Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.
Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10.
Lanreotide autogel is a long-acting somatostatin analogue with proven efficacy and safety in patients with well-differentiated (WD) gastroenteropancreatic-neuroendocrine tumors (GEP-NETs) in a prior randomized phase III trial (CLARINET). However, the CLARINET study only enrolled patients with Ki-67 index <10%, and few patients of Asian ethnicity were included. We retrospectively analyzed the efficacy and safety of lanreotide in Korean patients with GEP-NETs in the daily practice setting. Between January 2015 and May 2018, 64 patients with metastatic WD GEP-NETs received lanreotide at Asan Medical Center, Seoul, Korea. Of them, 45 (70.3%) patients who received lanreotide as monotherapy were included in the current analysis. The most common primary tumor site was the pancreas (n = 22, 48.9%), followed by the rectum (10, 22.2%) and the small bowel (7, 15.6%). According to RECIST v1.1, a partial response was achieved in one patient (2.2%) and stable disease was achieved in 40 patients (88.9%). The median progression-free survival (PFS) was 16.4 months (95% confidence interval, 9.5-23.3 months). There were no differences in PFS according to the primary tumor site (p = 0.77). Hepatic tumor volume > 25% and prior systemic therapy were significantly associated with poorer PFS in the multivariate analysis. Lanreotide is well-tolerated and effective for Korean patients with GEP-NETs in the daily practice setting.
兰瑞肽长效微球是一种长效生长抑素类似物,在一项先前的随机 III 期临床试验(CLARINET)中已证明其在分化良好(WD)的胃肠胰神经内分泌肿瘤(GEP-NETs)患者中的疗效和安全性。然而,CLARINET 研究仅纳入了 Ki-67 指数<10%的患者,且纳入的亚洲患者较少。我们回顾性分析了兰瑞肽在韩国 GEP-NETs 患者中的疗效和安全性。2015 年 1 月至 2018 年 5 月,韩国首尔 Asan 医疗中心收治了 64 例转移性 WD GEP-NETs 患者,接受兰瑞肽治疗。其中,45 例(70.3%)接受兰瑞肽单药治疗的患者纳入本分析。最常见的原发肿瘤部位是胰腺(n=22,48.9%),其次是直肠(10 例,22.2%)和小肠(7 例,15.6%)。根据 RECIST v1.1 标准,1 例患者(2.2%)达到部分缓解,40 例患者(88.9%)疾病稳定。中位无进展生存期(PFS)为 16.4 个月(95%置信区间,9.5-23.3 个月)。根据原发肿瘤部位,PFS 无差异(p=0.77)。多因素分析显示,肝肿瘤体积>25%和既往全身治疗与 PFS 较差显著相关。兰瑞肽在韩国 GEP-NETs 患者的日常治疗中具有良好的耐受性和疗效。