Efficacy and safety of tislelizumab combined with chemotherapy in the treatment of advanced esophageal cancer

doi:10.3760/cma.j.cn371439-20250619-00004

Abstract

Abstract:

Objective To retrospectively analyze the efficacy and safety of tislelizumab combined with chemotherapy in the treatment of advanced esophageal cancer. Methods A total of 128 patients with advanced esophageal cancer admitted to the Affiliated Hospital of Jiangsu University from March 2021 to June 2024 were selected as the study subjects. According to different treatment methods， they were divided into a conventional group （n=60， treated with paclitaxel liposome+nedaplatin） and a monoclonal antibody group （n=68， treated with paclitaxel liposome+nedaplatin+tislelizumab）. With 21 days as one cycle， a total of 4-6 cycles of chemotherapy were administered. The short-term efficacy， tumor markers and related factors， inflammatory factors， immune related indicators， quality of life-related score and safety of the two groups of patients were observed. Results After treatment， the objective response rate in the monoclonal antibody group （86.76%， 59/68） was higher than that in the conventional group （65.00%， 39/60）， with a statistically significant difference （χ²=8.42， P=0.004）. The levels of carcinoembryonic antigen （CEA）， cytokeratin 19 fragment antigen 21-1 （CYFRA21-1）， carbohydrate antigen （CA） 125， and squamous cell carcinoma antigen （SCC-Ag） in the monoclonal antibody group were （7.73±2.18） μg/L，（4.95±0.67） U/ml，（9.28±1.42） U/ml， and （0.50±0.16） μg/L， respectively， and those in the conventional group were （10.14±2.21） μg/L，（4.09±0.70） U/ml，（7.35±1.58） U/ml， and （0.68±0.22） μg/L， respectively， with statistically significant differences （t=6.20， P<0.001； t=7.10， P<0.001； t=7.28， P<0.001； t=5.34， P<0.001）. Moreover， the levels of CEA， CYFRA21-1， CA125， and SCC-Ag in both groups of patients after treatment were significantly lower than those before treatment （all P<0.05）. The levels of matrix metalloproteinase-9 （MMP-9） and vascular endothelial growth factor （VEGF） in the monoclonal antibody group were （118.28±10.47） ng/ml and （320.27±18.79） ng/L， respectively， and those in the conventional group were （126.75±14.51） ng/ml and （350.71±19.35） ng/L， respectively， with statistically significant differences （t=3.82， P<0.001； t=9.02， P<0.001）. The levels of MMP-9 and VEGF in both groups of patients after treatment were significantly lower than those before treatment （all P<0.05）. The levels of interleukin （IL）-6， C-reactive protein （CRP） and tumor necrosis factor-α （TNF-α） in the monoclonal antibody group were （5.46±1.26） ng/L，（7.89±1.45） mg/L， and （3.95±0.83） ng/L， respectively， and those in the conventional group were （8.66±2.13） ng/L，（9.51±1.64） mg/L， and （6.02±1.52） ng/L， respectively， with statistically significant differences （t=10.49， P<0.001； t=5.93， P<0.001； t=9.71， P<0.001）. The levels of IL-6， CRP， and TNF-α in both groups of patients after treatment were significantly lower than those before treatment （all P<0.05）. The T-cell subsets CD3⁺ and CD4⁺/CD8⁺ ratio in the monoclonal antibody group were （66.16±5.26）% and 1.52±0.25， respectively， and those in the conventional group were （58.41±5.17）% and 1.15±0.27， respectively， with statistically significant differences （t=8.39， P<0.001； t=8.05， P<0.001）. The T-cell subsets CD3⁺ and CD4⁺/CD8⁺ ratio in both groups of patients after treatment were significantly higher than those before treatment （all P<0.05）. Compared with before treatment， the Karnofsky performance status scores and the M. D. Anderson dysphagia inventory scores of both groups of patients were increased， and the scores in the monoclonal antibody group were significantly higher than those in the conventional group； the numerical rating scale scores of both groups were decreased， and the score in the monoclonal antibody group was significantly lower than that in the conventional group （all P<0.05）. The common adverse reactions in the two groups were leukopenia， nausea， fatigue， etc.， most of which were grade 1-2. The incidence of grade 3 adverse reactions was 10.00%（6/60） in the conventional group and 20.59%（14/68） in the monoclonal antibody group. No grade 4 adverse reactions occurred. There was no statistically significant difference in the total incidence of adverse reactions between the conventional group （78.33%， 47/60） and the monoclonal antibody group （75.00%， 51/68； χ²=0.20， P=0.657）. Conclusions Compared with chemotherapy alone， tislelizumab combined with chemotherapy in the treatment of advanced esophageal cancer can improve short-term efficacy with good safety.

