Division of Cancer Sciences/Department of Medical Oncology, The Christie NHS Foundation Trust, University of Manchester, Manchester M20 4BX, UK.
Department of Hepato-Gastroenterology, Cliniques Universitaires Saint-Luc, Av Hippocrate, 10 - 1200 Brussels, Belgium.
Future Oncol. 2019 Apr;15(11):1219-1230. doi: 10.2217/fon-2018-0882. Epub 2019 Jan 31.
To describe the long-term safety of sunitinib in patients with progressive, well-differentiated, advanced/metastatic pancreatic neuroendocrine tumors.
PATIENTS & METHODS: Sunitinib- and placebo-treated patients from the Phase III study continued to receive sunitinib (37.5 mg on a continuous daily-dosing regimen) in two open-label extension studies.
Median (range) treatment exposure: 30.2 (0.7-269.4) and 87.1 (3.9-319.4) weeks for medium-term (n = 41) and long-term-treated (n = 61) populations, respectively. All patients experienced ≥1 adverse event (AE); 47 (45.6%) reported serious AEs. Common all-causality AEs: diarrhea (63.1%); neutropenia (43.7%); abdominal pain (40.8%). Fifteen (14.6%) patients discontinued treatment due to treatment-related AEs.
The safety of extended sunitinib treatment was consistent with the known safety profile of sunitinib in pancreatic neuroendocrine tumors.
描述舒尼替尼治疗进展期、分化良好的晚期/转移性胰腺神经内分泌肿瘤患者的长期安全性。
来自 III 期研究的舒尼替尼和安慰剂治疗患者继续在两项开放标签扩展研究中接受舒尼替尼（37.5mg 连续每日剂量方案）治疗。
中程治疗（n=41）和长期治疗（n=61）人群的中位（范围）治疗暴露时间分别为 30.2（0.7-269.4）和 87.1（3.9-319.4）周。所有患者均发生≥1 次不良事件（AE）；47（45.6%）例报告严重 AE。常见的所有病因 AE：腹泻（63.1%）；中性粒细胞减少（43.7%）；腹痛（40.8%）。15（14.6%）例患者因治疗相关 AE 而停止治疗。
延长舒尼替尼治疗的安全性与舒尼替尼在胰腺神经内分泌肿瘤中的已知安全性特征一致。
