Abstract：
OBJECTIVE: RC48 is an antibody-drug conjugate (ADC) that targets HER2. In China, RC48 is approved for patients with HER-2-positive metastatic urothelial carcinoma (mUC) who have failed at least platinum-based chemotherapy. This study aimed to evaluate RC48 for mUC in a cohort of real-world patients.
METHODS: We retrospectively collected data from 103 mUC patients from 12 centers between July 2021 and August 2023 in China. RC48 alone or with immunotherapy was administered until disease progression, intolerable toxicity, death, or other reasons. The objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and incidence of treatment-related adverse events (TRAEs) were evaluated.
RESULTS: The median age of the patients was 68 years, and 68.0% were men. Twenty-nine (28.2%) patients received RC48 alone; 73 (70.9%) received RC48 combination therapy. The response rates were as follows: complete response in 2 (1.9%) patients, partial response in 50 (48.5%) patients, stable disease in 30 (29.1%) patients. The ORR was 50.5%. In patients with ≥80 years, Eastern Cooperative Oncology Group (ECOG) performance status ≥2 and creatinine clearance rate (CCr) <30 mL/min, the ORR was 75%, 48.6%, and 40.0%, respectively. The median PFS was 6 (3.9-8.1) months, and the median OS was not reached. The most reported TRAEs were peripheral sensory neuropathy (53.4%), alopecia (42.7%), asthenia (38.8%), decreased appetite (35.9%) and weight loss (35.9%) and TRAE did not increase in patients with poor condition or impaired renal function.
CONCLUSIONS: Administration of RC48 for real-world patients is both effective and safe. mUC patients can benefit from RC48-based therapy, regardless of their poor condition or impaired renal function.
METHODS: We retrospectively collected data from 103 mUC patients from 12 centers between July 2021 and August 2023 in China. RC48 alone or with immunotherapy was administered until disease progression, intolerable toxicity, death, or other reasons. The objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and incidence of treatment-related adverse events (TRAEs) were evaluated.
RESULTS: The median age of the patients was 68 years, and 68.0% were men. Twenty-nine (28.2%) patients received RC48 alone; 73 (70.9%) received RC48 combination therapy. The response rates were as follows: complete response in 2 (1.9%) patients, partial response in 50 (48.5%) patients, stable disease in 30 (29.1%) patients. The ORR was 50.5%. In patients with ≥80 years, Eastern Cooperative Oncology Group (ECOG) performance status ≥2 and creatinine clearance rate (CCr) <30 mL/min, the ORR was 75%, 48.6%, and 40.0%, respectively. The median PFS was 6 (3.9-8.1) months, and the median OS was not reached. The most reported TRAEs were peripheral sensory neuropathy (53.4%), alopecia (42.7%), asthenia (38.8%), decreased appetite (35.9%) and weight loss (35.9%) and TRAE did not increase in patients with poor condition or impaired renal function.
CONCLUSIONS: Administration of RC48 for real-world patients is both effective and safe. mUC patients can benefit from RC48-based therapy, regardless of their poor condition or impaired renal function.
摘要：
目的：RC48是一种靶向HER2的抗体-药物偶联物（ADC）。在中国,RC48被批准用于HER-2阳性转移性尿路上皮癌（mUC）患者，这些患者至少在基于铂的化疗中失败。本研究旨在评估RC48在真实世界患者队列中的mUC。
方法：我们回顾性收集了2021年7月至2023年8月中国12个中心103例mUC患者的数据。RC48单独或与免疫治疗，直到疾病进展，不能耐受的毒性,死亡,或其他原因。客观反应率(ORR)，无进展生存期（PFS），总生存期（OS），并评估治疗相关不良事件(TRAEs)的发生率.
结果：患者的中位年龄为68岁，68.0%是男性。29例（28.2%）患者单独接受RC48治疗；73例（70.9%）患者接受RC48联合治疗。反应率如下：2例（1.9％）患者完全缓解，50例（48.5%）患者部分缓解，30例（29.1%）患者病情稳定。ORR为50.5%。在≥80岁的患者中，东部肿瘤协作组（ECOG）的表现状态≥2，肌酐清除率（CCr）<30mL/min，ORR是75%,48.6%,和40.0%，分别。中位PFS为6（3.9-8.1）个月，未达到中位OS。报告最多的TRAE是周围感觉神经病变（53.4％），脱发(42.7%)，虚弱(38.8%)，在条件差或肾功能受损的患者中,食欲下降(35.9%)和体重减轻(35.9%)和TRAE没有增加.
结论：对现实世界患者使用RC48既有效又安全。MUC患者可以从基于RC48的治疗中受益，不管他们的条件差或肾功能受损。
方法：我们回顾性收集了2021年7月至2023年8月中国12个中心103例mUC患者的数据。RC48单独或与免疫治疗，直到疾病进展，不能耐受的毒性,死亡,或其他原因。客观反应率(ORR)，无进展生存期（PFS），总生存期（OS），并评估治疗相关不良事件(TRAEs)的发生率.
结果：患者的中位年龄为68岁，68.0%是男性。29例（28.2%）患者单独接受RC48治疗；73例（70.9%）患者接受RC48联合治疗。反应率如下：2例（1.9％）患者完全缓解，50例（48.5%）患者部分缓解，30例（29.1%）患者病情稳定。ORR为50.5%。在≥80岁的患者中，东部肿瘤协作组（ECOG）的表现状态≥2，肌酐清除率（CCr）<30mL/min，ORR是75%,48.6%,和40.0%，分别。中位PFS为6（3.9-8.1）个月，未达到中位OS。报告最多的TRAE是周围感觉神经病变（53.4％），脱发(42.7%)，虚弱(38.8%)，在条件差或肾功能受损的患者中,食欲下降(35.9%)和体重减轻(35.9%)和TRAE没有增加.
结论：对现实世界患者使用RC48既有效又安全。MUC患者可以从基于RC48的治疗中受益，不管他们的条件差或肾功能受损。