Key words: Esophageal neoplasms, Antineoplastic combined chemotherapy protocols, Tislelizumab

Yu Yunpeng, Dai Chunhua, Ling Rui. Efficacy and safety of tislelizumab combined with chemotherapy in the treatment of advanced esophageal cancer[J]. Journal of International Oncology, 2026, 53(1): 31-37.

Figures/Tables 7

References 21

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项目	常规组（n=60）	单抗组（n=68）	t/χ²值	P值
性别（例）
男	35	36	0.38	0.540
女	25	32	0.38	0.540
年龄（岁，$ \bar{x} \pm s$）	51.52±9.81	50.22±10.14	0.74	0.464
TNM分期（例）
Ⅱ期	40	43	0.17	0.685
Ⅲ期	20	25	0.17	0.685
病理类型（例）
鳞状细胞癌	56	64	<0.01	>0.999
腺癌	4	4	<0.01	>0.999
既往治疗史（例）
无	45	53	0.15	0.695
有	15	15	0.15	0.695
后续治疗（例）
无	8	7	0.94	0.624
局部放疗	25	34
其他方案化疗	27	27

组别	完全缓解	部分缓解	病情稳定	疾病进展	客观缓解
常规组（n=60）	4	35	19	2	39
单抗组（n=68）	10	49	9	0	59
χ²值					8.42
P值					0.004

组别	CEA（μg/L）		CYFRA21-1（U/ml）		CA125（U/ml）		SCC-Ag（μg/L）
组别	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
常规组（n=60）	16.54±4.17	10.14±2.21^a	9.82±1.13	4.09±0.70^a	15.19±2.23	7.35±1.58^a	1.40±0.15	0.68±0.22^a
单抗组（n=68）	16.38±4.23	7.73±2.18^a	9.76±1.25	4.95±0.67^a	15.23±2.14	9.28±1.42^a	1.42±0.17	0.50±0.16^a
t值	0.22	6.20	0.28	7.10	0.10	7.28	0.70	5.34
P值	0.830	<0.001	0.780	<0.001	0.920	<0.001	0.480	<0.001

组别	MMP-9（ng/ml）		VEGF（ng/L）
组别	治疗前	治疗后	治疗前	治疗后
常规组（n=60）	142.35±24.18	126.75±14.51^a	410.24±19.66	350.71±19.35^a
单抗组（n=68）	140.19±26.53	118.28±10.47^a	406.86±20.47	320.27±18.79^a
t值	0.48	3.82	0.95	9.02
P值	0.633	<0.001	0.344	<0.001

组别	IL-6（ng/L）		CRP（mg/L）		TNF-α（ng/L）
组别	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
常规组（n=60）	15.32±3.31	8.66±2.13^a	15.25±1.69	9.51±1.64^a	12.21±2.16	6.02±1.52^a
单抗组（n=68）	15.21±3.16	5.46±1.26^a	15.49±1.11	7.89±1.45^a	12.06±2.10	3.95±0.83^a
t值	0.19	10.49	0.96	5.93	0.40	9.71
P值	0.848	<0.001	0.339	<0.001	0.691	<0.001