mFOLFOX6联合贝伐珠单抗方案围手术期治疗局部进展期结肠癌的疗效和安全性

Efficacy and safety of mFOLFOX6 plus bevacizumab regimen in perioperative treatment for locally advanced colon cancer

目的:评估mFOLFOX6联合贝伐珠单抗方案作为局部进展期结肠癌(locally advanced colon cancer,LACC)围手术期治疗的有效性和安全性。方法:回顾性分析既往未接受过治疗的26例LACC患者,所有患者均接受4个周期mFOLFOX6联合贝伐珠单抗方案新辅助化疗和2个周期mFOLFOX6方案新辅助化疗。手术和贝伐珠单抗治疗相隔至少6周。术后继续接受6个周期mFOLFOX6联合贝伐珠单抗方案治疗。主要研究终点为客观有效率(objective response rate,ORR),次要研究终点为疾病控制率(disease control rate,DCR)、肿瘤消退程度(tumor regression grade,TRG)、安全性、无疾病进展生存时间(progression free survival,PFS)和总生存时间(overall survival,OS)。结果:中位年龄49.3(30~70)岁,中位随访时间22.6(11~39)个月,26例患者均完成预定治疗方案,ORR为84.6%(22/26),CR和PR分别为11.5%(3/26)和73.1%(19/26),SD的患者占15.4%(4/26),无PD患者,DCR为100.0%(26/26)。TRG0、TRG1、TRG2和TGR3的患者分别为2例(7.7%)、7例(26.9%)、16例(61.5%)和1例(3.9%)。无治疗相关死亡发生,最常见的Ⅲ-Ⅳ级毒副反应为粒细胞缺乏(19.2%)。1例(3.9%)患者新辅助化疗过程中出现肠穿孔。随访3年预期PFS和OS分别为83.5%和72.8%。结论:本研究显示mFOLFOX6联合贝伐珠单抗方案作为LACC的围手术期治疗是有效的和安全的,该治疗模式可以作为LACC患者的一种选择。

Objective:To investigated the treatment efficacy and safety of perioperative mFOLFOX6 plus bevacizumab for patients with locally advanced colon cancer(LACC).Methods:We retrospectively reviewed 26 patients with previously untreated LACC.Patients received six cycles of neoadjuvant treatment(four cycles of neoadjuvant mFOLFOX6 plus bevacizumab followed by two cycle of mFOLFOX6 alone).The interval between the last dose of bevacizumab and surgery was at least 6 weeks.Six cycles of adjuvant mFOLFOX6 plus bevacizumab was given after surgery.The objective response rate(ORR)was the primary end points.The disease control rate(DCR),tumor regression grade(TRG),safety,progression free survival(PFS)and overall survival(OS)were observed.Results:Median age was 49.3 years(30~70 years old)and median follow-up period was 22.6 months(11~39 months).26 patients completed the planned treatment.The total radiological ORR was 84.6%(22/26),including complete and partial response rates of 11.5%(3/26)and 73.1%(19/26),respectively.Stable disease was observed in 15.4%(4/26)and progressive disease was observed in none.The DCR was 100.0%(26/26).The TRG0,TRG1,TRG2 and TRG3 were achieved in 2(7.7%),7(26.9%),16(61.5%),and 1(3.9%)patients,respectively.There was no treatment-related death.The most common gradeⅢ-Ⅳadverse events were neutropenia(19.2%).One patient with gastrointestinal perforation occurred after neoadjuvant treatment(1/26,3.9%).The 3-year PFS and OS were 83.5%and 72.8%,respectively.Conclusion:Our results demonstrated that perioperative mFOLFOX6 plus bevacizumab is an effective and safe treatment.The multimodality therapy might be a treatment option for patients with LACC.