Risk-adapted use of intravesical immunotherapy

BJU International

Volumn 102, Issue 9B, 2008, Pages 1254-1264

  Braasch, Matthew R ^a   Böhle, Andreas ^b   O'Donnell, Michael A ^a  

^a UNIVERSITY OF IOWA   (United States)

^b HELIOS AGNES KARLL HOSPITAL   (Germany)

Author keywords

Bladder cancer; Immunotherapy; Survival analysis

Indexed keywords

ACETYLSALICYLIC ACID; ALPHA INTERFERON; BCG VACCINE; GEMCITABINE; ISONIAZID; MITOMYCIN C; NONSTEROID ANTIINFLAMMATORY AGENT; OFLOXACIN; PLACEBO; VALRUBICIN;

ADD ON THERAPY; ANAPHYLAXIS; ARTHRALGIA; BLADDER CANCER; BLADDER CONTRACTURE; CANCER GROWTH; CANCER IMMUNOTHERAPY; CANCER RECURRENCE; CANCER STAGING; CANCER SURGERY; CARCINOMA IN SITU; CHILL; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CYSTITIS; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG WITHDRAWAL; EPIDIDYMITIS; FEVER; FLU LIKE SYNDROME; HEMATURIA; HEPATITIS; HUMAN; INFLUENZA; MONOTHERAPY; ORCHITIS; PAPILLARY CARCINOMA; PNEUMONIA; PRIORITY JOURNAL; PROSTATITIS; RASH; REVIEW; SINGLE DRUG DOSE; SKIN MANIFESTATION; TRANSURETHRAL RESECTION; TREATMENT FAILURE; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; URETHRA CARCINOMA; URETHRITIS;

ADMINISTRATION, INTRAVESICAL; AGED; ANTINEOPLASTIC AGENTS; BCG VACCINE; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; IMMUNOTHERAPY; INTERFERON-ALPHA; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; RISK FACTORS; TREATMENT FAILURE; URINARY BLADDER NEOPLASMS;

EID: 54049094759     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2008.07968.x     Document Type: Review

References (88)

