Intravesical gemcitabine for superficial bladder cancer: Rationale for a new treatment option

BJU International

Volumn 96, Issue 7, 2005, Pages 970-976

  Gontero, Paolo ^a   Marini, Luca ^b   Frea, Bruno ^a  

^a UNIVERSITY OF EASTERN PIEDMONT   (Italy)

^b Eli Lilly Italia   (Italy)

Author keywords

Gemcitabine; Immunotherapy; Intravesical chemotherapy; Superficial bladder cancer

Indexed keywords

ALPHA2B INTERFERON; ANTINEOPLASTIC AGENT; BCG VACCINE; DOXORUBICIN; GEMCITABINE; MITOMYCIN C;

ABDOMINAL DISCOMFORT; ARTHRALGIA; ASTHENIA; BLADDER CANCER; BONE MARROW SUPPRESSION; CANCER CELL CULTURE; CANCER CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL TRIAL; CYSTITIS; DIZZINESS; DRUG CYTOTOXICITY; DRUG EFFICACY; DRUG MECHANISM; DRUG METABOLISM; DYSURIA; FATIGUE; HEADACHE; HUMAN; LIVER TOXICITY; MAJOR CLINICAL STUDY; MYALGIA; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; PRURITUS; SHORT SURVEY; THROMBOCYTOPENIA; TREATMENT OUTCOME; URINE INCONTINENCE; URINE RETENTION; VOMITING;

ADMINISTRATION, INTRAVESICAL; ANTIMETABOLITES, ANTINEOPLASTIC; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; HUMANS; PATIENT SELECTION; URINARY BLADDER NEOPLASMS;

EID: 27444441191     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2005.05739.x     Document Type: Short Survey

References (50)

