Primary mFOLFOX6 Plus Bevacizumab Without Resection of the Primary Tumor for Patients Presenting With Surgically Unresectable Metastatic Colon Cancer and an Intact Asymptomatic Colon Cancer: Definitive Analysis of NSABP Trial C-10
Primary mFOLFOX6 Plus Bevacizumab Without Resection of the Primary Tumor for Patients Presenting With Surgically Unresectable Metastatic Colon Cancer and an Intact Asymptomatic Colon Cancer: Definitive Analysis of NSABP Trial C-10
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DOI：
10.1200/jco.2012.42.4044
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发表时间：
2012-09-10
影响因子：
45.3
通讯作者：
Wolmark, Norman
中科院分区：
文献类型：
--
作者：
McCahill, Laurence E.;Yothers, Greg;Wolmark, Norman
主要关注贝伐单抗联合化疗治疗结肠癌患者，患者表现为无症状的完整原发肿瘤(IPT)和同步但不能切除的转移性疾病。无症状IPT的手术切除是有争议的。患者和方法这项前瞻性的多中心II期试验的可行性包括东部合作肿瘤组(ECOG)的表现状态0到1、无症状的IPT和无法切除的转移瘤。所有患者均接受氟尿嘧啶、亚叶酸钙和奥沙利铂(MFOLFOX6)联合贝伐单抗的治疗。主要终点是主要的发病率事件，定义为因IPT症状或与IPT相关的死亡而进行手术切除。25%的主要发病率被认为是可以接受的。次要终点包括总存活率(OS)和与需要住院、输血或非手术干预的IPT相关的轻微并发症。结果2006年3月至2009年6月登记的90名患者：86名符合随访条件，中位年龄58岁，52%为女性。中位随访期20.7个月。与IPT相关的主要并发症有12例(14%)：10例需要手术(8例梗阻，1例穿孔，1例腹痛)，2例死亡。24个月主要并发症累积发生率为16.3%(95%CI，7.6%~25.1%)。11例IPT被切除，无并发症发生：8例因试图治愈，3例因其他原因。两名患者仅有轻微的并发症：一名住院，一名非手术干预。中位OS为19.9个月(95%可信区间为15.0~27.2个月)。将mFOLFOX6与贝伐单抗联合使用并未导致与IPT相关的不可接受的梗阻、穿孔、出血或死亡。生存并未受到影响。这些患者可以避免最初无症状的IPT的非根治性切除。J Clin Oncol30：3223-3228。(C)2012年美国临床肿瘤学会
PurposeMajor concerns surround combining chemotherapy with bevacizumab in patients with colon cancer presenting with an asymptomatic intact primary tumor (IPT) and synchronous yet unresectable metastatic disease. Surgical resection of asymptomatic IPT is controversial.Patients and MethodsEligibility for this prospective, multicenter phase II trial included Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1, asymptomatic IPT, and unresectable metastases. All received infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) combined with bevacizumab. The primary end point was major morbidity events, defined as surgical resection because of symptoms at or death related to the IPT. A 25% major morbidity rate was considered acceptable. Secondary end points included overall survival (OS) and minor morbidity related to IPT requiring hospitalization, transfusion, or nonsurgical intervention.ResultsNinety patients registered between March 2006 and June 2009: 86 were eligible with follow-up, median age was 58 years, and 52% were female. Median follow-up was 20.7 months. There were 12 patients (14%) with major morbidity related to IPT: 10 required surgery (eight, obstruction; one, perforation; and one, abdominal pain), and two patients died. The 24-month cumulative incidence of major morbidity was 16.3% (95% CI, 7.6% to 25.1%). Eleven IPTs were resected without a morbidity event: eight for attempted cure and three for other reasons. Two patients had minor morbidity events only: one hospitalization and one nonsurgical intervention. Median OS was 19.9 months (95% CI, 15.0 to 27.2 months).ConclusionThis trial met its primary end point. Combining mFOLFOX6 with bevacizumab did not result in an unacceptable rate of obstruction, perforation, bleeding, or death related to IPT. Survival was not compromised. These patients can be spared initial noncurative resection of their asymptomatic IPT. J Clin Oncol 30:3223-3228. (C) 2012 by American Society of Clinical Oncology