Background The long-acting somatostatin analog lanreotide autogel is effective in the treatment of patients with neuroendocrine tumors. Objective To evaluate the long-term treatment response in patients with neuroendocrine tumors receiving lanreotide autogel in routine clinical practice. Methods Non-interventional, 24-month study in patients with neuroendocrine tumors treated with lanreotide autogel (NCT01840449). Results Patients (n=80) from 26 centers in Germany and Austria were enrolled. Neuroendocrine tumors were mainly grade 1/2, metastasized, intestinal, and associated with carcinoid syndrome; 88.9% had received previous neuroendocrine tumor treatment. Of those, 84.4% had previous surgery, 18.7% had received octreotide. The primary endpoint, defined by a <50% chromogranin A increase at month 12 compared with the lowest value between baseline and month 3 was achieved by 89.5% patients. Stable disease according to Response Evaluation Criteria in Solid Tumors 1.1 was observed in 76.9 and 75.0% patients at months 12 and 24 of lanreotide treatment, respectively. Mean change of chromogranin A levels from baseline to month 24 was −0.12 × upper limit of normal (95% CI, −0.22; −0.45). In a post hoc analysis, 38.5% of the subgroup of patients with carcinoid syndrome had daily diarrhea at baseline vs. 21.4% at month 24. At baseline, 27.8% of patients received lanreotide 120 mg every 4 weeks vs. 56.7% at month 24. Quality of life data were heterogeneous. No new safety issues arose and/or required further investigation. Conclusions Our study reflects routine lanreotide autogel use in patients with advanced/metastatic neuroendocrine tumors. This analysis shows effectiveness with stabilization of disease-related symptoms and good tolerability of lanreotide autogel in clinical practice.

中文翻译：

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在德国和奥地利的常规临床实践中，兰瑞肽 Autogel 用于治疗神经内分泌肿瘤患者的多中心观察性研究

背景 长效生长抑素类似物兰瑞肽自凝胶可有效治疗神经内分泌肿瘤患者。目的评价神经内分泌肿瘤患者在常规临床实践中接受兰瑞肽自凝凝胶的长期治疗反应。方法 对用兰瑞肽自凝胶 (NCT01840449) 治疗的神经内分泌肿瘤患者进行为期 24 个月的非干预性研究。结果 来自德国和奥地利 26 个中心的患者 (n=80) 被纳入研究。神经内分泌肿瘤主要为 1/2 级、转移性、肠内、并伴有类癌综合征；88.9% 曾接受过神经内分泌肿瘤治疗。其中，84.4% 曾接受过手术，18.7% 接受过奥曲肽。主要终点，由 < 89.5% 的患者在第 12 个月时与基线和第 3 个月之间的最低值相比增加了 50% 的嗜铬粒蛋白 A。在兰瑞肽治疗的第 12 个月和第 24 个月，分别有 76.9% 和 75.0% 的患者根据实体瘤反应评估标准 1.1 观察到疾病稳定。从基线到第 24 个月，嗜铬粒蛋白 A 水平的平均变化为 -0.12 × 正常上限（95% CI，-0.22；-0.45）。在一项事后分析中，38.5% 的类癌综合征患者亚组在基线时每天腹泻，而在第 24 个月时为 21.4%。在基线时，27.8% 的患者每 4 周接受 120 mg 兰瑞肽，而在第 24 个月时为 56.7% . 生活质量数据是异质的。没有出现新的安全问题和/或需要进一步调查。结论 我们的研究反映了在晚期/转移性神经内分泌肿瘤患者中常规使用兰瑞肽自凝胶。该分析显示兰瑞肽自凝胶在临床实践中具有稳定疾病相关症状的有效性和良好的耐受性。