Phase II multicenter trial of bevacizumab plus fluorouracil and leucovorin in patients with advanced refractory colorectal cancer: An NCI Treatment Referral Center trial TRC-0301
Phase II multicenter trial of bevacizumab plus fluorouracil and leucovorin in patients with advanced refractory colorectal cancer: An NCI Treatment Referral Center trial TRC-0301
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DOI：
10.1200/jco.2005.05.1573
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发表时间：
2006-07-20
影响因子：
45.3
通讯作者：
Kaplan, Richard S.
中科院分区：
文献类型：
--
作者：
Chen, Helen X.;Mooney, Margaret;Kaplan, Richard S.
PurposeTo提供贝伐单抗（BV）为基础的治疗晚期结直肠癌（CRC）的患者已经用尽标准化疗方案，并评估BV联合氟尿嘧啶（FU）和甲酰四氢叶酸（LV）在此患者population.Patients和MethodsThis是一个多中心，单臂治疗试验下进行的国家癌症研究所治疗转诊中心网络全国。患者接受BV 5 mg/kg每2周一次联合FU/LV治疗; FU通过推注或连续输注给药。入选标准包括在伊立替康和奥沙利铂化疗后进展的晚期CRC，东部肿瘤协作组体能状态0 - 2，无血栓栓塞。主要终点是前100名可评估患者的客观缓解率（RR）。所有患者接受后续的毒性和survival.ResultsDue的快速增长，共350例患者在全国32个参与网站2003年10月。在最初计划的100名可评估患者队列中，研究者评估的客观BR为4%（95%CI，1.1%至9.9%），基于独立审查的客观BR为1%（95%CI，0%至5.5%）;中位无进展生存期为3.5个月，中位总生存期为9.0个月。安全性特征与既往在CRC中进行的BV试验相似。5%的患者发生3 - 4级出血，包括3.8%的胃肠道出血。其他不良事件，如高血压，血栓形成，肠穿孔率也观察到与其他study.ConclusionFor晚期结直肠癌的患者，伊立替康为基础的和奥沙利铂为基础的化疗方案后进展，BV和FU/LV的组合与罕见的客观反应。
PurposeTo provide bevacizumab (BV) -based therapy to patients with advanced colorectal cancers (CRC) who had exhausted standard chemotherapy options, and to evaluate the response to BV combined with fluorouracil (FU) and leucovorin (LV) in this patient population.Patients and MethodsThis was a multicenter, single-arm treatment trial conducted under the National Cancer Institute Treatment Referral Center network nationwide. Patients were treated with BV 5 mg/kg every 2 weeks combined with FU/LV; FU was administered by bolus or continuous infusion. Eligibility criteria included advanced CRC that had progressed after irinotecan- and oxaliplatin-based chemotherapy, Eastern Cooperative Oncology Group performance status 0 to 2, and absence of thromboembolism. The primary end point was objective response rate (RR) in the first 100 assessable patients. All patients received follow-up for toxicity and survival.ResultsDue to rapid accrual, a total of 350 patients were enrolled at 32 participating sites nationwide by October 2003. In the initially planned cohort of 100 assessable patients, the objective BR was 4% (95% Cl, 1.1% to 9.9%) by investigators' assessment and 1% (95% Cl, 0% to 5.5%) based on independent review; median progression-free survival was 3.5 months and median overall survival was 9.0 months. The safety profile was similar to prior BV trials in CRC. Grade 3 to 4 hemorrhage occurred in 5% of patients, including 3.8% with bleeding in the GI tract. Other adverse events such as hypertension, thrombosis, and bowel perforation were also observed at rates consistent with other studies.ConclusionFor patients with advanced CRC that had progressed after both irinotecan-based and oxaliplatin-based chemotherapy regimens, the combination of BV and FU/LV was associated with rare objective responses.