JCO：贝伐单抗联用FOLFOX6不能改善2-3期结肠癌患者生存期

2012年12月10日在线出版的《临床肿瘤学杂志》(Journal of Clinical Oncology)上，参与美国乳腺与肠道外科辅助项目的Carmen J. Allegra等人发表了关于该项目C-08临床试验的一篇文章，该试验目的是，面向2-3期结肠癌患者，对贝伐单抗联用氟尿嘧啶、亚叶酸钙以及奥沙利铂(FOLFOX6)辅助治疗的安全性和有效性进行研究。该文分别对该试验主要终点和次要终点，即5年平均随访期中的无病存活期和整体存活期进行了归纳总结。

在为期6个月的时间内，参试患者每两周接受一次改良后的FOLFOX6治疗(对照组)，或在12个月的时间段内，每两周接受一次FOLFOX6联用贝伐单抗(5 mg/kg)治疗，共维持6个月(实验组)。该研究的主要终点为无病生存期(DFS)，次要终点为整体生存期(OS)。

研究人员发现，在研究分析的2,673例患者中，人口因素通过治疗取得均衡。在平均5年的随访期中，贝伐单抗联用mFOLFOX6的治疗方法并未使患者无病生存期取得显着提高(风险比[HR], 0.93; 95% CI, 0.81 至1.08;P = .35)。他们通过探索性分析发现，贝伐单抗对患者无病生存期的影响以1.25年为界而前后有所不同(时间-治疗关系， P值<.0001)。而在两个研究组所有患者中，次要终点整体生存期也不存在差异(HR,0.95; 95% CI, 0.79 至1.13; P = .56)，对于3期病情患者也不存在差异(HR, 1.0; 95% CI, 0.83 至1.21; P = .99)。

Carmen J. Allegra等人认为，贝伐单抗联用改良FOLFOX6不能显着改善2-3期结肠癌患者的无病生存期或整体生存期。但研究也未发现贝伐单抗给药对患者具有不利影响。此外，在研究实验组中还发现，贝伐单抗给药对患者无病生存期具有瞬时效应。

与结肠癌相关的拓展阅读：

• JCO：贝伐单抗联用FOLFOX6不能改善2-3期结肠癌患者生存期
• Ann Surg.：术前饮食因素影响结肠癌患者感染并发症发病率
• ANN SURG：结肠癌术前营养缺乏或可增加术后感染率
• 槲寄生治疗结肠癌
• JNCI：饮食血糖负荷增加III期结肠癌患者肿瘤复发风险
更多信息请点击：有关结肠癌更多资讯

doi: 10.1200/JCO.2012.44.4711
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Bevacizumab in Stage II-III Colon Cancer: 5-Year Update of the National Surgical Adjuvant Breast and Bowel Project C-08 Trial

Carmen J. Allegra, Greg Yothers, Michael J. O'Connell, Saima Sharif, Nicholas J. Petrelli, Samia H. Lopa, and Norman Wolmark

PURPOSEThe National Surgical Adjuvant Breast and Bowel Project trial C-08 was designed to investigate the safety and efficacy of adding bevacizumab to fluorouracil, leucovorin, and oxaliplatin (FOLFOX6) for the adjuvant treatment of patients with stage 2-3 colon cancer. Our report summarizes the primary and secondary end points of disease-free and overall survival, respectively, with 5 years median follow-up time.Patients And methodsPatients received modified FOLFOX6 once every 2 weeks for a 6-month period (control group) or modified FOLFOX6 for 6 months plus bevacizumab (5 mg/kg) once every 2 weeks for a 12-month period (experimental group). The primary end point of the study was disease-free survival (DFS) and overall survival (OS) was a secondary end point.ResultsOf 2,673 analyzed patients, demographic factors were well-balanced by treatment. With a median follow-up of 5 years, the addition of bevacizumab to mFOLFOX6 did not result in an overall significant increase in DFS (hazard ratio [HR], 0.93; 95% CI, 0.81 to 1.08; P = .35). Exploratory analyses found that the effect of bevacizumab on DFS was different before and after a 1.25-year landmark (time-by-treatment interaction P value <.0001). The secondary end point of OS was no different between the two study arms for all patients (HR, 0.95; 95% CI, 0.79 to 1.13; P = .56) and for those with stage 3 disease (HR, 1.0; 95% CI, 0.83 to 1.21; P = .99). CONCLUSIONBevacizumab for 1 year with modified FOLFOX6 does not significantly prolong DFS or OS in stage 2-3 colon cancer. We observed no evidence of a detrimental effect of exposure to bevacizumab. A transient effect on disease-free survival was observed during bevacizumab exposure in the study's experimental arm.