Sung H ， Ferlay J ， Siegel RL ， et al . Global cancer statistics 2020：GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J ] . CA Cancer J Clin ， 2021 ， 71 （ 3 ）： 209 - 249 .

Lenis AT ， Lec PM ， Chamie K ， et al . Bladder cancer：a review [J ] . JAMA ， 2020 ， 324 （ 19 ）： 1980 - 1991 .

Stecca C ， Abdeljalil O ， Sridhar SS . Metastatic urothelial cancer：a rapidly changing treatment landscape [J ] . Ther Adv Med Oncol ， 2021 ， 13 ： 175883592110473 .

Strebhardt K ， Ullrich A . Paul Ehrlich's magic bullet concept：100 years of progress [J ] . Nat Rev Cancer ， 2008 ， 8 （ 6 ）： 473 - 480 .

Khongorzul P ， Ling CJ ， Khan FU ， et al . Antibody-drug conjugates：a comprehensive review [J ] . Mol Cancer Res ， 2020 ， 18 （ 1 ）： 3 - 19 .

Zhao PX ， Zhang YB ， Li WQ ， et al . Recent advances of antibody drug conjugates for clinical applications [J ] . Acta Pharm Sin B ， 2020 ， 10 （ 9 ）： 1589 - 1600 .

Samanta D ， Almo SC . Nectin family of cell-adhesion molecules：structural and molecular aspects of function and specificity [J ] . Cell Mol Life Sci ， 2015 ， 72 （ 4 ）： 645 - 658 .

Hanna KS . Clinical overview of enfortumab vedotin in the management of locally advanced or metastatic urothelial carcinoma [J ] . Drugs ， 2020 ， 80 （ 1 ）： 1 - 7 .

FDA . FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer [EB/OL ] . ( 2019-12-19 ) [ 2022-02-26 ] . https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-metastatic-urothelial-cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-metastatic-urothelial-cancer .

Rosenberg JE ， O'Donnell PH ， Balar AV ， et al . Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy [J ] . J Clin Oncol ， 2019 ， 37 （ 29 ）： 2592 - 2600 .

Goldberg H . ESMO Virtual Congress 2020: Long-term results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer in the EV-201 study in patients previously treated with platinum and PD-1/PD-L1 inhibitors [EB/OL ] . ( 2021-06-25 ) [ 2022-02-25 ] . https://www.urotoday.com/conference-highlights/esmo-2020/bladder- https://www.urotoday.com/conference-highlights/esmo-2020/bladder- cancer/124501-esmo-virtual-congress-2020-long-term-results-of-enfortumab-vedotin-monotherapy-for-locally-advanced-or-metastatic-urothelial-cancer-in-the-ev-201-study-in-patients-previously-treated-with-platinum-and-pd-1-pd-l1 -inhibitors .html.

Yu EY ， Petrylak DP ， O'Donnell PH ， et al . Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma（EV‑201）：a multicentre，single-arm，phase 2 trial [J ] . Lancet Oncol ， 2021 ， 22 （ 6 ）： 872 - 882 .

Powles T ， Rosenberg JE ， Sonpavde GP ， et al . Enfortumab vedotin in previously treated advanced urothelial carcinoma [J ] . N Engl J Med ， 2021 ， 384 （ 12 ）： 1125 - 1135 .

SEAGEN . Seattle genetics and astellas announce updated results from phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in combination with immune therapy pembrolizumab as investigational first-line treatment for advanced bladder cancer [EB/OL ] . ( 2020-02-11 ) [ 2022-02-26 ] . https://investor.seagen.com/press-releases/news-details/2020/Seattle-Genetics-and-Astellas-Announce-Updated-Results-from-Phase- https://investor.seagen.com/press-releases/news-details/2020/Seattle-Genetics-and-Astellas-Announce-Updated-Results-from-Phase- 1 b 2 -Trial-of-PADCEV-enfortumab-vedotin-ejfv-in-Combination-with-Immune-Therapy-Pembrolizumab-as-Investigational-First-Line- Treatment-for-Advanced-Bladder-Cancer/default .aspx.

