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A 1-year maintenance after early adjuvant intravesical chemotherapy has a limited efficacy in preventing recurrence of intermediate risk non-muscle-invasive bladder cancer

机译：早期辅助膀胱灌注化疗后1年的维持治疗对预防中度风险非肌层浸润性膀胱癌复发的疗效有限

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摘要

OBJECTIVE To evaluate the efficacy of 1-year maintenance after a 6-week cycle of early intravesical chemotherapy, as the role of maintenance in intravesical chemotherapy is debated. PATIENTS AND METHODS Between May 2002 and August 2003, 577 patients with non-muscle-invasive bladder cancer (NMI-BC) underwent transurethral resection (TUR) and early intravesical chemotherapy (epirubicin, 80 mg/50 mL). They were randomized between a 6-week induction cycle and the induction cycle plus maintenance with 10 monthly instillations. In all, 95 patients with T1G3, Tis or single and primary Ta-T1 G1-G2 tumours were excluded; 482 patients at intermediate risk of recurrence continued the study. All patients had cytology and cystoscopy at 3-monthly intervals for the first 2-years and 6-monthly thereafter. RESULTS The tumours' characteristics were equally distributed between the two arms. Treatment interruption for toxicity was required in 39 patients. One death due to toxicity of early instillation occurred. The median follow-up was 48 months. Ten patients (2.5%) progressed and 117 patients (29.6%) recurred. No statistically significant difference in the recurrence-free rate (RFS) was detected between the two arms (P = 0.43). An advantage in favour of the maintenance arm was evident only at 18 months after TUR (P = 0.03). A trend for a higher benefit from maintenance in primary and multiple tumours was detected. CONCLUSIONS In patients with intermediate risk NMI-BC treated by TUR and early adjuvant chemotherapy, adding a maintenance regimen with monthly instillations for 1 year is of limited efficacy in preventing recurrence.
机译：目的探讨早期膀胱内化疗6周周期后1年维持的疗效，因为维持在膀胱内化疗中的作用尚存争议。患者与方法在2002年5月至2003年8月之间，对577例非肌肉浸润性膀胱癌（NMI-BC）患者进行了经尿道切除（TUR）和早期膀胱内化疗（厄普霉素，80 mg / 50 mL）。将他们随机分为6周的诱导周期和诱导周期，再加上每月10次滴注的维持。总共排除了95例T1G3，Tis或单一和原发性Ta-T1 G1-G2肿瘤患者； 482名处于中度复发风险的患者继续研究。所有患者在头2年每3个月进行一次细胞学检查和膀胱镜检查，之后每6个月进行一次。结果肿瘤的特征在两臂之间平均分布。 39名患者需要中断治疗以中毒。发生因早期滴注毒性而死亡的1例。中位随访时间为48个月。 10例（2.5％）进展，117例（29.6％）复发。两组之间的无复发率（RFS）在统计学上没有显着差异（P = 0.43）。仅在TUR后18个月才显示出有利于维护臂的优势（P = 0.03）。发现了从维持原发性和多发性肿瘤中获得更高收益的趋势。结论在通过TUR和早期辅助化疗治疗的中度风险NMI-BC患者中，增加维持方案并每月滴注1年对于预防复发的疗效有限。

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