Therapeutic advances in medical oncology · 2025
Efficacy and safety of a novel treatment scheme of RC48-ADC plus PD-1 inhibitors in metastatic urothelial carcinoma: a multicenter real-world study.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lin Jun, Bai Junjie, Li Xiaoyan, Wen Yaoan, Ye Yuzhong, Chen Shaoyuan, Chen Huijun, Qiu Qianyi, Huang Jianjia, Ye Yushi, Liu Rong, Kang Deyong, Chen Ru, Lu Qing, Su Yiming, Zhang Weiping, Wei Yongbao, Zhu Shaoxing, Chen Jianhui
Аннотация
BACKGROUND: Metastatic urothelial carcinoma (mUC) remains a challenging malignancy with limited treatment options. The combination of RC48 (Disitamab Vedotin) plus programmed cell death protein 1 (PD-1) inhibitor represents a promising therapeutic strategy.
OBJECTIVES: To evaluate the efficacy and safety of RC48 plus PD-1 inhibitors as first-line therapy for mUC in real-world practice.
DESIGN: A multicenter, retrospective cohort study.
METHODS: We retrospectively collected data from mUC patients who received RC48 plus PD-1 inhibitors as first-line therapy between July 2021 and February 2024 from three medical centers. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) were calculated to evaluate the clinical efficacy. Treatment-related adverse events (TRAEs) were analyzed to assess the safety profiles.
RESULTS: A total of 63 patients with mUC were included, with a mean age of 67 years, and 71.4% were male. The most frequent metastatic sites were lymph nodes (77.8%), followed by the lung (31.7%), bone (23.8%), liver (19.0%), and others. The treatment response rates were as follows: 12 patients (19.0%) achieved a complete response, 33 patients (52.4%) had a partial response, and 10 patients (15.9%) experienced stable disease. The ORR was 71.4%, and the DCR was 87.3%. The median PFS was 10.5 months (95% confidence interval: 8.8-14.6 months), and the median OS was not reached. The most common TRAEs included fatigue (36.5%), anemia (34.9%), pruritus (33.3%), peripheral sensory neuropathy (28.6%), and nausea (28.6%). Grade III TRAEs occurred in seven patients (11.1%), and no Grade IV or V TRAEs were observed.
CONCLUSION: The combination of RC48 and PD-1 inhibitors administered in 3-week cycles demonstrates efficacy and manageable safety as first-line therapy for mUC patients in a real-world setting.
OBJECTIVES: To evaluate the efficacy and safety of RC48 plus PD-1 inhibitors as first-line therapy for mUC in real-world practice.
DESIGN: A multicenter, retrospective cohort study.
METHODS: We retrospectively collected data from mUC patients who received RC48 plus PD-1 inhibitors as first-line therapy between July 2021 and February 2024 from three medical centers. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) were calculated to evaluate the clinical efficacy. Treatment-related adverse events (TRAEs) were analyzed to assess the safety profiles.
RESULTS: A total of 63 patients with mUC were included, with a mean age of 67 years, and 71.4% were male. The most frequent metastatic sites were lymph nodes (77.8%), followed by the lung (31.7%), bone (23.8%), liver (19.0%), and others. The treatment response rates were as follows: 12 patients (19.0%) achieved a complete response, 33 patients (52.4%) had a partial response, and 10 patients (15.9%) experienced stable disease. The ORR was 71.4%, and the DCR was 87.3%. The median PFS was 10.5 months (95% confidence interval: 8.8-14.6 months), and the median OS was not reached. The most common TRAEs included fatigue (36.5%), anemia (34.9%), pruritus (33.3%), peripheral sensory neuropathy (28.6%), and nausea (28.6%). Grade III TRAEs occurred in seven patients (11.1%), and no Grade IV or V TRAEs were observed.
CONCLUSION: The combination of RC48 and PD-1 inhibitors administered in 3-week cycles demonstrates efficacy and manageable safety as first-line therapy for mUC patients in a real-world setting.