Abstract
Key words
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to UrologyReferences
- Cancer Statistics, 2021.CA Cancer J Clin. 2021; 71: 7-33https://doi.org/10.3322/caac.21654
Flaig TW, Spiess PE, Chair V, et al. NCCN Guidelines Version 2.2022 Bladder Cancer.; 2022. https://www.nccn.org/home/member-
- Treatment of patients with metastatic urothelial cancer “Unfit” for cisplatin-based chemotherapy.Journal of Clinical Oncology. 2011; 29: 2432-2438https://doi.org/10.1200/JCO.2011.34.8433
- Mechanisms of resistance to immune checkpoint inhibitors.Br J Cancer. 2018; 118: 9-16https://doi.org/10.1038/bjc.2017.434
- CTLA-4 and PD-1 pathways similarities, differences, and implications of their inhibition.American Journal of Clinical Oncology: Cancer Clinical Trials. 2016; 39: 98-106https://doi.org/10.1097/COC.0000000000000239
- Neoadjuvant chemotherapy in invasive bladder cancer: Update of a systematic review and meta-analysis of individual patient data.Eur Urol. 2005; 48: 202-206https://doi.org/10.1016/j.eururo.2005.04.006
- Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer.N Engl J Med. 2003; 349: 859-866https://doi.org/10.1056/NEJMoa022148
- Pembrolizumab as neoadjuvant therapy before radical cystectomy in patients with muscle-invasive urothelial bladder carcinoma (PURE-01): An open-label, single-arm, phase II study.Journal of Clinical Oncology. 2018; 36: 3353-3360https://doi.org/10.1200/JCO.18.01148
- Updated Results of PURE-01 with Preliminary Activity of Neoadjuvant Pembrolizumab in Patients with Muscle-invasive Bladder Carcinoma with Variant Histologies.Eur Urol. 2020; 77: 439-446https://doi.org/10.1016/j.eururo.2019.10.026
- Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303.Future Oncology. 2021; 17: 3137-3150https://doi.org/10.2217/fon-2021-0273
- Preoperative CTLA-4 blockade: Tolerability and immune monitoring in the setting of a presurgical clinical trial.Clinical Cancer Research. 2010; 16: 2861-2871https://doi.org/10.1158/1078-0432.CCR-10-0569
- Phase Ib/II Neoadjuvant (N-) Pembrolizumab (P) and Chemotherapy for Locally Advanced Urothelial Cancer (laUC): Final Results from the Cisplatin (C)-eligible Cohort of HCRN GU14-188.J Clin Oncol. 2020; 38 (5047-5047)
- Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy.Journal of Clinical Oncology. 2020; 38 (439-439)https://doi.org/10.1200/JCO.2020.38.6_suppl.439
- Biomarker analysis and updated clinical follow-up from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in patients with muscle-invasive bladder cancer (MIBC) undergoing cystectomy.Journal of Clinical Oncology. 2022; 40 (528-528)https://doi.org/10.1200/JCO.2022.40.6_suppl.528
- Final Results of Neoadjuvant Atezolizumab in Cisplatin-ineligible Patients with Muscle-invasive Urothelial Cancer of the Bladder.Eur Urol. August 1, 2022; (Published online)https://doi.org/10.1016/j.eururo.2022.04.013
- Efficacy of neoadjuvant atezolizumab treatment in patients with advanced urothelial bladder cancer according to the BASQ classification: A study protocol for an open-label, two-cohort, phase II trial.BMJ Open. 2020; 10https://doi.org/10.1136/bmjopen-2019-035530
- Updated results of phase II trial using escalating doses of neoadjuvant atezolizumab for cisplatin-ineligible patients with nonmetastatic urothelial cancer (NCT02451423).Journal of Clinical Oncology. 2021; 39 (e16510-e16510)https://doi.org/10.1200/JCO.2021.39.15_suppl.e16510
- A phase III, randomized, open-label, multicenter, global study of efficacy and safety of durvalumab in combination with gemcitabine plus cisplatin for neoadjuvant treatment followed by durvalumab alone for adjuvant treatment in muscle-invasive bladder cancer (NIAGARA).Journal of Clinical Oncology. 2021; 39 (TPS505-TPS505)https://doi.org/10.1200/JCO.2021.39.6_suppl.TPS505
- Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial).BMC Cancer. 2021; 21https://doi.org/10.1186/s12885-021-08990-3
- Preoperative ipilimumab plus nivolumab in locoregionally advanced urothelial cancer: the NABUCCO trial.Nat Med. 2020; 26: 1839-1844https://doi.org/10.1038/s41591-020-1085-z
- Neoadjuvant PD-L1 plus CTLA-4 blockade in patients with cisplatin-ineligible operable high-risk urothelial carcinoma.Nat Med. 2020; 26: 1845-1851https://doi.org/10.1038/s41591-020-1086-y
- Open-label phase II to evaluate the efficacy of NEoadjuvant dose-dense MVAC In cOmbination with durvalumab and tremelimumab in muscle-invasive urothelial carcinoma: NEMIO.Bull Cancer. 2020; 107: eS8-eS15https://doi.org/10.1016/S0007-4551(20)30281-2
- ENERGIZE: A Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer.Future Oncology. 2019; 16: 4359-4368https://doi.org/10.2217/fon-2019-0611
- Safety evaluation of combined PD-1+CTLA4 inhibition concurrently to chemoradiotherapy (CRT) in localized muscle invasive bladder carcinoma (MIBC).Journal of Clinical Oncology. 2021; 39 (4531-4531)https://doi.org/10.1200/JCO.2021.39.15_suppl.4531
- Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma.New England Journal of Medicine. 2021; 384: 2102-2114https://doi.org/10.1056/nejmoa2034442
U.S. Food & Drug Administration. FDA approves nivolumab for adjuvant treatment of urothelial carcinoma. FDA News Release. Published August 19, 2021. Accessed August 18, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma#:∼:text=FDA%20approves%20nivolumab%20for%20adjuvant%20treatment%20of%20urothelial%20carcinoma,-Share&text=On%20August%2019%2C%202021%2C%20the,recurrence%20after%20undergoing%20radical%20resection.
- Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial.Lancet Oncol. 2021; 22: 525-537https://doi.org/10.1016/S1470-2045(21)00004-8
- ctDNA guiding adjuvant immunotherapy in urothelial carcinoma.Nature. 2021; 595: 432-437https://doi.org/10.1038/s41586-021-03642-9
- Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer (AMBASSADOR).ClinicalTrials.gov Identifier:NCT03244384. 2017; (Published onlineAccessed August 18, 2022)
U.S. Food & Drug Administration. Nivolumab for Treatment of Urothelial Carcinoma. Published February 2, 2017. Accessed September 18, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/nivolumab-treatment-urothelial-carcinoma
Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma. FDA.
- FDA Grants Genentech's Tecentriq (Atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer.Genentech. April 17, 2017; (PublishedAccessed August 18, 2022)
Galsky MD, Ángel J, Arija A, et al. Atezolizumab with or without Chemotherapy in Metastatic Urothelial Cancer (IMvigor130): A Multicentre, Randomised, Placebo-Controlled Phase 3 Trial. Vol 395.; 2020. www.thelancet.com
- 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.Lancet Oncol. 2020; 21: 1574-1588https://doi.org/10.1016/S1470-2045(20)30541-6
- Immunotherapy versus chemotherapy as first-line treatment for advanced urothelial cancer: A systematic review and meta-analysis.Cancer Treat Rev. 2022; 104102360https://doi.org/10.1016/j.ctrv.2022.102360
Balar A v., 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. The Lancet. 2017;389(10064):67-76. doi:10.1016/S0140-6736(16)32455-2
- FDA approves new, targeted treatment for bladder cancer.FDA News Release. May 16, 2016; (PublishedAccessed August 18, 2022)
- Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: A single-arm, multicentre, phase 2 trial.The Lancet. 2016; 387: 1909-1920https://doi.org/10.1016/S0140-6736(16)00561-4
- Atezolizumab in platinum-treated locally advanced or metastatic urothelial carcinoma: Post-progression outcomes from the phase II IMvigor210 study.Annals of Oncology. 2017; 28: 3044-3050https://doi.org/10.1093/annonc/mdx518
- Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial.The Lancet. 2018; 391: 748-757https://doi.org/10.1016/S0140-6736(17)33297-X
- 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: 7-11https://doi.org/10.1016/j.eururo.2021.03.024
- Concomitant proton pump inhibitor use and survival in urothelial carcinoma treated with atezolizumab.Clinical Cancer Research. 2020; 26: 5487-5493https://doi.org/10.1158/1078-0432.CCR-20-1876
- Concomitant Antibiotic Use and Survival in Urothelial Carcinoma Treated with Atezolizumab.Eur Urol. 2020; 78: 540-543https://doi.org/10.1016/j.eururo.2020.06.061
- 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: 1483-1492https://doi.org/10.1016/S1470-2045(17)30616-2
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. Vol 38.; 2020. https://doi.org/10.
- Pembrolizumab as First-line Therapy in Cisplatin-ineligible Advanced Urothelial Cancer (KEYNOTE-052): Outcomes in Older Patients by Age and Performance Status.Eur Urol Oncol. 2020; 3: 351-359https://doi.org/10.1016/j.euo.2020.02.009
- Safety and Efficacy of Atezolizumab in Understudied Populations with Pretreated Urinary Tract Carcinoma: Subgroup Analyses of the SAUL Study in Real-World Practice.J Urol. 2021; 206: 240-251https://doi.org/10.1097/JU.0000000000001768
- 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: 931-945https://doi.org/10.1016/S1470-2045(21)00152-2
- Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.New England Journal of Medicine. 2017; 376: 1015-1026https://doi.org/10.1056/nejmoa1613683
- Efficacy of Pembrolizumab in Patients With Variant Urothelial Carcinoma: A Multicenter Retrospective Study.Clin Genitourin Cancer. 2022; (Published online)https://doi.org/10.1016/j.clgc.2022.05.001
Article info
Publication history
Publication stage
In Press Journal Pre-ProofFootnotes
Submission to “Review Article” section (invited narrative review): submission with minor revisions
Author Disclosures: UroGen Pharma (Scientific Advisory Board, Consultant, and Speaker Bureau); BMS (Scientific Advisory Board, Research Funding, and Speaker Bureau); and ImmunityBio (Scientific Advisory Board and Consultant)
Research Funding: None