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

doi:10.3760/cma.j.cn371439-20210416-00144

Abstract

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

Li Jia, Ma Xiaojie, Wang Yuxiang. Evaluation of the efficacy and safety of adjuvant mFOLFOX6 combined with bevacizumab regimen in the treatment of colorectal cancer liver metastases after radiofrequency ablation[J]. Journal of International Oncology, 2021, 48(12): 729-734.

Figures/Tables 5

References 13

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一般临床特征	对照组 (n=40)	研究组 (n=40)	χ²/t值	P值
性别
男	26	30	0.952	0.329
女	14	10
年龄(岁)	44.5±9.1	46.3±8.4	1.583	0.154
原发肿瘤部位
左半结肠	13	15
右半结肠	9	11	0.843	0.656
直肠	18	14
肿瘤直径(cm)	2.8±0.4	2.9±0.6	1.982	0.112
肝脏转移灶数目(个)	2.5±0.3	2.4±0.4	1.781	0.135
分化程度
高分化	9	8
中分化	23	21	0.623	0.732
低分化	8	11

组别	CR	PR	SD	PD	客观缓解	疾病控制
对照组(n=38)	1(2.63)	10(26.32)	12(31.58)	15(39.47)	11(28.95)	23(60.53)
研究组(n=37)	3(8.11)	17(45.95)	11(29.73)	6(16.22)	20(54.05)	31(83.78)
χ²值					4.873	5.030
P值					0.027	0.025

组别	CEA(ng/ml)			CA199(U/ml)
组别	治疗前	治疗后		治疗前	治疗后
对照组(n=38)	38.3±4.9	9.5±1.5	115.9±18.5			46.6±6.2
研究组(n=37)	40.2±5.4	4.6±1.1	119.6±16.7			35.6±5.3
t值	1.205	8.532	1.893			7.561
P值	0.194	0.016	0.127			0.023

组别	骨髓抑制	胃肠反应	肝功能异常	感染	出血	乏力
对照组(n=38)	19(50.00)	25(65.79)	5(13.16)	1(2.63)	1(2.63)	16(42.11)
研究组(n=37)	21(56.76)	28(75.68)	13(35.14)	2(5.41)	3(8.11)	19(51.35)
χ²值	0.344	0.884	4.964	0.001	0.293	0.644
P值	0.558	0.347	0.026	0.981	0.588	0.422

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