Treatment Options for Metastatic Urothelial Carcinoma After First-Line Chemotherapy

References

• Takahara T, Murase Y, Tsuzuki T, et al. Urothelial carcinoma: variant histology, molecular subtyping, and immunophenotyping significant for treatment outcomes. Pathology. 2021;53(1):56–66. doi:10.1016/j.pathol.2020.09.004
   PubMed Web of Science ®Google Scholar
• Rouprêt M, Babjuk M, Compérat E, et al. European association of urology guidelines on upper urinary tract urothelial carcinoma: 2017 update. Eur Urol. 2018;73(1):111–122. doi:10.1016/j.eururo.2017.07.036
   PubMed Web of Science ®Google Scholar
• 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. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660
   PubMed Web of Science ®Google Scholar
• Lenis AT, Lec MP, Chamie K, et al. Bladder cancer: a review. JAMA. 2020;324(19):1980–1991. doi:10.1001/jama.2020.17598
   PubMed Web of Science ®Google Scholar
• Von der Maase H, Sengelov L, Roberts JT, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23(21):4602–4608. doi:10.1200/JCO.2005.07.757
   PubMed Web of Science ®Google Scholar
• Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383(13):1218–1230. doi:10.1056/NEJMoa2002788
   PubMed Web of Science ®Google Scholar
• Bellmunt J, Théodore C, Demkov T, et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol. 2009;27(27):4454–4461. doi:10.1200/JCO.2008.20.5534
   PubMed Web of Science ®Google Scholar
• Vaughn DJ, Manola J, Dreicer R, et al. Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896): a trial of the Eastern Cooperative Oncology Group. Cancer. 2002;95(5):1022–1027. doi:10.1002/cncr.10782
   PubMed Web of Science ®Google Scholar
• McCaffrey JA, Hilton S, Mazumdar M, et al. Phase II trial of docetaxel in patients with advanced or metastatic transitional-cell carcinoma. J Clin Oncol. 1997;15(5):1853–1857. doi:10.1200/JCO.1997.15.5.1853
   PubMed Web of Science ®Google Scholar
• Han KS, Joung JY, Kim TS, et al. Methotrexate, vinblastine, doxorubicin and cisplatin combination regimen as salvage chemotherapy for patients with advanced or metastatic transitional cell carcinoma after failure of gemcitabine and cisplatin chemotherapy. Br J Cancer. 2008;98(1):86–90. doi:10.1038/sj.bjc.6604113
   PubMed Web of Science ®Google Scholar
• Albers P, Park S-I, Niegisch G, et al. Randomized phase III trial of 2nd line gemcitabine and paclitaxel chemotherapy in patients with advanced bladder cancer: short-term versus prolonged treatment [German Association of Urological Oncology (AUO) trial AB 20/99]. Ann Oncol. 2011;22(2):288–294. doi:10.1093/annonc/mdq398
   PubMed Web of Science ®Google Scholar
• Mollica V, Rizzo A, Montironi R, et al. Current strategies and novel therapeutic approaches for metastatic urothelial carcinoma. Cancers. 2020;12(6):1449. doi:10.3390/cancers12061449
   PubMed Web of Science ®Google Scholar
• Galsky MD, Hahn NM, Rosenberg JE, et al. Defining “cisplatin ineligible” patients with metastatic bladder cancer. J Clin Oncol. 2011;29(7_suppl):238. doi:10.1200/JCO.2011.34.8433
   Web of Science ®Google Scholar
• De Santis M, Bellmunt J, Mead G, 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. 2012;30(2):191–199. doi:10.1200/JCO.2011.37.3571
   PubMed Web of Science ®Google Scholar
• Samstein RM, Lee CH, Shoushtari AN, et al. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019;51(2):202–206. doi:10.1038/s41588-018-0312-8
   PubMed Web of Science ®Google Scholar
• Farina MS, Lundgren KT, Bellmunt J, et al. Immunotherapy in Urothelial Cancer: recent Results and Future Perspectives. Drugs. 2017;77(10):1077–1089. doi:10.1007/s40265-017-0748-7
   PubMed Web of Science ®Google Scholar
• Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, Phase 2 study. Lancet Oncol. 2017;18(11):1483–1492. doi:10.1016/S1470-2045(17)30616-2