1. Herr HW. Tumour progression and survival in patients with T1G3 bladder tumours: 15-years outcome. Br J Urol 1997; 80: 762-5
2. Hudson MA, Herr HW. Carcinoma in situ of the bladder. J Urol 1995; 153: 564-72
3. Oosterlinck W, Lobel B, Jakse G, Malmstrom PU, Stockle M, Sternberg C. Guidelines on bladder cancer. European Association of Urology (EAU) Working Group on Oncological Urology. Eur Urol 2002; 41: 105-12
4. Solsona E, Iborra I, Ricos JV, Monros JL, Casanova J, Dumont R. Effectiveness of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer: short and long-term followup. J Urol 1999; 161: 1120-3
5. Lamm DL. Intravesical therapy for superficial bladder cancer: slow but steady progress. J Clin Oncol 2003; 21: 4259-60
6. Bohle 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. Huncharek M, Kupelnick B. Impact of intravesical chemotherapy versus BCG immunotherapY on recurrence of superficial transitional cell carcinoma of the bladder: metaanalytic reevaluation. Am J Clin Oncol 2003; 26: 402-7
8. Krege S, Giani G, Meyer R, Otto T, Rubben H. A randomized multicenter trial of adjuvant therapy in superficial bladder cancer: transurethral resection only versus transurethral resection plus mitomycin C versus transurethral resection plus bacillus Calmette-Guerin. Participating Clinics. J Urol 1996; 156: 962-6
9. Sylvester RJ, van der Mejden 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
10. Bohle A, Bock PR. Intravesical bacille Calmette-Guerin versus mitomycin C in superficial bladder cancer, formal meta-analysis of comparative studies on tumor progression. Urology 2004; 63: 682-6
11. Peyromaure M, Guerin F, Amsellem-Ouazana D, Saighi D, Debre B, Zerbib M. Intravesical bacillus Calmette-Guerin therapy for stage T1 grade 3 transitional cell carcinoma of the bladder: recurrence, progression and survival in a study of 57 patients. J Urol 2003; 169: 2110-2
12. Shahin O, Thalmann GN, Rentsch C, Mazzucchelli L, Studer UE. A retrospective analysis of 153 patients treated with or without intravesical bacillus Calmette-Guerin for primary stage T1 grade 3 bladder cancer: recurrence, progression and survival. J Urol 2003; 169: 96-100
13. Malauvaud B. T1G3 bladder tumours: the case for radical cystectomy. Eur Urol 2004; 45: 406-10
14. Witjes JA. Bladder carcinoma in situ in 2003. state of the art. Eur Urol 2004; 45: 142-6
15. Herr HW, Dalbagni G. Defining bacillus calmette-guerin refractory superficial bladder tumors. J Urol 2003; 169: 1706-8
16. 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
17. Kaasinen E, Wijkstrom H, Malmstrom PU et al. Alternating mitomycin C and BCG instillations versus BCG alone in treatment of carcinoma in situ of the urinary bladder: a Nordic study. Eur Urol 2003; 43: 637-45
18. Joudi FN, O'Donnell MA. Second-line intravesical therapy versus cystectomy for bacille Calmette-Guerin (BCG) failures. Curr Opin Urol 2004; 14: 271-5
19. van der Meijden AP, Sylvester RJ, Oosterlinck W et al. 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
20. 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
21. Sylvester RJ, van der Meijden AP, Oosterlinck W et al. 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
22. Konety BR, Williams RD. Superficial transitional (Ta/T1/CIS) cell carcinoma of the bladder. BJU Int 2004; 94: 18-21
23. Bergman AM, Pinedo HM, Peters GJ. Determinants of resistance to 2′,2′-difluorodeoxycytidine (gemcitabine). Drug Resist Updat 2002; 5: 19-33
24. Stadler WM, Kuzel T, Roth B, Raghavan D, Dorr FA. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol 1997; 15: 3394-8
25. 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. Italian Co-operative Group on Bladder Cancer. Eur J Cancer 1998; 34: 1208-12
26. Laufer M, Ramalingam S, Schoenberg MP et al. Intravesical gemcitabine therapy for superficial transitional cell carcinoma of the bladder: a phase I and pharmacokinetic study. J Clin Oncol 2003; 21: 697-703
27. Kilani RT, Tamimi Y, Karmali S et al. Selective cytotoxicity of gemcitabine in bladder cancer cell lines. Anticancer Drugs 2002; 13: 557-66
28. O'Donnell MA, Evanoff D, Luo Y. Studies on Gemcitabine as an intravesical agent for superficial bladder cancer. J Urol Supplement 2003; 4: 508
29. Cozzi PJ, Bajorin DF, Tong W et al. Toxicology and pharmacokinetics of intravesical gemcitabine: a preclinical study in dogs. Clin Cancer Res 1999; 5: 2629-37
30. Witjes JA, Vriesema JL, van der Heijden AG, Peters GJ, Schalken JA. Pharmacokinetics of intravesical gemcitabine: a preclinical study in pigs. Eur Urol 2003; 44: 615-9
31. Matera M, Costantino G, Clementi G, Lempereur L, Vasta D, Vasquez E. Experimental study on the toxicity and the local and systemic tolerability of gemcitabine after topical treatment of the rabbit bladder. Oncol Rep 2004; 11: 1145-51
32. Kroep JR, Giaccone G, Voorn DA et al. Gemcitabine and paclitaxel: pharmacokinetic and pharmacodynamic interactions in patients with non-small-cell lung cancer. J Clin Oncol 1999; 17: 2190-7
33. Dalbagni G, Russo P, Sheinfeld J et al. Phase I trial of intravesical gemcitabine in bacillus Calmette-Guerin-refractory transitional-cell carcinoma of the bladder. J Clin Oncol 2002; 20: 3193-8
34. De Berardinis E, Antonini G, Peters GJ et al. Intravesical administration of gemcitabine in superficial bladder cancer: a phase I study with pharmacodynamic evaluation. BJU Int 2004; 93: 491-4
35. Witjes JA, van der Heijden AG, Vriesema JL, Peters GJ, Laan A, Schalken J. Intravesical gemcitabine. a phase 1 and pharmacokinetic study. Eur Urol 2004; 45: 182-6
36. Palou J, Carcas A, Segarra J et al. Phase I pharmacokinetic study of a single intravesical instillation of gemcitabine administered immediately after transurethral resection plus multiple random biopsies in patients with superficial bladder cancer. J Urol 2004; 172: 485-8
37. Trotti A, Colevas AD, Setser A et al. CTC-AE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003; 13: 176-81
38. Benet LZ, Kroetz DL, Sheiner LB. Pharmacokinetics. the dynamics of drug absorbtion, distribution and elimination, In Hanehman JG, Limbird LE eds, Goodman and Gilman. The Pharmacological Basis of Therapeutics, Edn 9. New York: Mc Graw-Hill, 1996: 4
39. Lamm DL, van der Meijden APM, Akaza H. Intravesical chemo- and immunotherapy. How do we assess their effectiveness and what are their limitations and uses? Proceedings of the Fourth International Bladder Cancer Consensus Conference. Int J Urol 1995; 2 (Suppl. 2): 23-35
40. Van der Meijden APM, Hall RR, Kurth KH, Bouffioux CH. Phase II trials in Ta, T1 bladder cancer. The marker tumour concept. A review. Br J Urol 1996; 77: 634-7
41. Hall RR. Transurethral resection for transitional cell carcinoma. Problems Urol 1992; 6: 460-70
42. Van der Meijden AP, Hall RR, Pavone Macaluso M, Pawinsky A, Sylvester R, Van Glabbeke M. Marker tumour response to the sequential combination of intravesical therapy with Mitomycin C and BCG-RIVM in multiple superficial bladder tumours. Report from the European Organization for Research and Treatment on Cancer- Genitourinary Group (EORTC 30897). Eur Urol 1996; 29: 199-203
43. Fellows G, Parmar M, Grigor R, Hall RR, Heal MR, Wallace MA. Marker tumour response to Evans and Pasteur BCG in multiple recurrent pTa, pT1 bladder tumours. Report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). Br J Urol 1994; 73: 639-44
44. Popert RJ, Goodall J, Coptcoat MJ, Thompson PM, Parmar MK. Superficial bladder cancer, the response of a marker tumour to a single intravesical instillation of Epirubicin. Br J Urol 1994; 74: 195-6
45. Mack D, Holtl W, Bassi P et al. The ablative effect of quarter dose BCG on a papillary lesion of the bladder. J Urol 2001; 165: 401-3
46. Gontero P, Casetta G, Maso G et al. Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC). Eur Urol 2004; 46: 339-43
47. De Berardinis E, Antonini G, Autran Gomez AM, Codacci Pisanelli G, Di Silverio F, Peters GJ. Intravesical administration of Gemcitabine in superficial bladder cancer: a phase I study with pharmacodynamic evaluation. A phase II study with chemoresection of the marker lesion. J Urol 2004; 171: A275
48. Serretta V, Pavone C, Galuffo A et al. A phase I-II study on intravesical gemcitabine in superficial bladder papillary tumors. J Urol 2004; 171: A272
49. Dalbagni G, Mazumdar M, Russo P et al. Phase II trial of intravesical gemcitabine in BCG-refractory transitional cell carcinoma of the bladder. J Urol 2004; 171: A274
50. Bouzid K, Ferhat A, Bounedjar A, Mahfouf H, Smaili K, Adjali K. Intravesical gemcitabine single agent as adjuvant chemotherapy in superficial transitional cell carcinoma (TCC) of the bladder. JCO 2004; 22 (Suppl): A4601