Prostate cancer (PCa), the sixth primary cause of cancer death. Still, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA). Aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa.
MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs compared with any comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer.
58 out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; P<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with NSAA group, But, the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest all the outcomes were appeared to be non-significant.
Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.
Reviews on recent clinical trials. 2019 Nov 05 [Epub ahead of print]
Muhammed Rashid, Madhan Ramesh, K Shamshavali, Amit Dang, Himanshu Patel, Krishna Undela
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, S S Nagara, Mysuru, India-570015. India., Head & Professor, Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education & Research, SS Nagara, Mysuru 570015. India., Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education & Research, SS Nagara, Mysuru 570015. India., MD Pharmacology, Founder & CEO, MarksMan Healthcare Communications Pvt. Ltd. TNGOS Colony, Financial District, Hyderabad, Telangana 500032. India.