Current advances in BCG-unresponsive non-muscle invasive bladder cancer

References

• Howlader N, Noone A, Krapcho M, et al. SEER cancer statistics review, 1975–2016. 2019 June 19. Available from: https://seer.cancer.gov/csr/1975_2016/.
   Google Scholar
• Babjuk M, Burger M, Zigeuner R, et al. EAU guidelines on non–muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol. 2013;64(4):639–653.
   PubMed Web of Science ®Google Scholar
• Chang SS, Boorjian SA, Chou R, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. 2016;196(4):1021–1029.
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network. Bladder cancer (Version 3.2019); 2019 June 19. Available from: https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf
   Google Scholar
• Sylvester RJ, van der Meijden APM, Oosterlinck W, et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006;49(3):466–477.
   PubMed Web of Science ®Google Scholar
• Chou R, Selph S, Buckley DI, et al. Intravesical therapy for the treatment of nonmuscle invasive bladder cancer: a systematic review and meta-analysis. J Urol. 2017;197(5):1189–1199.
   PubMed Web of Science ®Google Scholar
• Shelley MD, Kynaston H, Court J, et al. A systematic review of intravesical bacillus Calmette-Guérin plus transurethral resection vs transurethral resection alone in Ta and T1 bladder cancer. BJU Int. 2001;88(3):209–216.
   PubMed Web of Science ®Google Scholar
• Han RF, Pan JG. Can intravesical bacillus Calmette-Guérin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology. 2006;67(6):1216–1223.
   PubMed Web of Science ®Google Scholar
• Shelley MD, Wilt TJ, Court J, et al. Intravesical bacillus Calmette-Guérin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized trials. BJU Int. 2004;93(4):485–490.
   PubMed Web of Science ®Google Scholar
• Böhle A, Bock PR. Intravesical bacille calmette-guérin versus mitomycin c in superficial bladder cancer: formal meta-analysis of comparative studies on tumor progression. Urology. 2004;63(4):682–686.
   PubMed Web of Science ®Google Scholar
• Sylvester RJ, Meijden AVD, Lamm DL. Intravesical bacillus calmette-guerin reduces the risk of progression in patients with superficial bladder cancer: a meta-analysis of the published results of randomized clinical trials. J Urol. 2002;168(5):1964–1970.
   PubMed Web of Science ®Google Scholar
• Sarosdy MF, Lamm DL. Long-term results of intravesical bacillus calmette-guerin therapy for superficial bladder cancer. J Urol. 1989;142(3):719–722.
   PubMed Web of Science ®Google Scholar
• Shepherd AR, Shepherd E, Brook NR. Intravesical bacillus calmette-guérin with interferon-alpha versus intravesical bacillus calmette-guérin for treating non-muscle-invasive bladder cancer. Cochrane Database Syst Rev. 2017;3(3):CD012112–CD012112.
   PubMedGoogle Scholar
• Brake M, Loertzer H, Horsch R, et al. Long-term results of intravesical bacillus calmette-guérin therapy for stage T1 superficial bladder cancer. Urology. 2000;55(5):673–678.
   PubMed Web of Science ®Google Scholar
• Herr HW, Dalbagni G. Defining bacillus calmette-guerin refractory superficial bladder tumors. J Urol. 2003;169(5):1706–1708.
   PubMed Web of Science ®Google Scholar
• Lerner SP, Dinney C, Kamat A, et al. Clarification of bladder cancer disease states following treatment of patients with intravesical BCG. Bladder Cancer. 2015;1(1):29–30.
   PubMed Web of Science ®Google Scholar
• Li R, Tabayoyong WB, Guo CC, et al. Prognostic implication of the United States food and drug administration-defined BCG-unresponsive disease. Eur Urol. 2019;75(1):8–10.
   PubMed Web of Science ®Google Scholar
• Bui TT, Schellhammer PF. Additional bacillus calmette-guérin therapy for recurrent transitional cell carcinoma after an initial complete response. Urology. 1997;49(5):687–691.
