Department of Urology, Urological Research Institute, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy; Klinik für Urologie, Luzerner Kantonsspital, Lucerne, Switzerland.
Klinik für Urologie, Luzerner Kantonsspital, Lucerne, Switzerland.
Eur Urol Focus. 2021 Sep;7(5):1067-1074. doi: 10.1016/j.euf.2020.09.009. Epub 2020 Oct 2.
BACKGROUND: A prospective randomized trial (LEA AUO AB 25/02) found no survival benefit in extended compared with limited pelvic lymph node dissection (PLND) templates in bladder cancer (BCa) patients treated with radical cystectomy (RC). However, the rate of lymph node invasion (LNI) in the standard and extended templates was lower than estimated. OBJECTIVE: To assess the accuracy of preoperative clinical and pathological parameters to predict LNI and to develop a model to preoperatively select candidates for the extended PLND templates. DESIGN, SETTING, AND PARTICIPANTS: A total of 903 BCa patients treated at a single institution were retrospectively identified. The primary outcome was to identify preoperatively the risk of LNI to tailor the type of PLND. The extended PLND templates consisted in the removal of pelvic lymph nodes together with the common iliac, presacral, para-aortocaval, interaortocaval, and paracaval sites up to the inferior mesenteric artery. INTERVENTION: A total of 903 BCa patients were treated with RC and bilateral extended PLND templates. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Several models predicting LNI were evaluated using the area under the receiver operating characteristic curve (AUC), calibration plots and decision curve analyses. A nomogram predicting LNI in the extended pattern was developed and validated internally. RESULTS AND LIMITATIONS: Overall, 55 patients (6.1%) had LNI in the extended PLND templates at RC. The median number of nodes removed was 19 (interquartile range: 13-26). A model including age, clinical T stage, clinical node stage, lymphovascular invasion, and presence of carcinoma in situ at the last transurethral resection before RC was developed. The AUC of this model is 73%. Using a cutoff of 3%, 108 extended PLNDs (12%) would be spared and only two LNIs (3%) would be missed. The main limitations of our model are the retrospective nature of the data, lack of external validation, and low rate of LNI. CONCLUSIONS: This is the first proposed model to predict LNI in the extended PLND templates. This model might help urologists identify which patients might benefit from an extended PLND at the time of RC, reserving a standard PLND for all the others. PATIENT SUMMARY: We developed the first nomogram to predict lymph node invasion (LNI) in the extended pelvic lymph node dissection templates in bladder cancer patients treated with radical cystectomy. The adoption of our model to identify candidates for the extended pelvic lymph node dissection templates could avoid up to 12% of these procedures at the cost of missing only 3% of patients with LNI.
背景:一项前瞻性随机试验(LEA AUO AB 25/02)发现,在接受根治性膀胱切除术(RC)治疗的膀胱癌(BCa)患者中,与局限性盆腔淋巴结清扫术(PLND)模板相比,扩展 PLND 模板并没有生存获益。然而,标准和扩展模板中的淋巴结侵犯(LNI)率低于预期。
目的:评估术前临床和病理参数预测 LNI 的准确性,并建立一种模型,以便在术前选择接受扩展 PLND 模板的候选人。
设计、设置和参与者:共回顾性确定了 903 例在单一机构接受治疗的 BCa 患者。主要结局是术前识别 LNI 的风险,以定制 PLND 的类型。扩展 PLND 模板包括切除盆腔淋巴结,以及共同髂动脉、骶前、腹主动脉旁、腹主动脉内和腔静脉旁部位,直至肠系膜下动脉。
干预措施:共 903 例 BCa 患者接受 RC 和双侧扩展 PLND 模板治疗。
结局测量和统计分析:使用受试者工作特征曲线下面积(AUC)、校准图和决策曲线分析评估了几种预测 LNI 的模型。开发并内部验证了一种预测扩展模式 LNI 的列线图。
结果和局限性:总体而言,在 RC 中,55 例(6.1%)患者在扩展 PLND 模板中出现 LNI。切除的淋巴结中位数为 19 个(四分位距:13-26)。建立了一个包含年龄、临床 T 分期、临床淋巴结分期、淋巴血管侵犯和 RC 前最后一次经尿道切除术时原位癌存在的模型。该模型的 AUC 为 73%。使用 3%的截断值,可避免 108 例扩展 PLND(12%),仅漏诊 2 例 LNI(3%)。我们模型的主要局限性是数据的回顾性、缺乏外部验证以及 LNI 发生率低。
结论:这是第一个用于预测 RC 中扩展 PLND 模板中 LNI 的模型。该模型可能有助于泌尿科医生在 RC 时识别哪些患者可能受益于扩展 PLND,从而为所有其他患者保留标准 PLND。
患者总结:我们开发了第一个列线图来预测接受根治性膀胱切除术的膀胱癌患者的扩展盆腔淋巴结清扫模板中的淋巴结侵犯(LNI)。采用我们的模型来识别接受扩展盆腔淋巴结清扫模板的候选人,可以避免多达 12%的此类手术,而漏诊的 LNI 患者仅占 3%。
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