1. Jones JS, Campbell SC. Non-muscle-invasive bladder cancer (Ta, T1, CIS). In Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, Campbell-Walsh Urology, 9th edn, Vol. 3 Chapter 52. Philadelphia : WB Saunders, 2007 : 2447 67
2. 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 : 1964 70
3. Millan-Rodriguez F, Chechile-Toniolo G, Salvador-Bayarri J, Palou J, Vicente-Rodriguez J. Multivariate analysis of the prognostic factors of primary superficial bladder cancer. J Urol 2000 163 : 73 8
4. Shelley MD, Wilt TJ, Court J, Coles B, Kynaston H, Mason MD. Intravesical bacillus Calmette-Guèrin 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 : 485 90
5. Böhle A, Bock PR. Intravesical bacille Calmette-Guèrin versus mitomycin C in superficial bladder cancer: formal meta-analysis of comparative studies on tumor progression. Urology 2004 63 : 682 7
6. Böhle A, Jocham D, Bock PR. Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol 2003 169 : 90 5
7. van der Meijden AP, Sylvester R, Oosterlinck W et al. EAU guidelines on the diagnosis and treatment of urothelial carcinoma in situ. Eur Urol 2005 48 : 363 71
8. 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 : 86 92
9. Lamm DL, Blumenstein BA, Crissman JD 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 : 1124 9
10. Palou J, Baniel J, Klotz L et al. Urothelial carcinoma of the prostate. Urology 2007 69 (Suppl. 50 61
11. Jakse G, Algaba F, Malmstrom PU, Oosterlinck W. A second-look TUR in T1 transitional cell carcinoma: why? Eur Urol 2004 45 : 539 46
12. Oosterlinck W, Lobel B, Jaske G et al. Guidelines on bladder cancer. Eur Urol 2002 41 : 105 12
13. Hall MC, Chang SS, Dalbagni G et al. Guideline for the management of nonmuscle invasive bladder cancer (stages Ta, T1, and Tis): 2007 update. J Urol 2007 178 : 2314 30
14. Sylvester RJ, van der Meijden AP, 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 : 466 77
15. European Organisation for Research and Treatment of Cancer. EORTC Risk Tables for Predicting Recurrence and Progression in Individual Patients with Stage Ta T1 Bladder Cancer. Available at: http://www.eortc.be/tools/ bladdercalculator. Accessed January 2008
16. O'Donnell MA, Böhle A. Treatment options for BCG failures. World J Urol 2006 24 : 481 7
17. Malmström PU, Wijkström H, Lundholm C et al. 5-year followup of a randomized prospective study comparing mitomycin C and bacillus Calmette-Guerin in patients with superficial bladder carcinoma. Swedish-Norwegian Bladder Cancer Study Group. J Urol 1999 161 : 1124 7
18. Witjes JA. Management of BCG failures in superficial bladder cancer: a review. Eur Urol 2006 49 : 790 7
19. Lüftenegger W, Ackermann DK, Futterlieb A et al. Intravesical versus intravesical plus intradermal bacillus Calmette-Guerin: a prospective randomized study in patients with recurrent superficial bladder tumors. J Urol 1996 155 : 483 7
20. Sylvester RJ, van der Meijden AP, Oosterlinck W, Hoeltl W, Bono AV EORTC Genito-Urinary Tract Cancer Group. The side effects of Bacillus Calmette-Guerin in the treatment of Ta T1 bladder cancer do not predict its efficacy: results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial. Eur Urol 2003 44 : 423 8
21. van der Meijden AP, Sylvester RJ, Oosterlinck W, Hoeltl W, Bono AV EORTC Genito-Urinary Tract Cancer Group. Maintenance Bacillus Calmette-Guerin for Ta T1 bladder tumors is not associated with increased toxicity: results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial. Eur Urol 2003 44 : 429 34
22. Saint F, Irani J, Patard JJ et al. Tolerability of bacille Calmette-Guerin maintenance therapy for superficial bladder cancer. Urology 2001 57 : 883 8
23. Losa A, Hurle R, Lembo A. Low dose bacillus Calmette-Guerin for carcinoma in situ of the bladder: long-term results. J Urol 2000 163 : 68 72
24. Lamm DL, Stogdill VD, Stogdill BJ, Crispen RG. Complications of bacillus Calmette-Guerin immunotherapy in 1278 patients with bladder cancer. J Urol 1986 135 : 272 4
25. Martinez-Pineiro JA, Flores N, Isorna S et al. Long-term follow-up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette-Guèrin with a reduced dose of 27 mg in superficial bladder cancer. BJU Int 2002 89 : 671 80
