Current and recent clinical trials for perioperative systemic therapy for muscle invasive bladder cancer: A systematic review

BMC Cancer

Volumn 14, Issue 1, 2014, Pages

  Vashistha, Vishal ^a   Quinn, David I ^b   Dorff, Tanya B ^b   Daneshmand, Siamak ^c  

^a LERNER RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

Bladder cancer; Gene therapy; Immune therapy; mTOR inhibitor; Perioperative chemotherapy; Perioperative targeted therapy; Radical cystectomy; Vaccine therapy

Indexed keywords

ALPHA INTERFERON; ANTINEOPLASTIC AGENT; BEVACIZUMAB; CANCER VACCINE; CARBOPLATIN; CD40 LIGAND; CISPLATIN; DASATINIB; DN 24 02; DOXORUBICIN; ERLOTINIB; EVEROLIMUS; GEMCITABINE; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; METHOTREXATE; PACLITAXEL; RAPAMYCIN; SORAFENIB; SUNITINIB; UNCLASSIFIED DRUG; VINBLASTINE; MTOR PROTEIN, HUMAN; TARGET OF RAPAMYCIN KINASE;

ARTICLE; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER GENE THERAPY; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CANCER PREVENTION; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); CYSTECTOMY; DOSE RESPONSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; HUMAN; MUSCLE INVASIVE BLADDER CANCER; OVERALL SURVIVAL; PERIOPERATIVE PERIOD; SYSTEMATIC REVIEW; SYSTEMIC THERAPY; TREATMENT OUTCOME; TREATMENT PLANNING; ADJUVANT CHEMOTHERAPY; ANTAGONISTS AND INHIBITORS; GENE THERAPY; MOLECULARLY TARGETED THERAPY; NEOADJUVANT THERAPY; PATHOLOGY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); SMOOTH MUSCLE; TUMOR INVASION; URINARY BLADDER NEOPLASMS;

ANTINEOPLASTIC AGENTS; CANCER VACCINES; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; CYSTECTOMY; GENETIC THERAPY; HUMANS; MOLECULAR TARGETED THERAPY; MUSCLE, SMOOTH; NEOADJUVANT THERAPY; NEOPLASM INVASIVENESS; PERIOPERATIVE CARE; TOR SERINE-THREONINE KINASES; URINARY BLADDER NEOPLASMS;

EID: 84924720760     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-14-966     Document Type: Article

References (66)

