Please use this identifier to cite or link to this item: doi:10.22028/D291-37764
Title: Everolimus after failure of one prior VEGF-targeted therapy in metastatic renal cell carcinoma : Final results of the MARC-2 trial
Author(s): Staehler, Michael
Stöckle, Michael
Christoph, Daniel C.
Stenzl, Arnulf
Potthoff, Karin
Grimm, Marc-Oliver
Klein, Dunja
Harde, Johanna
Brüning, Fabian
Goebell, Peter J.
Augustin, Marinela
Roos, Frederik
Benz-Rüd, Iris
Marschner, Norbert
Grünwald, Viktor
Language: English
Title: International Journal of Cancer
Volume: 148 (2021)
Issue: 7
Pages: 1685–1694
Publisher/Platform: Wiley
Year of Publication: 2020
Free key words: 6-month PFS rate
phase IV
renal cell carcinoma
DDC notations: 610 Medicine and health
Publikation type: Journal Article
Abstract: MARC-2, a prospective, multicenter phase IV trial, aimed to investigate clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with everolimus after failure of one initial vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy and to identify subgroups benefiting most, based on clinical characteristics and biomarkers. Patients with clear cell mRCC failing one initial VEGFR-TKI received everolimus until progression or unacceptable toxicity. Primary endpoint was 6-month progression-free survival rate (6moPFS). Secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety. Between 2011 and 2015, 63 patients were enrolled. Median age was 65.4 years (range 43.3-81.1). 6moPFS was 39.3% (95% confidence interval [CI], 27.0-51.3) overall, 54.4% (95% CI, 35.2-70.1) vs 23.7% (95% CI, 10.5-39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7-65.7) vs 18.2% (95% CI, 5.7-36.3) for patients with body mass index (BMI) >25 vs ≤25 kg/m2. A Cox proportional hazards model confirmed a longer PFS for patients aged ≥65 years (hazard ratio [HR] 0.46; 95% CI, 0.26-0.80) and a longer OS for patients with BMI >25 kg/m2 (HR 0.36; 95% CI, 0.18-0.71). Median PFS and median OS were 3.8 months (95% CI, 3.2-6.2) and 16.8 months (95% CI, 14.3-24.3). ORR was 7.9% and disease control rate was 60.3%. No new safety signals emerged. Most common adverse events were stomatitis (31.7%), fatigue (31.7%), and anemia (30.2%). One patient died from treatment-related upper gastrointestinal hemorrhage. Everolimus remains a safe and effective treatment option for mRCC patients after one prior VEGFR-TKI therapy. Patients aged ≥65 years and patients with BMI >25 kg/m2 benefited most.
DOI of the first publication: 10.1002/ijc.33349
URL of the first publication:
Link to this record: urn:nbn:de:bsz:291--ds-377644
ISSN: 1097-0215
Date of registration: 28-Oct-2022
Description of the related object: Supporting Information
Related object:
Faculty: M - Medizinische Fakultät
Department: M - Urologie und Kinderurologie
Professorship: M - Prof. Dr. Michael Stöckle
Collections:SciDok - Der Wissenschaftsserver der Universität des Saarlandes

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