Real-World Outcomes in Patients with Metastatic Renal Cell Carcinoma According to Risk Factors: The STAR-TOR Registry

Strauß, Arne; Schmid, Marianne; Rink, Michael; Moran, Michael; Bernhardt, Stephan; Hubbe, Marcus; Bergmann, Lothar; Schlack, Katrin; Boegemann, Martin

doi:10.2217/fon-2020-1020

Cited by 4 publications

(3 citation statements)

References 44 publications

(76 reference statements)

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“…Target diseases are a/mRCC, recurrent or refractory mantle cell lymphoma, and gastrointestinal stromal tumors. Additional details regarding the STAR-TOR registry have been published previously [5][6][7][8][9].…”

Section: Methodsmentioning

confidence: 99%

Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review

Uhlig,

Bergmann,

Bögemann

et al. 2024

Urol Int

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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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Section: Methodsmentioning

confidence: 99%

Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review

Uhlig,

Bergmann,

Bögemann

et al. 2024

Urol Int

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“…The registry is intended to evaluate the effectiveness, tolerability, and safety of patients with advanced RCC, recurrent or refractory mantle cell lymphoma and gastrointestinal stromal tumors treated with a) Axitinib, b) Sunitinib, or c) Temsirolimus in a routine clinical setting. Additional details regarding the STAR-TOR registry have been previously published [19][20][21][22][23].…”

Section: Methodsmentioning

confidence: 99%

Axitinib beyond first-line therapy of Metastatic Renal Cell Carcinoma: Real World Data from the STAR-TOR registry

Uhlig¹,

Uhlig

Woike

et al. 2023

KCA

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Objective: To evaluate the effectiveness and safety profile of the tyrosine kinase inhibitor Axitinib for patients with advanced or metastatic renal cell carcinoma (a/mRCC) in a real-world setting. Methods: Adult patients from the German non-interventional post-approval multicenter STAR-TOR registry with a/mRCC (NCT00700258) were included if treated with Axitinib in second line or beyond. Overall survival (OS), progression-free survival (PFS) and adverse events were evaluated across subgroups using descriptive statistics and survival analyses. Results: Between November 2012 and December 2020, 75 study sites recruited 210 patients treated with Axitinib (69,6% male; median age 69 years; median Karnofsky Index 80%). Clear cell RCC was the most frequent histological subtype (81.0%). Axitinib was administered as second-line in 51.4%, third-line in 24.8%, and fourth-line treatment and beyond in 23.8% of the patients, respectively. MSKCC score was 15.0% favorable, 33.6% intermediate, and 51.3% poor risk. Median PFS was 5.6 months, and median OS 18.3 months. Patients with lactate dehydrogenase (LDH) levels > 300U/l had a nominally significantly shorter OS than patients with LDH≤300U/l (8.2 vs. 19.0 months, p = 0.008). Drug related adverse and serious adverse events were reported in 56.7% and 17.6% of the patients, respectively (most common adverse event: gastrointestinal disorders; 37.6%). Conclusions: This real-world study confirms the clinical relevance of Axitinib in the second-line and beyond setting for a/mRCC with OS and PFS reported in concordance with pivotal trials, while demonstrating a favorable safety profile. A high LDH serum level could be a negative predictive marker for Axitinib effectiveness, which can aid in clinical decision making.

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“…However, little is known about the impact of patient gender on the efficacy of ICI combination with ICI or targeted therapy (TT) as cancer treatments. The IMDC prognostic models are the current standard for mRCC patients' stratification, which provides information for patient consultation and treatment choice to a certain extent [ 20 ]. According to the IMDC prognostic model, mRCC patients can be classified as poor, moderate, or favorable risk, which has different biological characteristics.…”

Section: Introductionmentioning

confidence: 99%

The Predictive Value of Three Variables in Patients with Metastatic Renal Cell Carcinoma Treated with Immune-Based Combination Therapies in Randomized Clinical Trials: A Systematic Review and Meta-Analysis

Hou

Xing

et al. 2022

Journal of Oncology

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Background. Sex, age, and International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) prognostic risk may influence the immune response. Nonetheless, the correlation between these factors and the survival benefits of immune-based combination therapies in patients with metastatic renal cell carcinoma (mRCC) is controversial and undefined. As a result, the purpose of this research is to evaluate the potential differences of immune-based combination therapies on survival benefits from mRCC subgroups. Methods. PubMed, Cochrane Library, Embase, and http://www.clinicaltrials.gov were searched from inception to March 17, 2022. Randomized clinical trials (RCTs) comparing overall survival (OS) or progression-free survival (PFS) in patients with mRCC treated by immune-based combinations vs. contemporary first-line therapies were included. Results. Five RCTs with a total of 4206 subjects were included. An OS and PFS benefit of immune-based combinations were found for patients of different sex, age, and IMDC intermediate/poor risk. No obvious difference in relative PFS benefit from immune-based combinations over the control group was found in patients of different genders ( P = 0.71 , I2 = 0%), ages ( P = 0.55 , I2 = 0%), or IMDC prognostic risks ( P = 0.38 , I2 = 0%). However, the difference in OS benefit was significant regarding age ( P = 0.009 , I2 = 85.5%) and IMDC prognostic risk ( P = 0.004 , I2 = 82.2%). Conclusions. This meta-analysis found that immune-based combination therapies should not be restricted to certain patients with mRCC in gender categories. However, age and IMDC prognostic risk of mRCC patients are associated with different outcomes of OS and thus help identify those patients most probably to benefit from immune-based combination therapies.

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Real-World Outcomes in Patients with Metastatic Renal Cell Carcinoma According to Risk Factors: The STAR-TOR Registry

Cited by 4 publications

References 44 publications

Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review

Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review

Axitinib beyond first-line therapy of Metastatic Renal Cell Carcinoma: Real World Data from the STAR-TOR registry

The Predictive Value of Three Variables in Patients with Metastatic Renal Cell Carcinoma Treated with Immune-Based Combination Therapies in Randomized Clinical Trials: A Systematic Review and Meta-Analysis

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