26. Takashi M, Wakai K, Ohno Y, Murase T, Miyake K. Evaluation of a low-dose intravesical bacillus Calmette-Guèrin (Tokyo strain) therapy for superficial bladder cancer. Int Urol Nephrol 1995 27 : 723 33
27. Martinez-Pineiro JA, Martinez-Pineiro L, Solsona E et al. Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol 2005 174 : 1242 7
28. Ojea A, Nogueira JL, Solsona E et al. A multicentre, randomised prospective trial comparing three intravesical adjuvant therapies for intermediate-risk superficial bladder cancer: low-dose bacillus Calmette-Guerin (27 mg) versus very low-dose bacillus Calmette-Guerin (13.5 mg) versus mitomycin C. Eur Urol 2007 52 : 1398 406
29. Bassi P, Spinadin R, Carando R, Balta G, Pagano F. Modified induction course: a solution to side-effects? Eur Urol 2000 37 (Suppl. 1 31 2
30. Andius P, Fehrling M, Holmang S. Intravesical bacillus Calmette-Guerin therapy: experience with a reduced dwell-time in patients with pronounced side-effects. BJU Int 2005 96 : 1290 3
31. Colombel M, Saint F, Chopin D, Malavaud B, Nicolas L, Rischmann P. The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer: results of a randomized, prospective, double-blind, placebo controlled, multicenter study. J Urol 2006 176 : 935 9
32. van der Meijden AP, Brausi M, Zambon V et al. Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary carcinoma of the bladder: a European Organization for Research and Treatment of Cancer genito-urinary group randomized phase III trial. J Urol 2001 166 : 476 81
33. Schrier BP, Hollander MP, van Rhijn BW, Kiemeney LA, Witjes JA. Prognosis of muscle-invasive bladder cancer: difference between primary and progressive tumours and implications for therapy. Eur Urol 2004 45 : 292 6
34. Herr HW, Badalament RA, Amato DA, Laudone VP, Fair WR, Whitmore WF Jr. Superficial bladder cancer treated with bacillus Calmette-Guerin: a multivariate analysis of factors affecting tumor progression. J Urol 1989 141 : 22 9
35. Klein EA, Rogatko A, Herr HW. Management of local bacillus Calmette-Guerin failures in superficial bladder cancer. J Urol 1992 147 : 601 5
36. Fernandez-Gomez J, Solsona E, Unda M et al. Prognostic factors in patients with non-muscle-invasive bladder cancer treated with bacillus Calmette-Guerin: multivariate analysis of data from four randomized CUETO trials. Eur Urol 2008 53 : 992 1001
37. Solsona E, Iborra I, Dumont R, Rubio-Briones J, Casanova J, Almenar S. The 3-month clinical response to intravesical therapy as a predictive factor for progression in patients with high risk superficial bladder cancer. J Urol 2000 164 : 685 9
38. Ovesen H, Horn T, Steven K. Long-term efficacy of intravesical bacillus Calmette-Guerin for carcinoma in situ: relationship of progression to histological response and p53 nuclear accumulation. J Urol 1997 157 : 1655 9
39. Lockyer CR, Sedgwick JE, Gillatt DA. Beware the BCG failures: a review of one institution's results. Eur Urol 2002 42 : 542 6
40. Lerner SP, Tangen CM, Sucharew H, Wood D, Crawford ED. Patterns of recurrence and outcomes following induction bacillus Calmette-Guerin for high risk Ta, T1 bladder cancer. J Urol 2007 177 : 1727 31
41. Hurle R, Losa A, Manzetti A, Lembo A. Intravesical bacille Calmette-Guèrin in Stage T1 grade 3 bladder cancer therapy: a 7-year follow-up. Urology 1999 54 : 258 63
42. Mulders PF, Meyden AP, Doesburg WH, Oosterhof GO, Debruyne FM. Prognostic factors in pTa-pT1 superficial bladder tumours treated with intravesical instillations. The Dutch South-Eastern Urology Collaborative Group. Br J Urol 1994 73 : 403 8
43. Okamura T, Tozawa K, Yamada Y, Sakagami H, Ueda K, Kohri K. Clinicopathological evaluation of repeated courses of intravesical bacillus Calmette-Guerin instillation for preventing recurrence of initially resistant superficial bladder cancer. J Urol 1996 156 : 967 71
44. Shariat SF, Karakiewicz PI, Palapattu GS et al. Nomograms provide improved accuracy for predicting survival after radical cystectomy. Clin Cancer Res 2006 12 : 6663 76
45. Türkölmez K, Tokgöz H, Resorlu B, Köse K, Bedük Y. Muscle-invasive bladder cancer: predictive factors and prognostic difference between primary and progressive tumors. Urology 2007 70 : 477 81
