In a study involving nearly 1200 men with metastatic prostate cancer who had progressive disease after chemotherapy, enzalutamide, a novel androgen-receptor blocker, extended the median survival ...
Enzalutamide is an oral androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway. In the randomized phase III AFFIRM study, significant improvements in survival versus placebo were observed when enzalutamide was used as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) following prior treatment with docetaxel.
The primary endpoint in AFFIRM was overall survival, and patients were first assessed for disease progression at 13 weeks. 2. AFFIRM was a randomized (2:1), double-blind, placebo-controlled study for patients on LHRH therapy* who had progressed to metastatic CRPC. Patients with predisposing factors for seizure history were excluded.
Early study of enzalutamide in metastatic castrate-resistant prostate cancer. The efficacy and safety of enzalutamide was first investigated in a phase I–II study of 140 patients with progressive mCRPC in five US centers [Scher et al. 2010].Of the 140 patients, 65 had not received prior chemotherapy treatment.
Background Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy.
9/10/2009 · Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
10/30/2014 · Enzalutamide has been shown to significantly prolong overall survival in men with mCRPC after docetaxel-based chemotherapy, compared with placebo, in the AFFIRM study . This study also included a detailed assessment of patient HRQoL using the disease-specific FACT-P instrument.
The approval of enzalutamide for second-line use was based on results from the AFFIRM study, which showed a survival benefit in men with postdocetaxel prostate cancer, reducing the risk for death ...
XTANDI has been studied in men with advanced prostate cancer that no longer responds to treatment that lowers testosterone. In a study where the cancer had not spread to other parts of the body, XTANDI lowered the chance of prostate cancer progression by 71%.
Enzalutamide does this even when androgen receptors are over-expressed in prostate cancer cells that are resistant to anti-androgens. In the AFFIRM study enzalutamide the overall incidences of adverse events were comparable to placebo [66 C].
enzalutamide with bicalutamide—were to assess both the eﬃ cacy and safety of these agents in the treatment of men with metastatic castration-resistant prostate cancer. Methods Study design and participants TERRAIN was a multinational, randomised, double-blind, phase 2 trial of enzalutamide versus bicalutamide in
12/18/2014 · The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
Metastatic disease: Phase III trials of enzalutamide In AFFIRM and PREVAIL, ... (OS) by 8.5 months versus placebo in metastatic castration-resistant prostate cancer in a phase II study. This phase ...
The primary endpoint in AFFIRM was overall survival, and patients were first assessed for disease progression at 13 weeks. 5. AFFIRM was a randomized (2:1), double-blind, placebo-controlled study for patients on LHRH therapy* who had progressed to metastatic CRPC. Patients with predisposing factors for seizure history were excluded.
Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is indicated for use in conjunction with castration in the treatment of metastatic castration-resistant prostate cancer (mCRPC) and nonmetastatic castration-resistant prostate cancer. It is taken by mouth.
Enzalutamide is approved by the FDA for the treatment of men with metastatic castrate-resistant prostate cancer that is no longer responding to chemotherapy. However, chemotherapy is not a treatment option for many men with pre-existing medical conditions or who cannot tolerate the side effects. The Study
In the landmark phase III, double-blind, placebo-controlled AFFIRM (A Study Evaluating the Efficacy and Safety of the Investigational Drug MDV3100) trial , 1199 men with castration-resistant prostate cancer with ⩽2 prior chemotherapy regimens, including ⩾1 containing docetaxel, were randomly assigned in a 2:1 ratio, to receive oral ...
Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: Additional analyses from the AFFIRM randomized clinical trial
8/16/2012 · In another (perhaps more positive) article in today's issue of the New England Journal of Medicine is a full publication of the data from the AFFIRM trial of enzalutamide (MDV3100) in the treatment of men with metastatic, castration-resistant prostate cancer who had already received docetaxel-based chemotherapy. The article by Scher et al. offers no surprises…
The treatment of metastatic castrate-resistant prostate cancer (mCRPC) has evolved rapidly with the recent approval of a number of treatments and agents, including docetaxel, sipuleucel T, abiraterone, cabazitaxel, and enzalutamide. Enzalutamide (previously MDV-3100) is a novel oral androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway.
1/13/2016 · To our knowledge, the TERRAIN trial is the first study in men with metastatic castration-resistant prostate cancer who had not had disease progression while on previous antiandrogen treatment, with results that show a consistent benefit of enzalutamide over bicalutamide on all prespecified, exploratory, and post-hoc endpoints.
2/1/2014 · Treatment with enzalutamide was well tolerated by both younger and older patients in the AFFIRM study and the incidence of all grade AEs was similar between the two age groups in both treatment arms and comparable to the safety results reported with the intent-to-treat AFFIRM population. In general, the incidence of grade ≥3 AEs was low.
In a cohort of 115 patients with metastatic castration-resistant prostate cancer (mCRPC), we found that outcomes on enzalutamide following abiraterone are comparable in docetaxel-experienced and docetaxel-naive mCRPC patients. These data indicate that prior treatment with docetaxel does not contribute to cross-resistance between abiraterone and enzalutamide.