Rosemurgy Alexander S, Ross Sharona B, Vitulli Paul L, Malek Reza, Li Jaili, Agah Ramtin
Department of Surgery, Florida Hospital-Tampa, Tampa, Florida.
Department of Interventional Radiology, Florida Hospital-Tampa, Tampa, Florida.
J Pancreat Cancer. 2017 Aug 1;3(1):58-65. doi: 10.1089/pancan.2017.0011. eCollection 2017.
This is a first-in-man safety study in locally advanced pancreatic cancer (LAPC) using a targeted intra-arterial delivery catheter (RenovoCath™). Twenty patients were enrolled in a four-stage dose escalation of intra-arterial, locally delivered gemcitabine, at doses up to 1000 mg/m. Patients' symptoms and laboratory values were monitored for safety and tolerability. Secondary endpoints included the effect on tumor size, tumor markers, and survival. One hundred one treatments were administered to 20 patients. Five patients dropped out early due to adverse events or withdrawing consent. Serious adverse events and complications were as follows: sepsis ( = 3), grade 3 neutropenia ( = 3), guide-mediated vascular dissection ( = 3), and pulmonary toxicity ( = 1). There were no cases of elevated liver or pancreatic enzymes. All sepsis cases occurred in patients with biliary stent/drains, prompting the addition of periprocedural treatment with antibiotics, which effectively prevented further sepsis in the study. Efficacy analysis was limited to 15 patients who received more than two treatments. Fifty-eight percent of these patients had a reduction in CA 19-9 tumor markers, 3 patients had tumor progression, 1 had partial response, and 11 showed disease stability. The survival rate at 12 months was 60%. The results demonstrate feasibility of localized and selective intra-arterial chemotherapy delivery to the pancreas utilizing the RenovoCath. With gemcitabine, this approach is safe, with the sole prerequisite of perioperative antibiotics for patients with prior biliary drainage/stent. Efficacy results suggest a survival benefit when compared to historical control, especially in patients with prior radiation therapy.
这是一项针对局部晚期胰腺癌（LAPC）开展的首次人体安全性研究，使用了靶向动脉内给药导管（RenovoCath™）。20名患者参与了动脉内局部给予吉西他滨的四阶段剂量递增试验，剂量最高达1000mg/m。监测患者的症状和实验室值以评估安全性和耐受性。次要终点包括对肿瘤大小、肿瘤标志物和生存的影响。对20名患者进行了101次治疗。5名患者因不良事件或撤回同意而提前退出。严重不良事件和并发症如下：败血症（n = 3）、3级中性粒细胞减少（n = 3）、导丝介导的血管夹层（n = 3）和肺部毒性（n = 1）。未出现肝酶或胰酶升高的病例。所有败血症病例均发生在有胆道支架/引流管的患者中，促使在围手术期添加抗生素治疗，这有效地预防了研究中进一步的败血症。疗效分析仅限于接受超过两次治疗的15名患者。这些患者中有58%的CA 19-9肿瘤标志物降低，3名患者肿瘤进展，1名部分缓解，11名病情稳定。12个月时的生存率为60%。结果表明，利用RenovoCath对胰腺进行局部和选择性动脉内化疗给药是可行的。对于吉西他滨，这种方法是安全的，唯一的前提是对先前有胆道引流/支架的患者进行围手术期抗生素治疗。疗效结果表明，与历史对照相比有生存获益，尤其是在先前接受过放疗的患者中。
