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Clinical Trial
. 2006;76(2):106-11.
doi: 10.1159/000090870.

Intravesical gemcitabine in BCG-refractory T1G3 transitional cell carcinoma of the bladder: a pilot study

Mauro Gacci  1 , Riccardo Bartoletti, Tommaso Cai, Stefano Nerozzi, Novello Pinzi, Fabrizio Repetti, Fabrizio Viggiani, Paolo Ghezzi, Gabriella Nesi, Marco Carini; TUR (Toscana Urologia) Group
Affiliations
Clinical Trial

Intravesical gemcitabine in BCG-refractory T1G3 transitional cell carcinoma of the bladder: a pilot study

Mauro Gacci et al. Urol Int. 2006.

Abstract

Objective: The aim of this pilot study is to analyze the safety and short-term efficacy of gemcitabine (GEM) as salvage intravesical therapy in a very selected population of bacille Calmette-Guérin (BCG)-resistant T1G3 patients.

Methods: 9 recurrent BCG-refractory pT1G3 patients, unsuitable for radical treatment, were treated with GEM, and compared with 10 pT1G3 patients previously treated with at least two courses of transurethral resection plus BGC, with further conservative endovesical BCG administration.

Results: Both intravesical administrations of GEM and BCG were generally well tolerated: no severe adverse events were reported. Of the 9 patients treated with GEM, 3 were recurrence-free after 13, 17 and 21 months and 7 kept an intact bladder, with an overall survival rate of 9 of 9. Among 10 patients treated with BCG instillation, 1 was recurrence-free after 27 months and 6 kept their bladders, with a survival rate of 8 of 10.

Conclusions: Our experience confirms the high risk of tumor recurrence and progression of BCG-refractory pT1G3 transitional cell carcinoma. In this case, further BCG courses seem to be unsuitable, resulting in a high risk of tumor progression and mortality. The use of GEM in BCG-refractory pT1G3 patients has to be considered experimental until multicentric randomized studies with adequate follow-up are able to confirm the preliminary results of this pilot study.

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