   PubMed Web of Science ®Google Scholar
• Catalona WJ, M’liss AH, Gillen DP, et al. Risks and benefits of repeated courses of intravesical bacillus Calmette-Guerin therapy for superficial bladder cancer. J Urol. 1987;137(2):220–224.
   PubMed Web of Science ®Google Scholar
• Steinberg G, Bahnson R, Brosman S, et al. Efficacy and safety of valrubicin for the treatment of bacillus calmette-guerin refractory carcinoma in situ of the bladder. J Urol. 2000;163(3):761–767.
   PubMed Web of Science ®Google Scholar
• Dinney CPN, Greenberg RE, Steinberg GD. Intravesical valrubicin in patients with bladder carcinoma in situ and contraindication to or failure after bacillus Calmette-Guérin. Urol Oncol - Semin Ori. 2013;31(8):1635–1642.
   PubMed Web of Science ®Google Scholar
• Herr HW, Sogani PC. Does early cystectomy improve the survival of patients with high risk superficial bladder tumors? J Urol. 2001;166(4):1296–1299.
   PubMed Web of Science ®Google Scholar
• Raj GV, Herr H, Serio AM, et al. Treatment paradigm shift may improve survival of patients with high risk superficial bladder cancer. J Urol. 2007;177(4):1283–1286.
   PubMed Web of Science ®Google Scholar
• van Den Bosch S, Alfred Witjes J. Long-term cancer-specific survival in patients with high-risk, non–muscle-invasive bladder cancer and tumour progression: a systematic review. Eur Urol. 2011;60(3):493–500.
   PubMed Web of Science ®Google Scholar
• Schrier BP, Hollander MP, van Rhijn BWG, et al. Prognosis of muscle-invasive bladder cancer: difference between primary and progressive tumours and implications for therapy. Eur Urol. 2004;45(3):292–296.
   PubMed Web of Science ®Google Scholar
• Breau RH, Karnes RJ, Farmer SA, et al. Progression to detrusor muscle invasion during urothelial carcinoma surveillance is associated with poor prognosis. BJU Int. 2014;113(6):900–906.
   PubMed Web of Science ®Google Scholar
• Boström PJ, Kössi J, Laato M, et al. Risk factors for mortality and morbidity related to radical cystectomy. BJU Int. 2009;103(2):191–196.
   PubMed Web of Science ®Google Scholar
• Liberman D, Lughezzani G, Sun M, et al. Perioperative mortality is significantly greater in septuagenarian and octogenarian patients treated with radical cystectomy for urothelial carcinoma of the bladder. Urology. 2011;77(3):660–666.
   PubMed Web of Science ®Google Scholar
• McKiernan JM, Masson P, Murphy AM, et al. Phase I trial of intravesical docetaxel in the management of superficial bladder cancer refractory to standard intravesical therapy. J Clin Oncol. 2006;24(19):3075–3080.
   PubMed Web of Science ®Google Scholar
• Laudano MA, Barlow LJ, Murphy AM, et al. Long-term clinical outcomes of a phase I trial of intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to standard intravesical therapy. Urology. 2010;75(1):134–137.
   PubMed Web of Science ®Google Scholar
• Barlow L, McKiernan J, Sawczuk I, et al. A single-institution experience with induction and maintenance intravesical docetaxel in the management of non-muscle-invasive bladder cancer refractory to bacille Calmette-Guérin therapy. BJU Int. 2009;104(8):1098–1102.
   PubMed Web of Science ®Google Scholar
• Barlow LJ, McKiernan JM, Benson MC. Long-term survival outcomes with intravesical docetaxel for recurrent nonmuscle invasive bladder cancer after previous bacillus calmette-guerin therapy. J Urol. 2013;189(3):834–839.
   PubMed Web of Science ®Google Scholar
• Stadler WM, Kuzel T, Roth B, et al. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol. 1997;15(11):3394–3398.
