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Degarelix for the treatment of advanced prostate cancer compared with GnRh-Agonists: a systematic review and
Seyed Alireza Hosseini1, Fatemeh Rajabi2, Ali Akbari Sari3
1Associate Professor, Food and Drug Research Center, Clinical Trials Group, Iran Food and Drug Administration, Tehran, Iran. a.hosseini@fda.gov.ir .
Background:
Hormone therapy is currently the mainstay in the management of locally advanced and metastatic prostate cancer. We performed a systematic review to compare safety, efficacy and effectiveness of degarelix, a new gonadotropin-releasing hormone (GnRH) antagonist (blocker), versus gonadotropin-releasing hormone (GnRH) agonists.
Methods:
MEDLINE, Web of Science and the Cochrane library were searched to identify all of the published Randomized Controlled Trials (RCTs) that used degarelix versus gonadotropin-releasing hormone agonists with or without anti-androgen therapy for the treatment of prostate cancer. We performed meta-analysis of extracted data on safety and efficacy of the target medication.
Results:
Six studies were included. They involved a total of 2296 patients which were used in the meta-analysis. Follow-up times after treatment were between 12 weeks and 12 months. Three of six RCTs compared degarelix with goserelin and the others compared it with leuprolide. Meta-analysis on safety outcomes revealed that the only statistically significant difference between the degarelix treated group and GnRH agonists treated group was complication in the injection site which was higher in degarelix-treated group (OR= 46.34, 95% CI: 15.79 to 136, p<0.001). Although general mortality rate was lower in degarelix-treated group (OR= 2.06, 95% CI: 1.08 to 3.93, p=0.03); mortality due to the drug side effects was not different. Meta-analysis of efficacy data also showed that International Prostate Symptom Score (IPSS) reduction at week 12, (MD=-1.85, 95% CI: -2.97 to - 0.72, p=0.001) and Testosterone reduction between day 1-28, (OR=11.58, 95% CI: 5.77 to 23.22, p<0.001) was statistically higher in degarelix-treated group. Testosterone reduction after day 28 and prostate volume reduction did not have significant difference.
Conclusion:
Our meta-analysis indicates that, compared with GnRH agonists, degarelix has significantly more effects on lower urinary tract symptoms and also Prostate Specific Antigen (PSA) and testosterone reduction in the first month of the treatment. Except minor complications in the injection site like pain, erythema and swelling, there is no increase in major side effects and mortality due to degarelix. This is while the effect on testosterone and PSA after the first month of treatment is not statistically different between the two groups.
Insights
Degarelix, a gonadotropin-releasing hormone (GnRH) antagonist, shows faster testosterone and prostate-specific antigen (PSA) reduction than GnRH agonists for prostate cancer. While injection site complications are higher, major side effects and mortality are not increased.
Area of Science:
- Oncology
- Pharmacology
Background:
- Hormone therapy is the primary treatment for advanced prostate cancer.
- Degarelix is a novel gonadotropin-releasing hormone (GnRH) antagonist.
- This review compares degarelix with GnRH agonists.
Purpose of the Study:
- To systematically review and compare the safety, efficacy, and effectiveness of degarelix versus GnRH agonists in prostate cancer treatment.
- To conduct a meta-analysis of relevant randomized controlled trials (RCTs).
Main Methods:
- Systematic search of MEDLINE, Web of Science, and Cochrane Library for RCTs.
- Meta-analysis of extracted data on safety and efficacy outcomes.
- Included studies compared degarelix with goserelin or leuprolide.
Main Results:
- Six RCTs with 2296 patients were analyzed.
- Degarelix showed higher injection site complications (OR=46.34) but lower overall mortality (OR=2.06).
- Degarelix demonstrated greater reduction in International Prostate Symptom Score (IPSS) at week 12 (MD=-1.85) and faster testosterone reduction (days 1-28, OR=11.58).
Conclusions:
- Degarelix offers significant advantages in reducing lower urinary tract symptoms, PSA, and testosterone in the first month compared to GnRH agonists.
- Major side effects and mortality are not increased with degarelix, despite minor injection site issues.
- Long-term effects on testosterone and PSA are comparable between degarelix and GnRH agonists after the initial month.
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