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01-08-2011 | Original Article

Long-term experience with early single Mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer: prospective, single-centre randomised trial

Authors: Cosimo De Nunzio, Antonio Carbone, Simone Albisinni, Giorgio Alpi, Andrea Cantiani, Marcello Liberti, Andrea Tubaro, Francesco Iori

Published in: World Journal of Urology | Issue 4/2011

Abstract

Purpose

To study the benefits of a single, early, intravesical instillation of mitomycin C(MMC) after transurethral bladder resection (TURB) in patients with low-risk non-muscle-invasive bladder cancer (NMIBC).

Methods

In this prospective randomised single-centre trial, 211 patients with primary and low-risk tumours were enrolled between 2000 and 2009. Patients were randomly allocated to receive MMC intravesically within 24 h of TUR or no further treatment. The primary end point was recurrence rate reduction.

Results

A total of 202 patients (97 in the MMC group and 105 in the control group) remained for analysis after exclusions. Median age was 61 years (IQR 42–78), and median follow-up was 90 months (IQR 3–112). No significant differences for patients’ characteristics were observed between the two groups. During the study period, 10% (10/97) of the patients in the MMC group and 43% (46/105) in the control group experienced a recurrence (P = 0.0001). Four patients in the MMC group and 11 (P = 0.008) in the control group experienced an early recurrence (within 2 years). One patient in the control group presented a tumour progression (T2G3). MMC treatment was associated with a 31% absolute risk reduction of recurrence and a 3.26 numbers needed to treat to prevent one recurrence.

Conclusions

In this single-centre, long-term follow-up, experience a single, early instillation of MMC after TUR for low-risk NMIBC is associated with a significant reduction in risk of early and late recurrences.

Colombel M, Soloway M, Akaza H, Bohle A, Palou J, Buckley R, Lamm D, Brausi M, Witjes JA, Persad R (2008) Epidemiology, staging, grading, and risk stratification of bladder cancer. Eur Urol Suppl 7(10):618–626. doi:10.1016/j.eursup.2008.08.002 CrossRef

Kirkali Z, Chan T, Manoharan M, Algaba F, Busch C, Cheng L, Kiemeney L, Kriegmair M, Montironi R, Murphy WM, Sesterhenn IA, Tachibana M, Weider J (2005) Bladder cancer: epidemiology, staging and grading, and diagnosis. Urology 66(6 Suppl 1):4–34. doi:10.1016/j.urology.2005.07.062

Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Bohle A, Palou-Redorta J (2008) EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder. Eur Urol 54(2):303–314. doi:10.1016/j.eururo.2008.04.051 PubMedCrossRef

van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ, Witjes JA, Zlotta AR (2009) Recurrence and progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol 56(3):430–442. doi:10.1016/j.eururo.2009.06.028 PubMedCrossRef

Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K (2006) 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(3):466–465. doi:10.1016/j.eururo.2005.12.031. Discussion 475–467

Gudjonsson S, Adell L, Merdasa F, Olsson R, Larsson B, Davidsson T, Richthoff J, Hagberg G, Grabe M, Bendahl PO, Mansson W, Liedberg F (2009) 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(4):773–780. doi:10.1016/j.eururo.2009.01.006 PubMedCrossRef

Sylvester RJ, Oosterlinck W, van der Meijden AP (2004) 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(6 Pt 1):2186–2190, quiz 2435

Solsona E, Iborra I, Ricos JV, Monros JL, Casanova J, Dumont R (1999) Effectiveness of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer: short and long-term followup. J Urol 161(4):1120–1123PubMedCrossRef

Oosterlinck W, Kurth KH, Schroder F, Bultinck J, Hammond B, Sylvester R (1993) 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(4):749–752PubMed

10.

Bouffioux C, Kurth KH, Bono A, Oosterlinck W, Kruger CB, De Pauw M, Sylvester R (1995) Intravesical adjuvant chemotherapy for superficial transitional cell bladder carcinoma: results of 2 european organization for research and treatment of cancer randomized trials with mitomycin C and doxorubicin comparing early versus delayed instillations and short-term versus long-term treatment. European organization for research and treatment of cancer genitourinary group. J Urol 153(3 Pt 2):934–941PubMed

11.

Berrum-Svennung I, Granfors T, Jahnson S, Boman H, Holmang S (2008) A single instillation of epirubicin after transurethral resection of bladder tumors prevents only small recurrences. J Urol 179(1):101–105. doi:10.1016/j.juro.2007.08.166. Discussion 105–106

12.

Tolley DA, Parmar MK, Grigor KM, Lallemand G, Benyon LL, Fellows J, Freedman LS, Hall RR, Hargreave TB, Munson K, Newling DW, Richards B, Robinson MR, Rose MB, Smith PH, Williams JL, Whelan P (1996) The effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: a further report with 7 years of follow up. J Urol 155(4):1233–1238PubMedCrossRef

13.

Donat SM, North A, Dalbagni G, Herr HW (2004) Efficacy of office fulguration for recurrent low grade papillary bladder tumors less than 0.5 cm. J Urol 171(2 Pt 1):636–639. doi:10.1097/01.ju.0000103100.22951.5e

14.

Feifer A, Xie X, Brophy JM, Segal R, Kassouf W (2010) Contemporary cost analysis of single instillation of mitomycin after transurethral resection of bladder tumor in a universal health care system. Urology 76(3):652–656. doi:10.1016/j.urology.2009.12.070 PubMedCrossRef

15.

Clarke NS, Basu S, Prescott S, Puri R (2006) Chemo-prevention in superficial bladder cancer using mitomycin C: a survey of the practice patterns of British urologists. BJU Int 97(4):716–719. doi:10.1111/j.1464-410X.2006.05970.x PubMedCrossRef

16.

Oddens JR, van der Meijden AP, Sylvester R (2004) One immediate postoperative instillation of chemotherapy in low risk Ta, T1 bladder cancer patients. Is it always safe? Eur Urol 46(3):336–338. doi:10.1016/j.eururo.2004.05.003S0302283804002684

Title: Long-term experience with early single Mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer: prospective, single-centre randomised trial
Authors: Cosimo De Nunzio
Antonio Carbone
Simone Albisinni
Giorgio Alpi
Andrea Cantiani
Marcello Liberti
Andrea Tubaro
Francesco Iori
Publication date: 01-08-2011
Publisher: Springer-Verlag
Published in: World Journal of Urology / Issue 4/2011
Print ISSN: 0724-4983
Electronic ISSN: 1433-8726
DOI: https://doi.org/10.1007/s00345-011-0691-2

At a glance: The STEP trials

Springer Medicine

Long-term experience with early single Mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer: prospective, single-centre randomised trial

Abstract

Purpose

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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