   PubMed Web of Science ®Google Scholar
• Lorusso V, Pollera CF, Antimi M, et al. A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Eur J Cancer. 1998;34(8):1208–1212.
   PubMed Web of Science ®Google Scholar
• Maase HVD, Hansen SW, Roberts JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000;18(17):3068–3077.
   PubMed Web of Science ®Google Scholar
• Maase HVD, 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.
   PubMed Web of Science ®Google Scholar
• Zargar H, Espiritu PN, Fairey AS, et al. Multicenter assessment of neoadjuvant chemotherapy for muscle-invasive bladder cancer. Eur Urol. 2015;67(2):241–249.
   PubMed Web of Science ®Google Scholar
• Dash A, Pettus JAT, Herr HW, et al. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer. 2008;113(9):2471–2477.
   PubMed Web of Science ®Google Scholar
• Dalbagni G, Russo P, Sheinfeld J, et al. phase i trial of intravesical gemcitabine in bacillus calmette-guérin–refractory transitional-cell carcinoma of the bladder. J Clin Oncol. 2002;20(15):3193–3198.
   PubMed Web of Science ®Google Scholar
• Dalbagni G, Russo P, Bochner B, et al. Phase II trial of intravesical gemcitabine in bacille calmette-guérin–refractory transitional cell carcinoma of the bladder. J Clin Oncol. 2006;24(18):2729–2734.
   PubMed Web of Science ®Google Scholar
• Skinner EC, Goldman B, Sakr WA, et al. SWOG S0353: phase II trial of intravesical gemcitabine in patients with nonmuscle invasive bladder cancer and recurrence after 2 prior courses of intravesical bacillus Calmette-Guérin. J Urol. 2013;190(4):1200–1204.
   PubMed Web of Science ®Google Scholar
• Steinberg RL, Thomas LJ, O’Donnell MA, et al. Sequential intravesical gemcitabine and docetaxel for the salvage treatment of non-muscle invasive bladder cancer. Bladder Cancer. 2015;1(1):65–72.
   PubMed Web of Science ®Google Scholar
• Velaer KN, Steinberg RL, Thomas LJ, et al. Experience with sequential intravesical gemcitabine and docetaxel as salvage therapy for non-muscle invasive bladder cancer. Curr Urol Rep. 2016;17(5):38.
   PubMed Web of Science ®Google Scholar
• Milbar N, Kates M, Chappidi MR, et al. Oncological outcomes of sequential intravesical gemcitabine and docetaxel in patients with non-muscle invasive bladder cancer. Bladder Cancer. 2017;3(4):293–303.
   PubMed Web of Science ®Google Scholar
• Delto JC, Kobayashi T, Benson M, et al. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer progression. Oncotarget. 2013;4(2):269–276.
   PubMed Web of Science ®Google Scholar
• DeCastro GJ, Anderson C, Pak J, et al. MP43-14 A phase I trial of intravesical cabazitaxel, gemcitabine, and cisplatin (CGC) for the treatment of non-muscle invasive BCG unresponsive urothelial carcinoma of the bladder. J Urol. 2019;201(Supplement 4):e623–e623.
   Web of Science ®Google Scholar
• Dong Y, Sun Q, Zhang X. PD-1 and its ligands are important immune checkpoints in cancer. Oncotarget. 2016;8(2):2171–2186.
   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.
   PubMed Web of Science ®Google Scholar
• Rosenberg JE, Hoffman-Censits J, Powles T, et al. 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. Lancet. 2016;387(10031):1909–1920.
   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.
   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.
   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.
   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 studydurvalumab in locally advanced or metastatic urothelial carcinomadurvalumab in locally advanced or metastatic urothelial carcinoma. JAMA Oncol. 2017;3(9):e172411–e172411.
   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.
   PubMed Web of Science ®Google Scholar
• Inman BA, Sebo TJ, Frigola X, et al. PD-L1 (B7-H1) expression by urothelial carcinoma of the bladder and BCG-induced granulomata. Cancer. 2007;109(8):1499–1505.