1. Siegel R, Ma J, Zou Z, Jemal A: Cancer statistics, 2014. CA Cancer J Clin 2014, 64:9-29. 10.3322/caac.21208.
2. Ploeg M, Aben KK, LA Kiemeney World: The present and future burden of urinary bladder cancer in the world. J Urol 2009, 27:289-293.
3. Bassi P, Pappagallo GL, Cosciani S, Lembo A, Anselmo G, Sperandio P, Signorelli G, Di Tonno F, Hurle R, Lavelli D, Seren M, Piazza N, Faggiano L, Pagano F: Neoadjuvant MVAC chemotherapy of invasive bladder cancer results of a multicenter phase III trial. J Urol 1999, 161:264.
4. Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, de Vere White RW, Sarosdy MF, Wood DP Jr, Raghavan D, Crawford ED: Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med 2003, 349:859-866. 10.1056/NEJMoa022148.
5. Griffiths G, Hall R, Sylvester R, Raghavan D, Parmar MK: International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol 2011, 29:2171-2177.
6. Sherif A, Holmberg L, Rintala E, Mestad O, Nilsson J, Nilsson S, Malmström PU, Nordic Urothelial Cancer Group: Neoadjuvant cisplatinum based combination chemotherapy in patients with invasive bladder cancer: a combined analysis of two Nordic studies. Eur Urol 2004, 45:297-303. 10.1016/j.eururo.2003.09.019.
7. Bono AV, Benvenuti C, Gibba A: Adjuvant chemotherapy in locally advanced bladder cancer: final analysis of a controlled multicentre study. Acta Urol Ital 1997, 11:5-8.
8. Freiha F, Reese J, Torti FM: A randomized trial of radical cystectomy versus radical cystectomy plus cisplatin, vinblastine and methotrexate chemotherapy for muscle invasive bladder cancer. J Urol 1996, 155:495-499. discussion 499-500 10.1016/S0022-5347(01)66430-9
9. Stadler WM, Lerner SP, Groshen S, Stein JP, Shi SR, Rghavan D, Esrig D, Steinberg G, Wood D, Klotz L, Hall C, Skinner DG, Cote RJ: Phase III study of molecularly targeted adjuvant therapy in locally advanced urothelial cancer of the bladder based on p53 status. J Clin Oncol 2011, 29:3443-3449. 10.1200/JCO.2010.34.4028.
10. Lehmann J, Franzaring L, Thuroff J, Wellek S, Stockle M: Complete long-term survival data from a trial of adjuvant chemotherapy vs control after radical cystectomy for locally advanced bladder cancer. BJU Int 2006, 97:42-47. 10.1111/j.1464-410X.2006.05859.x.
11. Otto T, Goebell PJ, Rubben H: Perioperative chemotherapy in advanced bladder cancer-Part II: adjuvant treatment. Onkologie 2003, 26:484-488. 10.1159/000072983.
12. Paz-Ares LG, Solsona E, Esteban E, Saez A, Gonzalez-Larriba J, Anton A, Hevia M, de la Rosa F, Guillem V, Bellmunt J: Randomized phase III trial comparing adjuvant paclitaxel/gemcitabine/cisplatin (PGC) to observation in patients with resected invasive bladder cancer: results of the Spanish Oncology Genitourinary Group (SOGUG) 99/01study [abstract]. J Clin Oncol 2010, 28:18.
13. Skinner DG, Daniels JR, Russell CA, Lieskovsky G, Boyd SD, Nichols P, Kern W, Sakamoto J, Krailo M, Groshen S: The role of adjuvant chemotherapy following cystectomy for invasive bladder cancer: a prospective comparative trial. J Urol 1991, 145:459-464. discussion 464-467
14. Zaid HB, Patel SG, Stimson CJ, Resnick MJ, Cookson MS, Barocas DA, Chang SS: Trends in the utilization of neoadjuvant chemotherapy in muscle-invasive bladder cancer: results from the National Cancer Database. Urology 2014, 83:75-80. 10.1016/j.urology.2013.07.072.
15. Apolo AB, Kim JW, Bochner BH, Steinberg AM, Bajorin DF, Kelly KW, Agarwal PK, Koppie TM, Kaag MG, Quinn DI, Vogelzang NJ, Sridhar SS: Examining the management of Muscle Invasive Bladder Cancer (MIBC) by medical oncologists in the United States. Urol Oncol in press
