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Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma 期刊论文 WOS高被引论文

编号：

17525868565883DA1010A2993230FEF1
作者：

Sheng, Xinan#^[1]Yan, Xieqiao^[1];Wang, Lin^[2,3];Shi, Yanxia^[4];Yao, Xin(姚欣)^[5]Luo, Hong^[6,7];Shi, Benkang^[8];Liu, Jiyan^[9,10];He, Zhisong^[11];Yu, Guohua^[12];Ying, Jianming^[3,13];Han, Weiqing^[14];Hu, Changlu^[15];Ling, Yun^[3,13];Chi, Zhihong^[1];Cui, Chuanliang^[1];Si, Lu^[1];Fang, Jianmin^[16,17];Zhou, Aiping*^[2,3]Guo, Jun*^[1]
语种：

英文
期刊：

CLINICAL CANCER RESEARCH ISSN：1078-0432 2021 年 27 卷 1 期 (43 - 51) ; JAN 1
收录：
摘要：

Purpose: To evaluate the efficacy and safety of RC48-ADC, a novel humanized anti-HER2 antibody conjugated with monomethyl auristatin E, in patients with HER2(+) locally advanced or metastatic urothelial carcinoma (mUC) refractory to standard therapies.
Patients and Methods: This was a phase II, open-label, multicenter, single-arm study of patients with HER2(+) (IHC status 3+ or 2+) locally advanced or mUC who previously failed at least one line of systemic chemotherapy. The primary endpoint was the objective response rate (ORR) assessed by a blinded independent review committee (BIRC). The secondary endpoint included progression-free survival (PFS), disease control rate, duration of response, overall survival (OS), and safety.
Results: Forty-three patients were enrolled. The median follow-up was 20.3 months. The overall confirmed ORR as assessed by the BIRC was 51.2% [95% confidence interval (CI), 35.5%-66.7%]. Similar responses were observed in prespecified subgroups, such as those with liver metastasis and those previously treated with anti-programmed cell death 1 (PD-1)/programmed death ligand 1 (PD-L1) therapies. The median PFS and OS were 6.9 months (95% CI, 5.6-8.9) and 13.9 months (95% CI, 9.1-NE), respectively. The most common treatment-related adverse events (TRAE) were hypoesthesia (60.5%), alopecia (55.8%), and leukopenia (55.8%). Twenty-five (58%) patients experienced grade 3 TRAEs, including hypoesthesia (23.3%) and neutropenia (14.0%). No grade 4 or grade 5 TRAEs occurred.
Conclusions: RC48-ADC demonstrated a promising efficacy with a manageable safety profile in patients with HER2(+) locally advanced or mUC who had failed at least one line of systemic chemotherapy.
推荐引用方式
GB/T 7714：

Sheng Xinan,Yan Xieqiao,Wang Lin, et al. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma [J].CLINICAL CANCER RESEARCH,2021,27(1):43-51.
APA：

Sheng Xinan,Yan Xieqiao,Wang Lin,Shi Yanxia,&Guo Jun.(2021).Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma .CLINICAL CANCER RESEARCH,27(1):43-51.
MLA：

Sheng Xinan, et al. "Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma" .CLINICAL CANCER RESEARCH 27,1(2021):43-51.
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