国际肿瘤学杂志

国际肿瘤学杂志 ›› 2021, Vol. 48 ›› Issue (12): 729-734.doi: 10.3760/cma.j.cn371439-20210416-00144

• 论著 • 上一篇    下一篇

射频消融后辅助mFOLFOX6联合贝伐珠单抗方案在结直肠癌肝转移瘤中的疗效和安全性评价

李佳1, 马晓捷1, 王宇翔2()   

  1. 1山西省肿瘤医院放疗盆腔一病区,太原 030013
    2山西省肿瘤医院超声科,太原 030013
  • 收稿日期:2021-04-16 修回日期:2021-07-07 出版日期:2021-12-08 发布日期:2022-01-12
  • 通讯作者: 王宇翔 E-mail:liyongcai120@163.com

Evaluation of the efficacy and safety of adjuvant mFOLFOX6 combined with bevacizumab regimen in the treatment of colorectal cancer liver metastases after radiofrequency ablation

Li Jia1, Ma Xiaojie1, Wang Yuxiang2()   

  1. 1Radiotherapy Pelvic No.1 Ward, Shanxi Provincial Cancer Hospital, Taiyuan 030013, China
    2Department of Ultrasound, Shanxi Provincial Cancer Hospital, Taiyuan 030013, China
  • Received:2021-04-16 Revised:2021-07-07 Online:2021-12-08 Published:2022-01-12
  • Contact: Wang Yuxiang E-mail:liyongcai120@163.com

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摘要： 目的 探讨射频消融(RFA)后辅助改良FOLFOX6(mFOLFOX6,奥沙利铂+亚叶酸钙+5-氟尿嘧啶)联合贝伐珠单抗方案在KRAS、BRAF V600E突变型结直肠癌术后不可手术切除肝转移患者的疗效及不良反应。 方法 选取2016年1月至2020年6月山西省肿瘤医院确诊的KRAS、BRAF V600E突变型结直肠癌肝转移(CRLM)患者作为研究对象,按照随机数字表法分为对照组和研究组,每组40例;对照组患者给予mFOLFOX6联合贝伐珠单抗治疗,14 d为一个周期,共6个周期;研究组患者给予RFA治疗后mFOLFOX6联合贝伐珠单抗方案治疗。对照组患者治疗过程中1例因发生4级中性粒细胞减少、1例4级胃肠反应退出研究;研究组患者2例因发生4级中性粒细胞减少、1例4级肝功能异常退出临床研究。比较两组患者近期疗效、中位总生存期(OS)、中位无进展生存期(PFS)、血清肿瘤标志物CEA、CA199水平变化及不良反应发生情况。 结果 研究组客观缓解率(ORR)、疾病控制率(DCR)分别为54.05%(20/37)、83.78%(31/37),高于对照组的28.95%(11/38)、60.53%(23/38),差异均具有统计学意义(χ 2=4.873,P=0.027;χ 2=5.030,P=0.025)。研究组患者中位OS、中位PFS分别为23.5个月、14.6个月,长于对照组的19.2个月、10.5个月,差异均具有统计学意义(χ 2=7.863,P=0.015;χ 2=7.016,P=0.019)。研究组患者治疗后血清肿瘤标志物CEA、CA199分别为(4.6±1.1)ng/ml、(35.6±5.3)U/ml,低于对照组的(9.5±1.5)ng/ml、(46.6±6.2)U/ml,差异均具有统计学意义(t=8.532,P=0.016;t=7.561,P=0.023)。研究组患者的骨髓抑制、胃肠反应、感染、出血、乏力发生率分别为56.76%(21/37)、75.68%(28/37)、5.41%(2/37)、8.11%(3/37)、51.35%(19/37),对照组分别为50.00%(19/38)、65.79%(25/38)、2.63%(1/38)、2.63%(1/38)、42.11%(16/38),差异均无统计学意义(χ 2=0.344,P=0.558;χ 2=0.884,P=0.347;χ 2=0.001,P=0.981;χ 2=0.293,P=0.588;χ 2=0.644,P=0.422);研究组患者肝功能异常发生率为35.14%(13/37),高于对照组的13.16%(5/38),差异具有统计学意义(χ 2=4.964,P=0.026)。 结论 RFA后辅助mFOLFOX6联合贝伐珠单抗在KRAS、BRAF V600E突变型结直肠癌术后不可手术切除肝转移患者中疗效确切,可有效延长生存期,不良反应可控、可耐受。

