{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T22:44:57Z","timestamp":1789771497424,"version":"4.0.1"},"reference-count":39,"publisher":"Wiley","issue":"23","license":[{"start":{"date-parts":[[2023,11,7]],"date-time":"2023-11-07T00:00:00Z","timestamp":1699315200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Previous RC48 (Disitamab Vedotin) studies established that the safety and efficacy of RC48\u2010antibody\u2013drug conjugate (ADC), either alone or combined with toripalimab, for metastatic urothelial carcinoma (mUC) patients exhibiting human epidermal growth factor receptor 2 (HER2)\u2010positive or even HER2\u2010negative status after standard chemotherapy failure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>With locally advanced or metastatic urothelial carcinoma (la\/mUC), patients who received RC48\u2010ADC monotherapy or a combination with programmed cell death protein 1 (PD\u20101) inhibitors between August 2021 and October 2022 were enrolled in this retrospective observational study to evaluate the real\u2010world antitumor effectiveness and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among the 38 enrolled patients (29 males; median age 67.5\u2009years [38\u201393]), 8 received RC48\u2010ADC monotherapy, while 30 received combination therapy. Initially, 63.2% (24\/38) of the patients had received \u22651 line of prior treatment, and 63.2% (24\/38) had visceral metastasis. UC of the bladder represented the majority type in 68.4% (26\/38) of cases. By the data cutoff in March 2023, the overall objective response rate (ORR) was 63.2% (95% CI, 47.1%\u201379.2%), with a disease control rate (DCR) of 89.5% (95% CI, 79.3%\u201399.7%). Median follow\u2010up time was 10.6\u2009months. The median progression\u2010free survival (PFS) was 8.2\u2009months (95% CI, 5.9\u201310.5), with a 6\u2010month PFS rate of 63.2% and a 12\u2010month PFS rate of 34.1%. Median overall survival (OS) was not reached, with a 12\u2010month OS rate of 76.7%. The median duration of response was 7.3\u2009months (95% CI, 4.6\u201310.0) among 24 patients evaluated as partial response (PR). The most common treatment\u2010related adverse events (TRAEs) included anemia (71.1%), anorexia (57.9%), asthenia (52.6%), hypoesthesia (52.6%), bone marrow suppression (47.4%), alopecia (47.4%), nausea (44.7%), proteinuria (36.8%), vomiting (34.2%), and hypoalbuminemia (31.6%). No patient experienced TRAEs of Grade \u22653. One patient had an immune\u2010related adverse event (irAE) of rash related to toripalimab.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Both as monotherapy and in combination with PD\u20101 inhibitors, RC48\u2010ADC exhibits promising effectiveness and manageable safety profile for mUC patients in real\u2010world settings.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.6680","type":"journal-article","created":{"date-parts":[[2023,11,7]],"date-time":"2023-11-07T23:04:16Z","timestamp":1699398256000},"page":"21159-21171","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Real\u2010world effectiveness and safety of <scp>RC48\u2010ADC<\/scp> alone or in combination with <scp>PD<\/scp>\u20101 inhibitors for patients with locally advanced or metastatic urothelial carcinoma: A multicenter, retrospective clinical study"],"prefix":"10.1002","volume":"12","author":[{"given":"Jingwei","family":"Xu","sequence":"first","affiliation":[{"name":"Department of Oncology The Fifth Affiliated Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongqiao","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Oncology The Fifth Affiliated Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Oncology The Fifth Affiliated Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiufeng","family":"Chu","sequence":"additional","affiliation":[{"name":"Department of Oncology The Fifth Affiliated Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Oncology The Fifth Affiliated Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangyuan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Oncology The Fifth Affiliated Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caiyun","family":"Nie","sequence":"additional","affiliation":[{"name":"Department of Oncology Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meng","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Radiology The First Affiliated Hospital of Zhengzhou University  Zhengzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9817-5612","authenticated-orcid":false,"given":"Yanwei","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Oncology The Fifth Affiliated Hospital of Zhengzhou University  Zhengzhou China"},{"name":"Department of Oncology The Second Affiliated Hospital of The Chinese University of Hong Kong, Shenzhen &amp; Longgang District People's Hospital of Shenzhen  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,11,7]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.07.757"},{"key":"e_1_2_15_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/CM9.0000000000002108"},{"key":"e_1_2_15_4_1","first-page":"1315","article-title":"Temporal trends and projections of bladder cancer burden in China from 1990 to 2030: findings from the global burden of disease study","volume":"14","author":"Zhisheng X","year":"2022","journal-title":"Clin Epidemiol"},{"key":"e_1_2_15_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.38.6979"},{"issue":"3","key":"e_1_2_15_6_1","first-page":"489","article-title":"Safety, efficacy and biomarker analysis of Toripalimab in patients with previously treated advanced urothelial carcinoma: results from a multicenter phase II trial POLARIS\u201003. 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