   PubMed Web of Science ®Google Scholar
• Vuky J, Balar AV, Castellano D, et al. Long-term outcomes in KEYNOTE-052: phase II study investigating first-line pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. J Clin Oncol. 2020;38(23):2658–2666. doi:10.1200/JCO.19.01213
   PubMed Web of Science ®Google Scholar
• Balar AV, Galsky MD, Rosenberg JE, 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. doi:10.1016/S0140-6736(16)32455-2
   PubMed Web of Science ®Google Scholar
• Vaddepally RK, Kharel P, Pandey R, et al. Review of indications of FDA-approved immune checkpoint inhibitors per NCCN guidelines with the level of evidence. Cancers. 2020;12(3):738. doi:10.3390/cancers12030738
   PubMed Web of Science ®Google Scholar
• Emens LA, Middleton G. The interplay of immunotherapy and chemotherapy: harnessing potential synergies. Cancer Immunol Res. 2015;3(5):436–443. doi:10.1158/2326-6066.CIR-15-0064
   PubMed Web of Science ®Google Scholar
• Galsky MD, Arija JÁA, Bamias A, et al. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10236):1547–1557. doi:10.1016/S0140-6736(20)30230-0
   PubMed Web of Science ®Google Scholar
• Powles T, Csőszi T, Özgüroğlu M, et al. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(7):931–945. doi:10.1016/S1470-2045(21)00152-2
   PubMed Web of Science ®Google Scholar
• Powles T, van der Heijden MS, Castellano D, et al. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (Danube): a randomised, open-label, multicentre, phase 3 trial [published correction appears in Lancet Oncol 2021; 22: e5]. Lancet Oncol. 2020;21(12):1574–1588. doi:10.1016/S1470-2045(20)30541-6
   PubMed Web of Science ®Google Scholar
• Christopher JDW. First-line pembrolizumab with or without lenvatinib in patients with advanced urothelial carcinoma (LEAP-011): a Phase 3, randomized, double-blind study. Abstract from the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19; 2022.
   Google Scholar
• Powles T, Park SH, Voog E, et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): long-term follow-up results from the JAVELIN bladder 100 trial. J Clin Oncol. 2022;40(6_suppl):487. doi:10.1200/JCO.2022.40.6_suppl.487
   Web of Science ®Google Scholar
• Nakanishi J, Wada Y, Matsumoto K, et al. Overexpression of B7-H1 (PD-L1) significantly associates with tumor grade and postoperative prognosis in human urothelial cancers. Cancer Immunol Immunother. 2007;56(8):1173–1182. PMID: 17186290. doi:10.1007/s00262-006-0266-z
   PubMed Web of Science ®Google Scholar
• Lopez-Beltran A, Cimadamore A, Blanca A, et al. Immune checkpoint inhibitors for the treatment of bladder cancer. Cancers. 2021;13(1):131. doi:10.3390/cancers13010131
   PubMed Web of Science ®Google Scholar
• Bellmunt J, De Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376(11):1015–1026. PMID: 28212060; PMCID: PMC5635424. doi:10.1056/NEJMoa1613683
   PubMed Web of Science ®Google Scholar
• Van der Heijden MS, Loriot Y, Durán I, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma: a long-term overall survival and safety update from the Phase 3 IMvigor211 clinical trial. Eur Urol. 2021;80(1):7–11. PMID: 33902955. doi:10.1016/j.eururo.2021.03.024
   PubMed Web of Science ®Google Scholar
• Bellmunt J, Necchi A, De Wit R, et al. Pembrolizumab (pembro) versus investigator’s choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC): 5-year follow-up from the phase 3 KEYNOTE-045 trial. J Clin Oncol. 2021;39(15_suppl):4532. doi:10.1200/JCO.2021.39.15_suppl.4532
   Web of Science ®Google Scholar
• Powles T, Durán I, Van der Heijden MS, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018;391(10122):748–757. Erratum in: Lancet. 2018 Oct 20;392(10156):1402. PMID: 29268948. doi:10.1016/S0140-6736(17)33297-X