16. Tjokrowidjaja A, Lee C, Stockler MR: Does chemotherapy improve survival in muscle-invasive bladder cancer (MIBC)? A systematic review and meta-analysis (MA) of randomized controlled trials (RCT) [abstract]. J Clin Oncol 2013, 31:4544. 10.1200/JCO.2013.49.9616.
17. Advanced Bladder Cancer (ABC) Meta-analysis Collaboration: Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data. Eur Urol 2005, 48:202-206. 10.1016/j.eururo.2005.04.006.
18. Winquist E, Kirchner TS, Segal R, Chin J, Lukka H, Genitourinary Cancer Disease Site Group, Cancer Care Ontario Program in Evidence-based Care Practice Guidelines Initiative: Neoadjuvant chemotherapy for transitional cell carcinoma of the bladder: a systematic review and meta-analysis. J Urol 2004, 171:561-569. 10.1097/01.ju.0000090967.08622.33.
19. Leow JJ, Martin-Doyle W, Rajagopal PS, Patel CG, Anderson EM, Rothman AT, Cote RJ, Urun Y, Chang SL, Choueiri TK, Bellmunt J: Adjuvant chemotherapy for invasive bladder cancer: a 2013 updated systematic review and meta-analysis of randomized trials. Eur Urol 2013, 13:1-13.
20. Advanced Bladder Cancer (ABC) Meta-analysis Collaboration: Adjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis of individual patient data Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Eur Urol 2005, 48:189-199. discussion 199-201 10.1016/j.eururo.2005.04.005
21. Kumar Pal S, Southwest Oncology Group: Examining the Pre-Metastatic Niche in Muscle Invasive Bladder Cancer. [http://www.swog.org/Visitors/Fall13GpMtg/plenary/04-McConkey-plenaryI-october-2013.pdf]
22. Kitamura H, Tsukamoto T, Shibata T, Masumori N, Fujimoto H, Hirao Y, Fujimoto K, Kitamura Y, Tomita Y, Tobisu K, Niwakawa M, Naito S, Eto M, Kakehi Y, Urologic Oncology Study Group of the Japan Clinical Oncology Group: Randomised phase III study of neoadjuvant chemotherapy with methotrexate, doxorubicin, vinblastine and cisplatin followed by radical cystectomy compared with radical cystectomy alone for muscle-invasive bladder cancer: Japan Clinical Oncology Group study JCOG0209. Ann Oncol 2014. [Epub ahead of print]
23. Cognetti F, Ruggeri EM, Felici A, Gallucci M, Muto G, Pollera CF, Massidda B, Rubagotti A, Giannarelli D, Boccardo F, Study Group: Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy at relapse in patients with muscle-invasive bladder cancer submitted to radical cystectomy: an Italian, multicenter, randomized phase III trial. Ann Oncol 2012, 3:695-700.
24. Zaghloul MS, Khaled HM, Lotayef M, William HM, Nazmy Attia G: A controlled prospective randomized trial of adjuvant chemoradiotherapy following radical cystectomy in advanced high risk bladder cancer [abstract]. J Clin Oncol 2007, 25:5082. 10.1200/JCO.2007.11.3183.
25. Lehmann J, Kuehn M, Fischer C, Volkmer B, von Rundstedt F, Albers P, Becht E, Bannowsky A, Hofmann R, Langbein S, Retz M, Stoeckle M: Randomized phase III study of adjuvant versus progression-triggered treatment with gemcitabine (G) after radical cystectomy (RC) for locally advanced bladder cancer (LABC) in patients not suitable for cisplatin-based chemotherapy (CBC) (AUO-trial AB22/00) [abstract]. J Clin Oncol 2007, 25:250.
26. Pruthi RS, Nielsen M, Heathcote S, Wallen EM, Rathmell WK, Godley P, Whang Y, Fielding J, Schultz H, Grigson G, Smith A, Kim W: A phase II trial of neoadjuvant erlotinib in patients with muscle-invasive bladder cancer undergoing radical cystectomy: clinical and pathological results. BJU Int 2010, 106:349-354.
27. Dinney CP, Fisher MB, Navai N, O'Donnell MA, Cutler D, Abraham A, Young S, Hutchins B, Caceres M, Kishnani N, Sode G, Cullen C, Zhang G, Grossman HB, Kamat AM, Gonzales M, Kincaid M, Ainslie N, Maneval DC, Wszolek MF, Benedict WF: 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, 190:850-856. 10.1016/j.juro.2013.03.030.
