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一项欧洲癌症研究与治疗组织泌尿生殖系统肿瘤组的前瞻性随机试验,比较经尿道切除术联合单次膀胱内灌注表柔比星或水用于单发Ta、T1期膀胱乳头状癌的单阶段治疗。

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.

作者信息

Oosterlinck W, Kurth K H, Schröder F, Bultinck J, Hammond B, Sylvester R

机构信息

Department of Urology, University Hospital, Gent, Belgium.

出版信息

J Urol. 1993 Apr;149(4):749-52. doi: 10.1016/s0022-5347(17)36198-0.

DOI:10.1016/s0022-5347(17)36198-0
PMID:8455236
Abstract

A total of 431 eligible patients with solitary, primary or recurrent stages Ta and T1 transitional cell carcinoma of the bladder was included in a randomized multicenter trial to compare a single intravesical instillation of 80 mg. epirubicin with water given immediately after resection, with respect to the disease-free interval and recurrence rate. The interval to initial recurrence was significantly better in favor of the epirubicin group. After a mean followup of 2 years it became evident that the recurrence rate after a single epirubicin instillation was decreased by nearly half with the same trend being found in all subgroups examined. Toxicity was mainly restricted to bladder irritation in plus or minus 10% of the cases. Pathology review brought considerable changes in T category from stages T1 to Ta (53%). Changes in grade were less pronounced but nevertheless important.

摘要

共有431例符合条件的膀胱Ta期和T1期单发、原发性或复发性移行细胞癌患者被纳入一项随机多中心试验,以比较在切除术后立即膀胱内单次灌注80mg表柔比星与灌注水在无病间期和复发率方面的差异。首次复发的间期明显有利于表柔比星组。平均随访2年后发现,单次表柔比星灌注后的复发率降低了近一半,在所检查的所有亚组中均发现相同趋势。毒性主要局限于约10%的病例出现膀胱刺激。病理复查使T分期从T1期到Ta期有相当大的变化(53%)。分级变化不太明显,但仍然很重要。

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