   PubMed Web of Science ®Google Scholar
• Kulkarini GS, Wit RD, Balar AV, et al. MP43-01 Phase 2 KEYNOTE-057 study: pembrolizumab for patients with high-risk non-muscle invasive bladder cancer unresponsive to bacillus calmette-guerin. J Urol. 2019;201(Supplement 4):e616–e616.
   Web of Science ®Google Scholar
• Jamil ML, Deebajah M, Sood A, et al. Protocol for phase I study of pembrolizumab in combination with bacillus calmette-guérin for patients with high-risk non-muscle invasive bladder cancer. BMJ Open. 2019;9(7):e028287.
   PubMed Web of Science ®Google Scholar
• Alanee S, El-Zawahry A, McVary K, et al. MP43-09 phase I trial of intravesical bacillus calmette-guerin combined with intravenous pembrolizumab in high grade nonmuscle invasive bladder cancer. J Urol. 2019;201(Supplement 4):e620–e621.
   PubMed Web of Science ®Google Scholar
• Waldmann TA. The biology of interleukin-2 and interleukin-15: implications for cancer therapy and vaccine design. Nat Rev Immunol. 2006;6(8):595–601.
   PubMed Web of Science ®Google Scholar
• Gomes-Giacoia E, Miyake M, Goodison S, et al. Intravesical ALT-803 and BCG treatment reduces tumor burden in a carcinogen induced bladder cancer rat model; a role for cytokine production and NK cell expansion. PloS One. 2014;9(6):e96705–e96705.
   PubMed Web of Science ®Google Scholar
• Rosser CJ, Nix J, Ferguson L, et al. Phase Ib trial of ALT-803, an IL-15 superagonist, plus BCG for the treatment of BCG-naïve patients with non-muscle-invasive bladder cancer. J Clin Oncol. 2018;36(6_suppl):510.
   Google Scholar
• Huang J, Schisler J, Wong HC, et al. Intravesical ALT-803 for BCG-unresponsive bladder cancer - a case report. Urol Case Rep. 2017;14:15–17.
   PubMed Web of Science ®Google Scholar
• Fishman MN, Thompson JA, Pennock GK, et al. Phase I trial of ALT-801, an interleukin-2/T-cell receptor fusion protein targeting p53 (aa264-272)/HLA-A*0201 complex, in patients with advanced malignancies. Clin Can Res. 2011;17(24):7765–7775.
   PubMed Web of Science ®Google Scholar
• Sonpavde G, Rosser CJ, Pan C-X, et al. Phase I trial of ALT-801, a first-in-class T-cell receptor (TCR)-interleukin (IL)-2 fusion molecule, plus gemcitabine (G) for Bacillus Calmette Guerin (BCG)-resistant non-muscle-invasive bladder cancer (NMIBC). J Clin Oncol. 2015;33(15_suppl):e15509.
   Web of Science ®Google Scholar
• Phillips NC, Filion MC. Therapeutic potential of mycobacterial cell wall-DNA complexes. Expert Opin Investig Drugs. 2001;10(12):2157–2165.
   PubMed Web of Science ®Google Scholar
• Morales A, Phadke K, Steinhoff G. Intravesical mycobacterial cell wall-DNA complex in the treatment of carcinoma in situ of the bladder after standard intravesical therapy has failed. J Urol. 2009;181(3):1040–1045.
   PubMed Web of Science ®Google Scholar
• Morales A, Herr H, Steinberg G, et al. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus calmette-guerin. J Urol. 2015;193(4):1135–1143.
   PubMed Web of Science ®Google Scholar
• Madan RA, Arlen PM, Gulley JL. PANVAC™-VF: poxviral-based vaccine therapy targeting CEA and MUC1 in carcinoma. Expert Opin Biol Ther. 2007;7(4):543–554.
   PubMed Web of Science ®Google Scholar
• Brancato SJ, Stamatakis L, Apolo AB, et al. A randomized, prospective, phase II study to determine the efficacy of BCG given in combination with panvac versus BCG alone in adults with high grade non-muscle invasive bladder cancer who failed at least one induction course of BCG. J Clin Oncol. 2014;32(15_suppl):TPS4590.
