone / prednisolone. The study was sponsored by Ortho Biotech Oncology Research & Development, Unity of Cougar Biotechnology, Inc., an affiliate of Janssen Pharmaceutical.
Abiraterone acetate is a selective inhibitor of the biosynthesis of androgens, which play a key role in the progression of prostate cancer. The tumor itself, this type of cancer is an additional source of production of androgens, in addition to the testes and adrenal glands where they are first produced.
After a median follow up of 12.8 months, overall survival of the group who was being administered abiraterone acetate with prednisone / prednisolone was 14.8 months, whereas the group that was being administered prednisone / prednisolone with placebo was 10.9 months (representing an improvement in median survival of 36%). Treatment with abiraterone acetate also resulted in a 35% reduction in risk of death compared to placebo. This study included 1,195 patients with metastatic prostate cancer resistant to castration that had been previously treated with one or two chemotherapy regimens, one of which containing docetaxel.
Researchers also add that, despite the higher state of frailty and advanced age of the population in treatment, patients adhere well to treatment with abiraterone acetate, whose toxicity was easily manageable and reversible.
"Given the fact that men with advanced metastatic prostate cancer have few options, we are pleased with the results of this rigorous study that shows that the acetate abiraterone may allow greater survival of these patients" says Johann S. de Bono, MD, FRCP, MSC, PhD, Institute for Cancer Research, The Royal Marsden NHS Foundation Trust and lead author of the study. "The data indicate that acetate Abiraterone has the potential to address a medical need not met for these patients with advanced metastatic prostate cancer and their families."
The group of patients treated with abiraterone in combination with prednisone / prednisolone also showed significant improvements in secondary endpoints of this study: the time to PSA progression (median 10.2 months versus 6.6 months with abiraterone placebo) and an increase in progression-free survival Radiographic (median 5.6 months versus 3.6 months with abiraterone placebo). Also the total confirmed PSA response, defined as a reduction of more than 50% compared to baseline, was achieved in 29% of patients treated with abiraterone and only 6% of patients in the control group.
Arnaldo Castro Figueiredo, a specialist in Urology and professor at the University of Coimbra states that this treatment "is opening a new avenue, because it enables something that until now was not possible" and explains that, for cases of metastatic prostate tumor "initial therapy consists of androgen deprivation. However, it appears that, at one time, the tumor grows back, designating themselves as "hormone-independent." However, there remain levels, although very low, androgen, so the term "hormone-independent" is not, strictly speaking, adequate. The only recourse at this stage is chemotherapy, which is the finish line. "
Professor concludes that "This drug has been shown that, after all, one can go further with the castration androgen ablation, and thus demonstrated with this study, the tumors that had progressed after androgen ablation, respond to this new hormonal manipulation, with little toxicity to patients, which is relevant because it is not always better survival with quality of life. " It also says "like this drug brings new hope, no cure, but constitutes a significant development" and says that "The study was done to placebo, demonstrating that there is no alternative at present.
Arnaldo Figueiredo Castro asks himself: "the question is whether this drug also could be used prior to chemotherapy," which could be important.
With regard to side effects, the most frequently recorded in the group treated with abiraterone and in the control group were fluid retention (31% versus 22%), hypertension (10% versus 8%) and hypokalemia (17% versus 8%).
Given the results of this phase 3 trial, in its interim analysis, the Independent Data Monitoring Committee recommended that patients in the control group, treated with prednisone / prednisolone, all involve transit for treatment with abiraterone acetate. This decision was due to the fact of survival results were so impressive that it would be clinically acceptable to keep patients in the control group.
Source: http://www.pop.eu.com
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