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经尿道切除术治疗新发性早期浅表性膀胱癌最大程度预防的膀胱内化疗:日本泌尿生殖系统癌症研究组使用平滑风险函数对试验进行的综合分析

Intravesical chemotherapy for maximum prophylaxis of new early phase superficial bladder carcinoma treated by transurethral resection: a combined analysis of trials by the Japanese Urological Cancer Research Group using smoothed hazard function.

作者信息

Hinotsu S, Akaza H, Ohashi Y, Kotake T

机构信息

Biostatistics, School of Health Sciences and Nursing, University of Tokyo, Tokyo, Japan.

出版信息

Cancer. 1999 Nov 1;86(9):1818-26.

Abstract

BACKGROUND

The effect of intravesical instillation of doxorubicin or epirubicin after transurethral resection (TUR) was estimated from the data of five randomized clinical trials in Japan. The authors provided the estimated hazard function plots with a smoothing technique, to evaluate the prophylactic effect of an intravesical therapy over time and to estimate the natural history of superficial bladder carcinoma.

METHODS

Data on a total of 1732 patients from 5 studies of the Japanese Urological Cancer Research Group who were eligible to receive doxorubicin and epirubicin were analyzed. The patients were divided into four subgroups based on their background characteristics. Their tumors were categorized as "primary and solitary," "primary and multiple," "recurrent and solitary," or "recurrent and multiple."

RESULTS

Multivariate analysis revealed that intravesical instillation reduced the risk of recurrence to about one-half to two-thirds compared with the controls. The shapes of the graphs that estimated the hazard function for patients with no prophylaxis indicated that multiple tumors showed an earlier peak of recurrence than solitary tumors and recurrent tumors had a higher hazard of recurrence than primary tumors. Graphic presentation of the hazard function in each subgroup suggested that the effect of prophylaxis continued for 500 days after TUR but not for longer.

CONCLUSIONS

This analysis indicated that there are two patterns of tumor recurrence of superficial bladder carcinoma after TUR, namely, early phase and late phase. Intravesical chemotherapy may be effective mainly in reducing the hazard for recurrence in the early phase.

摘要

背景

根据日本五项随机临床试验的数据,评估了经尿道切除术(TUR)后膀胱内灌注阿霉素或表柔比星的效果。作者采用平滑技术提供了估计的风险函数图,以评估膀胱内治疗随时间的预防效果,并估计浅表性膀胱癌的自然病程。

方法

分析了日本泌尿生殖系统癌症研究组5项研究中总共1732例符合接受阿霉素和表柔比星治疗条件的患者的数据。根据患者的背景特征将其分为四个亚组。他们的肿瘤被分类为“原发性单发”、“原发性多发”、“复发性单发”或“复发性多发”。

结果

多变量分析显示,与对照组相比,膀胱内灌注将复发风险降低至约二分之一至三分之二。未进行预防的患者的风险函数估计图的形状表明,多发肿瘤的复发高峰比单发肿瘤更早,复发性肿瘤的复发风险比原发性肿瘤更高。每个亚组的风险函数图形显示,预防效果在TUR后持续500天,但不会更长。

结论

该分析表明,TUR后浅表性膀胱癌存在两种肿瘤复发模式,即早期和晚期。膀胱内化疗可能主要有效降低早期复发风险。

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