舒尼替尼
医学
肾细胞癌
肿瘤科
内科学
重症监护医学
泌尿科
作者
Annemarie Uhlig,Lothar Bergmann,Martin Bögemann,Thomas Fischer,Peter J. Goebell,Marianne Leitsmann,Mathias Reichert,Michael Rink,Katrin Schlack,Lutz Trojan,Johannes Uhlig,Michael Woike,Arne Strauß
出处
期刊:Urologia Internationalis
[S. Karger AG]
日期:2024-02-02
摘要
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 was 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 (ccRCC) (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.
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