46. Quek ML, Stein JP, Nichols PW et al. Prognostic Significance of lymphovascular invasion of bladder cancer treated with radical cystectomy. J Urol 2005 174 : 103 6
47. Lotan Y, Gupta A, Shariat SF et al. Lymphovascular invasion is independently associated with overall survival, cause-specific survival, and local and distant recurrence in patients with negative lymph nodes at radical cystectomy. J Clin Oncol 2005 23 : 6533 9
48. Lee T, Montie JE, Zhang YX, Dunn RL, Wood DP. Lymphovascular invasion is an independent predictor of survival in CT1 bladder cancer. J Urol 2005 173 (Suppl. 246, Abstract 911
49. Kamat AM, Dinney CP, Gee JR et al. Micropapillary bladder cancer: a review of the University of Texas M. D. Anderson Cancer Center experience with 100 consecutive patients. Cancer 2007 110 : 62 7
50. OíDonnell MA. Advances in the management of superficial bladder cancer. Semin Oncol 2007 34 : 85 97
51. Huguet J, Crego M, Sabate S, Salvador J, Palou J, Villavicencio H. Cystectomy in patients with high risk superficial bladder tumors who fail intravesical BCG therapy: pre-cystectomy prostate involvement as a prognostic factor. Eur Urol 2005 48 : 53 9
52. Taylor JH, Davis J, Schellhammer P. Long-term follow-up of intravesical bacillus Calmette-Guèrin treatment for superficial transitional-cell carcinoma of the bladder involving the prostatic urethra. Clin Genitourin Cancer 2007 5 : 386 9
53. Lebret T, Gaudez F, Hervè JM, Barrè P, Lugagne PM, Botto H. Low-dose BCG instillations in the treatment of stage T1 grade 3 bladder tumours: recurrence, progression and success. Eur Urol 1998 34 : 67 72
54. Lynch CF, Cohen MB. Urinary system. Cancer 1995 75 (Suppl. 316 29
55. Narayana AS, Loening SA, Slymen DJ, Culp DA. Bladder cancer: factors affecting survival. J Urol 1983 130 : 56 60
56. Takashi M, Murase T, Mizuno S, Hamajima N, Ohno Y. Multivariate evaluation of prognostic determinants in bladder cancer patients. Urol Int 1987 42 : 368 74
57. Rodríguez-Alonso A, Pita-Fernández S, González- Carreró J, Nogueira-March JL. Multivariate analysis of survival, recurrence, progression and development of metastasis in T1 and T2a transitional cell bladder carcinoma. Cancer 2002 94 : 1677 84
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-Guèrin plus interferon alpha-2B for reducing recurrence of superficial bladder cancer. Urol Oncol 2006 24 : 344 8
59. Saint F, Patard JJ, Maille P et al. Prognostic value of a T helper 1 urinary cytokine response after intravesical bacillus Calmette-Guerin treatment for superficial bladder cancer. J Urol 2002 167 : 364 7
60. Lebret T, Bohin D, Kassardjian Z et al. Recurrence, progression and success in stage Ta grade 3 bladder tumors treated with low dose bacillus Calmette-Guerin instillations. J Urol 2000 163 : 63 7
61. Kipp BR, Karnes RJ, Brankley SM et al. Monitoring intravesical therapy for superficial bladder cancer using fluorescence in situ hybridization. J Urol 2005 173 : 401 4
62. Mengual L, Marin-Aguilera M, Ribal MJ et al. Clinical utility of fluorescent in situ hybridization for the surveillance of bladder cancer patients treated with bacillus Calmette-Guèrin therapy. Eur Urol 2007 52 : 752 9
63. Watanabe E, Matsuyama H, Matsuda K et al. Urinary interleukin-2 may predict clinical outcome of intravesical bacillus Calmette-Guèrin immunotherapy for carcinoma in situ of the bladder. Cancer Immunol Immunother 2003 52 : 481 6
64. de Reijke TM, de Boer EC, Kurth KH, Schamhart DH. Urinary cytokines during intravesical bacillus Calmette-Guerin therapy for superficial bladder cancer: processing, stability and prognostic value. J Urol 1996 155 : 477 82
65. Saint F, Kurth N, Maille P et al. Urinary IL-2 assay for monitoring intravesical bacillus Calmette-Guèrin response of superficial bladder cancer during induction course and maintenance therapy. Int J Cancer 2003 107 : 434 40
66. Thalmann GN, Sermier A, Rentsch C, Möhrle K, Cecchini MG, Studer UE. Urinary Interleukin-8 and 18 predict the response of superficial bladder cancer to intravesical therapy with bacillus Calmette-Guerin. J Urol 2000 164 : 2129 33
67. Orsola A, Trias I, Raventós CX et al. Initial high-grade T1 urothelial cell carcinoma: feasibility and prognostic significance of lamina propria invasion microstaging (T1a/b/c) in BCG-treated and BCG-non-treated patients. Eur Urol 2005 48 : 231 8
