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

Uhlig A, Uhlig J, Woike M, Fischer T, Trojan L, Bergmann L, Bögemann M, Goebell P, Rink M, Schlack K, Leitsmann M, Strauß A (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Kidney Cancer IOS Press

Book Volume: 7

Pages Range: 37-48

Journal Issue: 1

DOI: 10.3233/KCA-220011

Abstract

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.

Authors with CRIS profile

Peter Goebell Urologische Klinik

Involved external institutions

Westfälische Wilhelms-Universität (WWU) Münster DE Germany (DE) Universitätsklinikum Göttingen DE Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE) Universitätsklinikum Münster DE Germany (DE) Pfizer, Inc. US United States (USA) (US) Goethe-Universität Frankfurt am Main DE Germany (DE) Medizinische Universität Graz AT Austria (AT) Winicker Norimed GmbH DE Germany (DE)

How to cite

APA:

Uhlig, A., Uhlig, J., Woike, M., Fischer, T., Trojan, L., Bergmann, L.,... Strauß, A. (2023). Axitinib beyond first-line therapy of Metastatic Renal Cell Carcinoma: Real World Data from the STAR-TOR registry. Kidney Cancer, 7(1), 37-48. https://dx.doi.org/10.3233/KCA-220011

MLA:

Uhlig, Annemarie, et al. "Axitinib beyond first-line therapy of Metastatic Renal Cell Carcinoma: Real World Data from the STAR-TOR registry." Kidney Cancer 7.1 (2023): 37-48.

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