PDF(Pubmed)
Abstract：
Lutathera® is the first EMA- and FDA-approved radiopharmaceutical for radioligand therapy (RLT). Currently, on the legacy of the NETTER1 trial, only adult patients with progressive unresectable somatostatin receptor (SSTR) positive gastroenteropancreatic (GEP) neuroendocrine neoplasms (NET) can be treated with Lutathera®. Conversely, patients with SSTR-positive disease arising from outside the gastroenteric region do not currently have access to Lutathera® treatment despite several papers in the literature reporting the effectiveness and safety of RLT in these settings. Moreover, patients with well-differentiated G3 GEP-NET are also still \"Lutathera orphans\", and retreatment with RLT in patients with disease relapse is currently not approved. The aim of this critical review is to summarize current literature evidence assessing the role of Lutathera® outside the approved indications. Moreover, ongoing clinical trials evaluating new possible applications of Lutathera® will be considered and discussed to provide an updated picture of future investigations.
摘要：
Lutathera®是第一个EMA和FDA批准的放射性配体治疗（RLT）的放射性药物。目前,关于NETTER1审判的遗产，只有进行性不可切除生长抑素受体(SSTR)阳性胃肠胰腺(GEP)神经内分泌肿瘤(NET)的成年患者可以使用Lutathera®治疗。相反，来自胃肠道区域以外的SSTR阳性疾病患者目前无法获得Lutathera®治疗,尽管有几篇文献报道了RLT在这些环境中的有效性和安全性.此外，分化良好的G3GEP-NET患者也仍然是“Lutathera孤儿”，目前尚未批准对疾病复发的患者进行RLT再治疗。这项关键审查的目的是总结目前的文献证据，评估Lutathera®在批准的适应症之外的作用。此外，将考虑和讨论正在进行的临床试验，以评估Lutathera®的新的可能应用，以提供未来研究的最新情况。
