Department of Clinical Therapeutics, University of Athens, National and Kapodistrian University of Athens Alexandra Hospital, 80 Vas. Sofias Avenue, 11528 Athens, Greece.
Department of Urology and Pediatric Urology, University Medical Center, Baldingerstreet, 35033 Marburg, Germany.
Crit Rev Oncol Hematol. 2019 Aug;140:80-87. doi: 10.1016/j.critrevonc.2019.05.006. Epub 2019 May 21.
Vinflunine (VFL) is approved in Europe as second-line treatment of metastatic urothelial cancer after failure of platinum-containing therapy. We performed a systematic review and meta-analysis of real-world data (RWD) to assess utilization, efficacy and safety of VFL.
We performed a MEDLINE search for the period of 1/1/2000-31/8/2017. Full-length articles providing post-marketing RWD on VFL in patients failing previous chemotherapy were eligible. Interventional clinical trials were excluded.
Ten studies with 797 patients were identified. According to pooled REs analysis, overall response rate was 19%, most frequent, all-grade toxicities were fatigue (41%), constipation (39%), nausea/vomiting (25%), and most prevalent Grade 3-4 toxicities were neutropenia (13%), anaemia (9%), fatigue (8%). Median OS was comparable to results reported in recent randomized studies.
Our findings confirm the efficacy and safety of VFL in an unselected population and support the use of VFL in the changing treatment paradigm of relapsed mUC.
维莫非尼（VFL）在欧洲被批准用于铂类化疗失败后的转移性尿路上皮癌的二线治疗。我们进行了一项系统评价和荟萃分析，以评估真实世界数据（RWD）中 VFL 的使用、疗效和安全性。
我们对 2000 年 1 月 1 日至 2017 年 8 月 31 日期间的 MEDLINE 进行了搜索。符合条件的是提供 VFL 在先前化疗失败后患者的上市后 RWD 的全文文章。排除了干预性临床试验。
共确定了 10 项研究，涉及 797 名患者。根据汇总的 REs 分析，总缓解率为 19%，最常见的所有级别毒性是疲劳（41%）、便秘（39%）、恶心/呕吐（25%），最常见的 3-4 级毒性是中性粒细胞减少症（13%）、贫血（9%）、疲劳（8%）。中位 OS 与最近随机研究报告的结果相当。
我们的研究结果证实了 VFL 在未选择人群中的疗效和安全性，支持在复发 mUC 的治疗模式不断变化的情况下使用 VFL。
