Single Postoperative Instillation of Gemcitabine in Patients with Non-muscle-invasive Transitional Cell Carcinoma of the Bladder: A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Study

European Urology

Volumn 56, Issue 3, 2009, Pages 495-503

  Böhle, Andreas ^a   Leyh, Herbert ^b   Frei, Christian ^b   Kühn, Michael ^c   Tschada, Reinhold ^d   Pottek, Tobias ^e   Wagner, Walter ^d   Knispel, Helmut H ^f   von Pokrzywnitzki, Wolfgang ^g   Zorlu, Ferruh ^h   Helsberg, Karin ⁱ   Lübben, Birgit ⁱ   Soldatenkova, Victoria ⁱ   Stoffregen, Clemens ⁱ   Büttner, Hartwig ⁱ  

^a Bad Schwartau

^b Klinikum Garmisch Partenkirchen   (Germany)

^c Johanniter Hospital   (Germany)

^d Diakonissenkrankenhaus Mannheim ^*  (Germany)

^e Klinikum Wedel   (Germany)

^f St Hedwig Hospital   (Germany)

^g VIVANTES KLINIKUM AM URBAN   (Germany)

^h SSK Tepecik Research and Education Hospital   (Turkey)

ⁱ LILLY DEUTSCHLAND GMBH   (Germany)

Author keywords

Gemcitabine; Non muscle invasive bladder cancer; Transurethral resection

Indexed keywords

BCG VACCINE; GEMCITABINE;

ADULT; AGED; ALOPECIA; ARTICLE; BLADDER CARCINOMA; CARCINOMA IN SITU; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYSTOSCOPY; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FEVER; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAIN; PEROPERATIVE COMPLICATION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT CANCER; SINGLE DRUG DOSE; TRANSITIONAL CELL CARCINOMA; TRANSURETHRAL RESECTION;

ADMINISTRATION, INTRAVESICAL; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; CARCINOMA, TRANSITIONAL CELL; COMBINED MODALITY THERAPY; DEOXYCYTIDINE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; POSTOPERATIVE CARE; URINARY BLADDER NEOPLASMS;

EID: 67651008250     PISSN: 03022838     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eururo.2009.06.010     Document Type: Article

References (32)

