Menshawy Amr, Eltonob Abdelrahman A, Barkat Sarah A, Ghanem Ahmed, Mniesy Mahmoud M, Mohamed Ishak, Abdel-Maboud Mohamed, Mattar Omar M, Elfil Mohamed, Bahbah Eshak I, Elgebaly Ahmed
Medical Research Education and Practice Association.
Al-Azhar Medical Students' Association.
Melanoma Res. 2018 Oct;28(5):371-379. doi: 10.1097/CMR.0000000000000467.
Nivolumab, a completely human programmed death-1 inhibitor antibody, was first approved by the Food and Drug Administration for patients with advanced malignant melanoma resistant to other modalities of treatment. In 2015, it received approval as the first line of treatment for malignant melanoma. We aimed to synthesize evidence from published randomized-controlled trials on the safety and efficacy of nivolumab, either alone or in combination with ipilimumab, in the management of advanced unresectable melanoma. We searched the following electronic databases: PubMed, Scopus, Web of Science, and Cochrane Central. The records retrieved were screened for eligibility. Time-to-event data were pooled as Hazard ratio using the generic inverse variance method and dichotomous data were pooled as relative risk (RR) in a random-effects model. We used Review Manager 5.3 software for windows. Four unique randomized-controlled trials (five reports) with a total of 1910 patients (nivolumab group, n=1207 and control group, n=703) were included. The overall effect estimate favored nivolumab plus ipilimumab versus ipilimumab alone in terms of the objective response rate [RR: 3.58, 95% confidence interval (CI): 2.08-6.14], the complete response rate (RR: 5.93, 95% CI: 2.45-14.37), the partial response rate (RR: 2.80, 95% CI: 2.16-3.64), the stable disease rate (RR: 0.56, 95% CI: 0.41-0.76), and progression-free survival (hazard ratio: 0.67, 95% CI: 0.60-0.74). The pooled studies were homogenous. Similar results were obtained for nivolumab monotherapy versus chemotherapy comparison. Nivolumab alone or combined with ipilimumab significantly improved the overall and complete response rates compared with ipilimumab alone. In addition, nivolumab resulted in longer progression-free survival with a comparable safety profile.
纳武单抗是一种完全人源化的程序性死亡-1抑制抗体，最初由美国食品药品监督管理局批准用于治疗对其他治疗方式耐药的晚期恶性黑色素瘤患者。2015年，它被批准作为恶性黑色素瘤的一线治疗药物。我们旨在综合已发表的随机对照试验的证据，以评估纳武单抗单独或与伊匹单抗联合使用在治疗晚期不可切除黑色素瘤方面的安全性和有效性。我们检索了以下电子数据库：PubMed、Scopus、科学网和Cochrane中心。对检索到的记录进行资格筛选。生存时间数据采用通用逆方差法合并为风险比，二分数据在随机效应模型中合并为相对风险（RR）。我们使用适用于Windows的Review Manager 5.3软件。纳入了四项独特的随机对照试验（五份报告），共1910例患者（纳武单抗组，n = 1207；对照组，n = 703）。在客观缓解率方面，总体效应估计支持纳武单抗联合伊匹单抗优于单独使用伊匹单抗[RR：3.58，95%置信区间（CI）：2.08 - 6.14]、完全缓解率（RR：5.93，95% CI：2.45 - 14.37）、部分缓解率（RR：2.80，95% CI：2.16 - 3.64）、疾病稳定率（RR：0.56，95% CI：0.41 - 0.76）以及无进展生存期（风险比：0.67，95% CI：0.60 - 0.74）。汇总的研究具有同质性。纳武单抗单药治疗与化疗比较也获得了类似结果。与单独使用伊匹单抗相比,纳武单抗单独或联合伊匹单抗显著提高了总体缓解率和完全缓解率。此外，纳武单抗可延长无进展生存期，且安全性相当。
