Marra Giancarlo, Lesma Federico, Montefusco Gabriele, Filippini Claudia, Olivier Jonathan, Affentranger Andres, Grogg Josias Bastian, Hermanns Thomas, Afferi Luca, Fankhauser Christian D, Mattei Agostino, Malkiewicz Bartosz, Scuderi Simone, Barletta Francesco, Gallina Sebastian, Antonelli Alessandro, Zattoni Fabio, Dal Moro Fabrizio, Lieke Wever, Soeterik Timo, van den Bergh Roderick C N, Rajwa Pawel, Shariat Shahrokh F, Rodriguez-Sanchez Lara, Nicoletti Rossella, Campi Riccardo, Ahmed Mohamed, Jeffrey Karnes R, Ladurner Michael, Heidegger Isabel, Briganti Alberto, Gontero Paolo, Gandaglia Giorgio
Division of Urology, Department of Surgical Sciences, University of Turin and Città della Salute e della Scienza, Turin, Italy.
Department of Urology, Lille University Hospital, Lille, France.
Eur Urol Open Sci. 2024 Aug 22;68:32-39. doi: 10.1016/j.euros.2024.06.016. eCollection 2024 Oct.
More than 10% of patients with negative clinical metastatic status (cN0M0) on conventional imaging for prostate cancer (PCa) harbor lymph node involvement (pN+) at final pathology following radical prostatectomy (RP) and lymphadenectomy. Our aim was to assess outcomes of initial observation for cN0M0 pN+ PCa and identify prognostic factors that may help in clinical decision-making.
We performed a retrospective multicenter study of patients with cN0M0 PCa on conventional imaging (computed tomography and/or magnetic resonance imaging, and a bone scan) who were found to have pN+ disease at RP between 2000 and 2021. Biochemical recurrence (BCR) and systemic progression/recurrence were the primary outcomes. Kaplan-Meier curves and Cox proportional hazards model were used for survival and multivariate analysis.
A total of 469 men were included in this retrospective multicenter trial. Median prostate-specific antigen (PSA) was 10.1 ng/ml (interquartile range [IQR] 6.6-18.0). Among these patients, 56% had grade group ≥4, 53.7% had stage ≥pT3b, 42.6% had positive margins, and 19.6% had PSA persistence. The median number of positive nodes and of nodes removed were 1 (IQR 1-3) and 20 (14-28), respectively. At median follow-up of 41 mo, 48.5% experienced BCR. The 5-yr BCR-free survival rate was 31.7% (95% confidence interval [CI] 26.33-37.1%). Salvage treatments were needed in 211 patients and included radiotherapy (RT; = 53), RT + androgen deprivation therapy (ADT; = 88), ADT alone ( = 68), and salvage lymphadenectomy ( = 2). The 5-yr estimated survival rates were 66.3% (95% CI 60.4-72.1) for metastasis-free survival, 97.7% (95% CI 95.5-99.8%) for cancer-specific survival, and 95.3% (95% CI 92.4-98.1%) for overall survival. On multivariable analysis, PSA persistence was an independent predictor of BCR (odds ratio [OR] 51.8, 95% CI 12.2-219.2), exit from observation (OR 8.5, 95% CI 4.4-16.5), and systemic progression (OR 3.0, 95% CI 1.771-4.971).
Initial observation in the management of pN+ cN0M0 PCa is feasible and has excellent survival rates in the intermediate term. Patients with worse disease features, especially PSA persistence, have a higher likelihood of recurrence and progression and may be candidates for more aggressive upfront management.
We investigated the value of initial observation for men with prostate cancer with negative scan findings for metastasis who were then found to have positive lymph nodes after surgery to remove the prostate. Our results show that initial observation is a good option for patients with less aggressive prostate cancer features.
在前列腺癌（PCa）的传统影像学检查中，临床转移状态为阴性（cN0M0）的患者中，超过10%在根治性前列腺切除术（RP）及淋巴结清扫术后的最终病理检查中存在淋巴结转移（pN+）。我们的目的是评估cN0M0 pN+ PCa患者初始观察的结果，并确定可能有助于临床决策的预后因素。
我们对2000年至2021年间在传统影像学检查（计算机断层扫描和/或磁共振成像以及骨扫描）中cN0M0 PCa且在RP时发现有pN+疾病的患者进行了一项回顾性多中心研究。生化复发（BCR）和全身进展/复发是主要结局。采用Kaplan-Meier曲线和Cox比例风险模型进行生存分析和多变量分析。
这项回顾性多中心试验共纳入469名男性。前列腺特异性抗原（PSA）中位数为10.1 ng/ml（四分位间距[IQR] 6.6 - 18.0）。在这些患者中，56%的分级组≥4，53.7%的分期≥pT3b，42.6%的手术切缘阳性，19.6%的患者PSA持续存在。阳性淋巴结的中位数和切除淋巴结的中位数分别为1（IQR 1 - 3）和20（14 - 28）。中位随访41个月时，48.5%的患者出现BCR。5年无BCR生存率为31.7%（95%置信区间[CI] 26.33 - 37.1%）。211名患者需要挽救性治疗，包括放疗（RT； = 53）、RT + 雄激素剥夺治疗（ADT； = 88）、单纯ADT（ = 68）以及挽救性淋巴结清扫术（ = 2）。5年无转移生存率估计为66.3%（95% CI 60.4 - 72.1），癌症特异性生存率为97.7%（95% CI 95.5 - 99.8%），总生存率为95.3%（95% CI 92.4 - 98.1%）。多变量分析显示，PSA持续存在是BCR（优势比[OR] 51.8，95% CI 12.2 - 219.2）、终止观察（OR 8.5，95% CI 4.4 - 16.5）和全身进展（OR 3.0，95% CI 1.771 - 4.971）的独立预测因素。
pN+ cN0M0 PCa患者的初始观察是可行的，中期生存率良好。疾病特征较差的患者，尤其是PSA持续存在的患者，复发和进展的可能性更高，可能是更积极初始治疗的候选者。
我们研究了对前列腺癌转移扫描结果为阴性但术后发现淋巴结阳性的男性进行初始观察的价值。我们的结果表明，初始观察对于前列腺癌侵袭性较低的患者是一个不错的选择。
