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Journal of pancreatic cancer最新文献

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A Phase I/II Open-Label Multicenter Single-Arm Study of FABLOx (Metronomic 5-Fluorouracil Plus nab-Paclitaxel, Bevacizumab, Leucovorin, and Oxaliplatin) in Patients with Metastatic Pancreatic Cancer. FABLOx(计量5-氟尿嘧啶加nab-帕西他赛、贝伐单抗、Leucovorin和奥沙利铂)在转移性胰腺癌癌症患者中的I/II期开放标签多中心单臂研究。
Pub Date : 2019-09-25 eCollection Date: 2019-01-01 DOI: 10.1089/pancan.2019.0012
Vaibhav Sahai, M Wasif Saif, Aparna Kalyan, Philip A Philip, Caio M Rocha-Lima, Allyson Ocean, Michael S Ondovik, Diane M Simeone, Sibabrata Banerjee, Rafia Bhore, Chrystal U Louis, Vincent Picozzi

Purpose: To evaluate safety and preliminary efficacy of metronomic 5-fluorouracil plus nab-paclitaxel, bevacizumab, leucovorin, and oxaliplatin (FABLOx) in patients with newly diagnosed metastatic pancreatic cancer (MPC). Methods: A total of 12 treatment-naive patients (aged 18-65 years, Eastern Cooperative Oncology Group performance status [ECOG PS] ≤1) with MPC received 5-fluorouracil 180 mg/m2 per day (days 1-14 continuous infusion); nab-paclitaxel 75 mg/m2, leucovorin 20 mg/m2, and oxaliplatin 40 mg/m2 (days 1, 8, and 15); and bevacizumab 5 mg/kg (days 1 and 15) administered intravenously in each 28-day cycle. The primary end-point was incidence of dose-limiting toxicities (DLTs) in cycle 1. Safety was further evaluated as a secondary end-point; preliminary efficacy was also examined. Results: Two DLTs (grade 3 anemia requiring transfusion and grade 3 mucositis unresponsive to treatment within 4 days of onset) were observed in one of six patients enrolled in dose cohort 1. Cohort 1 was expanded from 6 to 12 patients to further evaluate safety, per the investigators' recommendation. All patients discontinued treatment. The most common grade ≥3 adverse events were abdominal pain, fatigue, mucositis, and decreased neutrophil count. Objective response rate was 33% (four partial responses). Median progression-free survival (PFS) and overall survival (OS) were 5.6 (95% confidence interval [CI], 1.7-11.3) and 9.9 (95% CI, 4.4-13.2) months, respectively; 1-year PFS and OS rates were 12.2% (95% CI, 0.7-40.8) and 38.9% (95% CI, 12.6-65.0). Conclusion: FABLOx is feasible and tolerable in patients newly diagnosed with MPC. However, preliminary efficacy data are inconclusive for continued investigation in a phase II trial.

目的:评估节拍5-氟尿嘧啶联合nab-paclitaxel、贝伐单抗、leucovorin和奥沙利铂(FABLOx)治疗新诊断的转移性癌症(MPC)患者的安全性和初步疗效。方法:共有12名MPC治疗初期患者(年龄18-65岁,东部肿瘤协作组表现状态[ECOG PS]≤1)接受5-氟尿嘧啶180 mg/m2/天(连续输注1-14天);nab-紫杉醇75 mg/m2,亚叶酸20 mg/m2和奥沙利铂40 mg/m2(第1、8和15天);和贝伐单抗5 mg/kg(第1天和第15天),在每个28天周期中静脉内给药。主要终点是第1周期的剂量限制性毒性(DLTs)发生率。安全性被进一步评估为次要终点;还检查了初步疗效。结果:在剂量队列1中的6名患者中,有1名观察到两种DLT(需要输血的3级贫血和发病4天内对治疗无反应的3级粘膜炎)。根据研究人员的建议,第1组患者从6名扩大到12名,以进一步评估安全性。所有患者均停止治疗。最常见的≥3级不良事件是腹痛、疲劳、粘膜炎和中性粒细胞计数下降。客观缓解率为33%(4个部分缓解)。中位无进展生存期(PFS)和总生存期(OS)分别为5.6个月(95%置信区间[CI],1.7-11.3)和9.9个月(95%CI,4.4-13.2);1年PFS和OS发生率分别为12.2%(95%可信区间,0.7-40.8)和38.9%(95%置信区间,12.6-65.0)。然而,在第二阶段试验中继续研究的初步疗效数据是不确定的。
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引用次数: 8
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Journal of pancreatic cancer
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