Bitte benutzen Sie diese Referenz, um auf diese Ressource zu verweisen: doi:10.22028/D291-37764
Titel: Everolimus after failure of one prior VEGF-targeted therapy in metastatic renal cell carcinoma : Final results of the MARC-2 trial
VerfasserIn: 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
Sprache: Englisch
Titel: International Journal of Cancer
Bandnummer: 148 (2021)
Heft: 7
Seiten: 1685–1694
Verlag/Plattform: Wiley
Erscheinungsjahr: 2020
Freie Schlagwörter: 6-month PFS rate
everolimus
phase IV
renal cell carcinoma
second-line
DDC-Sachgruppe: 610 Medizin, Gesundheit
Dokumenttyp: Journalartikel / Zeitschriftenartikel
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 der Erstveröffentlichung: 10.1002/ijc.33349
URL der Erstveröffentlichung: https://onlinelibrary.wiley.com/doi/10.1002/ijc.33349
Link zu diesem Datensatz: 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
Datum des Eintrags: 28-Okt-2022
Bezeichnung des in Beziehung stehenden Objekts: Supporting Information
In Beziehung stehendes Objekt: https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fijc.33349&file=ijc33349-sup-0001-TableS1.pdf
Fakultät: M - Medizinische Fakultät
Fachrichtung: M - Urologie und Kinderurologie
Professur: M - Prof. Dr. Michael Stöckle
Sammlung:SciDok - Der Wissenschaftsserver der Universität des Saarlandes



Diese Ressource wurde unter folgender Copyright-Bestimmung veröffentlicht: Lizenz von Creative Commons Creative Commons