From the Departments of Oncology.
Quantitative Health Sciences, Mayo Clinic, Rochester, MN.
Pancreas. 2021;50(10):1435-1439. doi: 10.1097/MPA.0000000000001950.
Systemic therapies for pancreatic neuroendocrine tumors (PNETs) are limited. The combination of bevacizumab and temsirolimus showed significant antitumor activity, but the single-agent activity of bevacizumab was unknown. We conducted a single-arm, phase II trial to evaluate the efficacy of bevacizumab in PNETs.
Patients with progressive disease by the Response Evaluation Criteria in Solid Tumors version 1.1 within 7 months of enrollment were eligible for bevacizumab 10 mg/kg every 2 weeks. Adverse events were assessed according to the Common Terminology Criteria for Adverse Events version 3.0. The primary end point was response rate (RR).
Twenty-four patients were enrolled and followed up for a median duration of 36.1 months. Confirmed RR was 12.5%; 75.0% of patients had stable disease at 6 months. Median progression-free survival was 18.0 months; median overall survival was not reached. Common grade 3 adverse events were hypertension (45.8%) and proteinuria (8.3%). No grade 4 adverse events were observed.
Bevacizumab demonstrated promising antitumor activity in progressive PNETs comparable to standard targeted therapy. Although this study failed to reject the null hypothesis (RR, 10%), bevacizumab seems a reasonable monotherapy and a potential component of combination therapies given clinical activity and low rates of adverse events.
用于胰腺神经内分泌肿瘤（PNETs）的系统疗法有限。贝伐珠单抗联合替西罗莫司显示出显著的抗肿瘤活性，但贝伐珠单抗的单药活性尚不清楚。我们进行了一项单臂、二期试验，以评估贝伐珠单抗在 PNETs 中的疗效。
在入组后 7 个月内根据实体瘤反应评价标准 1.1 出现疾病进展的患者有资格接受贝伐珠单抗 10 mg/kg 每 2 周 1 次的治疗。根据不良事件通用术语标准 3.0 评估不良事件。主要终点是缓解率（RR）。
共纳入 24 例患者，中位随访时间为 36.1 个月。确认的 RR 为 12.5%；6 个月时 75.0%的患者疾病稳定。中位无进展生存期为 18.0 个月；中位总生存期未达到。常见的 3 级不良事件是高血压（45.8%）和蛋白尿（8.3%）。未观察到 4 级不良事件。
贝伐珠单抗在进展性 PNETs 中显示出有希望的抗肿瘤活性，与标准靶向治疗相当。尽管该研究未能拒绝零假设（RR，10%），但鉴于其临床活性和不良事件发生率低，贝伐珠单抗似乎是一种合理的单药治疗方法，也是联合治疗的潜在组成部分。
