Cathomas R, Lorch A, Bruins HM, Compérat EM, Cowan NC, Efstathiou JA, Fietkau R, Gakis G, Hernández V, Espinós EL, et al. The 2021 updated European association of urology guidelines on metastatic urothelial carcinoma. Eur Urol. 2022;81(1):95–103.

Article  PubMed  Google Scholar 

Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017;389(10064):67–76.

Article  CAS  PubMed  Google Scholar 

De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Gil T, Marreaud S, Daugaard G, Skoneczna I, et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for Cisplatin-Based chemotherapy: EORTC study 30986. J Clin Oncol. 2011;30(2):191–9.

Article  PubMed  PubMed Central  Google Scholar 

Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, et al. Enfortumab Vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med. 2024;390(10):875–88.

Article  CAS  PubMed  Google Scholar 

Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Fléchon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, et al. TROPHY-U-01: a phase II open-label study of sacituzumab Govitecan in patients with metastatic urothelial carcinoma progressing after Platinu m-Based chemotherapy and checkpoint inhibitors. Off J Am Societ Y Clin Oncol. 2021;39(22):2474–85.

Article  CAS  Google Scholar 

Deeks ED. Disitamab vedotin: first approval. Drugs. 2021;81(16):1929–35.

Article  CAS  PubMed  Google Scholar 

Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, et al. Open-label, multicenter, phase II study of RC48-ADC, a HER2-Targeting Antibody–Drug conjugate, in patients with locally advanced or metastatic urothelial carcinoma. Clin Cancer Res. 2021;27(1):43–51.

Article  CAS  PubMed  Google Scholar 

Sheng X, Wang L, He Z, Shi Y, Luo H, Han W, Yao X, Shi B, Liu J, Hu C, et al. Efficacy and safety of disitamab Vedotin in patients with human epidermal growth factor receptor 2–Positive locally advanced or metastatic urothelial carcinoma: A combined analysis of two phase II clinical trials. J Clin Oncol. 2023;42:1391.

Article  PubMed  Google Scholar 

Powles T, Yu EY, Iyer G, Campbell MT, Loriot Y, De Santis M, O’Donnell PH, Burgess EF, Necchi A, Krieger LEM, et al. Phase 2 clinical study evaluating the efficacy and safety of disitamab Vedotin with or without pembrolizumab in patients with HER2-expressing urothelial carcinoma (RC48G001). J Clin Oncol. 2023;41(6suppl):TPS594–594.

Article  Google Scholar 

Xu Z, Ma J, Chen T, Yang Y. Case report: the remarkable response of pembrolizumab combined with RC48 in the third-line treatment of metastatic urothelial carcinoma. Front Immunol. 2022;13:978266.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Wei Y, Zhang R, Yu C, Hong Z, Lin L, Li T, Chen J. Disitamab Vedotin in combination with immune checkpoint inhibitors for locally and locally advanced bladder urothelial carcinoma: a two-center’s real-world study. Front Pharmacol. 2023;14:1230395.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Dumontet C, Reichert JM, Senter PD, Lambert JM, Beck A. Antibody–drug conjugates come of age in oncology. Nat Rev Drug Discovery. 2023;22(8):641–61.

Article  CAS  PubMed  Google Scholar 

Kartolo A, Robinson A, Vera Badillo FE. Can oncogenic driver alterations be responsible for the lack of immunotherapy efficacy in First-line advanced urothelial carcinoma?? Eur Urol. 2023;83(1):1–2.

Article  CAS  PubMed  Google Scholar 

Nadal R, Valderrama BP, Bellmunt J. Progress in systemic therapy for advanced-stage urothelial carcinoma. Nat Reviews Clin Oncol. 2024;21(1):8–27.

Article  CAS  Google Scholar 

Schwartz LH, Litière S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, et al. RECIST 1.1-Update and clarification: from the RECIST committee. Eur J Cancer. 2016;62:132–7.