1. Sylvester R.J., van der Meijden A.P.M., 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 49 (2006) 466-477
2. Sylvester R.J., Oosterlinck W., and van der Meijden A. 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 171 (2004) 2186-2190
3. Babjuk M., Oosterlinck W., Sylvester R., Kaasinen E., Böhle A., and Palou-Redorta J. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder. Eur Urol 54 (2008) 303-314
4. Hall M.C., Chang S.S., Dalbagni G., et al. Guideline for the management of nonmuscle invasive bladder cancer (stages Ta, T1, and Tis): 2007 update. J Urol 178 (2007) 2314-2330
5. Grimm M.O., Steinhoff C., Simon X., Spiegelhalder P., Ackermann R., and Vogeli T.A. Effect of routine repeat transurethral resection for superficial bladder cancer: a long-term observational study. J Urol 170 (2003) 433-437
6. Nieder A.M., Brausi M., Lamm D., et al. Management of stage T1 tumours of the bladder: International Consensus Panel. Urology 6 Suppl 1 (2005) 108-125
7. Böhle A., Jocham D., and Bock P.R. Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol 169 (2003) 90-95
8. Braasch M.R., Böhle A., and O'Donnell M.A. Risk-adapted use of intravesical immunotherapy. BJU Int 102b (2008) 1254-1264
9. Gontero P., Marini L., and Frea B. Intravesical gemcitabine for superficial bladder cancer: rationale for a new treatment option. BJU Int 96 (2005) 970-976
10. Stadler W.M., Kuzel T., Roth B., Raghavan D., and Dorr F.A. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol 15 (1997) 3394-3398
11. Lorusso V., Pollera C.F., 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 34 (1998) 1208-1212
12. Brocks C.P., Büttner H., and Böhle A. Inhibition of tumor implantation by intravesical gemcitabine in a murine model of superficial bladder cancer. J Urol 174 (2005) 1115-1118
13. Gontero P., and Tizzani A. Intravesical gemcitabine: state of the art. Eur Urol Suppl 6 (2007) 809-815
14. 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 172 (2004) 485-488
15. Buettner H., Stoffregen C., Heyer J., Nentwig A., and Böhle A. Immediate postoperative instillation of gemcitabine after transurethral resection of bladder tumors [abstract]. J Clin Oncol 22 (2004) 4685
16. Buettner H., Stoffregen C., Heinemann V., and Böhle A. Immediate postoperative instillation of gemcitabine into the bladder in patients with superficial bladder cancer [abstract]. Proc Am Soc Clin Oncol 22 (2003) 1785
17. Okamura K., Ono Y., Kinukawa T., et al. Randomized study of single early instillation of (2′′R)-4′-O-tetrahydropyranyl-doxorubicin for a single superficial bladder carcinoma. Cancer 94 (2002) 2363-2368
18. Oosterlinck W., Kurth K.H., Schröder F., Bultinck J., Hammond B., Sylvester R., European Organization for Research, and Treatment of Cancer. A prospective European Organization for Research and Treatment of Cancer genitourinary group randomized trial comparing transurethral resection followed by a single intravesical instillation of epirubicin or water in single stage Ta,T1 papillary carcinoma of the bladder. J Urol 149 (1993) 749-752
19. Rajala P., Kaasinen E., Raitanen M., Luikkonen T., Rintala E., and FinBladder Group. Perioperative single dose instillation of epirubicin or interferon-alpha after transurethral resection for the prophylaxis of primary superficial bladder cancer recurrence: a prospective randomized multicenter study-FinBladder III long-term results. J Urol 168 (2002) 981-985
20. American Joint Committee on Cancer. Urinary bladder. American Joint Committee on Cancer: AJCC Cancer Staging Manual. 6th ed (2002), Springer, New York, NY 335-340
21. Pampallona S., Tsiatis A.A., and Kim K.M. Interim monitoring of group sequential trials using spending functions for the type I and type II error probabilities. Drug Inf J 35 (2001) 1113-1121
22. Gudjónsson S., Adell L., Merdasa F., et al. Should all patients with non-muscle-invasive bladder cancer receive early intravesical chemotherapy after transurethral resection? The results of a prospective randomised multicentre study. Eur Urol 55 (2009) 773-780
23. Berrum-Svennung I., Granfors T., Jahnson S., Boman H., and Holmäng S. A single instillation of epirubicin after transurethral resection of bladder tumors prevents only small recurrences. J Urol 179 (2008) 101-105
24. Symon Z., Davis M., McGinn C.J., Zalupski M.M., and Lawrence T.S. Concurrent chemoradiotherapy with gemcitabine and cisplatin for pancreatic cancer: from the laboratory to the clinic. Int J Radiat Oncol Biol Phys 53 (2002) 140-145
25. Heinemann V., Hertel L.W., Grindey G.B., and Plunkett W. Comparison of the cellular pharmacokinetics and toxicity of 2',2'-difluorodeoxycytidine and 1-beta-D-arabinofuranosylcytosine. Cancer Res 48 (1988) 4024-4031
26. Gårdmark T., Carringer M., Beckman E., Malmström P.U., and Intravesical Gemcitabine Study Group. Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent stage Ta urothelial cell carcinoma of the bladder. Urology 66 (2005) 527-530
27. Cai T., Nesi G., Tinacci G., et al. Can early single dose instillation of epirubicin improve bacillus Calmette-Guerin efficacy in patients with nonmuscle invasive high risk bladder cancer? Results from a prospective, randomized, double-blind controlled study. J Urol 180 (2008) 110-115
28. Sylvester R.J., Oosterlinck W., and O'Donnell M. Re: Can early single dose instillation of epirubicin improve bacillus Calmette-Guérin efficacy in patients with nonmuscle invasive high risk bladder cancer? Results from a prospective, randomized, double-blind controlled study. Cai T, Nesi G, Tinacci G, Zini E, Mondaini N, Boddi N, Mazzoli S, Bartoletti R. J Urol 181 (2009) 410
29. Jalón Monzón A., Fernández Gómez J.M., Escaf Barmadah S., Alvarez Múgica M., Martín Benito J.L., and Regadera Sejas F.J. Therapeutic effect of mitomycin C in the immediate postoperative period in patients with intermediate-risk non-muscle-invasive bladder tumors. Actas Urol Esp 32 (2008) 894-903
30. Whelan P., Griffiths G., Stower M., Wallace D., Hetherington J., and Hargreave T. Preliminary results of a MRC randomised controlled trial of post-operative irrigation of superficial bladder cancer [abstract]. Proc Am Soc Clin Oncol 20 (2001) 708
31. Stenzl A., Jocham D., Jichlinski P., et al. Photodynamic diagnostics in the urinary tract. Consensus paper of the Working Group for Oncology of the German Society for Urology. Urologe A 47 (2008) 982-987
32. Lee C.S., Yoon C.Y., and Witjes J.A. The past, present and future of cystoscopy: the fusion of cystoscopy and novel imaging technology. BJU Int 102b (2008) 1228-1233