腎細胞癌術後輔助治療之演進：從標靶藥物到免疫治療之系統性文獻回顧

楊富程

國立台灣大學醫學院附設醫院 教學部

The Changing Paradigm of Post-Surgical Management for Renal Cell Carcinoma: A Systematic Literature Review of the Last Decade

Fu-Cheng Yang

 Department of Medical Education, National Taiwan University Hospital, Taiwan

Purpose: The landscape of post-surgical management for renal cell carcinoma (RCC) has evolved dramatically over the last decade. While surgical resection remains the primary treatment, the challenge of recurrence persists for approximately 30% of patients. This systematic review evaluates the shift from traditional adjuvant targeted therapies to the current era of immune checkpoint inhibitors (ICI) and biomarker-driven precision medicine.

Materials and Methods: Following PRISMA guidelines, a systematic literature search was conducted using databases including PubMed, Embase, and the Cochrane Library for studies published between January 2016 and February 2026. The review focused on phase III randomized controlled trials (RCTs) and high-quality meta-analyses investigating adjuvant targeted therapies (VEGF-TKIs) and immunotherapies for non-metastatic RCC. Primary endpoints analyzed included disease-free survival (DFS), overall survival (OS), and adverse events (AEs).

Results: The analysis of the last decade reveals a distinct paradigm shift in the post-surgical management of renal cell carcinoma. While early large-scale randomized controlled trials evaluated adjuvant VEGF-TKIs such as sunitinib, sorafenib, and pazopanib, meta-analyses confirmed these agents did not consistently provide significant disease-free survival (DFS) or overall survival (OS) benefits and were associated with a high incidence of grade ≥3 adverse events. In contrast, the emergence of adjuvant immunotherapy—specifically pembrolizumab (KEYNOTE-564) for high-risk clear cell RCC—demonstrated a statistically significant improvement in both DFS and OS, providing a more effective and generally better-tolerated alternative. Furthermore, recent evidence highlights the integration of circulating kidney injury molecule-1 (KIM-1) as a non-invasive, blood-based liquid biopsy tool to detect minimal residual disease (MRD), allowing for the identification of patients most likely to benefit from adjuvant immunotherapy based on molecular indicators rather than pathological features alone.

Conclusions: The paradigm of post-surgical management for RCC has shifted from the largely ineffective use of adjuvant targeted therapies toward more effective immunotherapy-based regimens. Future management is trending toward precision oncology, where treatment decisions are guided by molecular biomarkers like KIM-1 rather than pathological features alone. This shift aims to optimize survival outcomes while minimizing the overtreatment of low-risk patients.