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Phase 2 or 3 results paper on Abiraterone acetate in Prostate cancer, in New England Journal of Medicine (2013), one of the most cited Europe PMC records with Abiraterone acetate in its title.
Background: Abiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival in patients with metastatic castration-resistant prostate cancer after chemotherapy. We evaluated this agent in patients who had not received previous chemotherapy.
Methods: In this double-blind study, we randomly assigned 1088 patients to receive abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. The coprimary end points were radiographic progression-free survival and overall survival.
Results: The study was unblinded after a planned interim analysis that was performed after 43% of the expected deaths had occurred. The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone (hazard ratio for abiraterone-prednisone vs. prednisone alone, 0.53; 95% confidence interval [CI], 0.45 to 0.62; P<0.001). Over a median follow-up period of 22.2 months, overall survival was improved with abiraterone-prednisone (median not reached, vs. 27.2 months for prednisone alone; hazard ratio, 0.75; 95% CI, 0.61 to 0.93; P=0.01) but did not cross the efficacy boundary. Abiraterone-prednisone showed superiority over prednisone alone with respect to time to initiation of cytotoxic chemotherapy, opiate use for cancer-related pain, prostate-specific antigen progression, and decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and abnormalities on liver-function testing were more common with abiraterone-prednisone.
Conclusions: Abiraterone improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer. (Funded by Janssen Research and Development, formerly Cougar Biotechnology; ClinicalTrials.gov number, NCT00887198.).
Indexed on Europe PMC as PubMed record 23228172 (DOI 10.1056/nejmoa1209096). Its title names Abiraterone acetate and its text names Prostate cancer; PubMed types it as a clinical trial report (Research Support, Non-U.S. Gov't, research-article, Multicenter Study, Randomized Controlled Trial). It was matched automatically to the idea "Prescribe a quarter dose of abiraterone with breakfast" and no figure has been checked by an editor.
One of the most cited trial reports Europe PMC returns for Abiraterone acetate in Prostate cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
The trial that made an androgen receptor inhibitor the usual first treatment for castration-resistant prostate cancer, and that delayed chemotherapy by a long margin for most men. Its effect sizes are why later trials in this setting are judged against a hazard ratio near 0.7 for survival.
The proof, in people, that castration-resistant prostate cancer is usually still androgen-driven. It renamed the disease (hormone-refractory became castration-resistant) and it opened the line of drugs that now dominate treatment at every stage from first diagnosis of metastatic disease onwards.
Shares COU-AA-301: abiraterone and increased survival in metastatic castration-resistant prostate cancer after docetaxel, PREVAIL: enzalutamide in metastatic prostate cancer before chemotherapy, Radiographic progression-free survival (rPFS), PSA (prostate-specific antigen).
Shares PSA (prostate-specific antigen), Castration-resistant prostate cancer (CRPC), Prednisone, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch.
Shares Radiographic progression-free survival (rPFS), PSA (prostate-specific antigen), Abiraterone acetate, Castration-resistant prostate cancer (CRPC).
Shares Phase 1 trial of abiraterone acetate confirms that castration-resistant prostate cancer commonly remains hormone driven, Prednisone, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch, New England Journal of Medicine.
Shares Radiographic progression-free survival (rPFS), PSA (prostate-specific antigen), Abiraterone acetate, Castration-resistant prostate cancer (CRPC).
Shares Prescribe a quarter dose of abiraterone with breakfast, Abiraterone acetate, Prednisone, Prostate cancer.
Shares Prescribe a quarter dose of abiraterone with breakfast, Abiraterone acetate, Prednisone, Prostate cancer.
Shares PSA (prostate-specific antigen), Castration-resistant prostate cancer (CRPC), Prednisone, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch.