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Multicenter phase II study of sunitinib in patients with non-clear cell renal cell carcinoma
1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
Background:
Retrospective and molecular biologic data suggest that sunitinib may be effective in patients with non-clear cell renal cell carcinoma (nccRCC).
Patients And Methods:
Eligibility criteria included advanced nccRCC except for collecting duct carcinoma and sarcomatoid carcinoma without identifiable renal cell carcinoma subtypes. Patients were treated with 50 mg/day oral sunitinib for 4 weeks, followed by 2 weeks of rest. The primary end point was overall response rate (RR).
Results:
Thirty-one eligible patients were enrolled. Twenty-four patients (77%) had prior nephrectomy. By Memorial Sloan-Kettering Cancer Center criteria, 8 patients (26%) had poor risk and 14 (45%) had intermediate risk. Twenty-two patients had papillary renal cell carcinoma (RCC), and three had chromophobe RCC. Eleven patients had partial response with a RR of 36% (95% confidence interval (CI) 19% to 52%) and an additional 17 patients (55%) had stable disease. Median duration of response was 12.7 months (95% CI 6.3-19.1 months), and median progression-free survival was 6.4 months (95% CI 4.2-8.6 months). At a median follow-up duration of 18.7 months (95% CI 13.7-23.7 months), 13 patients (42%) had died, resulting in an estimated median survival of 25.6 months (95% CI 8.4-42.9 months). Toxicity profiles were commensurate with prior reports.
Conclusions:
Sunitinib has promising activity in patients with nccRCC (NCT01219751).
Insights
Sunitinib shows promising activity in patients with non-clear cell renal cell carcinoma (nccRCC). The study observed a 36% overall response rate, indicating potential efficacy for this cancer subtype.
Area of Science:
- Oncology
- Medical research
Background:
- Retrospective and molecular data suggest sunitinib's potential efficacy in non-clear cell renal cell carcinoma (nccRCC).
- This study investigated sunitinib's activity in advanced nccRCC patients.
Purpose of the Study:
- To evaluate the efficacy and safety of sunitinib in patients with advanced non-clear cell renal cell carcinoma (nccRCC).
Main Methods:
- Patients with advanced nccRCC (excluding collecting duct and sarcomatoid subtypes) received oral sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest.
- The primary endpoint was the overall response rate (RR).
- Eligibility criteria were established, and patient risk stratification was performed using Memorial Sloan-Kettering Cancer Center criteria.
Main Results:
- Thirty-one patients were enrolled; 22 had papillary RCC and 3 had chromophobe RCC.
- An overall response rate (RR) of 36% was observed, with 11 patients achieving a partial response and 17 (55%) having stable disease.
- Median progression-free survival was 6.4 months, and median overall survival was 25.6 months, with manageable toxicity.
Conclusions:
- Sunitinib demonstrates promising activity and a manageable toxicity profile in patients with advanced non-clear cell renal cell carcinoma (nccRCC).
- Further investigation is warranted to confirm these findings in a larger patient cohort.
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