28. Chaudhary UB, Golshayan AR, Brisendine A, Kraft AS, Clarke H, Keane TE: Phase II trial of neoadjuvant cisplatin, gemcitabine, and bevacizumab followed by radical cystectomy (RC) in patients with muscle-invasive transitional cell carcinoma (TCC) of the bladder [abstract]. J Clin Oncol 2011, 29:276.
29. Galsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G: Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer 2013, 11:175-181. 10.1016/j.clgc.2012.10.001.
30. Balar AV, Iyer G, Apolo AB, Regazzi AM, Garcia-Grossman IR, Pendse D, Ostrovnaya I, Chou JF, Bochner B, Dalbagni G, Herr HW, Milowsky MI, Bajorin DF: Phase II trial of neoadjuvant gemcitabine (G) and cisplatin (C) with sunitinib in patients (pts) with muscle-invasive bladder cancer (MIBC) [abstract]. J Clin Oncol 2012, 30:4581.
31. Hahn NM, Daneshmand S, Posadas EM, Koch MO, Bihrle R, Foster R, Masterson TA, Cheng L, Liu Z, Breen T, Fleming MT, Lance R, Ryan CW, Corless CL, Galsky MD, Alva AS, Mitchell C, Shen SS, Lerner SP: A phase II trial of neoadjuvant dasatinib (Neo-D) in muscle-invasive urothelial carcinoma of the bladder (miUCB): Hoosier Oncology Group GU07-122 trial [abstract]. J Clin Oncol 2012, 30:4586. 10.1200/JCO.2012.44.1824.
32. Knudsen B, Hahn NM, Daneshmand S, Posadas EM, Muhanty S, Lerner SP, Sonpavde G: Biologic activity of dasatinib administered as neoadjuvant therapy preceding radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC) [abstract]. J Clin Oncol 2014, 32:324.
33. Malmström PU, Loskog AS, Lindqvist CA, Mangsbo SM, Fransson M, Wanders A, Gårdmark T, Tötterman TH: AdCD40L immunogene therapy for bladder carcinoma-the first phase I/IIa trial. Clin Cancer Res 2010, 16:3279-3287. 10.1158/1078-0432.CCR-10-0385.
34. Meeks JJ, Bellmunt J, Bochner BH, Clarke NW, Daneshmand S, Galsky MD, Hahn NM, Lerner SP, Mason M, Powles T, Sternberg CN, Sonpavde G: A systematic review of neoadjuvant and adjuvant chemotherapy for muscle-invasive bladder cancer. Eur Urol 2012, 62:523-533. 10.1016/j.eururo.2012.05.048.
35. Ohyama C, Hatakeyama S, Yoneyama T, Koie T: Neoadjuvant chemotherapy with gemcitabine plus carboplatin followed by immediate radical cystectomy for muscle-invasive bladder cancer. Int J Urol 2012, 21:3-4.
36. Koie T, Ohyama C, Hashimoto Y, Hatakeyama S, Yamamoto H, Yoneyama T, Kamimura N: Efficacies and safety of neoadjuvant gemcitabine plus carboplatin followed by immediate cystectomy in patients with muscle-invasive bladder cancer, including those unfit for cisplatin: a prospective single-arm study. Int J Clin Oncol 2013, 18:724-730. 10.1007/s10147-012-0447-z.
37. Rosenblatt R, Sherif A, Rintala E, Wahlqvist R, Ullén A, Nilsson S, Malmström PU, Nordic Urothelial Cancer Group: Pathologic downstaging is a surrogate marker for efficacy and increased survival following neoadjuvant chemotherapy and radical cystectomy for muscle-invasive urothelial bladder cancer. Eur Urol 2012, 61:1229-1238. 10.1016/j.eururo.2011.12.010.
38. Scosyrev E, Ely BW, Messing EM, Speights VO, Grossman HB, Wood DP, de Vere White RW, Vogelzang NJ, Trump DL, Natale RB, Tangen CM, Crawford ED, Thompson IM: Do mixed histological features affect survival benefit from neoadjuvant platinum-based combination chemotherapy in patients with locally advanced bladder cancer? A secondary analysis of Southwest Oncology Group-Directed Intergroup Study (S8710). BJU Int 2011, 108:693-699.
39. Hussain SA, Palmer DH, Lloyd B, Collins SI, Barton D, Ansari J, James ND: A study of split-dose cisplatin-based neo-adjuvant chemotherapy in muscle-invasive bladder cancer. Oncol Lett 2012, 3:855-859.
40. Witjes JA, Compérat E, Cowan NC, De Santis M, Gakis G, Lebret T, Ribal MJ, Van der Heijden AG, Sherif A: EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol 2014, 65:778-792. 10.1016/j.eururo.2013.11.046.
