Background

The efficacy of an immediate single chemotherapy instillation after transurethral resection of a bladder tumour (TURBT) in patients with non–muscle-invasive bladder cancer (NMIBC) remains a topic of debate. Evidence is even more scarce when an immediate instillation is followed by adjuvant instillations.

Objective

To compare the effect of a mitomycin C (MMC) instillation within 24 h to an instillation 2 wk after TURBT in patients with NMIBC with or without adjuvant instillations.

Design, Setting, and participants

Between 1998 and 2003, 2844 NMIBC patients were randomised for immediate versus delayed MMC instillation after TURBT. Patients were categorised in low-risk (LOR), intermediate-risk (IMR), and high-risk (HIR) groups. Total numbers of instillations in these groups were 1, 9, and 15, respectively.

Outcome measurements and statistical analysis

Primary end point was 3-yr recurrence risk for the IMR and HIR groups and 5-yr risk for the LOR group. Secondary outcomes were time to recurrence and incidence of adverse events. Analyses were performed with the log-rank test, Cox-regression, and χ² test in SPSS.

Results and limitations

A total of 2243 patients were eligible on an intention-to-treat basis. Recurrence risks were 43% and 46% in the LOR group (5-yr follow-up, p = 0.11), 20% and 32% in the IMR group (3-yr follow-up, p = 0.037), and 28% and 35% in the HIR group (3-yr follow-up, p = 0.007), for an immediate and a delayed instillation, respectively. For all patients, the recurrence risk was 27% (95% confidence interval [CI], 24–30) in the immediate and 36% (95% CI, 33–39) in the delayed instillation group (p < 0.001) with a 27% reduction in relative recurrence risk (hazard ratio: 0.73, 95% CI, 0.63–0.85, p < 0.001). The incidence of adverse events did not differ significantly between treatment groups (immediate instillation 25%, delayed instillation 22%, p = 0.08). The risk groups in our study differ slightly from the current guidelines, which is a limitation of our study.

Conclusions

An immediate, single instillation after TURBT reduces the recurrence risk in NMIBC patients, independent of the number of adjuvant installations.

Patient summary

A single instillation of chemotherapy after the resection of non–muscle-invasive bladder cancer reduces the recurrence risk, even if patients are treated with an adjuvant schedule of instillations.

中文翻译：

---

丝裂霉素C即时膀胱内滴注在非肌肉浸润性膀胱癌患者中的价值：一项针对2243例患者的前瞻性多中心随机研究

背景

经非尿道浸润性膀胱癌（NMIBC）患者经尿道膀胱肿瘤（TURBT）手术后立即进行单次化疗滴注的疗效仍是一个争论的话题。当立即滴注后再进行佐剂滴注时，证据甚至更少。

客观的

为了比较NMIBC患者接受或不接受佐剂滴注后24h内丝裂霉素C（MMC）滴注与TURBT后2周滴注的效果。

设计，设置和参与者

在1998年至2003年之间，随机分配了2844名NMIBC患者接受TURBT后立即或延迟MMC滴注。将患者分为低危（LOR），中危（IMR）和高危（HIR）组。这些组的滴注总数分别为1、9和15。

成果测量和统计分析

主要终点是IMR和HIR组的3年复发风险和LOR组的5年风险。次要结果是不良事件的复发时间和发生率。分析用对数秩检验，考克斯回归进行，并且χ ²在SPSS测试。

结果与局限性

共有2243名患者符合意向治疗的条件。LOR组的复发风险分别为43％和46％（5年随访，p  = 0.11），IMR组的复发风险为20％和32％（3年随访，p  = 0.037），以及28％在HIR组中 ，立即滴注和延迟滴注分别为35％（3年随访，p = 0.007）。对于所有患者，延迟滴注组的立即复发风险为27％（95％置信区间[CI]，24–30），延迟滴注组为36％（95％CI，33–39）（p  <0.001）。相对复发风险降低27％（危险比：0.73，95％CI，0.63-0.85，p <0.001）。治疗组之间不良事件的发生率无显着差异（立即滴注25％，延迟滴注22％，p  = 0.08）。我们研究中的风险人群与当前指南略有不同，这是我们研究的局限性。

结论

TURBT后立即单次滴注降低了NMIBC患者的复发风险，而与佐剂的安装数量无关。

病人总结

非肌肉浸润性膀胱癌切除术后单次滴注化疗可降低复发风险，即使患者接受了辅助滴注方案治疗也是如此。