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 everolimus phase IV renal cell carcinoma second-line |
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: | https://onlinelibrary.wiley.com/doi/10.1002/ijc.33349 |
Link to this record: | urn:nbn:de:bsz:291--ds-377644 hdl:20.500.11880/34159 http://dx.doi.org/10.22028/D291-37764 |
ISSN: | 1097-0215 0020-7136 |
Date of registration: | 28-Oct-2022 |
Description of the related object: | Supporting Information |
Related object: | https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fijc.33349&file=ijc33349-sup-0001-TableS1.pdf |
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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File | Description | Size | Format | |
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Intl Journal of Cancer - 2020 - Staehler - Everolimus after failure of one prior VEGF‐targeted therapy in metastatic renal.pdf | 1,01 MB | Adobe PDF | View/Open |
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