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贝伐珠单抗联合以5-FU为基础的双药化疗用于结直肠癌仅肝转移患者新辅助治疗:一项多中心单臂研究
作者:万德森  张苏展  陈玉泽  许剑民  陶凯雄  王贵玉  郝纯毅 
单位:中山大学附属肿瘤医院结直肠外科  广东 广州 510060 浙江大学医学院附属第二医院肿瘤外科  浙江 杭州 310009 辽宁省肿瘤医院结直肠外科  辽宁 沈阳 110046 复旦大学附属中山医院普外科  上海 200032 华中科技大学同济医学院附属协和医院胃肠外科  湖北 武汉 430000 哈尔滨医科大学 附属第二医院结直肠肿瘤外科  黑龙江 哈尔滨 150070 北京大学肿瘤医院肝胆胰外二科  北京 100048 
关键词:结直肠肿瘤/药物疗法 结直肠肿瘤/外科学 肝肿瘤/继发性 肝肿瘤/药物疗法 化学疗法 辅助 抗体 单克隆/治疗应用 氟尿嘧啶/治疗应用 抗肿瘤联合化疗方案/治疗应用 肝切除术 前瞻性研究 
DOI:R735.3;R730.53
出版年,卷(期):页码:2018,33(1):41-46
摘要:

目的 通过开放标签的多中心探索性研究评估贝伐珠单抗联合氟尿嘧啶(5-FU)作为新辅助化疗方案对仅肝转移、转移灶初始不可切除且未经治疗的结直肠癌(colorectal cancer,CRC)患者R0切除率的影响。方法 在全国7家中心招募既往未经治疗(原发灶已切除)、只存在肝转移灶且不可切除的中国转移性结直肠癌(metastatic colorectal cancer,mCRC)患者。入组患者均接受贝伐珠单抗(静脉注射,5 mg/kg,每2周1次,d1)联合以氟尿嘧啶(5-FU)为基础的双药化疗方案进行新辅助治疗。患者术前和术后共接受≤ 12个周期的治疗,术前最后1个周期的化疗(无贝伐珠单抗)不计入12个周期内。主要终点为R0切除率,次要终点为R1切除率、客观缓解率(objective response rate,ORR)、无进展生存(progression free survival,PFS)、无瘤生存率(disease free survival,DFS)和安全性。结果 本研究共纳入50例患者,其中男性39例,女性11例;患者中位年龄57岁(范围37~73岁),R0切除率为30.0%,R1切除率为0.0%。50例患者的ORR为15.0%,中位PFS为12.06个月(95%CI:6.70~13.31),接受R0切除的15例患者中位DFS为8.57个月(95%CI:1.84~17.74)。总体安全性良好,32例患者(64.0%)共发生159次不良事件(adverse events,AE),其中24次为3级AE,无≥4级AE。最常见的与贝伐珠单抗相关的≥3级AE为高血压(8.0%)。手术安全人群(n=17)中,5例(29.4%)发生手术相关并发症,但均为肝脏局部并发症,仅1例发生肺部感染。结论 对于肝脏为唯一转移灶且初始不可切除的CRC患者,使用贝伐珠单抗联合以5-FU为基础的双药化疗进行新辅助治疗可提高R0切除率,且耐受性良好。

Objective This open label, multi-center pilot study aims to examine the clinical effects of bevacizumab in combination with 5-FU as a neoadjuvant therapy for the R0 resection rates of colorectal cancer (CRC) patients with untreated and unresectable liver-only metastasis. Methods Chinese patients with untreated (primary lesion surgically removed), unresectable liver-only metastatic colorectal cancer (mCRC) were recruited from seven centers in the country. All enrolled patients received bevacizumab and 5-FU based doublet neoadjuvant chemotherapy. Bevacizumab was administered as an intravenous infusion at 5 mg/kg, twice a week and given on the first day of each cycle. The total number of cycles given pre-and post-surgery was less than 12, which does not include the last cycle of preoperative chemotherapy given without bevacizumab. The primary endpoint was R0 resection rate, and the secondary endpoints were R1 resection rate, objective response rate (ORR), progression free survival (PFS), disease free survival (DFS) and safety. Results Fifty eligible patients were enrolled in this study, which included 39 males and 11 females, with a median age of 57 years (age range:37-73 years). The R0 resection rate was 30.0%, and the R1 resection rate was 0.0%. Besides, for the 50 patients, the ORR was 30.0%, and the median PFS was 12.06 months (95% CI:6.70~13.31). For the 15 patients receiving R0 resection, the median DFS was 8.57 months (95% CI:1.84~17.74). Moreover, the overall safety of the doublet chemotherapy was good. During the study, 159 adverse events were observed in 32 patients (64.0% of 50 patients). Among them, 24 adverse events were grade 3. No adverse event equal to or higher than grade 4 was recorded. The most common bevacizumab related grade 3 adverse events were hypertension (8.0%). Among the 17 patients of surgical safety population, 5 patients (29.4%) experienced surgery-related complications. Nevertheless, only one case was pulmonary infection, and all the rest cases were local hepatic complications. Conclusion Bevacizumab combined with 5-FU based doublet chemotherapy is a good neoadjuvant therapy for colorectal cancer patients with unresectable liver-only metastasis, which can increase R0 resection rate and has high tolerance.

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