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最大化膀胱内治疗方案:在卡介苗诱导疗程之前给予围手术期丝裂霉素C是否有优势?

Maximizing intravesical therapy options: is there an advantage to the administration of perioperative mitomycin C prior to an induction course of BCG?

作者信息

Badalato Gina M, Hruby Gregory, Razmjoo Mani, McKiernan James M

机构信息

Department of Urology, Columbia University Medical Center, New York, New York 10032, USA.

出版信息

Can J Urol. 2011 Oct;18(5):5890-5.

Abstract

INTRODUCTION

This study sought to evaluate cancer-specific outcomes among patients who received perioperative mitomycin C (MMC) prior to induction BCG versus those who received induction BCG alone.

MATERIALS AND METHODS

Between January 2000 and August 2010, 260 patients were identified who underwent a course of induction BCG with or without concomitant perioperative MMC. Specifically, patients who received 40 mg MMC following transurethral resection of all visible tumor followed by an induction course of BCG were compared to a similar cohort of patients who received induction BCG alone. The primary endpoints were overall and recurrence-free survival (RFS).

RESULTS

A total of 212 patients were identified who received induction BCG alone, and 48 who received perioperative MMC with induction BCG. The aggregate patient cohort was comprised of those with non-muscle invasive disease (NMI), and there was no difference between groupings with respect to common demographic and pathologic variables. Over a median follow up of 34.5 months, there was no difference in overall survival between cohorts. RFS was superior among patients who received combined therapy (5 year survival: 37.5% versus 56.3%, p = 0.023). Nevertheless, the regimen of intravesical therapy did not reach significance as an independent predictor (HR 0.61, p = 0.055, CI 0.36-1.01).

CONCLUSION

Although the combination therapy group demonstrated a significant RFS advantage, the intravesical therapy regimen did not independently modulate this benefit. Further investigation is warranted to determine if immediate MMC prior to a course of induction BCG confers a benefit to RFS. Nevertheless, this pilot investigation sets an important precedent on the management of NMI bladder cancer, nonwithstanding the absence of contemporary large scale, randomized trials.

摘要

引言

本研究旨在评估在诱导性卡介苗(BCG)治疗前接受围手术期丝裂霉素C(MMC)治疗的患者与仅接受诱导性BCG治疗的患者的癌症特异性结局。

材料与方法

在2000年1月至2010年8月期间,确定了260例接受诱导性BCG治疗(伴或不伴围手术期MMC)的患者。具体而言,将经尿道切除所有可见肿瘤后接受40mg MMC治疗并随后进行诱导性BCG治疗的患者与仅接受诱导性BCG治疗的类似队列患者进行比较。主要终点为总生存期和无复发生存期(RFS)。

结果

共确定了212例仅接受诱导性BCG治疗的患者和48例接受围手术期MMC联合诱导性BCG治疗的患者。总体患者队列包括非肌层浸润性疾病(NMI)患者,两组在常见人口统计学和病理变量方面无差异。在中位随访34.5个月期间,各队列之间的总生存期无差异。联合治疗患者的RFS更佳(5年生存率:37.5%对56.3%,p = 0.023)。然而,膀胱内治疗方案作为独立预测因素未达到显著性(HR 0.61,p = 0.055,CI 0.36 - 1.01)。

结论

虽然联合治疗组显示出显著的RFS优势,但膀胱内治疗方案并未独立调节这一益处。有必要进一步研究以确定在诱导性BCG治疗前立即使用MMC是否对RFS有益。尽管缺乏当代大规模随机试验,但这项初步研究为NMI膀胱癌的管理树立了重要先例。

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