   Web of Science ®Google Scholar
• Sanford T, Donahue R, Jochems C, et al. MP15-10 immunologic response to a therapeutic cancer vaccine (PANVAC): initial results from a randomized phase 2 clinical trial. J Urol. 2017;197(4S):e174–e174.
   Google Scholar
• Keehn A, Gartrell B, Schoenberg MP. Vesigenurtacel-L (HS-410) in the management of high-grade nonmuscle invasive bladder cancer. Future Oncol. 2016;12(23):2673–2682.
   PubMed Web of Science ®Google Scholar
• Steinberg G, Shore ND, Karsh L, et al. Top-line results from vesigenurtacel-L (HS-410) in combination with BCG from a randomized, blinded phase 2 trial in patients with non-muscle invasive bladder cancer (NMIBC0) [abstract]. In: Society of urologic oncology. San Antonio, Texas; 2016.
   Google Scholar
• Steinberg GD, Shore ND, Karsh LI, et al. Immune response results of vesigenurtacel-l (HS-410) in combination with BCG from a randomized phase II trial in patients with non-muscle invasive bladder cancer (NMIBC). J Clin Oncol. 2017;35(6_suppl):319.
   Web of Science ®Google Scholar
• Erdmann VA, Barciszewska MZ, Szymanski M, et al. The non-coding RNAs as riboregulators. Nucleic Acids Res. 2001;29(1):189–193.
   PubMed Web of Science ®Google Scholar
• Ayesh S, Matouk I, Schneider T, et al. Possible physiological role of H19 RNA. Mol Carcinog. 2002;35(2):63–74.
   PubMed Web of Science ®Google Scholar
• Ariel I, Sughayer M, Fellig Y, et al. The imprinted H19 gene is a marker of early recurrence in human bladder carcinoma. Mol Pathol. 2000;53(6):320–323.
   PubMedGoogle Scholar
• Ohana P, Bibi O, Matouk I, et al. Use of H19 regulatory sequences for targeted gene therapy in cancer. Int J Cancer. 2002;98(5):645–650.
   PubMed Web of Science ®Google Scholar
• Sidi AA, Ohana P, Benjamin S, et al. Phase I/II marker lesion study of intravesical BC-819 DNA plasmid in H19 over expressing superficial bladder cancer refractory to bacillus calmette-guerin. J Urol. 2008;180(6):2379–2383.
   PubMed Web of Science ®Google Scholar
• Gofrit ON, Benjamin S, Halachmi S, et al. DNA based therapy with diphtheria toxin-A BC-819: a phase 2b marker lesion trial in patients with intermediate risk nonmuscle invasive bladder cancer. J Urol. 2014;191(6):1697–1702.
   PubMed Web of Science ®Google Scholar
• Halachmi S, Leibovitch I, Zisman A, et al. Phase II trial of BC-819 intravesical gene therapy in combination with BCG in patients with non-muscle invasive bladder cancer (NMIBC). J Clin Oncol. 2018;36(6_suppl):499.
   Web of Science ®Google Scholar
• Fukuhara H, Ino Y, Todo T. Oncolytic virus therapy: a new era of cancer treatment at dawn. Cancer Sci. 2016;107(10):1373–1379.
   PubMed Web of Science ®Google Scholar
• Shafren DR, Dorahy DJ, Ingham RA, et al. Coxsackievirus A21 binds to decay-accelerating factor but requires intercellular adhesion molecule 1 for cell entry. J Virol. 1997;71(6):4736–4743.
   PubMed Web of Science ®Google Scholar
• Annels NE, Mansfield D, Arif M, et al. Viral targeting of non-muscle invasive bladder cancer and priming of anti-tumour immunity following intravesical Coxsackievirus A21. Clin Cancer Res. 2019;4022:2018.
