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

Journal of Urology

Volumn 180, Issue 1, 2008, Pages 110-115

  Cai, Tommaso ^a   Nesi, Gabriella ^a   Tinacci, Galliano ^b   Zini, Enzo ^b   Mondaini, Nicola ^a   Boddi, Vieri ^a   Mazzoli, Sandra ^b   Bartoletti, Riccardo ^a  

^a UNIVERSITY OF FLORENCE   (Italy)

^b SANTA MARIA ANNUNZIATA HOSPITAL   (Italy)

Author keywords

adjuvant; administration; chemotherapy; epirubicin; intravesical; mycobacterium bovis; urinary bladder neoplasms

Indexed keywords

BCG VACCINE; EPIRUBICIN;

ARTICLE; BLADDER CANCER; CANCER INVASION; CANCER PATIENT; CANCER RECURRENCE; CLINICAL TRIAL; COLONY FORMING UNIT; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE INTERVAL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FOLLOW UP; HIGH RISK PATIENT; HUMAN; KAPLAN MEIER METHOD; MULTIVARIATE ANALYSIS; PERIOPERATIVE PERIOD; PRIORITY JOURNAL; PROGNOSIS; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE;

ADJUVANTS, IMMUNOLOGIC; ADMINISTRATION, INTRAVESICAL; AGED; AGED, 80 AND OVER; ANTIBIOTICS, ANTINEOPLASTIC; BCG VACCINE; DOUBLE-BLIND METHOD; DRUG SYNERGISM; EPIRUBICIN; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM INVASIVENESS; PROSPECTIVE STUDIES; RISK FACTORS; TIME FACTORS; URINARY BLADDER NEOPLASMS;

EID: 44649193794     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.juro.2008.03.038     Document Type: Article

References (20)

1. Jemal A., Siegel R., Ward E., Murray T., Xu J., and Thun M.J. Cancer statistics, 2007. CA Cancer J Clin 57 (2007) 43
2. Sylvester R.J., van der Meijden A.P., Oosterlinck W., Witjes J.A., 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 49 (2006) 466
3. 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
4. Oosterlinck W., Lobel B., Jakse G., Malmström P.U., Stöckle M., Sternberg C., et al. Guidelines on bladder cancer. Eur Urol 41 (2002) 105
5. van der Meijden A.P., Brausi M., Zambon V., Kirkels W., de Balincourt C., Sylvester R., 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 166 (2001) 476
6. Shelley M.D., Kynaston H., Court J., Wilt T.J., Coles B., Burgon K., et al. A systematic review of intravesical bacillus Calmette-Guérin plus transurethral resection vs transhuretral resection alone in Ta and T1 bladder cancer. BJU Int 88 (2001) 209
7. Segupta S., and Blute M.L. The management of superficial transitional cell carcinoma of the bladder. Urology 67 (2006) 48
8. Kaasinen E., Rintala E., Hellström P., Viitanen J., Juusela H., Rajala P., et al., The FinnBladder Group. Factors explaining recurrence in patients undergoing chemoimmunotherapy regimens for frequently recurring superficial bladder carcinoma. Eur Urol 42 (2002) 167
9. Rintala E., Jauhiainen K., Kaasinen E., Nurmi M., Alfthan O., et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation prophylaxis for recurrent papillary (stages Ta to T1) superficial bladder cancer. FinnBladder Group. J Urol 164 (2000) 47
10. Kaasinen E., Wijkström H., Malmström P., Hellsten S., Duchek M., Mestad O., 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 43 (2003) 637
11. Solsona E., Iborra I., Ricos J.V., Monros J.L., Casanova J., and 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 161 (1999) 1120
12. Oosterlinck W., Kurth K.H., Schröder F., Bultinck J., Hammond B., Sylvester R., et al. 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
13. Snyder C., Harlan L., Knopf K., Potosky A., and Kaplan R. Patterns of care for the treatment of bladder cancer. J Urol 169 (2003) 1697
14. Soloway M.S., Lee C.T., Steinberg G.D., Ghandi A.A., and Jewett M.A. Difficult decisions in urologic oncology: management of high-grade T1 transitional cell carcinoma of the bladder. Urol Oncol 25 (2007) 338
15. Lamm D.L., Crawford E.D., Blumenstein B., Crismann J.D., Montie J.E., Gottesman J.E., et al. Maintenance BCG immunotherapy for recurrent Ta, T1 and Tis transitional cell carcinoma of the bladder: a randomized prospective Southwest Oncology Group study. J Urol 163 (2000) 1124
16. Smith Jr. J.A., Labasky R.F., Cockett A.T.K., Fracchia J.A., Montie J.E., and Rowland R.G. Bladder cancer clinical guidelines panel summary report on the management of non-invasive bladder cancer (stage Ta, T1 and TIS). J Urol 162 (1999) 1967
17. Zar J.H. Biostatistical Analysis. 3rd ed. (1974), Prentice-Hall, International Inc, New York
18. Oddens J.R., van der Meijden A.P.M., and Sylvester R. One immediate postoperative instillation of chemotherapy in low risk Ta, T1 bladder cancer patients. Is it always safe?. Eur Urol 46 (2004) 336
19. Koga H., Kuroiwa K., Yamaguchi A., Osada Y., Tsuneyoshi M., and Naito S. A randomized controlled trial of short-term versus long-term prophylactic intravesical instillation chemotherapy for recurrence after transurethral resection of Ta/T1 transitional cell carcinoma of the bladder. J Urol 171 (2004) 153
20. Rajala P., Kaasinen E., Raitanen M., Liukkonen T., Rintala E., and Finnbladder Group. Perioperative single dose instillation of epirubicin or interferon-alpha after transurethral resection for the prophylaxis of primary superficial bladder cancer recurrencea prospective randomized multicenter study-FinnBladder III long-term results. J Urol 168 (2002) 981