Department of Urology, James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Department of Radiation Oncology and Molecular Radiation Sciences and Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
BJU Int. 2019 Feb;123(2):252-260. doi: 10.1111/bju.14241. Epub 2018 May 1.
To perform a comparative analysis of three current management strategies for patients with lymph node metastases (LNM; pN1) following radical prostatectomy (RP): observation, androgen-deprivation therapy (ADT), and external beam radiation therapy (EBRT) + ADT.
Patients with LNM after RP were identified using the National Cancer Database (2004-2013). Exclusion criteria included any use of radiation therapy or ADT before RP, clinical M1 disease, or incomplete follow-up data. Patients were categorised according to postoperative management strategy. The primary outcome was overall survival (OS). Kaplan-Meier curves and adjusted multivariable Cox proportional hazards models were employed. Sub-analyses further evaluated patient risk stratification and time to receipt of adjuvant therapy.
A total of 8 074 patients met the inclusion criteria. Postoperatively, 4 489 (55.6%) received observation, 2 065 (25.6%) ADT, and 1 520 (18.8%) ADT + EBRT. The mean (median; interquartile range) follow-up was 52.3 (48.0; 28.5-73.5) months. Patients receiving ADT or ADT + EBRT had higher pathological Gleason scores, T-stage, positive surgical margin rates, and nodal burden. Adjusted multivariable Cox models showed improved OS for ADT + EBRT vs observation (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.64-0.94; P = 0.008) and vs ADT (HR 0.76, 95% CI: 0.63-0.93; P = 0.007). There was no difference in OS for ADT vs observation (HR 1.01, 95% CI: 0.87-1.18; P = 0.88). Findings were similar when restricting adjuvant cohorts for timing of adjuvant therapy. There was no difference in OS between groups for up to 2 549 (31.6%) patients lacking any of the following adverse features: ≥pT3b disease, Gleason score ≥9, three or more positive nodes, or positive surgical margin.
For patients with LNM after RP, the use of adjuvant ADT + EBRT improved OS in the majority of patients, especially those with adverse pathological features. Conversely, adjuvant therapy did not confer significant OS benefit in up to 30% of patients without high-risk features, who may be managed with observation and forego the morbidity associated with immediate ADT or radiation.
对根治性前列腺切除术（RP）后淋巴结转移（LNM；pN1）患者的三种当前管理策略（观察、雄激素剥夺治疗（ADT）和外照射放疗（EBRT）+ADT）进行比较分析。
使用国家癌症数据库（2004-2013 年）确定 RP 后发生 LNM 的患者。排除标准包括 RP 前使用任何放射治疗或 ADT、临床 M1 疾病或随访数据不完整。根据术后管理策略对患者进行分类。主要结局是总生存（OS）。采用 Kaplan-Meier 曲线和调整后的多变量 Cox 比例风险模型进行分析。亚分析进一步评估了患者风险分层和接受辅助治疗的时间。
共纳入 8074 例符合条件的患者。术后，4489 例（55.6%）接受观察，2065 例（25.6%）接受 ADT，1520 例（18.8%）接受 ADT+EBRT。平均（中位数；四分位距）随访时间为 52.3（48.0；28.5-73.5）个月。接受 ADT 或 ADT+EBRT 的患者具有更高的病理 Gleason 评分、T 分期、阳性切缘率和淋巴结负荷。调整后的多变量 Cox 模型显示，ADT+EBRT 与观察（风险比 [HR] 0.77，95%置信区间 [CI] 0.64-0.94；P=0.008）和 ADT（HR 0.76，95%CI：0.63-0.93；P=0.007）相比，OS 有所改善。ADT 与观察相比（HR 1.01，95%CI：0.87-1.18；P=0.88），OS 无差异。当限制辅助队列的辅助治疗时间时，结果相似。对于没有以下不良特征的多达 2549 例（31.6%）患者，各组之间的 OS 无差异：≥pT3b 疾病、Gleason 评分≥9、三个或更多阳性淋巴结或阳性切缘。
对于 RP 后发生 LNM 的患者，辅助 ADT+EBRT 的应用改善了大多数患者的 OS，尤其是那些具有不良病理特征的患者。相反，在多达 30%的没有高危特征的患者中，辅助治疗并没有显著改善 OS，这些患者可以通过观察和避免与立即 ADT 或放疗相关的发病率来进行管理。
