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References: Bladder cancer

121 sources cited on this page. Links open the primary source.

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  2. CASE RA, PEARSON JT. Tumours of the urinary bladder in workmen engaged in the manufacture and use of certain dyestuff intermediates in the British chemical industry. II. Further consideration of the role of aniline and of the manufacture of auramine and magenta (fuchsine) as possible causative agents. Br J Ind Med. 1954;11(3):213-6. PubMedDOI
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  6. Lamm DL, Blumenstein BA, Crawford ED, Montie JE, Scardino P, Grossman HB, et al. A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder. N Engl J Med. 1991;325(17):1205-9. PubMedDOI
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  7. Loehrer PJ Sr, Einhorn LH, Elson PJ, Crawford ED, Kuebler P, Tannock I, et al. A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol. 1992;10(7):1066-73. PubMedDOI
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  8. International Collaboration of Trialists. Neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: a randomised controlled trial. Lancet. 1999;354(9178):533-40. PubMedDOI
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  9. Lamm DL, Blumenstein BA, Crissman JD, Montie JE, Gottesman JE, Lowe BA, et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. J Urol. 2000;163(4):1124-9. PubMedDOI
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  10. von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, 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):3068-77. PubMedDOI
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  11. Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001;19(3):666-75. PubMedDOI
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  12. Sylvester RJ, van der MEIJDEN AP, 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):1964-70. PubMedDOI
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  13. Advanced Bladder Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis. Lancet. 2003;361(9373):1927-34. PubMedDOI
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  14. Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003;349(9):859-66. PubMedDOI
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  15. Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer: a meta-analysis of published results of randomized clinical trials. J Urol. 2004;171(6 Pt 1):2186-90, quiz 2435. PubMedDOI
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  16. Sylvester RJ, van der Meijden AP, Witjes JA, Kurth K. Bacillus calmette-guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials. J Urol. 2005;174(1):86-91; discussion 91-2. PubMedDOI
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  17. von der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, 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):4602-8. PubMedDOI
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  18. Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, 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). PubMedDOI
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  20. International Collaboration of Trialists, 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(16):2171-7. PubMedDOI
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  22. Efstathiou JA, Spiegel DY, Shipley WU, Heney NM, Kaufman DS, Niemierko A, et al. Long-term outcomes of selective bladder preservation by combined-modality therapy for invasive bladder cancer: the MGH experience. Eur Urol. 2012;61(4):705-11. PubMedDOI
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  23. James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012;366(16):1477-88. PubMedDOI
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  24. Mak RH, Hunt D, Shipley WU, Efstathiou JA, Tester WJ, Hagan MP, et al. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: a pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol. 2014;32(34):3801-9. PubMedDOI
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  25. FDA. Accelerated approval letter, BLA 761034 (Tecentriq, atezolizumab), signed 18 May 2016. Source
  26. Kamat AM, Sylvester RJ, Böhle A, Palou J, Lamm DL, Brausi M, et al. Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group. J Clin Oncol. 2016;34(16):1935-44. PubMedDOI
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  27. Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, 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):1909-20. PubMedDOI
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  28. Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, 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. PubMedDOI
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  29. Balar AV, Castellano D, O'Donnell PH, Grivas P, Vuky J, Powles T, 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. PubMedDOI
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  30. Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, et al. Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med. 2017;376(11):1015-1026. PubMedDOI
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  31. FDA. Replacement approval letter, BLA 761069 (Imfinzi, durvalumab); the effective approval date remains 1 May 2017 (replacement letter corrects a manufacturing-facility error); includes accelerated approval requirements. Source
  32. FDA. Accelerated approval letter, BLA 125514/S-017 (Keytruda, pembrolizumab; urothelial carcinoma ineligible for cisplatin), signed 18 May 2017. Source
  33. FDA. Supplement approval letter, BLA 125514/S-018 (Keytruda, pembrolizumab; urothelial carcinoma after platinum-containing chemotherapy), signed 18 May 2017. Source
  34. FDA. Tecentriq (atezolizumab) prescribing information, BLA 761034/S-001, revised 4/2017. Source
  35. FDA. Accelerated approval letter, BLA 761034/S-001 (Tecentriq, atezolizumab; urothelial carcinoma in patients not eligible for cisplatin-containing chemotherapy), signed 17 April 2017. Source
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  37. Powles T, O'Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, 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. PubMedDOI
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  38. Powles T, Durán I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, 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. PubMedDOI
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  39. Coen JJ, Zhang P, Saylor PJ, Lee CT, Wu CL, Parker W, et al. Bladder Preservation With Twice-a-Day Radiation Plus Fluorouracil/Cisplatin or Once Daily Radiation Plus Gemcitabine for Muscle-Invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial. J Clin Oncol. 2019;37(1):44-51. PubMedDOI
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  40. FDA. Accelerated approval letter, NDA 212018 (Balversa, erdafitinib), signed 12 April 2019. Source
  41. FDA. Accelerated approval letter, BLA 761137 (Padcev, enfortumab vedotin-ejfv), signed 18 December 2019. Source
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  44. Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, 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. PubMedDOI
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  45. EMA. Bavencio (avelumab): European public assessment report page; lists first-line maintenance treatment of urothelial carcinoma among its indications; conditional marketing authorisation of 18 September 2017 switched to full authorisation on 19 August 2020 (page read 20 October 2026). Source
  46. FDA. Supplement approval and fulfilment of postmarketing requirement letter, BLA 761049/S-009 (Bavencio, avelumab; maintenance treatment of urothelial carcinoma), signed 30 June 2020. Source
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  49. Vuky J, Balar AV, Castellano D, O'Donnell PH, Grivas P, Bellmunt J, 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. PubMedDOI
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  50. Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, et al. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021;384(22):2102-2114. PubMedDOI
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  51. Balar AV, Kamat AM, Kulkarni GS, Uchio EM, Boormans JL, Roumiguié M, et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol. 2021;22(7):919-930. PubMedDOI
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  53. FDA. Supplement approval letter, BLA 761069/S-029 (Imfinzi, durvalumab; removal of an indication previously approved under accelerated approval), signed 19 February 2021. Source
  54. FDA. Supplement approval and fulfilment of postmarketing requirement letter, BLA 761137/S-006 and S-008 (Padcev, enfortumab vedotin-ejfv), signed 9 July 2021. Source
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  70. FDA. Accelerated approval letter, BLA 125514/S-136 (Keytruda, pembrolizumab, in combination with enfortumab vedotin), signed 3 April 2023. Source
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