ASTELLAS . Astellas and seattle genetics receive FDA breakthrough therapy designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with pembrolizumab in first-line advanced bladder cancer [EB/OL ] . ( 2020-02-19 ) [ 2022-02-26 ] . https://newsroom.astellas.us/2020-02-19-Astellas-and-Seattle-Genetics-Receive-FDA-Breakthrough- https://newsroom.astellas.us/2020-02-19-Astellas-and-Seattle-Genetics-Receive-FDA-Breakthrough- ough-Therapy-Designation-for-PADCEV-TM-enfortumab-vedotin-ejfv-in-Combination-with-Pembrolizumab-in-First-Line-Advanced-Bladder-Cancer.

Daniel PTW , Nataliya MAR . ASCO GU 2022: study EV-103 cohort H: antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with MIBC who are cisplatin ineligible [EB/OL ] . ( 2022-01-19 ) [ 2022-03-16 ] . https://www.urotoday.com/conference-highlights/asco-gu-2022/asco-gu-2022-bladder-cancer/135463-asco-gu-2022-study-ev-103-cohort-h-antitumor-activity-of-neoadjuvant- treatment-with-enfortumab-vedotin-monotherapy-in-patients-with-mibc-who-are-cisplatin-ineligible.html https://www.urotoday.com/conference-highlights/asco-gu-2022/asco-gu-2022-bladder-cancer/135463-asco-gu-2022-study-ev-103-cohort-h-antitumor-activity-of-neoadjuvant-treatment-with-enfortumab-vedotin-monotherapy-in-patients-with-mibc-who-are-cisplatin-ineligible.html .

Gutierrez C ， Schiff R . HER2：biology，detection，and clinical implications [J ] . Arch Pathol Lab Med ， 2011 ， 135 （ 1 ）： 55 - 62 .

Zhao JJ ， Xu WD ， Zhang ZS ， et al . Prognostic role of HER2 expression in bladder cancer：a systematic review and Meta-analysis [J ] . Int Urol Nephrol ， 2015 ， 47 （ 1 ）： 87 - 94 .

中国抗癌协会肿瘤病理专业委员会 ， 中国临床肿瘤学会尿路上皮癌专家委员会 . 中国尿路上皮癌人表皮生长因子受体2检测临床病理专家共识 [J ] . 中华肿瘤杂志 ， 2021 ， 43 （ 10 ）： 1001 - 1006 .

Tumor Pathology Committee of Chinese Anti-Cancer Association ， Expert Committee on Urothelial Carcinoma of Chinese Society of Clinical Oncology . Clinical pathological expert consensus on HER-2 testing in urothelial carcinoma in China [J ] . Chin J Oncol ， 2021 ， 43 （ 10 ）： 1001 - 1006 .

Peddi PF ， Hurvitz SA . Trastuzumab emtansine：the first targeted chemotherapy for treatment of breast cancer [J ] . Future Oncol ， 2013 ， 9 （ 3 ）： 319 - 326 .

von Minckwitz G ， Huang CS ， Mano MS ， et al . Trastuzumab emtansine for residual invasive HER2-positive breast cancer [J ] . N Engl J Med ， 2019 ， 380 （ 7 ）： 617 - 628 .

Li BT ， Makker V ， Buonocore DJ ， et al . A multi-histology basket trial of ado-trastuzumab emtansine in patients with HER2 amplified cancers [J ] . J Clin Oncol ， 2018 ， 36 （ 15_suppl ）： 2502 .

