Marra Giancarlo, Barletta Francesco, Scuderi Simone, Montefusco Gabriele, Olivier Jonathan, Affentranger Andres, Grogg Josias Bastian, Hermanns Thomas, Afferi Luca, Fankhauser Christian, Mattei Agostino, Malkiewicz Bartosz, Bianchi Alberto, Antonelli Alessandro, Zattoni Fabio, Dal Moro Fabrizio, Wever Lieke, Soeterik Timo F W, Van Den Bergh Roderick C N, Rajwa Pawel, Shariat Shahrokh F, Sanchez-Salas Rafael, Rodriguez-Sanchez Lara, Nicoletti Rossella, Campi Riccardo, Ahmed Mohamed, Karnes R Jeffrey, Heidegger Isabel, Briganti Alberto, Montorsi Francesco, Gontero Paolo, Gandaglia Giorgio
Division of Urology, Department of Surgical Sciences, University of Turin and Città della Salute e della Scienza, Turin, Italy.
Unit of Urology/Division of Oncology, IRCCS Ospedale San Raffaele, Milan, Italy.
J Urol. 2025 Jun;213(6):702-712. doi: 10.1097/JU.0000000000004468. Epub 2025 Feb 10.
Our goals were to assess the survival outcomes of adjuvant radiation therapy (aRT) vs observation with or without early salvage radiation therapy for cN0M0 pN1 prostate cancer (PCa) and to create a model for clinical decision-making.
We retrospectively identified 1103 patients with cN0M0 PCa with pN1 PCa after surgery (2000-2021) at 18 referral centers. Kaplan-Meier curves and Cox proportional hazards models were used.
Overall, 670 patients (61%) had International Society of Urological Pathology (ISUP) 4 to 5, and the median number of positive nodes was 1. On multivariable analyses, ≥ 3 positive nodes (HR, 2.03, 95% CI, 1.22-3.37; = .006) and ISUP 5 (HR, 1.92, 95% CI, 1.15-3.18; = .01) were associated with an increased all-cause mortality. Based on pT stage, ISUP, and positive nodes, a 2 risk categories model was created. In men undergoing observation, 7-year disease-free survival was 27% (95% CI, 20.4-36) for low- to intermediate-risk and 11% (95% CI, 6.7-17) for high-risk patients; aRT had higher overall survival rates in the high-risk group (92%; 95% CI, 87-96 vs observation 84%, 95% CI, 77-90; = .006). In interaction term analyses, aRT confirmed its protective effect on mortality in high-risk patients (HR, 0.28, 95% CI, 0.09-0.84, = .024). Results were comparable when excluding men with PSA persistence.
In cN0M0 pN+ PCa, aRT yields a survival benefit compared with observation with or without early salvage radiation therapy only in men with a high-risk disease based on unfavorable prognostic factors. We created a risk model to guide clinical decision-making in this setting.
我们的目标是评估辅助放疗（aRT）与观察（无论是否联合早期挽救性放疗）对cN0M0 pN1前列腺癌（PCa）患者生存结局的影响，并建立一个临床决策模型。
我们回顾性纳入了18个转诊中心在2000年至2021年期间术后病理为cN0M0且pN1的1103例PCa患者。采用Kaplan-Meier曲线和Cox比例风险模型。
总体而言，670例患者（61%）国际泌尿病理学会（ISUP）分级为4至5级，阳性淋巴结的中位数为1个。多变量分析显示，≥3个阳性淋巴结（HR = 2.03，95%CI：1.22 - 3.37；P = 0.006）和ISUP 5级（HR = 1.92，95%CI：1.15 - 3.18；P = 0.01）与全因死亡率增加相关。基于pT分期、ISUP分级和阳性淋巴结情况，创建了一个2风险类别模型。在接受观察的患者中，低至中风险患者的7年无病生存率为27%（95%CI：20.4 - 36），高风险患者为11%（95%CI：6.7 - 17）；高风险组中aRT的总生存率更高（92%；95%CI：87 - 96，观察组为84%，95%CI：77 - 90；P = 0.006）。在交互项分析中，aRT证实了其对高风险患者死亡率的保护作用（HR = 0.28，95%CI：0.09 - 0.84，P = 0.024）。排除前列腺特异抗原（PSA）持续存在的患者后，结果相似。
在cN0M0 pN+ PCa中，与观察（无论是否联合早期挽救性放疗）相比，仅在基于不良预后因素属于高风险疾病的男性患者中，aRT能带来生存获益。我们创建了一个风险模型来指导这一情况下的临床决策。
