Unit of Urology, Urological Research Institute (URI), IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
University Hospitals Leuven, Leuven, Belgium.
BJU Int. 2020 Jun;125(6):867-875. doi: 10.1111/bju.15054. Epub 2020 Apr 1.
To identify predictors of poor overall survival (OS) amongst patients with penile squamous cell carcinoma (pSCC) with clinical inguinal lymphadenopathy (cN+), in order to define the best candidates for neoadjuvant chemotherapy (NAC).
Using an international, multicentre database of 924 patients with pSCC, we identified 334 men who harboured cN+ with available clinical and follow-up data. Lymph node involvement was defined either by the presence of palpable inguinal node disease or by preoperative computed tomography (CT) assessment. Fluorine-18 fluorodeoxyglucose positron-emission tomography ( F-FDG-PET)/CT scan was performed based on clinical judgment of the treating physician. Regression-tree analysis generated a risk stratification tool for prediction of 24-month overall mortality (OM). Kaplan-Meier explored the OS benefit related to the use of NAC according to the regression-tree-stratified subgroups.
Overall, 120 (35.9%), 152 (45.5%), and 62 (18.6%) patients harboured cN1, cN2, and cN3 disease. F-FDG-PET/CT was performed in 48 (14.4%) patients, and 16 (4.8%) had inguinal and pelvic nodal PET detection. The median OS was 107 months, with a 24-month OS of 66%. At regression-tree analysis (area under the curve = 70%), patients with cN3 and cN2 with PET/CT-detected inguinal and pelvic nodal activity had a higher risk of 24-month OM (>50%). NAC was associated with improved 24-month OS rates (54% vs 33%) only in this subgroup of patients (P = 0.002), which was also confirmed after multivariable adjustment (hazard ratio 0.28, 95% confidence interval 0.13-0.62; P = 0.002).
Patients with pSCC with cN3 or cN2 and inguinal and pelvic 18F-FDG-PET/CT scan detected disease had higher 24-month OM rates according to our regression-tree model. NAC was associated with improved OS only in these subgroups of patients. Our novel decision model may help to stratify cN+ patients, and identify those who most likely will benefit from NAC prior to radical surgical resection.
确定患有临床腹股沟淋巴结病（cN+）的阴茎鳞状细胞癌（pSCC）患者总体生存（OS）不良的预测因素，以便确定新辅助化疗（NAC）的最佳候选者。
我们使用 924 名 pSCC 患者的国际多中心数据库，确定了 334 名具有可获得临床和随访数据的 cN+男性。淋巴结受累通过可触及的腹股沟淋巴结疾病的存在或术前计算机断层扫描（CT）评估来定义。氟-18 氟代脱氧葡萄糖正电子发射断层扫描（F-FDG-PET）/CT 扫描根据治疗医生的临床判断进行。回归树分析生成了一种风险分层工具，用于预测 24 个月的总死亡率（OM）。Kaplan-Meier 根据回归树分层亚组探索了与 NAC 使用相关的 OS 获益。
总体而言，120 名（35.9%）、152 名（45.5%）和 62 名（18.6%）患者患有 cN1、cN2 和 cN3 疾病。48 名（14.4%）患者进行了 F-FDG-PET/CT 检查，16 名（4.8%）患者有腹股沟和骨盆淋巴结 PET 检测。中位 OS 为 107 个月，24 个月 OS 为 66%。在回归树分析（曲线下面积=70%）中，cN3 和 cN2 患者伴有 PET/CT 检测到腹股沟和骨盆淋巴结活性的患者，24 个月 OM 风险较高（>50%）。仅在这一组患者中，NAC 与 24 个月 OS 率的提高相关（54%比 33%）（P=0.002），在多变量调整后也得到证实（风险比 0.28，95%置信区间 0.13-0.62；P=0.002）。
根据我们的回归树模型，患有 cN3 或 cN2 且腹股沟和骨盆 18F-FDG-PET/CT 扫描检测到疾病的 pSCC 患者，24 个月 OM 发生率较高。NAC 仅在这些亚组患者中与 OS 改善相关。我们的新决策模型可能有助于分层 cN+患者，并确定那些最有可能从根治性手术切除前的 NAC 中获益的患者。
