Garofano Giuseppe, Saitta Cesare, Musso Giacomo, Meagher Margaret F, Capitanio Umberto, Dabbas Mai, Birouty Natalie, Karamcheti Sanjana, Kim Breanna, Yuen Kit L, Larcher Alessandro, Baker Benjamin, Autorino Riccardo, Pandolfo Savio D, Montorsi Francesco, Saita Alberto, Lazzeri Massimo, Lughezzani Giovanni, Casale Paolo, Buffi Nicolò M, Derweesh Ithaar H
Department of Urology, UC San Diego Health System, San Diego, CA 92121, USA.
Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, MI, Italy.
J Clin Med. 2025 Jun 2;14(11):3908. doi: 10.3390/jcm14113908.
To evaluate the prognostic impact of positive surgical margins (PSMs) after partial or radical nephrectomy for clear cell renal cell carcinoma (ccRCC) across AJCC stages and assess its relevance to adjuvant therapy eligibility, given that landmark trials excluded patients with PSMs. : We conducted a retrospective study using the National Cancer Database, including 171,151 ccRCC patients treated with partial or radical nephrectomy (2004-2020). Patients receiving systemic therapy or with missing key data were excluded. OS was analyzed using Kaplan-Meier curves, log-rank tests, and multivariable Cox regression. Subgroup analyses compared T2 G2/G3 PSM vs. T2 G4 negative surgical margin (NSM) (N0/Nx M0) and assessed PSM impact within KEYNOTE-564 risk groups. : PSMs were present in 5.9% of patients and independently predicted worse OS (HR 1.43; < 0.001). No OS difference was observed in AJCC stage I ( = 0.54), while stages II ( = 0.001), III, and IV ( < 0.001) showed poorer survival with PSMs. OS in patients with T2 G2/G3 tumors and PSMs was comparable to those with T2 G4 and NSMs ( = 0.69). Within the KEYNOTE-564 risk population, PSMs were associated with a 62% increased risk of death (HR 1.62; < 0.001). : PSMs are independently associated with worse OS in ccRCC. Their prognostic impact varies across AJCC stages, supporting the use of margin status to refine risk models, guide surveillance, and consider PSM patients for adjuvant trials.
鉴于具有里程碑意义的试验排除了手术切缘阳性（PSM）的患者，为了评估AJCC各分期的透明细胞肾细胞癌（ccRCC）患者行部分或根治性肾切除术后PSM的预后影响，并评估其与辅助治疗资格的相关性，我们进行了一项回顾性研究，使用国家癌症数据库，纳入了171151例接受部分或根治性肾切除术的ccRCC患者（2004 - 2020年）。排除接受全身治疗或关键数据缺失的患者。采用Kaplan - Meier曲线、对数秩检验和多变量Cox回归分析总生存期（OS）。亚组分析比较了T2 G2/G3 PSM与T2 G4阴性手术切缘（NSM）（N0/Nx M0），并评估了PSM在KEYNOTE - 564风险组中的影响。5.9%的患者存在PSM，其独立预测较差的OS（HR 1.43；P < 0.001）。AJCC I期未观察到OS差异（P = 0.54），而II期（P = 0.001）、III期和IV期（P < 0.001）患者PSM时生存较差。T2 G2/G3肿瘤且有PSM的患者的OS与T2 G4且有NSM的患者相当（P = 0.69）。在KEYNOTE - 564风险人群中，PSM与死亡风险增加62%相关（HR 1.62；P < 0.001）。PSM在ccRCC中独立与较差的OS相关。其预后影响在AJCC各分期有所不同，支持利用切缘状态来完善风险模型、指导监测，并考虑将有PSM的患者纳入辅助试验。
