依维莫司治疗对含铂化疗耐药或不耐受的晚期胰腺神经内分泌癌患者的 II 期临床试验（NECTOR 试验）。
A Phase II Trial of Everolimus in Patients with Advanced Pancreatic Neuroendocrine Carcinoma Refractory or Intolerant to Platinum-Containing Chemotherapy (NECTOR Trial).
机构信息
Department of Clinical Oncology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
出版信息
Neuroendocrinology. 2020;110(11-12):988-993. doi: 10.1159/000505550. Epub 2020 Jan 2.
BACKGROUND
Platinum-containing regimens are widely used as first-line chemotherapy for unresectable pancreatic neuroendocrine carcinoma (NEC), but second-line chemotherapies have yet to be established.
OBJECTIVES
We evaluated the safety and efficacy of everolimus in patients with pancreatic NEC refractory or intolerant to platinum-containing chemotherapy.
METHODS
This study was a prospective, multicenter, phase II trial in patients with pancreatic NEC after platinum-containing chemotherapy. Everolimus treatment was continued until disease progression or intolerable toxicity was observed. The primary endpoint was progression-free survival (PFS).
RESULTS
Participants comprised 25 patients. Median age was 63 years, median PFS was 1.2 months (95% confidence interval [CI] 0.9-3.1 months), median overall survival was 7.5 months (95% CI 3.1-13.5 months), overall response rate was 0%, and disease control rate was 39.1%. Common grade 3/4 adverse events were hyperglycemia (20%), thrombocytopenia (16%), and anemia (16%).
CONCLUSION
The efficacy of everolimus was limited in patients with unresectable pancreatic NEC.
背景
含铂方案广泛用于不可切除的胰腺神经内分泌癌（NEC）的一线化疗，但二线化疗尚未确立。
目的
我们评估依维莫司在铂类化疗耐药或不耐受的胰腺 NEC 患者中的安全性和疗效。
方法
这是一项铂类化疗后胰腺 NEC 患者的前瞻性、多中心、二期试验。依维莫司治疗持续至疾病进展或出现不可耐受的毒性。主要终点是无进展生存期（PFS）。
结果
参与者包括 25 名患者。中位年龄为 63 岁，中位无进展生存期为 1.2 个月（95%置信区间 [CI] 0.9-3.1 个月），中位总生存期为 7.5 个月（95%CI 3.1-13.5 个月），总缓解率为 0%，疾病控制率为 39.1%。常见的 3/4 级不良事件有高血糖（20%）、血小板减少（16%）和贫血（16%）。
结论
依维莫司在不可切除的胰腺 NEC 患者中的疗效有限。
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