接受術後Pembrolizumab治療之高風險腎細胞癌患者的復發臨床病理預後因子

黃昱凱¹, 魏子鈞^1,2, 張延驊^1,2, 黃逸修^1,2, 鍾孝仁^1,2, 黃子豪^1,2

¹泌尿部 臺北榮民總醫院

²書田泌尿科學研究中心 國立陽明交通大學醫學院泌尿學科

Clinicopathological Predictors of Recurrence in High-Risk Renal Cell Carcinoma Patients Receiving Adjuvant Pembrolizumab: Real-World Experience

Yu-Kai Huang¹, Tzu-Chun Wei^1,2, Yen-Hwa Chang^1,2, Eric Yi-Hsiu Huang^1,2

Hsiao-Jen Chung^1,2, Tzu-Hao Huang^1,2,

¹Department of Urology, Taipei Veterans General Hospital

²Department of Urology, School of Medicine and Shu-Tien Urological Science Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan

Purpose: Adjuvant Pembrolizumab has become the standard of care for high-risk renal cell carcinoma (RCC) based on the KEYNOTE-564 trial. However, real-world predictive factors for recurrence in this specific cohort remain to be elucidated. This study aims to evaluate the clinicopathological factors and safety outcomes of patients with ≥ pT3 RCC receiving adjuvant immunotherapy.

Materials and Methods: We retrospectively reviewed 27 patients with pathologic ≥ T3 RCC who underwent radical or partial nephrectomy followed by adjuvant Pembrolizumab between 2024 and 2026. Clinicopathological parameters, including SSIGN score, BAP1 loss, tumor necrosis, capsular penetration, renal sinus invasion and hilar vein invasion, were analyzed. Recurrence-free status was compared using the Chi-square test and independent t-tests.

Results: Among 27 patients (mean age: 52.6 years), 7 (25.9%) experienced tumor recurrence or metastasis during a mean follow-up of 30.4 months. While the small sample size limited statistical significance (p < 0.05), several factors showed strong trends toward recurrence. Hilar vein invasion present in 85.7% of the recurrence group vs. 45.0% in the no-recurrence group (p=0.062). Positive surgical margin showed 14.3% vs. 0% (p=0.085). BAP1 loss showed numerically higher in the recurrence group (28.6% vs. 5.3%, p=0.167). High SSIGN risk: was 42.9% in the recurrence group vs. 15.0% in the no-recurrence group. Regarding safety, ≥grade 3 immune-related adverse events (irAEs) occurred in 29.6% (8/27) of the total cohort, with no significant difference between groups (p=0.633).

Conclusions: In this real-world cohort of high-risk RCC, hilar vein invasion and positive surgical margins appear to be potential indicators for recurrence despite adjuvant immunotherapy. BAP1 loss also warrants further investigation as a molecular predictor. Adjuvant Pembrolizumab remains a safe and viable option for pT3+ RCC patients in clinical practice.