Lahner H, Rinke A, Unger N, Poeppel T D, Kühl H, Lehmann N, Führer D
Department of Endocrinology and Metabolism, Division of Laboratory Research, University of Duisburg-Essen, Essen, Germany.
Department of Gastroenterology and Endocrinology, Philipps University Marburg, Marburg Germany.
Horm Metab Res. 2016 Sep;48(9):575-80. doi: 10.1055/s-0042-105289. Epub 2016 Apr 21.
Sunitinib treatment leads to improvement in progression-free survival in patients with advanced pancreatic neuroendocrine tumours (pNETs). However, limited data exist regarding the effectiveness, safety and tolerability in clinical practice. We present the results of the first detailed pNET cohort analysis since sunitinib was approved. Patients with advanced, differentiated pNET treated with sunitinib were retrospectively analysed. All patients had progressive disease before start of sunitinib treatment. Twenty-one patients, with a median age of 64 years (range 28-78), were included in this study. Nineteen patients could be analysed for treatment effectiveness. Twelve (57%) patients exhibited either a partial response (1 patient) or stable disease (11 patients) according to the RECIST criteria. The median progression-free survival was 7.0 months (95% CI 3.0-12.0); the probability of being event-free at 6 months was 52.6% (95% CI 28.4-72.1). Potential influencing factors as Ki-67 index, age or duration of disease did not show significant correlations with the response to sunitinib therapy. Considering the differences in patients' characteristics, sunitinib in daily practice showed effectiveness parameters similar to the phase III trial.
舒尼替尼治疗可改善晚期胰腺神经内分泌肿瘤（pNETs）患者的无进展生存期。然而，关于其在临床实践中的有效性、安全性和耐受性的数据有限。我们呈现了自舒尼替尼获批以来首个详细的pNET队列分析结果。对接受舒尼替尼治疗的晚期、分化型pNET患者进行了回顾性分析。所有患者在开始舒尼替尼治疗前均有疾病进展。本研究纳入了21例患者，中位年龄为64岁（范围28 - 78岁）。19例患者可进行治疗有效性分析。根据RECIST标准，12例（57%）患者表现出部分缓解（1例患者）或疾病稳定（11例患者）。中位无进展生存期为7.0个月（95%可信区间为3.0 - 12.0）；6个月时无事件发生的概率为52.6%（95%可信区间为28.4 - 72.1）。Ki-67指数、年龄或疾病持续时间等潜在影响因素与舒尼替尼治疗反应无显著相关性。考虑到患者特征的差异，日常实践中的舒尼替尼显示出与III期试验相似的有效性参数。
