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低危非肌层浸润性膀胱癌主动监测失败患者的病理结局:膀胱癌意大利主动监测项目的更新和结果。

Pathological Outcomes for Patients Who Failed To Remain Under Active Surveillance for Low-risk Non-muscle-invasive Bladder Cancer: Update and Results from the Bladder Cancer Italian Active Surveillance Project.

机构信息

Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Rozzano, Italy.

Department of Pathology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Rozzano, Italy.

出版信息

Eur Urol Oncol. 2018 Oct;1(5):437-442. doi: 10.1016/j.euo.2018.05.006. Epub 2018 Jun 5.

DOI:10.1016/j.euo.2018.05.006
PMID:31158085
Abstract

BACKGROUND

It has been shown that active surveillance (AS) is feasible and effective in a subset of patients with recurrent low-grade (LG) non-muscle-invasive bladder cancer (NMIBC).

OBJECTIVE

To update a previous preliminary series and investigate pathological outcomes for patients who failed to remain on AS.

DESIGN, SETTING, AND PARTICIPANTS: Prospective observational cohort study started in February 2008, and currently still active, at a tertiary university hospital, including patients with pathologically confirmed NMIBC who experienced recurrence during follow-up.

INTERVENTION

AS monitoring consisted of cytology and in-office flexible cystoscopy every 3 mo for the first year, and every 6 mo thereafter.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary endpoint was pathological results for patients who failed to remain on AS. The secondary outcome was an update of clinical results from our previous series. Data were complemented by descriptive statistical analysis and univariable and multivariable proportional hazards Cox regression.

RESULTS AND LIMITATIONS

Overall, 167 patients were included. Of 181 AS events, 61 (33.7%) were deemed to require treatment because of positive cytology (n=10), gross haematuria (n=11), and increases in the tumour number (n=15), or size (n=17), or both (n=8). The median time on AS was 12 mo (interquartile range 4-26). Pathological specimens from AS failures did not show any malignancy in 20 cases. Histopathology identified urothelial hyperplasia and oedema, submucosal vascular ectasia, mucosal erosion, polypoid cystitis, von Brunn nest hyperplasia, and squamous metaplasia. The time from first transurethral resection to AS start was inversely associated with recurrence-free survival (hazard ratio 0.97, 95% confidence interval 0.96-1.00; p=0.024). The study lacks statistical subanalyses focusing on patients with failure and negative neoplastic pathological outcomes.

CONCLUSIONS

AS might be a reasonable strategy in patients presenting with small LG pTa/pT1a recurrent bladder tumours. Approximately 30% of patients deemed to have AS failure did not harbour any neoplastic lesion, strengthening the role of AS.

PATIENT SUMMARY

Patients with small low-grade pTa/pT1a recurrent papillary bladder tumours could benefit from an active surveillance protocol with no significant risk of pathological progression to muscle-invasive cancer.

摘要

背景

已经证明,主动监测(AS)在一部分复发性低级别(LG)非肌肉浸润性膀胱癌(NMIBC)患者中是可行且有效的。

目的

更新之前的初步系列研究结果,并调查未能继续接受 AS 治疗的患者的病理结局。

设计、设置和参与者:这是一项前瞻性观察队列研究,于 2008 年 2 月在一家三级大学医院开始,目前仍在进行中,纳入了经病理证实患有 NMIBC 并在随访期间复发的患者。

干预措施

AS 监测包括细胞学检查和门诊软性膀胱镜检查,第 1 年每 3 个月 1 次,此后每 6 个月 1 次。

结局测量和统计分析

主要终点是未能继续接受 AS 治疗的患者的病理结果。次要结局是更新我们之前系列研究的临床结果。通过描述性统计分析以及单变量和多变量比例风险 Cox 回归对数据进行补充。

结果和局限性

共纳入 167 例患者。在 181 例 AS 事件中,有 61 例(33.7%)因细胞学阳性(n=10)、肉眼血尿(n=11)、肿瘤数量增加(n=15)、肿瘤大小增加(n=17)或两者兼而有之(n=8)而需要治疗。AS 中位时间为 12 个月(四分位间距 4-26)。AS 失败后的病理标本在 20 例中未发现任何恶性肿瘤。组织病理学显示尿路上皮增生和水肿、黏膜下血管扩张、黏膜糜烂、息肉状膀胱炎、von Brunn 巢增生和鳞状化生。首次经尿道电切术至 AS 开始的时间与无复发生存时间呈反比(风险比 0.97,95%置信区间 0.96-1.00;p=0.024)。该研究缺乏针对具有失败和阴性肿瘤病理学结果的患者的统计学亚分析。

结论

AS 可能是一种合理的策略,适用于具有小的 LG pTa/pT1a 复发性膀胱肿瘤的患者。大约 30%的 AS 失败患者未发现任何肿瘤病变,这进一步证实了 AS 的作用。

患者总结

患有小的低级别 pTa/pT1a 复发性乳头状膀胱肿瘤的患者可以从无显著进展为肌层浸润性癌症风险的主动监测方案中获益。

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