Impact of HER2 Expression on the Prognosis of Muscle-Invasive Bladder Cancer Patients Treated with Bladder-Preservation Comprehensive Therapy.

IF 4.3 3区 生物学 Q1 BIOCHEMICAL RESEARCH METHODS
Yatong Chen, Fei Luo, Tingji Zhang, Jian Li
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Recurrence-free survival (RFS) and overall survival (OS) in HER2-negative and HER2-positive patients were compared to analyze the correlation between HER2 expression and prognosis. RFS and OS in the 83 HER2-positive patients administered cTURBT combined with GC chemotherapy and the 42 HER2-positive patients administered cTURBT combined with RC48-ADC were compared to analyze the differences in prognosis between the two treatment methods. The adverse reactions of GC and RC48-ADC were also compared.</p><p><strong>Results: </strong>Among the 217 included patients, 125 (57.6%) were HER2 positive (IHC 2 + or 3 +). HER2 positivity was significantly associated with tumor size, multifocality, pathological grade, tumor stage, and pelvic lymph node metastasis (P < 0.05). Totally 175 patients underwent cTURBT combined with GC chemotherapy, including 92 HER2-negative and 83 HER2-positive cases. There were no significant differences in gender, age, smoking status, tumor location, and ECOG score between the two groups (P > 0.05), but the proportions of patients with tumors > 3 cm, multifocal tumors, T3 stage, high-grade tumors, and pelvic lymph node metastasis were higher in the HER2-positive group versus the HER2-negative group (P < 0.05). Tumor recurrence rate in the 83 HER2-positive patients was 67.5%, with a median RFS of 19.0 months (95% CI: 10.3-27.7). Totally 22 deaths occurred during the follow-up period, with a median OS of 56.0 months (95% CI: 45.7-66.3). In the 92 HER2-negative patients, the tumor recurrence rate was 56.5%, with a median RFS of 36.0 months (95% CI: 26.1-45.9); 4 deaths occurred during the follow-up period, with the median OS not reached. After cTURBT, of the 125 HER2-positive patients examined, 83 were included in the GC treatment group versus 42 in the RC48-ADC group. 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引用次数: 0

Abstract

Background: HER2 expression has been confirmed to be associated with bladder cancer aggressiveness. Anti-HER2 RC48-ADC is approved in China for the treatment of patients with advanced urothelial carcinoma with failed chemotherapy who are HER2 positive (IHC 2 + or 3 +). The discovery of HER2 positivity in urothelial carcinoma and the development of anti-HER2 drugs have brought new hope for bladder preservation treatment in MIBC.

Objective: To investigate HER2 expression in MIBC patients and its correlations with clinical characteristics, to analyze the impact of HER2 expression on the prognosis of MIBC patients administered bladder-preservation comprehensive therapy, and to explore the efficacy and safety of RC48-ADC in MIBC patients administered bladder-preservation comprehensive therapy.

Methods: We retrospectively collected information on MIBC patients. All 217 patients underwent cTURBT, of whom 175 received GC chemotherapy, while the remaining 42, due to intolerance to GC chemotherapy and HER2 positivity (IHC 2 + or 3 +), received RC48-ADC treatment. Of the 175 patients administered cTURBT combined with GC chemotherapy, 92 and 83 were HER2-negative and HER2-positive, respectively. Recurrence-free survival (RFS) and overall survival (OS) in HER2-negative and HER2-positive patients were compared to analyze the correlation between HER2 expression and prognosis. RFS and OS in the 83 HER2-positive patients administered cTURBT combined with GC chemotherapy and the 42 HER2-positive patients administered cTURBT combined with RC48-ADC were compared to analyze the differences in prognosis between the two treatment methods. The adverse reactions of GC and RC48-ADC were also compared.