41. Apolo AB, Grossman HB, Bajorin D, Steinberg G, Kamat AM: Practical use of perioperative chemotherapy for muscle-invasive bladder cancer: summary of session at the Society of Urologic Oncology annual meeting. Urol Oncol 2012, 30:772-780. 10.1016/j.urolonc.2012.01.012.
42. Choi W, Porten S, Kim S, Willis D, Plimack ER, Hoffman-Censits J, Roth B, Cheng T, Tran M, Lee IL, Melquist J, Bondaruk J, Majewski T, Zhang S, Pretzsch S, Baggerly K, Siefker-Radtke A, Czerniak B, Dinney CP, McConkey DJ: Identification of distinct basal and luminal subtypes of muscle-invasive bladder cancer with different sensitivities to frontline chemotherapy. Cancer Cell 2014, 25:152-165. 10.1016/j.ccr.2014.01.009.
43. Abol-Enein H, El-Mekresh M, El-Baz M, Ghoneim MA: Neo-adjuvant chemotherapy in the treatment of invasive transitional bladder cancer: a controlled prospective randomised study. Br J Urol 1997, 79:174.
44. Grivas PD, Hussain M, Hafez K, Daignault-Newton S, Wood D, Lee CT, Weizer A, Montie JE, Hollenbeck B, Montgomery JS, Alva A, Smith DC: A phase II trial of neoadjuvant nab-paclitaxel, carboplatin, and gemcitabine (ACaG) in patients with locally advanced carcinoma of the bladder. Urology 2013, 82:111-117. 10.1016/j.urology.2013.03.044.
45. Smith DC, Mackler NJ, Dunn RL, Hussain M, Wood D, Lee CT, Sanda M, Vaishampayan U, Petrylak DP, Quinn DI, Beekman K, Montie JE: Phase II trial of paclitaxel, carboplatin and gemcitabine in patients with locally advanced carcinoma of the bladder. J Urol 2008, 6:2384-2388.
46. Sternberg CN, Bellmunt J, Sonpavde G, Siefker-Radtke AO, Stadler WM, Bajorin DF, Dreicer R, George DJ, Milowsky MI, Theodorescu D, Vaughn DJ, Galsky MD, Soloway MS, Quinn D, International Consultation on Urologic Disease-European Association of Urology Consultation on Bladder Cancer 2012: ICUD-EAU International Consultation on Bladder Cancer 2012: Chemotherapy for urothelial carcinoma-neoadjuvant and adjuvant settings. Eur Urol 2013, 63:58-66. 10.1016/j.eururo.2012.08.010.
47. Bamias A, Deliveliotis C, Aravantinos G, Kalofonos C, Karayiannis A, Dimopoulos MA, Hellenic Cooperative Oncology Group: Adjuvant chemotherapy with paclitaxel and carboplatin in patients with advanced bladder cancer: a study by the Hellenic Cooperative Oncology Group. J Urol 2004, 171:1467-1470. 10.1097/01.ju.0000118956.96871.18.
48. Mak RH, Hunt D, Shipley WU, Efstathiou JA, Tester WJ, Hagan MP, Kaufman DS, Heney NM, Zietman AL: Long-term outcomes in patients with muscle-invasive bladder cancer after bladder-preserving combined-modality therapy: A pooled analysis of RTOG 8802, 8903, 9506, 9706, 9906, and 0233 [abstract]. J Clin Oncol 2012, 30:264. 10.1200/JCO.2011.41.0332.
49. Jiang L, Zhang Z, Dong P, Li Y, Yao K, Liu Z, Han H, Qin Z, Yao M, Zhou F: Efficacy of radical cystectomy plus adjuvant intraarterial chemotherapy with gemcitabine and cisplatin on locally advanced bladder cancer. Chin Med J (Engl) 2014, 127:1249-1254.
50. Gofrit ON, Stadler WM, Zorn KC, Lin S, Silvestre J, Shalhav AL, Zagaja GP, Steinberg GD: Adjuvant chemotherapy in lymph node positive bladder cancer. Urol Oncol 2009, 27:160-164. 10.1016/j.urolonc.2007.12.013.
51. Paz-Ares LG, Solsona E, Esteban E, Saez A, Gonzalez-Larriba J, Anton A, Hevia M, de la Rosa F, Guillem V, Bellmunt J: Randomized phase III trial comparing adjuvant paclitaxel/gemcitabine/cisplatin (PGC) to observation in patients with resected invasive bladder cancer: Results of the Spanish Oncology Genitourinary Group (SOGUG) 99/01 study [abstract]. J Clin Oncol 2010., 28: LBA4518