CLINICALTRIALS . GOV . A study to determine best tumor response with trastuzumab emtansine in human epidermal growth factor receptor 2 (HER2) overexpressing solid tumors (KAMELEON)[EB/OL ] . ( 2019-08-28 ) [ 2022-02-28 ] . https://clinicaltrials.gov/ct2/show/results/NCT02999672?term=NCT02999672&draw=2&rank=1 https://clinicaltrials.gov/ct2/show/results/NCT02999672?term=NCT02999672&draw=2&rank=1 .

Ogitani Y ， Aida T ， Hagihara K ， et al . DS-8201a，A novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor，demonstrates a promising antitumor efficacy with differentiation from T-DM1 [J ] . Clin Cancer Res ， 2016 ， 22 （ 20 ）： 5097 - 5108 .

Ogitani Y ， Hagihara K ， Oitate M ， et al . Bystander killing effect of DS-8201a，a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate，in tumors with human epidermal growth factor receptor 2 heterogeneity [J ] . Cancer Sci ， 2016 ， 107 （ 7 ）： 1039 - 1046 .

Modi SN ， Saura C ， Yamashita T ， et al . Trastuzumab deruxtecan in previously treated HER2-positive breast cancer [J ] . N Engl J Med ， 2020 ， 382 （ 7 ）： 610 - 621 .

Iwata TN ， Ishii C ， Ishida S ， et al . A HER2-targeting antibody-drug conjugate，trastuzumab deruxtecan （DS-8201a），enhances antitumor immunity in a mouse model [J ] . Mol Cancer Ther ， 2018 ， 17 （ 7 ）： 1494 - 1503 .

CLINICALTRIALS . GOV . Trastuzumab deruxtecan with nivolumab in advanced breast and urothelial cancer[EB/OL ] . ( 2021-08-12 ) [ 2022-04-12 ] . https://clinicaltrials.gov/ct2/show/NCT03523572?term=NCT03523572&draw=1&rank=1 https://clinicaltrials.gov/ct2/show/NCT03523572?term=NCT03523572&draw=1&rank=1 .

Xu YY ， Wang YK ， Gong JF ， et al . Phase I study of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors [J ] . Gastric Cancer ， 2021 ， 24 （ 4 ）： 913 - 925 .

Sheng XN ， Yan XQ ， Wang L ， 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 [J ] . Clin Cancer Res ， 2021 ， 27 （ 1 ）： 43 - 51 .

Cubas R ， Zhang S ， Li M ， et al . Trop2 expression contributes to tumor pathogenesis by activating the ERK MAPK pathway [J ] . Mol Cancer ， 2010 ， 9 ： 253 .

Syed YY . Sacituzumab govitecan：first approval [J ] . Drugs ， 2020 ， 80 （ 10 ）： 1019 - 1025 .

Pommier Y . Topoisomerase I inhibitors：camptothecins and beyond [J ] . Nat Rev Cancer ， 2006 ， 6 （ 10 ）： 789 - 802 .

FDA . FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer [EB/OL ] . ( 2021-04-13 ) [ 2022-02-26 ] . https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer .

Tagawa ST ， Balar AV ， Petrylak DP ， et al . TROPHY-U-01：a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors [J ] . J Clin Oncol ， 2021 ， 39 （ 22 ）： 2474 - 2485 .

Petros Grivas DP , Chandler H. PARK . ASCO GU 2022: TROPHY-U-01 Cohort 3: sacituzumab govitecan in combination with pembrolizumab in patients with metastatic urothelial cancer who progressed after platinum-based regimens [EB/OL ] . ( 2022-02-18 ) [ 2022-03-21 ] . https://www.urotoday.com/site-search.html?term=sacituzumab+govitecan+2022 https://www.urotoday.com/site-search.html?term=sacituzumab+govitecan+2022 & task=search.query & limitstart= 0 .

CLINICALTRIALS . GOV . Sacituzumab govitecan plus EV in metastatic UC[EB/OL ] . ( 2021-10-15 ) [ 2022-04-12 ] . https://clinicaltrials.gov/ct2/show/NCT04724018?term=NCT04724018&draw=2&rank=1 https://clinicaltrials.gov/ct2/show/NCT04724018?term=NCT04724018&draw=2&rank=1 .

