1. Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review.
- Author
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Uhlig A, Bergmann L, Bögemann M, Fischer T, Goebell PJ, Leitsmann M, Reichert M, Rink M, Schlack K, Trojan L, Uhlig J, Woike M, and Strauß A
- Subjects
- Humans, Male, Aged, Female, Middle Aged, Treatment Outcome, Neoplasm Metastasis, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell secondary, Carcinoma, Renal Cell mortality, Sunitinib therapeutic use, Sunitinib adverse effects, Kidney Neoplasms drug therapy, Kidney Neoplasms pathology, Registries, Antineoplastic Agents therapeutic use, Antineoplastic Agents adverse effects
- Abstract
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)., (© 2024 S. Karger AG, Basel.)
- Published
- 2024
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