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Response of the primary tumor to neoadjuvant sunitinib in patients with advanced renal cell carcinoma
Anil A Thomas1, Brian I Rini, Brian R Lane
1Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Purpose:
We assessed the activity of neoadjuvant sunitinib on primary renal tumors in patients with advanced renal cell carcinoma as well as the feasibility and safety of subsequent surgical resection.
Methods:
A total of 19 patients with advanced renal cell carcinoma deemed unsuitable for initial nephrectomy due to locally advanced disease or extensive metastatic burden were treated with 50 mg sunitinib daily for 4 weeks on followed by 2 weeks off. Tumor response was assessed by Response Evaluation Criteria in Solid Tumors every 2 cycles and the rate of conversion to resectable status was estimated.
Results:
Median patient age was 64 years and initial median radiographic renal tumor size was 10.5 cm. Clinical stage was N+ (10) and M+ (15). No patients experienced a complete response. Partial responses of the primary tumor were noted in 3 patients (16%), 7 (37%) had stable disease and 9 (47%) had disease progression in the primary tumor. Overall tumor response included 2 patients (11%) with partial response, 7 (37%) with stable disease and 10 (53%) with disease progression. At a median followup of 6 months (range 1 to 15) 4 patients (21%) had undergone nephrectomy and 5 died of disease progression. No unexpected surgical morbidity was encountered. Viable tumor was present in all 4 specimens. Sunitinib was associated with grade 3-4 toxicity in 7 patients (37%) and treatment was discontinued in 1 due to toxicity.
Conclusions:
Administration of sunitinib in patients with advanced renal cell carcinoma with the primary tumor in place is feasible and can lead to a reduction in tumor burden that can facilitate subsequent surgical resection.
Insights
Neoadjuvant sunitinib is a feasible treatment for advanced renal cell carcinoma, potentially reducing tumor burden to enable surgery. Some patients experienced partial responses, but others had disease progression or toxicity.
Area of Science:
- Oncology
- Nephrology
- Pharmacology
Background:
- Advanced renal cell carcinoma (RCC) presents challenges for initial surgical management.
- Neoadjuvant therapy aims to downstage tumors or improve resectability.
- Sunitinib is a tyrosine kinase inhibitor with anti-cancer properties.
Purpose of the Study:
- To evaluate neoadjuvant sunitinib activity on primary RCC tumors.
- To assess the feasibility and safety of subsequent surgical resection after sunitinib treatment.
Main Methods:
- 19 patients with advanced RCC unsuitable for immediate nephrectomy received sunitinib (50 mg daily, 4 weeks on/2 weeks off).
- Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST).
- Conversion to resectable status and surgical outcomes were evaluated.
Main Results:
- Partial response in 16% of primary tumors; 37% had stable disease; 47% progressed.
- Overall tumor response showed partial response in 11%, stable disease in 37%, and progression in 53%.
- Four patients (21%) underwent nephrectomy; viable tumor was present in all resected specimens. Grade 3-4 toxicity occurred in 37%.
Conclusions:
- Neoadjuvant sunitinib is feasible in advanced RCC patients with unresectable primary tumors.
- Sunitinib can reduce tumor burden, potentially facilitating surgical resection.
- While feasible, sunitinib treatment is associated with significant toxicity and variable tumor response.
