一项关于依维莫司治疗胰腺神经内分泌肿瘤的真实世界、多中心前瞻性研究：“PROTOR”研究。

A Real-world Multicenter Prospective Study of Everolimus in Pancreatic Neuroendocrine Tumors: The 'PROTOR' Study.

机构信息

Laiko Hospital, 1 Propaedeutic Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece;

3 Department of Clinical Oncology, Theagenio Cancer Hospital, Thessaloniki, Greece.

出版信息

Anticancer Res. 2022 Apr;42(4):1941-1948. doi: 10.21873/anticanres.15672.

DOI:10.21873/anticanres.15672

PMID:35347014

Abstract

BACKGROUND/AIM: Pancreatic neuroendocrine tumors (panNETs) are rare neoplasms with challenging disease management. We aimed to evaluate the progression-free survival (PFS) and overall response rate (ORR) in chemotherapy-naïve patients with unresectable or metastatic Grade (G) 1-2 panNETs treated with everolimus in the routine care in Greece.

PATIENTS AND METHODS

This was a multicenter, prospective, observational study. Eligible patients were recently (≤4 weeks) initiated on treatment with everolimus and were followed for up to 48 months.

RESULTS

Nineteen eligible patients (mean age 55.1 years) were enrolled. All patients had metastatic disease and 84.2% had G2 panNET. Everolimus was initiated in combination with somatostatin analogues in 84.2% of the patients. The mean everolimus treatment duration was 21.5 months. The median Kaplan-Meier-estimated PFS was 20.4 months (95% confidence interval=14.1-41.5). The ORR was 27.8%. The rate of everolimus-related adverse events was 84.2% (Grade ≥3: 31.6%).

CONCLUSION

Everolimus displayed clinical benefit and a predictable safety profile in pancreatic neuroendocrine tumors.

摘要

背景/目的：胰腺神经内分泌肿瘤（panNETs）是一种罕见的肿瘤，疾病管理极具挑战性。我们旨在评估在希腊常规治疗中，未经化疗的不可切除或转移性 1-2 级 panNET 患者使用依维莫司治疗的无进展生存期（PFS）和总缓解率（ORR）。

患者和方法

这是一项多中心、前瞻性、观察性研究。符合条件的患者最近（≤4 周）开始接受依维莫司治疗，并随访了长达 48 个月。

结果

19 名符合条件的患者（平均年龄 55.1 岁）被纳入研究。所有患者均患有转移性疾病，84.2%的患者为 G2 panNET。84.2%的患者在开始依维莫司治疗时同时使用了生长抑素类似物。依维莫司的中位治疗持续时间为 21.5 个月。中位 Kaplan-Meier 估计 PFS 为 20.4 个月（95%置信区间=14.1-41.5）。ORR 为 27.8%。依维莫司相关不良事件的发生率为 84.2%（≥3 级：31.6%）。