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一项欧洲癌症研究与治疗组织(EORTC)的随机前瞻性试验的长期随访,该试验比较了卡介苗-荷兰国家公共卫生与环境研究所(Bacille Calmette-Guérin-RIVM)与丝裂霉素C在浅表性膀胱癌中的应用。EORTC泌尿生殖系统肿瘤组和荷兰东南部泌尿外科合作组。欧洲癌症研究与治疗组织泌尿生殖系统癌症协作组。

Long-term follow-up of an EORTC randomized prospective trial comparing intravesical bacille Calmette-Guérin-RIVM and mitomycin C in superficial bladder cancer. EORTC GU Group and the Dutch South East Cooperative Urological Group. European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Collaborative Group.

作者信息

Witjes J A, v d Meijden A P, Collette L, Sylvester R, Debruyne F M, van Aubel A, Witjes W P

机构信息

Department of Urology, University Hospital, Nijmegen, The Netherlands.

出版信息

Urology. 1998 Sep;52(3):403-10. doi: 10.1016/s0090-4295(98)00212-x.

DOI:10.1016/s0090-4295(98)00212-x
PMID:9730451
Abstract

OBJECTIVES

To determine long-term efficacy of intravesical mitomycin C (MMC) versus bacille Calmette-Guérin (BCG) in patients with superficial bladder cancer with regard to recurrences and progression.

METHODS

Patients with superficial bladder cancer (pTa, pT1, pTis) were treated with intravesical MMC (30 mg, weekly for 4 weeks, and thereafter monthly for 5 months) or BCG (weekly for 6 weeks).

RESULTS

Three hundred forty-four patients were eligible (171 in the BCG group, 173 in the MMC group). The median follow-up was 7.2 years. Toxicity was not significantly different between the two treatment groups. Efficacy of the two treatment policies was similar with regard to tumor recurrence. With regard to progression to invasive disease, MMC was more effective than BCG in patients without carcinoma in situ (CIS) (P = 0.006).

CONCLUSIONS

We can confirm the conclusions of other studies that intravesical treatment with 30 mg of MMC remains an effective treatment option that can also be used in high-risk patients. Like others, we could not confirm that a 6-week course of BCG is more effective in the prevention of tumor progression. Of the 33 patients with tumor progression after intravesical therapy, 20 died of bladder cancer, confirming that tumor progression after intravesical therapy carries a poor prognosis. In this study the difference in toxicity between BCG and MMC was not significant. When comparing studies with MMC and BCG, differences in treatment schedule and/or patient selection should be kept in mind.

摘要

目的

确定膀胱内注射丝裂霉素C(MMC)与卡介苗(BCG)相比,在浅表性膀胱癌患者中预防复发和进展的长期疗效。

方法

浅表性膀胱癌(pTa、pT1、pTis)患者接受膀胱内注射MMC(30mg,每周1次,共4周,此后每月1次,共5个月)或BCG(每周1次,共6周)治疗。

结果

344例患者符合条件(BCG组171例,MMC组173例)。中位随访时间为7.2年。两组治疗的毒性无显著差异。两种治疗方案在肿瘤复发方面疗效相似。在无原位癌(CIS)的患者中,MMC在预防疾病进展方面比BCG更有效(P = 0.006)。

结论

我们可以证实其他研究的结论,即膀胱内注射30mg MMC仍然是一种有效的治疗选择,也可用于高危患者。与其他研究一样,我们无法证实6周疗程的BCG在预防肿瘤进展方面更有效。在33例膀胱内治疗后出现肿瘤进展的患者中,20例死于膀胱癌,证实膀胱内治疗后肿瘤进展预后不良。在本研究中,BCG和MMC之间的毒性差异不显著。在比较MMC和BCG的研究时,应考虑治疗方案和/或患者选择的差异。

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