Clinical efficacy and safety analysis of cetuximab combined with mFOLFOX6 chemotherapy in the treatment of advanced colorectal cancer patients

doi:10.3760/cma.j.cn371439-20240727-00129

Abstract

Abstract:

Objective To analyze the clinical efficacy of cetuximab combined with mFOLFOX6 chemotherapy regimen in the treatment of advanced colorectal cancer， to explore its effects on the distribution of T lymphocyte subsets， patients' physical status and tumor marker levels， and to analyze its safety. Methods A total of 90 patients with advanced colorectal cancer admitted to the Hainan Cancer Hospital from April 2020 to April 2022 were selected and randomly divided into observation group （n=45） and control group （n=45） according to random number table method. The control group was treated with the mFOLFOX6 chemotherapy regimen， while the observation group was treated with cetuximab combined with the mFOLFOX6 chemotherapy regimen. Objective response rate （ORR）， disease control rate （DCR）， T lymphocyte subsets levels （percentages of CD3⁺， CD4⁺， CD8⁺）， Karnofsky performance status （KPS） score， tumor marker vascular endothelial growth factor （VEGF）， endothelial cell-specific molecule 1 （ESM1）， carcino-embryonic antigen （CEA） levels and the incidence of adverse reactions were compared between the two groups after treatment. Results After 4 cycles of treatment， the ORR was 66.67% （30/45） in the observation group and 42.22% （19/45） in the control group， and there was a statistically significant difference （χ²=5.42， P=0.020）. The DCR of the observation group was 86.67% （39/45） and that of the control group was 66.67% （30/45）， and there was a statistically significant difference （χ²=5.03， P=0.025）. The percentages of T lymphocyte subsets CD3⁺， CD4⁺ and CD8⁺ in the observation group were （63.35±6.71） %，（35.67±3.96） % and （17.03±2.11） %， respectively， while those in the control group were （52.23±5.92） %，（30.55±3.51） % and （20.64±2.83） %， respectively. The percentages of CD3⁺ and CD4⁺ in the observation group were significantly higher than those in the control group （t=8.34， P<0.001； t=6.49， P<0.001）， while the percentage of CD8⁺ ratio was significantly lower （t=6.86， P<0.001）. The KPS score of the observation group was （95.55±9.74） points， and that of the control group was （85.03±8.92） points， and there was a statistically significant difference （t=5.34， P<0.001）. VEGF， ESM1 and CEA levels in the observation group were （303.45±33.21） ng/L，（75.66±8.36） pg/ml and （7.73±0.98） ng/ml， respectively， while those in the control group were （364.53±39.07） ng/L，（92.53±9.91） pg/ml and （9.95±1.13） ng/ml， respectively. VEGF， ESM1 and CEA levels in observation group were significantly lower compared with control group （t=7.99， P<0.001； t=8.73， P<0.001； t=9.96， P<0.001）. The total incidence of adverse reactions was 75.56% （34/45） in the observation group and 66.67% （30/45） in the control group， and there was no statistically significant difference （χ²=0.87， P=0.352）. Conclusion Cetuximab combined with mFOLFOX6 chemotherapy regimen in the treatment of advanced colorectal cancer patients has significant clinical efficacy， can improve the immune function of patients， alleviate clinical symptoms， regulate the level of serum tumor markers in patients without increasing adverse reactions， and has good safety.

Key words: Colorectal neoplasms, Cetuximab, Drug therapy， combination, Treatment outcome, T-lymphocyte subsets

Liu Jiaqi, Wang Wenjun, Zhong Ping, Yang Min, Zhao Xinkai. Clinical efficacy and safety analysis of cetuximab combined with mFOLFOX6 chemotherapy in the treatment of advanced colorectal cancer patients[J]. Journal of International Oncology, 2024, 51(12): 763-768.

Figures/Tables 6

References 19

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组别	性别		年龄（岁）	分化类型			肿瘤类型		结肠原发肿瘤部位
组别	男	女	年龄（岁）	低分化	中分化	高分化	直肠癌	结肠癌	左半结肠	右半结肠
观察组（n=45）	28	17	57.44±6.22	10	15	20	25	20	13	7
对照组（n=45）	30	15	57.16±6.15	13	14	18	27	18	11	7
χ²/t值	0.19		0.22		0.53		0.18		0.06
P值	0.660		0.830		0.767		0.670		0.804

组别	CR	PR	SD	PD	客观缓解	疾病控制
观察组（n=45）	4（8.89）	26（57.78）	9（20.00）	6（13.33）	30（66.67）	39（86.67）
对照组（n=45）	1（2.22）	18（40.00）	11（24.44）	15（33.33）	19（42.22）	30（66.67）
χ²值					5.42	5.03
P值					0.020	0.025

组别	CD3⁺占比		CD4⁺占比		CD8⁺占比
组别	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
观察组（n=45）	49.42±5.37	63.35±6.71^a	24.27±3.28	35.67±3.96^a	25.12±3.05	17.03±2.11^a
对照组（n=45）	49.38±5.34	52.23±5.92^a	24.33±3.31	30.55±3.51^a	25.16±3.08	20.64±2.83^a
t值	0.04	8.34	0.09	6.49	0.06	6.86
P值	0.972	<0.001	0.931	<0.001	0.951	<0.001

组别	治疗前	治疗后	t值	P值
观察组（n=45）	77.65±8.01	95.55±9.74	9.52	<0.001
对照组（n=45）	77.71±8.05	85.03±8.92	4.09	<0.001
t值	0.04	5.34
P值	0.972	<0.001

组别	VEGF（ng/L）		ESM1（pg/ml）		CEA（ng/ml）
组别	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
观察组（n=45）	437.22±45.35	303.45±33.21^a	111.25±13.28	75.66±8.36^a	13.72±2.02	7.73±0.98^a
对照组（n=45）	435.98±45.14	364.53±39.07^a	110.83±13.01	92.53±9.91^a	13.69±2.05	9.95±1.13^a
t值	0.13	7.99	0.15	8.73	0.07	9.96
P值	0.897	<0.001	0.880	<0.001	0.944	<0.001