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).
■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)。