关键词: 肾细胞癌, 免疫治疗, 免疫检查点抑制剂, 药学解读

Abstract:

In 2026， the Society for Immunotherapy of Cancer released the Clinical Practice Guideline on Immunotherapy for Renal Cell Carcinoma （version 3.0）， which provides updated recommendations covering postoperative adjuvant therapy， first-line combination therapy， post-immunotherapy progression management， non-clear-cell renal cell carcinoma subtypes， and management for special populations. Compared with the 2019 SITC consensus statement on immunotherapy for advanced renal cell carcinoma （RCC）， this updated guideline expands the scope of recommendations from advanced disease to full-spectrum disease course management. Based on the disease-free survival and overall survival benefits validated by the KEYNOTE-564 trial， adjuvant pembrolizumab has become a core treatment option for postoperative patients at high recurrence risk. For metastatic clear-cell RCC， dual immunotherapy regimens and immunotherapy in combination with tyrosine kinase inhibitors are both established as recommended first-line strategies. Following disease progression on immunotherapy， routine sequential anti-programmed cell death protein 1/programmed death ligand 1 therapy is no longer recommended， and subsequent-line treatment places greater emphasis on alternative tyrosine kinase inhibitors and novel agents targeting mechanisms such as hypoxia-inducible factor-2α inhibition. Although clinical evidence for non-clear-cell RCC has expanded， enrollment in clinical trials remains the preferred approach when clinically feasible. From the perspective of clinical pharmacy， this article interprets key updates to this guideline， with a focus on changes to drug recommendations and their supporting evidence. It further compares these recommendations with domestic drug approval status， reimbursement policies， drug accessibility， and the renal cell carcinoma management guideline released by the Chinese Society of Clinical Oncology. This article also discusses core pharmaceutical considerations including indication verification， toxicity attribution， identification and management of immune-related adverse events， management of tyrosine kinase inhibitor-associated toxicities， treatment duration monitoring， patient education， and pharmacoeconomic evaluation， so as to provide a reference for clinical pharmacists engaged in individualized immunotherapy decision-making and medication safety management for patients with renal cell carcinoma.

Key words: renal cell carcinoma, immunotherapy, immune checkpoint inhibitor, pharmaceutical interpretation