PMID- 38310863 OWN - NLM STAT- Publisher LR - 20240204 IS - 1423-0399 (Electronic) IS - 0042-1138 (Linking) DP - 2024 Feb 2 TI - Sunitinib for metastatic renal cell carcinoma: Real world data from the STAR-TOR registry and detailed literature review. LID - 10.1159/000536563 [doi] AB - 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. CI - S. Karger AG, Basel. FAU - Uhlig, Annemarie AU - Uhlig A FAU - Bergmann, Lothar AU - Bergmann L FAU - Bogemann, Martin AU - Bogemann M FAU - Fischer, Thomas AU - Fischer T FAU - Goebell, Peter J AU - Goebell PJ FAU - Leitsmann, Marianne AU - Leitsmann M FAU - Reichert, Mathias AU - Reichert M FAU - Rink, Michael AU - Rink M FAU - Schlack, Katrin AU - Schlack K FAU - Trojan, Lutz AU - Trojan L FAU - Uhlig, Johannes AU - Uhlig J FAU - Woike, Michael AU - Woike M FAU - Strauss, Arne AU - Strauss A LA - eng PT - Journal Article DEP - 20240202 PL - Switzerland TA - Urol Int JT - Urologia internationalis JID - 0417373 SB - IM EDAT- 2024/02/05 00:42 MHDA- 2024/02/05 00:42 CRDT- 2024/02/04 18:27 PHST- 2023/08/03 00:00 [received] PHST- 2024/01/15 00:00 [accepted] PHST- 2024/02/05 00:42 [medline] PHST- 2024/02/05 00:42 [pubmed] PHST- 2024/02/04 18:27 [entrez] AID - 000536563 [pii] AID - 10.1159/000536563 [doi] PST - aheadofprint SO - Urol Int. 2024 Feb 2. doi: 10.1159/000536563.