Article  PubMed  PubMed Central  Google Scholar 

Zhou L, Shao Z, Liu Y, Yan X, Li J, Wu X, Tang B, Li S, Cui C, Chi Z, et al. HER2 expression associated with clinical characteristics and prognosis of urothelial carcinoma in a Chinese population. Oncologist. 2023;28(8):e617–24.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Garrido C, Manoogian M, Ghambire D, Lucas S, Karnoub M, Olson MT, Hicks DG, Tozbikian G, Prat A, Ueno NT, et al. Analytical and clinical validation of PATHWAY Anti-HER-2/neu (4B5) antibody to assess HER2-low status for trastuzumab Deruxtecan treatment in breast cancer. Virchows Arch. 2024;484(6):1005–14.

Article  CAS  PubMed  Google Scholar 

Wolff AC, Somerfield MR, Dowsett M, Hammond MEH, Hayes DF, McShane LM, Saphner TJ, Spears PA, Allison KH. Human epidermal growth factor receptor 2 testing in breast cancer: ASCO-College of American pathologists guideline update. J Clin Oncol. 2023;41(22):3867–72.

Article  CAS  PubMed  Google Scholar 

Tai S, Xu DD, Yu Z, Guan Y, Yin S, Xiao J, Xue S, Liang C. Genomic profiles of renal cell carcinoma in a small Chinese cohort. Front Oncol. 2023;13:1095775.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Fang B, Wei Y, Zeng H, Li Y, Chen S, Zhang T, Pan J, Wang B, Wu J, Jin S, et al. Prevalence of mismatch repair genes mutations and clinical activity of PD-1 therapy in Chinese prostate cancer patients. Cancer Immunol Immunother. 2023;72(6):1541–51.

Article  CAS  PubMed  Google Scholar 

Sha D, Jin Z, Budczies J, Kluck K, Stenzinger A, Sinicrope FA. Tumor mutational burden as a predictive biomarker in solid tumors. Cancer Discov. 2020;10(12):1808–25.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Apolo AB, Ostrovnaya I, Halabi S, Iasonos A, Philips GK, Rosenberg JE, Riches J, Small EJ, Milowsky MI, Bajorin DF. Prognostic model for predicting survival of patients with metastatic urothelial cancer treated with cisplatin-based chemotherapy. J Natl Cancer Inst. 2013;105(7):499–503.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zegard A, Okafor O, de Bono J, Kalla M, Lencioni M, Marshall H, Hudsmith L, Qiu T, Steeds R, Stegemann B, et al. Myocardial fibrosis as a predictor of sudden death in patients with coronary artery disease. J Am Coll Cardiol. 2021;77(1):29–41.

Article  PubMed  Google Scholar 

Firth D. Bias reduction of maximum likelihood estimates. Biometrika. 1993;80(1):27–38.

Article  Google Scholar 

Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17(8):857–72.

Article  CAS  PubMed  Google Scholar 

Kim ES, Velcheti V, Mekhail T, Yun C, Shagan SM, Hu S, Chae YK, Leal TA, Dowell JE, Tsai ML, et al. Blood-based tumor mutational burden as a biomarker for Atezolizumab in non-small cell lung cancer: the phase 2 B-F1RST trial. Nat Med. 2022;28(5):939–45.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Maguire WF, Lee D, Weinstock C, Gao X, Bulik CC, Agrawal S, Chang E, Hamed SS, Bloomquist EW, Tang S, et al. FDA approval summary: enfortumab Vedotin plus pembrolizumab for Cisplatin-Ineligible locally advanced or metastatic urothelial carcinoma. Clin Cancer Res. 2011;2024:30.

Google Scholar 

Lei H, Ling Y, Yuan P, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, et al. Assessment of the expression pattern of HER2 and its correlation with HER2-targeting antibody-drug conjugate therapy in urothelial cancer. J Natl Cancer Cent. 2023;3(2):121–8.

PubMed  PubMed Central  Google Scholar 

Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, et al. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019;51(2):202–6.

Article  CAS  PubMed  PubMed Central  Google Scholar