Breij ECW ， de Goeij BECG ， Verploegen S ， et al . An antibody-drug conjugate that targets tissue factor exhibits potent therapeutic activity against a broad range of solid tumors [J ] . Cancer Res ， 2014 ， 74 （ 4 ）： 1214 - 1226 .

Markham A . Tisotumab vedotin：first approval [J ] . Drugs ， 2021 ， 81 （ 18 ）： 2141 - 2147 .

de Bono JS ， Concin N ， Hong DS ， et al . Tisotumab vedotin in patients with advanced or metastatic solid tumours（InnovaTV 201）：a first-in-human，multicentre，phase 1-2 trial [J ] . Lancet Oncol ， 2019 ， 20 （ 3 ）： 383 - 393 .

Eyvazi S ， Farajnia S ， Dastmalchi S ， et al . Antibody based EpCAM targeted therapy of cancer，review and update [J ] . Curr Cancer Drug Targets ， 2018 ， 18 （ 9 ）： 857 - 868 .

MacDonald GC ， Rasamoelisolo M ， Entwistle J ， et al . A phase I clinical study of VB4-845：weekly intratumoral administration of an anti-EpCAM recombinant fusion protein in patients with squamous cell carcinoma of the head and neck [J ] . Drug Des Devel Ther ， 2009 ， 2 ： 105 - 114 .

Kowalski M ， Entwistle J ， Cizeau J ， et al . A Phase I study of an intravesically administered immunotoxin targeting EpCAM for the treatment of nonmuscle-invasive bladder cancer in BCGrefractory and BCG-intolerant patients [J ] . Drug Des Devel Ther ， 2010 ， 4 ： 313 - 320 .

Kowalski M ， Guindon J ， Brazas L ， et al . A phase II study of oportuzumab monatox：an immunotoxin therapy for patients with noninvasive urothelial carcinoma in situ previously treated with Bacillus calmette-guérin [J ] . J Urol ， 2012 ， 188 （ 5 ）： 1712 - 1718 .

Dickstein R ， Wu N ， Cowan B ， et al . phase 3 trial of vicinium, an epcam-targeted pseudomonas exotoxin，in BCGunresponsive non-muscle invasive bladder cancer [EB/OL ] . ( 2018-03-20 ) [ 2022-03-16 ] . https://sesenbio.com/wp-content/uploads/2019/01/BLADDR_Congress_2018_Posterl.pdf https://sesenbio.com/wp-content/uploads/2019/01/BLADDR_Congress_2018_Posterl.pdf .

Deininger S ， Törzsök P ， Mitterberger M ， et al . From interferon to checkpoint inhibition therapy-a systematic review of new immune-modulating agents in Bacillus calmette-guérin（BCG） refractory non-muscle-invasive bladder cancer（NMIBC） [J ] . Cancers ， 2022 ， 14 （ 3 ）： 694 .

GERSHMAN J . FDA Denies vicineum approval for non-muscle invasive bladder cancer [EB/OL ] . ( 2021-09-01 ) [ 2022-04-12 ] . https://www.managedhealthcareexecutive.com/view/approval-of-vicineum-for-bladder-cancer-denied https://www.managedhealthcareexecutive.com/view/approval-of-vicineum-for-bladder-cancer-denied .

宋洪彬 ， 刘冬连 ， 李鹏飞 ， 等 . 抗体偶联药物发展与进展 [J ] . 药学学报 ， 2019 ， 54 （ 10 ）： 1810 - 1817 .

Song HB ， Liu DL ， Li PF ， et al . Advanced research and technology development of antibody-drug conjugates [J ] . Acta Pharm Sin ， 2019 ， 54 （ 10 ）： 1810 - 1817 .