   Google Scholar
• Ramesh N, Ge Y, Ennist DL, et al. CG0070, a conditionally replicating granulocyte macrophage colony-stimulating factor–armed oncolytic adenovirus for the treatment of bladder cancer. Clin Cancer Res. 2006;12(1):305–313.
   PubMed Web of Science ®Google Scholar
• Burke JM, Lamm DL, Meng MV, et al. A first in human phase 1 study of CG0070, a GM-CSF expressing oncolytic adenovirus, for the treatment of nonmuscle invasive bladder cancer. J Urol. 2012;188(6):2391–2397.
   PubMed Web of Science ®Google Scholar
• Packiam VT, Barocas DA, Chamie K, et al. MP43-02 CG0070, an oncolytic adenovirus, for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC): 18 month follow-up from a multicenter phase II trial . J Urol. 2019;201(Supplement 4):e617–e617.
   Web of Science ®Google Scholar
• Packiam VT, Lamm DL, Barocas DA, et al. An open label, single-arm, phase II multicenter study of the safety and efficacy of CG0070 oncolytic vector regimen in patients with BCG-unresponsive non–muscle-invasive bladder cancer: interim results. Urol Oncol - Semin Ori. 2018;36(10):440–447.
   PubMed Web of Science ®Google Scholar
• Joudi FN, Smith BJ, O’Donnell MA. Final results from a national multicenter phase II trial of combination bacillus Calmette-Guérin plus interferon α-2B for reducing recurrence of superficial bladder cancer☆. Urol Oncol - Semin Ori. 2006;24(4):344–348.
   PubMed Web of Science ®Google Scholar
• Correa AF, Theisen K, Ferroni M, et al. The role of interferon in the management of BCG refractory nonmuscle invasive bladder cancer. Adv Urol. 2015;2015:6.
   Google Scholar
• Adam L, Black PC, Kassouf W, et al. Adenoviral mediated interferon-alpha 2b gene therapy suppresses the pro-angiogenic effect of vascular endothelial growth factor in superficial bladder cancer. J Urol. 2007;177(5):1900–1906.
   PubMed Web of Science ®Google Scholar
• Dinney CPN, Fisher MB, Navai N, et al. Phase I trial of intravesical recombinant adenovirus mediated interferon-α2b formulated in Syn3 for bacillus calmette-guérin failures in nonmuscle invasive bladder cancer. J Urol. 2013;190(3):850–856.
   PubMed Web of Science ®Google Scholar
• Shore ND, Boorjian SA, Canter DJ, et al. Intravesical rAd-IFNα/Syn3 for patients with high-grade, bacillus calmette-guerin-refractory or relapsed non-muscle-invasive bladder cancer: a phase II randomized study. J Clin Oncol. 2017;35(30):3410–3416.
   PubMed Web of Science ®Google Scholar
• Lammers RJM, Witjes JA, Inman BA, et al. The role of a combined regimen with intravesical chemotherapy and hyperthermia in the management of non-muscle-invasive bladder cancer: a systematic review. Eur Urol. 2011;60(1):81–93.
   PubMed Web of Science ®Google Scholar
• van Valenberg FJP, van der Heijden AG, Lammers RJM, et al. Intravesical radiofrequency induced hyperthermia enhances mitomycin C accumulation in tumour tissue. Int J Hyperthermia. 2018;34(7):988–993.
   PubMed Web of Science ®Google Scholar
• Colombo R, Pozzo LFD, Salonia A, et al. Multicentric study comparing intravesical chemotherapy alone and with local microwave hyperthermia for prophylaxis of recurrence of superficial transitional cell carcinoma. J Clin Oncol. 2003;21(23):4270–4276.
   PubMed Web of Science ®Google Scholar
• Colombo R, Salonia A, Leib Z, et al. Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). BJU Int. 2011;107(6):912–918.
   PubMed Web of Science ®Google Scholar
• Arends TJH, Nativ O, Maffezzini M, et al. Results of a randomised controlled trial comparing intravesical chemohyperthermia with mitomycin C versus bacillus calmette-guérin for adjuvant treatment of patients with intermediate- and high-risk non–muscle-invasive bladder cancer. Eur Urol. 2016;69(6):1046–1052.
