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enzalutamide (Xtandi)
Indications:
- late-stage, castration-resistant prostate cancer previously treated with docetaxel
- progression of metastatic prostate cancer despite androgen-deprivation therapy [2]
- metastatic castration-resistant prostate cancer [1,2,3]
- prior to indication for chemotherapy (NGC, NICE)
- nonmetastatic castration-resistant prostate cancer [4]
- alternative to active surveillance alone in patients with low-risk or intermediate-risk localized prostate cancer [5]
Dosage:
- 160 mg PO
Capsule: 40 mg, Tablets: 40 mg, 80 mg
Adverse effects:
- fatigue
- hot flush
- back pain
- joint pain
- tissue swelling
- musculoskeletal pain
- headache
- paresthesia
- diarrhea
- upper respiratory infections
- lower respiratory infections
- dizziness
- spinal cord compression & cauda equina syndrome
- muscular weakness
- difficulty sleeping
- hematuria
- anxiety
- hypertension
- seizures (1%)
Mechanism of action:
- androgen receptor antagonist
General
antineoplastic agent (chemotherapeutic agent)
androgen receptor antagonist; androgen receptor signaling inhibitor (ARSI)
References
- FDA News Release: Aug. 31, 2012
FDA approves new treatment for a type of late stage prostate
cancer
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317838.htm
- Beer TM et al
Enzalutamide in Metastatic Prostate Cancer before Chemotherapy.
N Engl J Med. June 1, 2014
PMID: 24881730
http://www.nejm.org/doi/full/10.1056/NEJMoa1405095
- Rathkopf DE, Beer TM, Loriot Y et al
Radiographic Progression-Free Survival as a Clinically
Meaningful End Point in Metastatic Castration-Resistant
Prostate Cancer. The PREVAIL Randomized Clinical Trial.
JAMA Oncol. Published online March 8, 2018
PMID: 29522174
https://jamanetwork.com/journals/jamaoncology/fullarticle/2674383
- Hussain M, Fizazi K, Saad F et al.
Enzalutamide in men with nonmetastatic, castration-resistant
prostate cancer.
N Engl J Med 2018 Jun 28; 378:2465.
PMID: 29949494
https://www.nejm.org/doi/10.1056/NEJMoa1800536
- Smith MR.
Progress in nonmetastatic prostate cancer.
N Engl J Med 2018 Jun 28; 378:2531
PMID: 29949488
https://www.nejm.org/doi/10.1056/NEJMe1805733
- Bassett M
Xtandi During AS Reduced Progression Risk in Early Prostate Cancer.
Risk of disease progression cut by 46% versus those on active surveillance alone.
MedPage Today June 16, 2022
https://www.medpagetoday.com/hematologyoncology/prostatecancer/99291
- Shore ND, Renzulli J, Fleshner E et al
Active Surveillance Plus Enzalutamide Monotherapy vs Active Surveillance
Alone in Patients With Low-risk or Intermediate-risk Localized Prostate
Cancer. The ENACT Randomized Clinical Trial.
JAMA Oncol. Published online June 16, 2022
PMID: 35708696
https://jamanetwork.com/journals/jamaoncology/fullarticle/2793567
- Medscape: enzalutamide (Rx)
https://reference.medscape.com/drug/xtandi-enzalutamide-999769