68. Mhawech-Fauceglia P, Fischer G, Alvarez V Ahmed A, Herrmann FR. Predicting outcome in minimally invasive (T1a and T1b) urothelial bladder carcinoma using a panel of biomarkers: a high throughput tissue microarray analysis. BJU Int 2007 100 : 1182 7
69. Lamm DL, Griffith JG. Intravesical therapy: does it affect the natural history of superficial bladder cancer? Semin Urol 1992 10 : 39 44
70. Prout GR Wesley MN, Yancik R, Ries LA, Havlik RJ, Edwards BK. Age and comorbidity impact surgical therapy in older bladder carcinoma patients: a population-based study. Cancer 2005 104 : 1638 47
71. Mendiola FP, Zorn KC, Gofrit ON et al. Cystectomy in the ninth decade: operative results and long-term survival outcomes. Can J Urol 2007 14 : 3628 34
72. Thalmann GN, Markwalder R, Shahin O, Burkhard FC, Hochreiter WW, Studer UE. Primary T1G3 bladder cancer: organ preserving approach or immediate cystectomy? J Urol 2004 172 : 70 5
73. Bui TT, Schellhammer PF. Additional bacillus Calmette-GuÈrin therapy for recurrent transitional cell carcinoma after an initial complete response. Urology 1997 49 : 687 91
74. O'Donnell MA, Maymi JL. Complications of intravesical therapy. In Loughlin KR, Complications of Urologic Surgery and Practice. London : Informa Healthcare, 2007 : 455 75
75. Belldegrun AS, Franklin JR, O'Donnell MA et al. Superficial bladder cancer: the role of interferon-alpha. J Urol 1998 159 : 1793 801
76. Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol 2000 163 : 761 7
77. Dalbagni G, Russo P, Bochner B et al. Phase II trial of intravesical gemcitabine in bacille Calmette-Guèrin-refractory transitional cell carcinoma of the bladder. J Clin Oncol 2006 24 : 2729 34
78. Maymi JL, Saltsgaver N, O'Donnell MA. Intravesical sequential gemcitabine-mitomycin chemotherapy as salvage treatment for patients with refractory superficial bladder cancer. J Urol 2006 174 (Suppl. 271, Abstract 840
79. Hendricksen K, Witjes JA. Current strategies for first and second line intravesical therapy for nonmuscle invasive bladder cancer. Curr Opin Urol 2007 17 : 352 7
80. Luo Y, Chen X, Downs TM, DeWolf WC, O'Donnell MA. IFN-alpha 2B enhances Th1 cytokine responses in bladder cancer patients receiving Mycobacterium bovis bacillus Calmette-Guèrin immunotherapy. J Immunol 1999 162 : 2399 405
81. Punnen SP, Chin JL, Jewett MA. Management of bacillus Calmette-Guerin (BCG) refractory superficial bladder cancer: results with intravesical BCG and Interferon combination therapy. Can J Urol 2003 10 : 1790 5
82. O'Donnell MA, Krohn J, DeWolf WC. Salvage intravesical therapy with interferon-alpha 2b plus low dose bacillus Calmette-Guerin is effective in patients with superficial bladder cancer in whom bacillus Calmette-Guerin alone previously failed. J Urol 2001 166 : 1300 5
83. Luciani LG, Neulander E, Murphy WM, Wajsman Z. Risk of continued intravesical therapy and delayed cystectomy in BCG-refractory superficial bladder cancer: an investigational approach. Urology 2001 58 : 376 9
84. Lam JS, Benson MC, O'Donnell MA et al. Bacillus Calmete-Guèrin plus interferon-alpha2B intravesical therapy maintains an extended treatment plan for superficial bladder cancer with minimal toxicity. Urol Oncol 2003 21 : 354 60
85. Maymi JL, O'Donnell MA, for the National BCG/Interferon Investigator Group. Factors affecting response to BCG plus interferon in patients with urothelial carcinoma in situ. J Urol 2005 173 (Suppl. 248, Abstract 918
86. O'Donnell MA, Lilli K, Leopold C National Bacillus Calmette-Guerin/ Interferon Phase 2 Investigator Group. Interim results from a national multicenter phase II trial of combination bacillus Calmette-Guerin plus interferon alfa-2b for superficial bladder cancer. J Urol 2004 172 : 888 93
87. Gallagher BL, Joudi FN, Maymi JL, O'Donnell MA. Impact of prior BCG failure pattern on subsequent response to BCG plus interferon intravesical therapy. Urology 2008 71 : 297 301
88. Joudi FN, Smith BJ, O'Donnell MA, Konety BR. The impact of age on the response of patients with superficial bladder cancer to intravesical immunotherapy. J Urol 2006 175 : 1634 40