   PubMed Web of Science ®Google Scholar
• Sternberg CN, Loriot Y, James N, et al. Primary results from SAUL, a multinational single-arm safety study of atezolizumab therapy for locally advanced or metastatic urothelial or nonurothelial carcinoma of the urinary tract. Eur Urol. 2019;76(1):73–81. PMID: 30910346. doi:10.1016/j.eururo.2019.03.015
   PubMed Web of Science ®Google Scholar
• Tural D, Ölmez ÖF, Sümbül AT, et al. Atezolizumab in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy: results of real-life experiences. Eur Urol Focus. 2021;7(5):1061–1066. doi:10.1016/j.euf.2020.09.010
   PubMedGoogle Scholar
• Tural D, Ölmez ÖF, Sümbül AT, et al. Prognostic factors in patients with metastatic urothelial carcinoma who have treated with Atezolizumab. Int J Clin Oncol. 2021;26(8):1506–1513. doi:10.1007/s10147-021-01936-6
   PubMed Web of Science ®Google Scholar
• Tural D, Selçukbiricik F, Ölmez ÖF, et al. Response to first-line chemotherapy regimen is associated with efficacy of ımmune checkpoint blockade therapies in patients with metastatic urothelial carcinoma. Int J Clin Oncol. 2022;27(3):585–591. doi:10.1007/s10147-021-02072-x
   PubMed Web of Science ®Google Scholar
• Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017;18(3):312–322. PMID: 28131785. doi:10.1016/S1470-2045(17)30065-7
   PubMed Web of Science ®Google Scholar
• Galsky MD, Saci A, Szabo PM, et al. Nivolumab in patients with advanced platinum-resistant urothelial carcinoma: efficacy, safety, and biomarker analyses with extended follow-up from CheckMate 275. Clin Cancer Res. 2020;26(19):5120–5128. PMID: 32532789; PMCID: PMC8166422. doi:10.1158/1078-0432.CCR-19-4162
   PubMed Web of Science ®Google Scholar
• Powles T, O’Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a Phase 1/2 open-label study. JAMA Oncol. 2017;3(9):e172411. PMID: 28817753; PMCID: PMC5824288. doi:10.1001/jamaoncol.2017.2411
   PubMed Web of Science ®Google Scholar
• Patel MR, Ellerton J, Infante JR, et al. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2018;19(1):51–64. Erratum in: Lancet Oncol. 2018;19(7):e335. PMID: 29217288; PMCID: PMC7984727. doi:10.1016/S1470-2045(17)30900-2
   PubMed Web of Science ®Google Scholar
• Kamoun A, de Reyniès A, Allory Y, et al. A consensus molecular classification of muscle-invasive bladder cancer. Eur Urol. 2020;77(4):420–433. PMID: 31563503; PMCID: PMC7690647. doi:10.1016/j.eururo.2019.09.006
   PubMed Web of Science ®Google Scholar
• Loriot Y, Necchi A, Park SH, et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N Engl J Med. 2019;381(4):338–348. PMID: 31340094. doi:10.1056/NEJMoa1817323
   PubMed Web of Science ®Google Scholar
• Stecca C, Abdeljalil O, Sridhar SS. Metastatic urothelial cancer: a rapidly changing treatment landscape. Ther Adv Med Oncol. 2021;13:17588359211047352. PMID: 34616491; PMCID: PMC8488509. doi:10.1177/17588359211047352
   Web of Science ®Google Scholar
• 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. Lancet Oncol. 2021;22(6):872–882. Erratum in: Lancet Oncol.P21;22(6):e239. PMID: 33991512. doi:10.1016/S1470-2045(21)00094-2
   PubMed Web of Science ®Google Scholar
• Sharma P, Siefker-Radtke A, de Braud F, et al. Nivolumab alone and with ipilimumab in previously treated metastatic urothelial carcinoma: checkMate 032 nivolumab 1 mg/kg plus ipilimumab 3 mg/kg expansion cohort results. J Clin Oncol. 2019;37(19):1608–1616. Erratum in: J Clin Oncol. 2019 Aug 10;37(23):2094. PMID: 31100038; PMCID: PMC6879315. doi:10.1200/JCO.19.00538
   PubMed Web of Science ®Google Scholar
• MO Grimm, BJ Schmitz-Dräger, U Zimmermann, et al. Tailored immunotherapy approach with nivolumab in advanced transitional cell carcinoma (TITAN-TCC). Abstract from the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19; 2022.
