Department of Surgery, Laval University, Quebec City, QC, Canada.
Eur Urol. 2013 Jul;64(1):19-25. doi: 10.1016/j.eururo.2012.08.002. Epub 2012 Aug 10.
Positive surgical margins (PSMs) increase the risk of biochemical recurrence (BCR) after radical prostatectomy (RP), but their impact on hard clinical end points is a topic of ongoing discussion.
To evaluate the influence of solitary PSMs (sPSMs) and multiple PSMs (mPSMs) on important clinical end points.
DESIGN, SETTING, AND PARTICIPANTS: Data from 1712 patients from the Centre Hospitalier Universitaire de Québec with pT2-4 N0 prostate cancer (PCa) and undetectable prostate-specific antigen after RP were analyzed.
RP without neoadjuvant or adjuvant treatment.
Kaplan-Meier analysis estimated survival functions, and Cox proportional hazards models addressed predictors of clinical end points.
Median follow-up was 74.9 mo. A total of 1121 patients (65.5%) were margin-negative, 281 patients (16.4%) had sPSMs, and 310 patients (18.1%) had mPSMs. A total of 280 patients (16.4%) experienced BCR, and 197 patients (11.5%) were treated with salvage radiotherapy (SRT). Sixty-eight patients (4.0%) received definitive androgen deprivation therapy, 19 patients (1.1%) developed metastatic disease, and 15 patients (0.9%) had castration-resistant PCa (CRPC). Thirteen patients (0.8%) died from PCa, and 194 patients (11.3%) died from other causes. Ten-year Kaplan-Meier estimates for BCR-free survival were 82% for margin-negative patients, 72% for patients with sPSMs, and 59% for patients with mPSMs (p<0.0001). Time to metastatic disease, CRPC, PCa-specific mortality (PCSM), or all-cause mortality did not differ significantly among the three groups (p=0.991, p=0.988, p=0.889, and p=0.218, respectively). On multivariable analysis, sPSMs and mPSMs were associated with BCR (hazard ratio [HR]: 1.711; p=0.001 and HR: 2.075; p<0.0001), but sPSMs and mPSMs could not predict metastatic disease (p=0.705 and p=0.242), CRPC (p=0.705 and p=0.224), PCSM (p=0.972 and p=0.260), or all-cause death (p=0.102 and p=0.067). The major limitation was the retrospective design.
In a cohort of patients who received early SRT in 70% of cases upon BCR, sPSMs and mPSMs predicted BCR but not long-term clinical end points. Adjuvant radiotherapy for margin-positive patients might not be justified, as only a minority of patients progressed to end points other than BCR. PCSM was exceeded 15-fold by competing risk mortality.
根治性前列腺切除术（RP）后，阳性切缘（PSM）增加了生化复发（BCR）的风险，但它们对硬临床终点的影响仍是一个讨论的话题。
评估单纯性 PSM（sPSM）和多发性 PSM（mPSM）对重要临床终点的影响。
设计、地点和参与者：对来自魁北克大学健康中心的 1712 名 pT2-4 N0 前列腺癌（PCa）和 RP 后前列腺特异性抗原无法检测到的患者的数据进行了分析。
无新辅助或辅助治疗的 RP。
Kaplan-Meier 分析估计了生存函数，Cox 比例风险模型分析了临床终点的预测因素。
中位随访时间为 74.9 个月。共有 1121 名患者（65.5%）为边缘阴性，281 名患者（16.4%）有 sPSM，310 名患者（18.1%）有 mPSM。共有 280 名患者（16.4%）发生了 BCR，197 名患者（11.5%）接受了挽救性放疗（SRT）。68 名患者（4.0%）接受了确定性雄激素剥夺治疗，19 名患者（1.1%）发生了转移性疾病，15 名患者（0.9%）发生了去势抵抗性 PCa（CRPC）。13 名患者（0.8%）死于 PCa，194 名患者（11.3%）死于其他原因。边缘阴性患者的 10 年 BCR 无复发生存率为 82%，sPSM 患者为 72%，mPSM 患者为 59%（p<0.0001）。三组之间，转移性疾病、CRPC、PCa 特异性死亡率（PCSM）或全因死亡率的时间均无显著差异（p=0.991、p=0.988、p=0.889 和 p=0.218）。多变量分析显示，sPSM 和 mPSM 与 BCR 相关（风险比[HR]：1.711；p=0.001 和 HR：2.075；p<0.0001），但 sPSM 和 mPSM 不能预测转移性疾病（p=0.705 和 p=0.242）、CRPC（p=0.705 和 p=0.224）、PCSM（p=0.972 和 p=0.260）或全因死亡（p=0.102 和 p=0.067）。主要的局限性在于回顾性设计。
在接受早期 SRT 的 70%的 BCR 患者队列中，sPSM 和 mPSM 预测了 BCR，但不能预测长期的临床终点。对阳性边缘患者进行辅助放疗可能是不合理的，因为只有少数患者进展到除 BCR 以外的终点。竞争风险死亡率使 PCSM 超过了 15 倍。
