Efficacy of presurgical therapy with tislelizumab and axitinib to downsize local lesions in locally advanced and metastatic renal cell carcinoma: a single-institution experience with long-term follow-up.

Abstract

Background: Systemic therapy with or without surgery is recommended in advanced renal cell carcinoma (RCC). The potential benefits of tislelizumab and axitinib as presurgical therapy in advanced RCC remain unclear. This study aimed to preliminarily assess the efficacy of short-term presurgical tislelizumab and axitinib in downsizing local lesions and its long-term oncological outcome with or without nephrectomy in advanced RCC.

Methods: Data were prospectively collected from patients with advanced RCC who received tislelizumab and axitinib and were scheduled for deferred nephrectomy. Efficacy was evaluated by the remission of all tumor lesions using computed tomography (CT), and oncological outcomes were also reported.

Results: Between March 2021 and May 2022, 11 patients were recruited, 10 of whom presented with metastases. Biopsy results confirmed clear-cell RCC in eight patients, and RCC not otherwise specified in three patients. Following a median of three cycles of presurgical treatment, the overall response rate (ORR) and disease control rate (DCR) were 18.2% (2/11) and 100% (11/11), respectively. The median percentage change in the long-axis diameter was -24.0% (range, -8.2% to -39.7%) for all lesions and -12.2% (range, -7.1% to -39.7%) for local lesions. Open nephrectomy was successfully performed in eight patients with high anatomical complexity. After a median follow-up of 23 months (range, 14-34 months), six patients (6/11, 54.5%) experienced disease progression and died, including three patients without nephrectomy (3/3, 100%) and another three with nephrectomy (3/8, 37.5%). Progression-free survival (PFS) and overall survival (OS) were significantly longer in patients who underwent nephrectomy (P=0.002 and P=0.004).

Conclusions: Short-term presurgical tislelizumab and axitinib can downsize local lesions and facilitate nephrectomy in advanced RCC with high anatomical complexity, potentially improving long-term oncological outcomes when followed by cytoreductive surgery.