Observation on efficacy of disitamab vedotin combined with toripalimab in the neoadjuvant therapy of muscle-invasive bladder cancer

doi:10.11958/20252884

Abstract

Abstract:

Objective To explore the clinical effect of disitamab vedotin combined with toripalimab in the neoadjuvant therapy of muscle-invasive bladder cancer (MIBC). Methods A total of 87 MIBC patients were divided into the control group (treated with gemcitabine+cisplatin combined with toripalimab, n=47) and the study group (treated with disitamab vedotin combined with toripalimab, n=40) based on the different neoadjuvant treatment regimens. Every 3 weeks was one course of treatment, for a total of 3 courses of treatment. The clinical objective response rate (ORR) and disease control rate (DCR) after three treatment courses were calculated in two groups, and the ORR and DCR of human epidermal growth factor receptor 2 (HER-2) in positive patients were also caculated. Immunohistochemical staining was used to detect the positive expression levels of cytokeratin 20 (CK20), GATA-binding protein 3 (GATA-3) and Ki-67 before and after treatment in the two groups. Serum vascular endothelial growth factor (VEGF) and urinary bladder tumor antigen (BTA) levels were detected by enzyme-linked immunosorbent assay. The incidence of grade 3 adverse reactions during the treatment process was compared between the two groups. Results After 3 courses of treatment, the ORR (75.0% vs. 51.1%) and DCR (95.0% vs. 80.9%) were higher in the study group than those of the control group (all P<0.05). After three courses of treatment, the ORR of HER-2 positive patients in the study group was higher than that in the control group (81.25% vs. 55.17%, P<0.05). There was no significant difference in DCR between the two groups (100.00% vs. 89.66%，P>0.05). After treatment, the proportions of patients with positive CK20, GATA-3 and Ki-67, urinary BTA, and serum VEGF expression levels were lower in the study group than those in the control group (all P<0.05). The incidence of grade 3 adverse reactions of leukopenia was lower in the research group than that in the control group (0.00% vs. 19.15%, P<0.05). There were no significant differences in the incidence of other grade 3 adverse reactions such as neutropenia, itching and rash between the two groups (all P>0.05). Conclusion Disitamab vedotin combined with toripalimab has high ORR and DCR in the neoadjuvant therapy of MIBC. Moreover, the ORR is higher in HER-2 positive patients, with controllable safety and good overall efficacy.

Key words: urinary bladder neoplasms, adverse reactions, efficacy, muscle layer infiltration, neoadjuvant therapy, disitamab vedotin, toripalimab

CLC Number:

R737.14

Figures/Tables 5

References 23

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组别		n	性别（男/女）			年龄/岁		BMI/（kg/m²）			吸烟史		饮酒史		HER-2阳性
对照组		47	42/5			72.30±8.03		22.56±2.46			31（65.96）		25（53.19）		29（61.70）
研究组		40	37/3			74.23±9.16		23.41±3.19			32（80.00）		22（55.00）		32（80.00）
χ²或t			0.018			1.045		1.407			2.133		0.028		3.453
组别	基础疾病									入院TNM分期
组别	高血压			糖尿病	冠心病		脑梗死		房颤	T₂N₀M₀		T₃N₀M₀		T₃N₁M₀		T_4aN₁M₀
对照组	35（74.47）			18（38.30）	8（17.02）		6（12.77）		2（4.26）	27（57.45）		18（38.30）		1（2.13）		1（2.13）
研究组	29（72.50）			12（30.00）	3（7.50）		3（7.50）		1（2.50）	22（55.00）		10（25.00）		4（10.00）		4（10.00）
χ²或P	0.043			0.659	1.774		0.203		0.000	0.132^▲

组别		n	性别（男/女）			年龄/岁		BMI/（kg/m²）			吸烟史		饮酒史		HER-2阳性
对照组		47	42/5			72.30±8.03		22.56±2.46			31（65.96）		25（53.19）		29（61.70）
研究组		40	37/3			74.23±9.16		23.41±3.19			32（80.00）		22（55.00）		32（80.00）
χ²或t			0.018			1.045		1.407			2.133		0.028		3.453
组别	基础疾病									入院TNM分期
组别	高血压			糖尿病	冠心病		脑梗死		房颤	T₂N₀M₀		T₃N₀M₀		T₃N₁M₀		T_4aN₁M₀
对照组	35（74.47）			18（38.30）	8（17.02）		6（12.77）		2（4.26）	27（57.45）		18（38.30）		1（2.13）		1（2.13）
研究组	29（72.50）			12（30.00）	3（7.50）		3（7.50）		1（2.50）	22（55.00）		10（25.00）		4（10.00）		4（10.00）
χ²或P	0.043			0.659	1.774		0.203		0.000	0.132^▲

组别	n	CR	PR	SD	PD	ORR	DCR
对照组	47	8（17.0）	16（34.0）	14（29.8）	9（19.2）	24（51.0）	38（80.9）
研究组	40	13（32.5）	17（42.5）	8（20.0）	2（5.0）	30（75.0）	38（95.0）
χ²						5.259^＊	3.917^＊

组别	n	CR	PR	SD	PD	ORR	DCR
对照组	47	8（17.0）	16（34.0）	14（29.8）	9（19.2）	24（51.0）	38（80.9）
研究组	40	13（32.5）	17（42.5）	8（20.0）	2（5.0）	30（75.0）	38（95.0）
χ²						5.259^＊	3.917^＊

组别	n	ORR	DCR
对照组	29	16（55.17）	26（89.66）
研究组	32	26（81.25）	32（100.00）
χ²		4.824^＊	1.621