关键词: 结直肠肿瘤, 治疗结果, 肝转移, 射频消融, 贝伐珠单抗

Abstract: Objective To explore the clinical efficacy and adverse reaction of the adjuvant modified FOLFOX6 (mFOLFOX6, oxaliplatin + leucovorin + 5-fluorouracil) combined with bevacizumab regimen after radiofrequency ablation (RFA) in KRAS and BRAF V600E mutant postoperative colorectal cancer patients with inoperable resection of liver metastases. Methods KRAS, BRAF V600E mutant colorectal liver metastasis (CRLM) patients diagnosed by Shanxi Provincial Cancer Hospital from January 2016 to June 2020 were selec-ted as the research objects. According to the random number table method, they were divided into control group and study group, 40 cases in each group. The patients in the control group were treated with mFOLFOX6 combined with bevacizumab for 6 cycles of 14 days. The patients in the study group were treated with mFOLFOX6 combined with bevacizumab after RFA treatment. One patient in the control group withdrew from the study due to grade 4 neutropenia and one patient due to grade 4 gastrointestinal reaction. In the study group, two patients withdrew from the study due to grade 4 neutropenia and one patient due to grade 4 liver function abnormalities. The short-term efficacy, median overall survival (OS), median progression-free survival (PFS), changes in serum tumor markers CEA and CA199 levels and the occurrence of adverse reactions were compared between the two groups. Results The objective response rate (ORR) and disease control rate (DCR) in the study group were 54.05% (20/37) and 83.78% (31/37), respectively, which were higher than 28.95% (11/38) and 60.53% (23/38) in the control group, with statistically significant differences (χ 2=4.873, P=0.027; χ 2=5.030, P=0.025). The median OS and median PFS in the study group were 23.5 months and 14.6 months, respectively, which were longer than 19.2 months and 10.5 months in the control group, with statistically significant differences (χ 2=7.863, P=0.015; χ 2=7.016, P=0.019). Serum tumor markers CEA and CA199 in the study group after treatment were (4.6±1.1) ng/ml and (35.6±5.3) U/ml, respectively, which were lower than (9.5±1.5) ng/ml and (46.6±6.2) U/ml in the control group, with statistically significant differences (t=8.532, P=0.016; t=7.561, P=0.023). The incidences of bone marrow suppression, gastrointestinal reaction, infection, bleeding and fatigue in the study group were 56.76% (21/37), 75.68% (28/37), 5.41% (2/37), 8.11% (3/37), 51.35% (19/37), and 50.00% (19/38), 65.79% (25/38), 2.63% (1/38), 2.63% (1/38), 42.11% (16/38) in the control group, with no statistically significant differences (χ 2=0.344, P=0.558; χ 2=0.884, P=0.347; χ 2=0.001, P=0.981; χ 2=0.293, P=0.588; χ 2=0.644, P=0.422). The incidence of abnormal liver function in the study group was 35.14% (13/37), which was higher than 13.16% (5/38) in the control group, with a statistically significant difference (χ 2=4.964, P=0.026). Conclusion The adjuvant mFOLFOX6 combined with bevacizumab after RFA is effective in KRAS, BRAF V600E mutant colorectal cancer patients with unresectable liver metas-tases after surgery, which can effectively prolong survival, and the adverse reactions are controllable and tolerable.

Key words: Colorectal neoplasms, Treatment outcome, Liver metastasis, Radiofrequency ablation, Bevacizumab