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根治性膀胱切除术治疗局部晚期和/或盆腔淋巴结阳性的肌层浸润性膀胱癌辅助化疗的疗效:倾向评分加权竞争风险分析。

Effectiveness of Adjuvant Chemotherapy After Radical Cystectomy for Locally Advanced and/or Pelvic Lymph Node-Positive Muscle-invasive Urothelial Carcinoma of the Bladder: A Propensity Score-Weighted Competing Risks Analysis.

机构信息

Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Division of Urological Surgery and Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Department of Urology, Pitié-Salpêtrière Hospital, Pierre and Marie Curie University, Paris, France.

出版信息

Eur Urol Focus. 2018 Mar;4(2):252-259. doi: 10.1016/j.euf.2016.07.001. Epub 2016 Jul 18.

Abstract

BACKGROUND

The benefit of adjuvant chemotherapy (AC) for muscle-invasive urothelial carcinoma of the bladder (UCB) after radical cystectomy (RC) is controversial.

OBJECTIVE

To assess the effectiveness of AC after RC for muscle-invasive UCB in contemporary European routine practice.

DESIGN, SETTING, AND PARTICIPANTS: By using a prospectively collected European multicenter database, we compared survival outcomes between patients who received AC versus observation after RC for locally advanced (pT3/T4) and/or pelvic lymph node-positive (pN+) muscle-invasive UCB in 2011.

INTERVENTION

AC versus observation after RC.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Inverse probability of treatment weighting (IPTW)-adjusted Cox regression and competing risks analyses were performed to compare overall survival (OS) as well as cancer-specific and other-cause mortality between patients who received AC versus observation.

RESULTS AND LIMITATIONS

Overall, 224 patients who received AC (n = 84) versus observation (n = 140) were included. The rate of 3-yr OS in patients who received AC versus observation was 62.1% versus 40.9%, respectively (p = 0.014). In IPTW-adjusted Cox regression analysis, AC versus observation was associated with an OS benefit (hazard ratio: 0.47; 95% confidence interval [CI]: 0.25-0.86; p = 0.014). In IPTW-adjusted competing risks analysis, AC versus observation was associated with a decreased risk of cancer-specific mortality (subhazard ratio: 0.51; 95% CI: 0.26-0.98; p = 0.044) without any increased risk of other-cause mortality (subhazard ratio: 0.48; 95% CI: 0.14-1.60; p = 0.233). Limitations include the relatively small sample size as well as the potential presence of unmeasured confounders related to the observational study design.

CONCLUSIONS

We found that AC versus observation was associated with a survival benefit after RC in patients with pT3/T4 and/or pN+ UCB. These results should encourage physicians to deliver AC and researchers to pursue prospective or large observational investigations.

PATIENT SUMMARY

Overall survival and cancer-specific survival benefit was found in patients who received adjuvant chemotherapy relative to observation after radical cystectomy for locally advanced and/or pelvic lymph node-positive bladder cancer.

摘要

背景

根治性膀胱切除术(RC)后辅助化疗(AC)对肌层浸润性膀胱癌(UCB)的益处仍存在争议。

目的

评估当代欧洲常规实践中 RC 后 AC 治疗肌层浸润性 UCB 的有效性。

设计、设置和参与者:通过使用前瞻性收集的欧洲多中心数据库,我们比较了 2011 年在局部晚期(pT3/T4)和/或盆腔淋巴结阳性(pN+)肌层浸润性 UCB 患者中接受 RC 后接受 AC 与观察治疗的患者的生存结局。

干预

RC 后接受 AC 与观察。

观察指标和统计分析

采用逆概率治疗加权(IPTW)调整的 Cox 回归和竞争风险分析比较接受 AC 与观察治疗的患者的总生存(OS)以及癌症特异性和其他原因死亡率。

结果和局限性

共有 224 名接受 AC(n=84)与观察(n=140)的患者被纳入。接受 AC 与观察的患者 3 年 OS 率分别为 62.1%和 40.9%(p=0.014)。在 IPTW 调整的 Cox 回归分析中,AC 与观察相比与 OS 获益相关(风险比:0.47;95%置信区间 [CI]:0.25-0.86;p=0.014)。在 IPTW 调整的竞争风险分析中,AC 与观察相比与癌症特异性死亡率降低相关(亚风险比:0.51;95%CI:0.26-0.98;p=0.044),而其他原因死亡率无增加风险(亚风险比:0.48;95%CI:0.14-1.60;p=0.233)。局限性包括样本量相对较小,以及与观察性研究设计相关的潜在未测量混杂因素。

结论

我们发现,在 pT3/T4 和/或 pN+ UCB 患者中,与观察相比,RC 后接受 AC 与生存获益相关。这些结果应该鼓励医生提供 AC,并促使研究人员进行前瞻性或大型观察性研究。

患者总结

与观察相比,局部晚期和/或盆腔淋巴结阳性膀胱癌患者接受根治性膀胱切除术后辅助化疗与总生存和癌症特异性生存获益相关。

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