   PubMed Web of Science ®Google Scholar
• Knemeyer I, Wientjes MG, Au JL-S. Cremophor reduces paclitaxel penetration into bladder wall during intravesical treatment [journal article]. Cancer Chemother Pharmacol. 1999;44(3):241–248.
   PubMed Web of Science ®Google Scholar
• Sparreboom A, Scripture CD, Trieu V, et al. Comparative preclinical and clinical pharmacokinetics of a cremophor-free, nanoparticle albumin-bound paclitaxel (ABI-007) and paclitaxel formulated in cremophor (Taxol). Clin Cancer Res. 2005;11(11):4136–4143.
   PubMed Web of Science ®Google Scholar
• Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil–based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794–7803.
   PubMed Web of Science ®Google Scholar
• McKiernan JM, Barlow LJ, Laudano MA, et al. A phase I trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of bacillus calmette-guerin refractory nonmuscle invasive bladder cancer. J Urol. 2011;186(2):448–451.
   PubMed Web of Science ®Google Scholar
• McKiernan JM, Holder DD, Ghandour RA, et al. Phase II trial of intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus calmette-guerin treatment failure. J Urol. 2014;192(6):1633–1638.
   PubMed Web of Science ®Google Scholar
• Robins DJ, Sui W, Matulay JT, et al. Long-term survival outcomes with intravesical nanoparticle albumin-bound paclitaxel for recurrent non–muscle-invasive bladder cancer after previous bacillus calmette-guérin therapy. Urology. 2017;103:149–153.
   PubMed Web of Science ®Google Scholar
• Lee S-W, Yun M-H, Jeong SW, et al. Development of docetaxel-loaded intravenous formulation, Nanoxel-PM™ using polymer-based delivery system. J Control Release. 2011;155(2):262–271.
   PubMed Web of Science ®Google Scholar
• Barlow LJ, McKiernan JM, Benson MC. The novel use of intravesical docetaxel for the treatment of non-muscle invasive bladder cancer refractory to BCG therapy: a single institution experience [journal article]. World J Urol. 2009;27(3):331–335.
   PubMed Web of Science ®Google Scholar
• Dizerega G, Maulhardt H, Peterson LM, et al. Evaluation of submicron particle docetaxel directly injected into uro-oncologic xenografts. J Clin Oncol. 2019;37(7_suppl):360.
   Web of Science ®Google Scholar
• Puzio-Kuter AM, Castillo-Martin M, Kinkade CW, et al. Inactivation of p53 and Pten promotes invasive bladder cancer. Genes Dev. 2009;23(6):675–680.
   PubMed Web of Science ®Google Scholar
• Seager CM, Puzio-Kuter AM, Patel T, et al. Intravesical delivery of rapamycin suppresses tumorigenesis in a mouse model of progressive bladder cancer. Cancer Prev Res. 2009;2(12):1008–1014.
   PubMed Web of Science ®Google Scholar
• Railkar R, Agarwal PK. Photodynamic therapy in the treatment of bladder cancer: past challenges and current innovations. Eur Urol Focus. 2018;4(4):509–511.
   PubMedGoogle Scholar
• Lazic S, Kaspler P, Mandel A, et al. MP61-06 photodynamic therapy for non-muscle invasive bladder cancer mediated by instilled photosensitizer TLD433 and green light activation. J Urol. 2016;195(4S):e805–e805.
   PubMedGoogle Scholar
• Stühler V, Maas JM, Bochem J, et al. Molecular predictors of response to PD-1/PD-L1 inhibition in urothelial cancer. World J Urol. 2018.
   PubMed Web of Science ®Google Scholar
• Hedegaard J, Lamy P, Nordentoft I, et al. Comprehensive transcriptional analysis of early-stage urothelial carcinoma. Cancer Cell. 2016;30(1):27–42.
   PubMed Web of Science ®Google Scholar