Management Of Superficial Bladder Tumors

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 06 Apr 2008 - 0:00 PDT

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UroToday.com - An Italian study group presented data on the optimal schedule regimen and the role of maintenance intravesical chemotherapy or BCG immunotherapy after transurethral resection (TUR for non muscle-invasive transitional cell cancer of the bladder (NMI TCCB) for patients at intermediate risk.

Between 2002 and 2003, 577 patients, undergoing TUR for NMI TCCB, were recruited. All patients underwent TUR and early (within 6 hours) intravesical chemotherapy with epirubicin at the dose of 80 mg diluted in 60 ml of saline solution. When histology was available, 95 patients were excluded from the study since they were harboring T1G3, TIS and single and primary Ta G1-G2 tumors. 482 patients with intermediate risk tumors were randomized according 2 different regimens: arm A: 5 more weekly instillations; arm B: 5 more weekly instillations plus monthly instillations for a total of 16 instillations. All patients were submitted every 3 months for the first 2 years and then 6-monthly to cytology, cystoscopy and biopsy of every suspicious bladder lesion.

From 482 randomized patients, 396 are evaluable for toxicity and 392 for efficacy. The tumors were multiple in 318 patients (66.2%) and recurrent in 192 (39.8%). No difference emerged between the 2 arms in relation to tumors' characteristics. The median follow-up time was 22 months. Eighty-two (20.9%) patients recurred at a median time of 9 months from TUR and 4 patients (1%) progressed. The incidence of recurrences was 24.4% in arm A and 18.5% in arm B. No difference emerged between the two arms for recurrence rate at 3 months. Statistical analysis demonstrated an advantage in favor of maintenance in terms of recurrence rate at 6 (p=0.01), 9 (p=0.04) and 12 months (p=0.03) and in terms of recurrence-free interval (p=0.03). No difference for toxicity emerged according to treatment schedule. The conclusion is that 0ne-year maintenance significantly reduces the risk of tumor recurrence, without enhanced toxicity, in patients with intermediate risk NMI TCCB treated with early epirubicin intravesical chemotherapy followed by 5 weekly instillations.

Presented by: V. Serretta, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD

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