(Prostate Cancer) What Is the Recommended Dose of Darolutamide?
Medical Supporter — Мэдээллийн мэдэгдэл
Энэ нийтлэл нь олон улсын эмнэлгийн мэдээллийн эмхэтгэл бөгөөд эмнэлгийн зөвлөгөө биш; таны эмчийн оношлогоо, эмчилгээний төлөвлөгөөг орлохгүй. Энд буй мэдээлэл нь Японы томоохон эмнэлгийн байгууллагуудын нээлттэй эх сурвалжаас эмхэтгэсэн бөгөөд аливаа эмчилгээний тохиромж, үр дүн өвчтөн бүрээр өөр тул мэргэшсэн эмч тус бүрчлэн үнэлэх ёстой.
- August 27, 2019
- Read time: 2 minutes
On July 30, 2019, the U.S. Food and Drug Administration (FDA) approved darolutamide for the treatment of non-metastatic castration-resistant prostate cancer patients.
This approval was based on the ARAMIS trial, a multicenter, double-blind, 2:1 randomized controlled trial enrolling 1,509 non-metastatic castration-resistant prostate cancer patients. Patients received either oral darolutamide 600 mg twice daily (N=955) or placebo (N=554). All patients, except those who had undergone bilateral orchiectomy, also received a gonadotropin-releasing hormone agonist. Patients with a history of seizures (N=12) were enrolled in the darolutamide group.
The primary endpoint was metastasis-free survival, defined as time to first distant metastasis, death, or any cause of death (within 33 weeks of the last imaging), whichever occurred first. The median metastasis-free survival was: darolutamide group 40.4 months / placebo group 18.4 months. However, this trial did not have confirmed overall survival data.
Adverse events occurring in 2% or more of the darolutamide group included fatigue, pain in extremities, and rash. Compared to the placebo group, the darolutamide group had higher rates of ischemic heart disease (4.3%) and heart failure (2.1%), while the incidence of seizures was the same between groups.
The recommended dose of darolutamide is 600 mg (two 300 mg tablets) taken orally twice daily with food. Patients who have not undergone bilateral orchiectomy should also receive a gonadotropin-releasing hormone agonist.
[Important Note] Medical Supporter's translations of overseas clinical trial data and pharmaceutical information are not intended to encourage participation in clinical trials or use of new drugs. The translated information is for reference only and not intended as medication guidelines. Please discuss with healthcare professionals and refer to the original text below the article for accurate information.
For the recommended dose of darolutamide, please refer to the data published by the U.S. FDA.
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Японд эмчлүүлэхээр төлөвлөж байна уу? Мэдээлэл, тусламж хэрэгтэй юу?
Бид Японд эмчлүүлэхэд шаардлагатай мэдээллийг эмхэтгэх, Японы эмнэлгийн байгууллагуудтай холбогдох, хоёр дахь саналын зөвлөгөө зохион байгуулахад тусална.Анхны зөвлөгөө үнэгүй; зөвлөх таны дараагийн алхмыг тодорхой болгоход тусална.
Figure 1
Figure 2
Figure 3
Figure 4