Cancer. 1984 Aug 15;54(4):756-61. doi: 10.1002/1097-0142(1984)54:4<756::aid-cncr2820540428>3.0.co;2-c.
A multicenter trial was carried out with patients with superficial Ta-T1 bladder tumors in 37 urology centers throughout Italy. After transurethral resection (TUR) patients were given intravesical doxorubicin instillations at the mean dose of 50 mg per instillation diluted in 50 ml of distilled water or physiologic saline. Chemoprophylaxis was performed at weekly intervals for the first 4 weeks and then monthly. Cystoscopies were taken every 3 months during the first year, every 4 months during the second year, and every 6 months thereafter. A total of 435 patients, with a median follow-up time of 436 days, were considered eligible for the evaluation of activity. The lowest recurrence rate and the longest disease-free interval was observed in the group of patients with primary or single tumor. Treatment was well tolerated; 119 patients (22.7%) complained of local adverse reactions, and 10 (1.9%) of systemic adverse reactions. In 34 of the patients (6.5%) treatment had to be discontinued.
在意大利全国37个泌尿外科中心，对浅表性Ta-T1期膀胱肿瘤患者开展了一项多中心试验。经尿道切除术（TUR）后，患者接受膀胱内阿霉素灌注，平均每次灌注剂量为50 mg，用50 ml蒸馏水或生理盐水稀释。在最初4周每周进行一次化学预防，之后每月进行一次。第一年每3个月进行一次膀胱镜检查，第二年每4个月进行一次，此后每6个月进行一次。共有435例患者符合活性评估条件，中位随访时间为436天。在原发性或单发肿瘤患者组中观察到最低的复发率和最长的无病间期。治疗耐受性良好；119例患者（22.7%）主诉有局部不良反应，10例患者（1.9%）有全身不良反应。34例患者（6.5%）不得不中断治疗。
