Gacci Mauro, Bartoletti Riccardo, Cai Tommaso, Nerozzi Stefano, Pinzi Novello, Repetti Fabrizio, Viggiani Fabrizio, Ghezzi Paolo, Nesi Gabriella, Carini Marco
Department of Urology, University of Florence, Florence, Italy.
Urol Int. 2006;76(2):106-11. doi: 10.1159/000090870.
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.
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.
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.
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.
本初步研究旨在分析吉西他滨（GEM）作为挽救性膀胱内治疗药物，在经过严格筛选的卡介苗（BCG）耐药的T1G3患者中的安全性和短期疗效。
9例复发的BCG难治性pT1G3患者，因不适合进行根治性治疗，接受了GEM治疗，并与10例先前接受过至少两个疗程经尿道切除术加BCG治疗且后续进行保守性膀胱内BCG给药的pT1G3患者进行比较。
膀胱内给予GEM和BCG的耐受性总体良好：未报告严重不良事件。接受GEM治疗的9例患者中，3例在13、17和21个月后无复发，7例膀胱保持完整，9例患者的总生存率为9/9。在接受BCG灌注治疗的10例患者中，1例在27个月后无复发，6例膀胱保持完整，生存率为8/10。
我们的经验证实了BCG难治性pT1G3移行细胞癌肿瘤复发和进展的高风险。在这种情况下，进一步的BCG疗程似乎不合适，会导致肿瘤进展和死亡的高风险。在多中心随机研究并进行充分随访能够证实本初步研究的初步结果之前，BCG难治性pT1G3患者使用GEM仍需视为试验性治疗。
