Background: Prostate cancer is the sixth leading cause of death, among all cancer deaths
By 2030, this burden is expected to increase with 1.7 million new cases and 499,000 new deaths.
We aimed to evaluate the efficacy and safety of Nilutamide in metastatic prostate cancer (mPCa)
patients who underwent orchiectomy.
Methods: A comprehensive search was conducted in the Medline/PubMed and Cochrane Library.
References from included studies and studies from clinicaltrials.gov were explored without language
and date restrictions. We included only randomized controlled trials, comparing the safety
and efficacy of Nilutamide in Metastatic Prostate Cancer (mPCa) patients who underwent orchiectomy
with placebo. The outcomes of concerns were survival and the response of drug and safety..
Quality of the included studies was assessed using the Cochrane Risk of Bias Tool. Two authors
were independently involved in the study selection, data extraction and quality assessment. Disagreements
between the two reviewers were resolved by consulting a third reviewer.
Results: A total of five out of 244 studies were included in meta-analysis involving1637 participants.
Nilutamide group showed improved response rate (RR=1.77, 95%CI 1.46-2.14, p<0.00001),
disease progression (RR=0.59, 95%CI 0.47-0.73, p<0.00001), complete response (RR=2.13, 95%CI
1.40-3.23, p=0.003) and clinical benefit (RR=1.23, 95%CI 1.13-1.34, p<0.00001) when compared
to placebo; however, stable disease favored the control group (RR=0.80, 95%CI 0.68-0.94,
p=0.007). In addition, patients on Nilutamide showed prolonged progression-free survival and
overall survival. Nausea and vomiting were the most common adverse events reported in Nilutamide
Conclusion: Evidence suggests that patients with mPCa who underwent orchiectomy receiving
Nilutamide showed significant improvement in progression-free survival and overall survival response
rate and clinical benefits in comparison with the placebo group.