   Google Scholar
• Marandino L, Raggi D, Calareso G, et al. Cabozantinib plus durvalumab in patients with Advanced urothelial carcinoma after platinum chemotherapy: safety and preliminary activity of the open-label, single-arm, Phase 2 ARCADIA trial. Clin Genitourin Cancer. 2021;19(5):457–465. PMID: 34006499. doi:10.1016/j.clgc.2021.04.001
   PubMed Web of Science ®Google Scholar
• Sadeghi S, Quinn DI, Dorffet T, et al. Phase II trial of pembrolizumab (P) in combination with sEphB4-HSA (B4) in previously treated metastatic urothelial carcinoma (mUC). Ann Oncol. 2021;32(5):S678. doi:10.1016/j.annonc.2021.08.047
   PubMed Web of Science ®Google Scholar
• Sheng X, Chen H, Hu B, et al. Safety, efficacy, and biomarker analysis of toripalimab in patients with previously treated advanced urothelial carcinoma: results from a multicenter Phase II trial POLARIS-03. Clin Cancer Res. 2022;28(3):489–497. PMID: 34740921. doi:10.1158/1078-0432.CCR-21-2210
   PubMed Web of Science ®Google Scholar
• Cebada J, Perez-Santos M, Bandala C, et al. OX40 agonists for cancer treatment: a patent review. Expert Opin Ther Pat. 2021;31(1):81–90. doi:10.1080/13543776.2021.1825688
   PubMed Web of Science ®Google Scholar
• Rhode PR, Egan JO, Xu W, et al. Comparison of the superagonist complex, ALT-803, to IL15 as cancer immunotherapeutics in animal models. Cancer Immunol Res. 2016;4(1):49–60. PMID: 26511282; PMCID: PMC4703482. doi:10.1158/2326-6066.CIR-15-0093-T
   PubMed Web of Science ®Google Scholar
• Mollica V, Maggio I, Lopez-Beltran A, et al. Combination therapy in advanced urothelial cancer: the role of PARP, HER-2 and mTOR inhibitors. Expert Rev Anticancer Ther. 2020;20(9):755–763. doi:10.1080/14737140.2020.1807334
   PubMed Web of Science ®Google Scholar
• Quinn DI, Petrylak DP, Bellmunt J, et al. FORT-1: phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression. J Clin Oncol. 2020;38(6_suppl):489. doi:10.1200/JCO.2020.38.6_suppl.489
   Web of Science ®Google Scholar
• Siefker-Radtke AO, Lugowska I, Tupikowski K, et al. Clinical activity of vofatamab (V), an FGFR3 selective antibody in combination with pembrolizumab (P) in metastatic urothelial carcinoma (mUC), updated interim analysis of FIERCE-22. Ann Oncol. 2019;30(suppl_5):v356–v402. doi:10.1093/annonc/mdz249.016
   Google Scholar
• Bouleftour W, Guillot A, Magné N. The anti-nectin 4: a promising tumor cells target. A systematic review [published online ahead of print, 2022 Feb 7]. Mol Cancer Ther. 2022:493–501. doi:10.1158/1535-7163.MCT-21-0846
   PubMed Web of Science ®Google Scholar
• 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 Clin Oncol. 2019;37(29):2592–2600. PMID: 31356140; PMCID: PMC6784850. doi:10.1200/JCO.19.01140
   PubMed Web of Science ®Google Scholar
• Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med. 2021;384(12):1125–1135. PMID: 33577729; PMCID: PMC8450892. doi:10.1056/NEJMoa2035807
   PubMed Web of Science ®Google Scholar
• Goldenberg DM, Stein R, Sharkey RM. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018;9(48):28989–29006. doi:10.18632/oncotarget.25615
   PubMedGoogle Scholar
• 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 Clin Oncol. 2021;39(22):2474–2485. doi:10.1200/JCO.20.03489
   PubMed Web of Science ®Google Scholar
• C Vulsteke, P Grivas, ST Tagawa, et al. TROPiCS-04: study of Sacituzumab govitecan in patients with locally advanced unresectable or metastatic urothelial cancer that has progressed after prior platinum and checkpoint inhibitor therapy. Abstract from the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19; 2022.
   Google Scholar