52. Kaneko G, Kikuchi E, Matsumoto K, Obata J, Nakamura S, Miyajima A, Oya M: Neoadjuvant gemcitabine plus cisplatin for muscle-invasive bladder cancer. Jpn J Clin Oncol 2011, 41:908-914. 10.1093/jjco/hyr068.
53. Cornu M, Albert V, Hall MN: mTOR in aging, metabolism, and cancer. Curr Opin Genet 2013, 23:53-62. 10.1016/j.gde.2012.12.005.
54. Chiong E, Lee IL, Dadbin A, Sabichi AL, Harris L, Urbauer D, McConkey DJ, Dickstein RJ, Cheng T, Grossman HB: Effects of mTOR inhibitor everolimus (RAD001) on bladder cancer cells. Clin Cancer Res 2011, 17:2863-2873. 10.1158/1078-0432.CCR-09-3202.
55. Pinto-Leite R, Arantes-Rodrigues R, Palmeira C, Colaço B, Lopes C, Colaço A, Costa C, da Silva VM, Oliveira P, Santos L: Everolimus combined with cisplatin has a potential role in treatment of urothelial bladder cancer. Biomed Pharmacother 2013, 2:116-121.
56. Gerullis H, Eimer C, Ecke TH, Georgas E, Freitas C, Kastenholz S, Arndt C, Heusch C, Otto T: A phase II trial of temsirolimus in second-line metastatic urothelial cancer. Med Oncol 2012, 29:2870-2876. 10.1007/s12032-012-0216-x.
57. Milowsky MI, Iyer G, Regazzi AM, Al-Ahmadie H, Gerst SR, Ostrovnaya I, Gellert LL, Kaplan R, Garcia-Grossman IR, Pendse D, Balar AV, Flaherty AM, Trout A, Solit DB, Bajorin DF: Phase II study of everolimus in metastatic urothelial cancer. BJU Int 2013, 112:462-470. 10.1111/j.1464-410X.2012.11720.x.
58. Joudi FN, Smith BJ, O'Donnell MA, National BCG-Interferon Phase 2 Investigator Group: Final results from a national multicenter phase II trial of combination bacillus Calmette-Guérin plus interferon alpha-2B for reducing recurrence of superficial bladder cancer. Urol Oncol 2006, 24:344-348. 10.1016/j.urolonc.2005.11.026.
59. Bajorin DF, Sharma P, Gomella LG, Plimack ER, O'Donnell PH, Hoffman-Censits JH, Flaig TW, Quinn DI, Sims RB, Locker M, Sheikh NA, DeVries T, Lerner SP: NeuACT, a phase II, randomized, open-label trial of DN24-02: Updated analysis of HER2 expression, immune responses, product parameters, and safety in patients with surgically resected HER2+ urothelial cancer [abstract]. J Clin Oncol 2014, 32:296.
60. Morse MA, Bradley DA, Keler T, Laliberte RJ, Green JA, Davis TA, Inman BA: CDX-1307: a novel vaccine under study as treatment for muscle-invasive bladder cancer. Expert Rev Vaccines 2011, 10:733-742. 10.1586/erv.11.20.
61. Morse MA, Chapman R, Powderly J, Blackwell K, Keler T, Green J, Riggs R, He LZ, Ramakrishna V, Vitale L, Zhao B, Butler SA, Hobeika A, Osada T, Davis T, Clay T, Lyerly HK: Phase I study utilizing a novel antigen-presenting cell-targeted vaccine with Toll-like receptor stimulation to induce immunity to self-antigens in cancer patients. Clin Cancer Res 2011, 17:4844-4853. 10.1158/1078-0432.CCR-11-0891.
62. Sharma P, Gnjatic S, Jungbluth AA, Williamson B, Herr H, Stockert E, Dalbagni G, Donat SM, Reuter VE, Santiago D, Chen YT, Bajorin DF, Old LJ: Frequency of NY-ESO-1 and LAGE-1 expression in bladder cancer and evidence of a new NY-ESO-1T-cell epitope in a patient with bladder cancer. Cancer Immun 2003, 3:19.
63. Sharma P, Bajorin DF, Jungbluth AA, Herr H, Old LJ, Gnjatic S: Immune responses detected in urothelial carcinoma patients after vaccination with NY-ESO-1 protein plus BCG and GM-CSF. J Immunother 2008, 31:849-857. 10.1097/CJI.0b013e3181891574.
64. Gnjatic S, Altorki NK, Tang DN, Tu SM, Kundra V, Ritter G, Old LJ, Logothetis CJ, Sharma P: NY-ESO-1 DNA vaccine induces T-cell responses that are suppressed by regulatory T cells. Clin Cancer Res 2009, 15:2130-2139. 10.1158/1078-0432.CCR-08-2632.
65. The Cancer Genome Atlas [https://tcga-data.nci.nih.gov/tcga/]
66. Cancer Genome Atlas Research Network: Comprehensive molecular characterization of urothelial bladder carcinoma. Nature 2014, 507:315-322. 10.1038/nature12965.