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Updated: Jul 4, 2025
A Syngeneic Mouse Model of Metastatic Renal Cell Carcinoma for Quantitative and Longitudinal Assessment of Preclinical Therapies
Published on: April 12, 2017
Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature
Annemarie Uhlig1, Lothar Bergmann2, Martin Bögemann3
1Department of Urology, University Medical Center Göttingen, Göttingen, Germany.
Introduction:
We evaluated the effectiveness and safety profile of the tyrosine kinase inhibitor sunitinib in patients with advanced or metastatic renal cell carcinoma (a/mRCC) in a real-world setting.
Methods:
We analyzed data of adult a/mRCC patients treated with sunitinib. Data were derived from the German non-interventional post-approval multicenter STAR-TOR registry (NCT00700258). Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated using descriptive statistics and survival analyses for the entire cohort and patient subgroups.
Results:
A total of 116 study sites recruited 702 patients treated with sunitinib (73.1% male; median age 68.0 years; median Karnofsky index 90%) between November 2010 and May 2020. The most frequent histological subtype was clear cell RCC (81.6%). Sunitinib was administered as first-line treatment in 83.5%, as second line in 11.7%, and as third line or beyond in 4.8% of the patients. Drug-related AEs and serious AEs were reported in 66.3% and 13.9% of the patients, respectively (most common AE: gastrointestinal disorders; 39.7% of all patients).
Conclusions:
This study adds further real-world evidence of the persisting relevance of sunitinib for patients with a/mRCC who cannot receive or tolerate immune checkpoint inhibitors. The study population includes a high proportion of patients with unfavorable MSKCC poor-risk score, but shows still good PFS and OS results, while the drug demonstrates a favorable safety profile. The STAR-TOR registry is also registered in the database of US library of medicine (NCT00700258).
Insights
Sunitinib is effective and safe for advanced renal cell carcinoma patients in real-world settings, showing good progression-free and overall survival even in high-risk groups. This tyrosine kinase inhibitor remains relevant when immune checkpoint inhibitors are not an option.
Area of Science:
- Oncology
- Pharmacology
Background:
- Real-world effectiveness and safety of sunitinib for advanced or metastatic renal cell carcinoma (a/mRCC) were evaluated.
- Sunitinib is a tyrosine kinase inhibitor used in RCC treatment.
Purpose of the Study:
- To assess the real-world effectiveness and safety of sunitinib in patients with advanced or metastatic renal cell carcinoma (a/mRCC).
- To provide evidence supporting sunitinib's continued use in a/mRCC management, particularly for patients unable to receive immune checkpoint inhibitors.
Main Methods:
- Analysis of adult a/mRCC patients treated with sunitinib from the German STAR-TOR registry (NCT00700258).
- Evaluation of progression-free survival (PFS), overall survival (OS), and adverse events (AEs) using descriptive statistics and survival analyses.
- Inclusion of patient subgroups and assessment of drug-related adverse events.
Main Results:
- 702 patients from 116 sites treated with sunitinib (median age 68.0 years; 81.6% clear cell RCC).
- Sunitinib used primarily as first-line treatment (83.5%).
- Drug-related adverse events (AEs) reported in 66.3% of patients, with gastrointestinal disorders being most common (39.7%).
Conclusions:
- Sunitinib demonstrates sustained relevance and a favorable safety profile in real-world a/mRCC treatment.
- Good PFS and OS results were observed, even in a population with a high proportion of unfavorable MSKCC poor-risk scores.
- The study provides valuable real-world evidence for sunitinib's role in a/mRCC, especially when immune checkpoint inhibitors are not suitable.
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