Urological Research Institute (URI), Unit of Urology, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
BJU Int. 2020 Nov;126(5):577-585. doi: 10.1111/bju.15177. Epub 2020 Aug 7.
To develop and externally validate a risk calculator for prediction of any cancer recurrence in patients with penile squamous cell carcinoma (pSCC) and inguinal lymph node metastases (ILNM), as to date no validated prognostic tool is available for patients with pSCC and ILNM.
The development cohort included 234 patients from seven referral centres. The external validation cohort included 273 patients from two additional referral centres. Cox regression identified predictors of any recurrence, which were used to develop a risk calculator. The risk-calculator grouped the development and the validation cohorts according to the individual risk of any recurrence at 24 months (24m-R). Adjuvant treatment effects were tested on overall survival (OS) according to the derived tertiles, within the development and validation cohorts.
Positive surgical margins, pN , and ILNM ratio were associated with higher recurrence rate. The 2-year OS rates were lower for patients with high (>37%) and intermediate (19-37%) compared to low (<19%) 24m-R risk of recurrence, for both the development (43% and 58% vs 83%, P < 0.001) and validation cohort (44% and 50% vs 85%, P < 0.001). Results were confirmed in the subgroup of patients who did not receive adjuvant treatment (P < 0.001), but not in patients who did receive adjuvant treatments in both the development and validation cohorts (P > 0.1).
Adjuvant treatment planning is crucial in patients with pSCC with ILNM, where only weak evidence is available. The current tool proved to successfully stratify patients according to their individual risk, potentially allowing better tailoring of adjuvant treatments.
开发并验证一种预测阴茎鳞状细胞癌（pSCC）伴腹股沟淋巴结转移（ILNM）患者任何癌症复发风险的计算器，因为目前尚无针对 pSCC 伴 ILNM 患者的验证预后工具。
该研究的开发队列纳入了来自 7 个转诊中心的 234 名患者。外部验证队列纳入了来自另外 2 个转诊中心的 273 名患者。Cox 回归分析确定了任何复发的预测因素，据此开发了风险计算器。根据个体 24 个月时任何复发的风险（24m-R），风险计算器将开发队列和验证队列分为不同的组。在开发和验证队列中，根据得出的三分位数，测试辅助治疗对总生存率（OS）的影响。
切缘阳性、pN 和 ILNM 比值与较高的复发率相关。高（>37%）和中危（19-37%）24m-R 复发风险的患者 2 年 OS 率低于低危（<19%）患者，无论是在开发队列（43%和 58% vs 83%，P<0.001）还是验证队列（44%和 50% vs 85%，P<0.001）。在未接受辅助治疗的患者亚组中，结果得到了证实（P<0.001），但在开发和验证队列中接受辅助治疗的患者中，结果则相反（P>0.1）。
在腹股沟淋巴结转移的阴茎鳞状细胞癌患者中，辅助治疗计划至关重要，但目前只有有限的证据支持。该工具能够成功地根据患者的个体风险对患者进行分层，有可能更好地为辅助治疗提供指导。
