Chen Ming-Huang, Lu Sheng-Nan, Chen Chien-Hung, Lin Peng-Chan, Jiang Jeng-Kai, D'yachkova Yulia, Lukanowski Mariusz, Cheng Rebecca, Chen Li-Tzong
Taipei Veterans General Hospital, Taipei 11217, Taiwan.
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City 83301, Taiwan.
Cancers (Basel). 2021 Jul 15;13(14):3536. doi: 10.3390/cancers13143536.
GI cancers are characterized by high recurrence rates and a dismal prognosis and there is an urgent need for new therapeutic approaches. This is a narrative review designed to provide a summary of the efficacy as measured by overall survival, progression free survival, and safety data from phase 3 randomized controlled GI clinical trials of ramucirumab including those from important pre-specified patient subgroups and evidence from real clinical practice worldwide. Quality of life (QOL) is discussed where data are available. Our aim was to summarize the efficacy and safety of ramucirumab in the treatment of GI cancers using these existing published data with a view to demonstrating how ramucirumab may help improve treatment outcome for patients with GI cancers. The data indicate that ramucirumab is efficacious, safe, and tolerable across the intent-to-treat patient populations as a whole and across several pre-specified subgroups, even those whose disease is traditionally more difficult to treat. Furthermore, survival outcomes observed in real-world clinical practice demonstrate similar data from phase 3 clinical trials even in patients with complications, suggesting that the benefits of ramucirumab translate in actual clinical practice.
胃肠道癌症的特点是复发率高且预后不佳，因此迫切需要新的治疗方法。这是一篇叙述性综述，旨在总结雷莫西尤单抗在3期随机对照胃肠道临床试验中的总生存期、无进展生存期及安全性数据所衡量的疗效，包括来自重要预先指定患者亚组的数据以及全球实际临床实践的证据。在有数据的情况下讨论生活质量（QOL）。我们的目的是利用这些已发表的现有数据总结雷莫西尤单抗治疗胃肠道癌症的疗效和安全性，以证明雷莫西尤单抗如何有助于改善胃肠道癌症患者的治疗结果。数据表明，雷莫西尤单抗在整个意向性治疗患者群体以及几个预先指定的亚组中都是有效、安全且可耐受的，即使是那些传统上更难治疗的疾病患者。此外，在实际临床实践中观察到的生存结果表明，即使在有并发症的患者中，3期临床试验的数据也相似，这表明雷莫西尤单抗的益处可转化到实际临床实践中。
