Everolimus after failure of one prior VEGF-targeted therapy in metastatic renal cell carcinoma: Final results of the MARC-2 trial.
Adult
Aged
Aged, 80 and over
Anemia
/ complications
Antineoplastic Agents
/ administration & dosage
Body Mass Index
Carcinoma, Renal Cell
/ complications
Everolimus
/ administration & dosage
Fatigue
/ complications
Female
Gastrointestinal Hemorrhage
/ complications
Humans
Kaplan-Meier Estimate
Kidney Neoplasms
/ complications
Male
Middle Aged
Progression-Free Survival
Proportional Hazards Models
Prospective Studies
Receptors, Vascular Endothelial Growth Factor
/ antagonists & inhibitors
Stomatitis
/ complications
Treatment Outcome
6-month PFS rate
everolimus
phase IV
renal cell carcinoma
second-line
Journal
International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124
Informations de publication
Date de publication:
01 04 2021
01 04 2021
Historique:
received:
09
01
2020
revised:
28
09
2020
accepted:
29
09
2020
pubmed:
19
10
2020
medline:
6
8
2021
entrez:
18
10
2020
Statut:
ppublish
Résumé
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/m
Substances chimiques
Antineoplastic Agents
0
Everolimus
9HW64Q8G6G
Receptors, Vascular Endothelial Growth Factor
EC 2.7.10.1
Banques de données
ClinicalTrials.gov
['NCT01266837']
Types de publication
Clinical Trial, Phase IV
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1685-1694Informations de copyright
© 2020 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of Union for International Cancer Control.
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