1 Department of Diagnostic Radiology, Division of Nuclear Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Mail Code L340, Portland, OR 97239.
AJR Am J Roentgenol. 2018 Aug;211(2):278-285. doi: 10.2214/AJR.18.19953. Epub 2018 Jun 27.
The purposes of this article are to increase understanding of the concepts of theranostics and peptide receptor radionuclide therapy (PRRT) as they apply to neuroendocrine tumors (NETs); review the key 1, 2, and 3 clinical trial data leading to the approval of Lu-tetraazacyclododecanetetraacetic acid-octreotide (Lu-DOTATATE); and foster understanding of the practical aspects and future directions of PRRT for NETs.
In January 2018, Lu-DOTATATE therapy was approved in the United States (previously approved in Europe in September 2017) for adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including those of the foregut, midgut, and hindgut. The results of the phase 3 Neuroendocrine Tumors Therapy (NETTER-1) trial show favorable outcomes with respect to the primary endpoint of progression-free survival and a host of secondary objectives, including overall survival, objective response rate, and quality of life measures. Patient selection is based on a number of specific factors and should be sequenced carefully with respect to other available therapies, ideally in multidisciplinary cancer conferences. Establishing the therapy at a new institution can be somewhat involved, but once it is established, the therapy is fairly straightforward to administer and is well tolerated with limited side-effects and toxicity. A number of approaches and issues are still to be worked out, and this therapy will continue to be studied and optimized.
本文旨在提高对治疗学和肽受体放射性核素治疗（PRRT）概念的理解，这些概念适用于神经内分泌肿瘤（NET）；回顾导致 Lu-四氮杂环十二烷四乙酸-奥曲肽（Lu-DOTATATE）批准的关键 1、2 和 3 期临床试验数据；并深入了解 PRRT 治疗 NET 的实际方面和未来方向。
2018 年 1 月，Lu-DOTATATE 疗法在美国获得批准（此前于 2017 年 9 月在欧洲获得批准），用于治疗生长抑素受体阳性的胃肠胰神经内分泌肿瘤患者，包括前肠、中肠和后肠的肿瘤。3 期神经内分泌肿瘤治疗（NETTER-1）试验的结果显示，在无进展生存期的主要终点和许多次要终点方面均有良好的结果，包括总生存期、客观缓解率和生活质量指标。患者选择基于多个特定因素，应根据其他可用疗法进行仔细排序，理想情况下在多学科癌症会议上进行。在新机构中建立治疗方案可能会有些复杂，但一旦建立，治疗方案就相当简单，副作用和毒性有限，患者的耐受性良好。仍有许多方法和问题需要解决，而且这种治疗方法将继续被研究和优化。
