Abstract：
UNASSIGNED: Sacituzumab govitecan (brand name: TRODELVY®) is a new treatment being studied for people with a type of bladder cancer, called urothelial cancer, that has progressed to a locally advanced or metastatic stage. Locally advanced and metastatic urothelial cancer are usually treated with platinum-based chemotherapy. Metastatic urothelial cancer is also treated with immune checkpoint inhibitors. There are few treatment options for people whose cancer gets worse after receiving these treatments. Sacituzumab govitecan is a suitable treatment option for most people with urothelial cancer because it aims to deliver an anti-cancer drug directly to the cancer in an attempt to limit the potential harmful side effects on healthy cells. This is a summary of a clinical study called TROPHY-U-01, focusing on the first group of participants, referred to as Cohort 1. All participants in Cohort 1 received sacituzumab govitecan.
UNASSIGNED: All participants received previous treatments for their metastatic urothelial cancer, including a platinum-based chemotherapy and a checkpoint inhibitor. The tumor in 31 of 113 participants became significantly smaller or could not be seen on scans after sacituzumab govitecan treatment; an effect that lasted for a median of 7.2 months. Half of the participants were still alive 5.4 months after starting treatment, without their tumor getting bigger or spreading further. Half of them were still alive 10.9 months after starting treatment regardless of tumor size changes. Most participants experienced side effects. These side effects included lower levels of certain types of blood cells, sometimes with a fever, and loose or watery stools (diarrhea). Side effects led 7 of 113 participants to stop taking sacituzumab govitecan.
UNASSIGNED: The study showed that sacituzumab govitecan had significant anti-cancer activity. Though most participants who received sacituzumab govitecan experienced side effects, these did not usually stop participants from continuing sacituzumab govitecan. Doctors can help control these side effects using treatment guidelines, but these side effects can be serious.Clinical Trial Registration: NCT03547973 (ClinicalTrials.gov) (TROPHY-U-1).
UNASSIGNED: All participants received previous treatments for their metastatic urothelial cancer, including a platinum-based chemotherapy and a checkpoint inhibitor. The tumor in 31 of 113 participants became significantly smaller or could not be seen on scans after sacituzumab govitecan treatment; an effect that lasted for a median of 7.2 months. Half of the participants were still alive 5.4 months after starting treatment, without their tumor getting bigger or spreading further. Half of them were still alive 10.9 months after starting treatment regardless of tumor size changes. Most participants experienced side effects. These side effects included lower levels of certain types of blood cells, sometimes with a fever, and loose or watery stools (diarrhea). Side effects led 7 of 113 participants to stop taking sacituzumab govitecan.
UNASSIGNED: The study showed that sacituzumab govitecan had significant anti-cancer activity. Though most participants who received sacituzumab govitecan experienced side effects, these did not usually stop participants from continuing sacituzumab govitecan. Doctors can help control these side effects using treatment guidelines, but these side effects can be serious.Clinical Trial Registration: NCT03547973 (ClinicalTrials.gov) (TROPHY-U-1).
摘要：
■Sacituzumabgovitecan（品牌名称：TRODELVY®）是一种正在研究的膀胱癌患者的新疗法，叫做尿路上皮癌，已经进展到局部晚期或转移阶段。局部晚期和转移性尿路上皮癌通常用铂类化疗治疗。转移性尿路上皮癌也用免疫检查点抑制剂治疗。对于接受这些治疗后癌症恶化的人，几乎没有治疗选择。Sacituzumabgovitecan是大多数尿路上皮癌患者的合适治疗选择，因为它旨在直接向癌症提供抗癌药物，以限制对健康细胞的潜在有害副作用。这是一项名为TROPHY-U-01的临床研究的摘要，重点是第一组参与者，称为队列1。队列1中的所有参与者都接受了sacituzumabgovitecan。
■所有参与者都曾接受过转移性尿路上皮癌的治疗，包括铂类化疗和检查点抑制剂。113名参与者中有31名的肿瘤在sacituzumabgovitecan治疗后变得明显变小或无法在扫描中看到;效果持续了7.2个月的中位数。一半的参与者在开始治疗后5.4个月仍然活着，没有他们的肿瘤变得更大或进一步扩散。无论肿瘤大小如何变化，其中一半在开始治疗后10.9个月仍然存活。大多数参与者都有副作用。这些副作用包括某些类型的血细胞水平降低，有时发烧，和松散或水样的粪便（腹泻）。副作用导致113名参与者中有7名停止服用sacituzumabgovitecan。
■研究表明，sacituzumabgovitecan具有显着的抗癌活性。尽管大多数接受sacituzumabgovitecan的参与者都有副作用，这些通常并不能阻止参与者继续服用sacituzumabgovitecan.医生可以使用治疗指南帮助控制这些副作用，但是这些副作用可能很严重。临床试验注册：NCT03547973（ClinicalTrials.gov）（TROPHY-U-1）。
■所有参与者都曾接受过转移性尿路上皮癌的治疗，包括铂类化疗和检查点抑制剂。113名参与者中有31名的肿瘤在sacituzumabgovitecan治疗后变得明显变小或无法在扫描中看到;效果持续了7.2个月的中位数。一半的参与者在开始治疗后5.4个月仍然活着，没有他们的肿瘤变得更大或进一步扩散。无论肿瘤大小如何变化，其中一半在开始治疗后10.9个月仍然存活。大多数参与者都有副作用。这些副作用包括某些类型的血细胞水平降低，有时发烧，和松散或水样的粪便（腹泻）。副作用导致113名参与者中有7名停止服用sacituzumabgovitecan。
■研究表明，sacituzumabgovitecan具有显着的抗癌活性。尽管大多数接受sacituzumabgovitecan的参与者都有副作用，这些通常并不能阻止参与者继续服用sacituzumabgovitecan.医生可以使用治疗指南帮助控制这些副作用，但是这些副作用可能很严重。临床试验注册：NCT03547973（ClinicalTrials.gov）（TROPHY-U-1）。
