Customize Consent Preferences

We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below.

The cookies that are categorized as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ... 

Always Active

Necessary cookies are required to enable the basic features of this site, such as providing secure log-in or adjusting your consent preferences. These cookies do not store any personally identifiable data.

No cookies to display.

Functional cookies help perform certain functionalities like sharing the content of the website on social media platforms, collecting feedback, and other third-party features.

No cookies to display.

Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics such as the number of visitors, bounce rate, traffic source, etc.

No cookies to display.

Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.

No cookies to display.

Advertisement cookies are used to provide visitors with customized advertisements based on the pages you visited previously and to analyze the effectiveness of the ad campaigns.

No cookies to display.

Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer

Author(s): Andrew J. Armstrong , MD, ScM1; Arun A. Azad , MBBS, PhD2,3; Taro Iguchi , MD, PhD4; Russell Z. Szmulewitz, MD5; Daniel P. Petrylak , MD6; Jeffrey Holzbeierlein, MD7; Arnauld Villers , MD8; Antonio Alcaraz , MD, PhD9; Boris Alekseev, MD10; Neal D. Shore , MD11; Francisco Gomez-Veiga, MD, PhD12,13; Brad Rosbrook, MS14; Fabian Zohren, MD, PhD14; Shunsuke Yamada, MEng15; Gabriel P. Haas, MD15; and Arnulf Stenzl, MD16
Source: DOI: 10.1200/JCO.22.00193 Journal of Clinical Oncology 40, no. 15 (May 20, 2022) 1616-1622.

Important clinical trial update with more mature data. Risk of death is 34% lower in combined enzalutamide and LHRH analog versus the latter alone.

In primary analysis, enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC); however, overall survival data were immature. In the phase III, double-blind, global ARCHES trial (ClinicalTrials.gov identifier: NCT02677896), 1,150 patients with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg once daily) plus ADT or placebo plus ADT, stratified by disease volume and prior docetaxel use. Here, we report the final prespecified analysis of overall survival (key secondary end point) and an update on rPFS, other secondary end points, and safety. After unblinding, 180 (31.3%) progression-free patients randomly assigned to placebo plus ADT crossed over to open-label enzalutamide plus ADT. As of May 28, 2021 (median follow-up, 44.6 months), 154 of 574 patients randomly assigned to enzalutamide plus ADT and 202 of 576 patients randomly assigned to placebo plus ADT had died. Enzalutamide plus ADT reduced risk of death by 34% versus placebo plus ADT (median not reached in either group; hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P < .001). Enzalutamide plus ADT continued to improve rPFS and other secondary end points. Adverse events were generally consistent with previous reports of long-term enzalutamide use. In conclusion, enzalutamide plus ADT significantly prolongs survival versus placebo plus ADT in patients with mHSPC.

Author Affiliations

1Duke Cancer Institute Center for Prostate & Urologic Cancers, Duke University, Durham, NC 2Peter MacCallum Cancer Center, Melbourne, Victoria, Australia 3Monash Health, Melbourne, Victoria, Australia 4Kanazawa Medical University, Ishikawa, Japan 5The University of Chicago, Chicago, IL 6Yale Cancer Center, New Haven, CT 7The University of Kansas Medical Center, Kansas City, KS 8University Hospital Centre, Lille University, Lille, France 9Hospital Clinic de Barcelona, Barcelona, Spain 10Hertzen Moscow Cancer Research Institute, Moscow, Russia 11Carolina Urologic Research Center, Myrtle Beach, SC 12Hospital Universitario de Salamanca, GITUR-IBSAL, Salamanca, Spain 13Complexo Hospitalario Universitario de A Coruña, Coruña, Spain 14Pfizer Inc, New York, NY 15Astellas Pharma Inc, Northbrook, IL 16University Hospital, Eberhard Karls University of Tübingen, Tübingen, Germany

Leave a Comment

Your email address will not be published. Required fields are marked *

Related Articles

Artificial intelligence and radiologists in prostate cancer detection on MRI (PI-CAI): an international, paired, non-inferiority, confirmatory study

Will we be replaced by AI? It seems that for radiologists, an AI system was better than the human counterpart in this study looking at prostate cancer diagnostic imaging. I doubt many of us would accept a solely computer-generated report, but this study highlights how AI may help as a supportive tool in the primary diagnostic setting. Of course, prospective validation will be needed.

Read More »

BRCAAway: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) bearing homologous recombination-repair mutations (HRRm).

We know that combination PARP and antiandrogen is better than antiandrogen alone. I have wondered if we need antiancrogen on those patients. This shows that, YES, we do. The combination also was better than PARP inhibitor monotherapy in those patients carrying HRRm.

Read More »