Results: Among the 217 included patients, 125 (57.6%) were HER2 positive (IHC 2 + or 3 +). HER2 positivity was significantly associated with tumor size, multifocality, pathological grade, tumor stage, and pelvic lymph node metastasis (P < 0.05). Totally 175 patients underwent cTURBT combined with GC chemotherapy, including 92 HER2-negative and 83 HER2-positive cases. There were no significant differences in gender, age, smoking status, tumor location, and ECOG score between the two groups (P > 0.05), but the proportions of patients with tumors > 3 cm, multifocal tumors, T3 stage, high-grade tumors, and pelvic lymph node metastasis were higher in the HER2-positive group versus the HER2-negative group (P < 0.05). Tumor recurrence rate in the 83 HER2-positive patients was 67.5%, with a median RFS of 19.0 months (95% CI: 10.3-27.7). Totally 22 deaths occurred during the follow-up period, with a median OS of 56.0 months (95% CI: 45.7-66.3). In the 92 HER2-negative patients, the tumor recurrence rate was 56.5%, with a median RFS of 36.0 months (95% CI: 26.1-45.9); 4 deaths occurred during the follow-up period, with the median OS not reached. After cTURBT, of the 125 HER2-positive patients examined, 83 were included in the GC treatment group versus 42 in the RC48-ADC group. There were no differences in gender, age, smoking status, tumor location, tumor size, multifocality, clinical T stage, pathological grade, pelvic lymph node metastasis, and ECOG score between the two groups (P > 0.05). In the GC group, 56 recurrences (67.5%) were detected during the follow-up period, with a median RFS of 19.0 months (95% CI: 10.3-27.7); meanwhile, 22 deaths (52.4%) occurred, with a median OS of 56.0 months (95% CI: 45.7-66.3). In the RC48-ADC group, 15 recurrences (35.7%) were recorded during the follow-up period, with the median RFS not reached; there were 2 deaths (4.8%), with the median OS not reached. The incidence rates of any-grade and grade ≥ 3 adverse reactions were both lower in the RC48-ADC group than in the GC treatment group.

Conclusions: This study confirms that cTURBT combined with RC48-ADC treatment for HER2-positive MIBC is superior to combined GC treatment in terms of RFS and OS, representing an effective treatment regimen for bladder preservation in MIBC patients.

HER2表达对保膀胱综合治疗肌肉侵袭性膀胱癌患者预后的影响
背景:HER2表达已被证实与膀胱癌侵袭性相关。抗HER2 RC48-ADC在中国被批准用于治疗HER2阳性(IHC 2 +或3 +)化疗失败的晚期尿路上皮癌患者。尿路上皮癌中HER2阳性的发现和抗HER2药物的开发为MIBC患者的膀胱保存治疗带来了新的希望。目的:研究HER2在MIBC患者中的表达及其与临床特征的相关性,分析HER2表达对MIBC患者保膀胱综合治疗预后的影响,探讨RC48-ADC在MIBC患者保膀胱综合治疗中的疗效和安全性。方法:回顾性收集MIBC患者的资料。217例患者均行ctturt治疗,其中175例接受GC化疗,其余42例因GC化疗不耐受和HER2阳性(IHC 2 +或3 +)接受RC48-ADC治疗。175例接受ctturbt联合GC化疗的患者中,her2阴性和her2阳性分别为92例和83例。比较HER2阴性和HER2阳性患者的无复发生存期(RFS)和总生存期(OS),分析HER2表达与预后的相关性。比较83例her2阳性患者ctturbt联合GC化疗和42例her2阳性患者ctturbt联合RC48-ADC治疗的RFS和OS,分析两种治疗方法的预后差异。比较GC和RC48-ADC的不良反应。结果:217例患者中,125例(57.6%)HER2阳性(IHC 2 +或3 +)。HER2阳性与肿瘤大小、多灶性、病理分级、肿瘤分期、盆腔淋巴结转移相关(P < 0.05),但HER2阳性组肿瘤bbb3 cm、多灶性、T3期、高级别肿瘤、盆腔淋巴结转移的比例高于HER2阴性组(P < 0.05)。在GC组中,随访期间发现56例复发(67.5%),中位RFS为19.0个月(95% CI: 10.3-27.7);同时,发生22例死亡(52.4%),中位OS为56.0个月(95% CI: 45.7-66.3)。在RC48-ADC组中,随访期间有15例复发(35.7%),中位RFS未达到;死亡2例(4.8%),中位生存期未达到。RC48-ADC组的不良反应发生率均低于GC治疗组。结论:本研究证实,ctturt联合RC48-ADC治疗her2阳性MIBC在RFS和OS方面优于联合GC治疗,是一种有效的MIBC患者膀胱保留的治疗方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Biological Procedures Online
Biological Procedures Online 生物-生化研究方法
CiteScore
10.50
自引率
0.00%
发文量
16
审稿时长
>12 weeks
期刊介绍: iological Procedures Online publishes articles that improve access to techniques and methods in the medical and biological sciences. We are also interested in short but important research discoveries, such as new animal disease models. Topics of interest include, but are not limited to: Reports of new research techniques and applications of existing techniques Technical analyses of research techniques and published reports Validity analyses of research methods and approaches to judging the validity of research reports Application of common research methods Reviews of existing techniques Novel/important product information Biological Procedures Online places emphasis on multidisciplinary approaches that integrate methodologies from medicine, biology, chemistry, imaging, engineering, bioinformatics, computer science, and systems analysis.
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