Rashid Muhammed, Shamshavali K, Chhabra Manik
Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, BG Nagara, Karnataka 571448, India.
Department of Pharmacy Practice, JSS College of Pharmacy, Jagadguru Shri Shivarathreeshwara University, S S Nagara, Mysuru, Karnataka 570015, India.
Curr Clin Pharmacol. 2019;14(2):108-115. doi: 10.2174/1574884714666190112151202.
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.
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.
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 group.
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.
前列腺癌是所有癌症死亡原因中的第六大死因。到2030年，预计这一负担将增加，新增病例达170万例，新增死亡49.9万例。我们旨在评估尼鲁米特在接受睾丸切除术的转移性前列腺癌（mPCa）患者中的疗效和安全性。
在Medline/PubMed和Cochrane图书馆进行了全面检索。对纳入研究的参考文献以及clinicaltrials.gov上的研究进行了探索，没有语言和日期限制。我们仅纳入了随机对照试验，比较尼鲁米特在接受睾丸切除术的转移性前列腺癌（mPCa）患者与安慰剂的安全性和疗效。关注的结果是生存率、药物反应和安全性。使用Cochrane偏倚风险工具评估纳入研究的质量。两位作者独立参与研究选择、数据提取和质量评估。两位评审员之间的分歧通过咨询第三位评审员解决。
244项研究中共有5项纳入荟萃分析，涉及1637名参与者。与安慰剂相比，尼鲁米特组的缓解率（RR = 1.77，95%CI 1.46 - 2.14，p < 0.00001）、疾病进展（RR = 0.59，95%CI 0.47 - 0.73，p < 0.00001）、完全缓解（RR = 2.13，95%CI 1.40 - 3.23，p = 0.003）和临床获益（RR = 1.23，95%CI 1.13 - 1.34，p < 0.00001）有所改善；然而，疾病稳定更倾向于对照组（RR = 0.80，95%CI 0.68 - 0.94，p = 0.007）。此外，接受尼鲁米特治疗的患者无进展生存期和总生存期延长。恶心和呕吐是尼鲁米特组报告的最常见不良事件。
证据表明，与安慰剂组相比，接受睾丸切除术的mPCa患者接受尼鲁米特治疗后，无进展生存期、总生存期、缓解率和临床获益均有显著改善。
