Activity of regorafenib in advanced pretreated soft tissue sarcoma: Results of a single-center phase II study.
Antineoplastic Agents
/ administration & dosage
Drug Monitoring
/ methods
Enzyme Inhibitors
/ administration & dosage
Female
Humans
Male
Middle Aged
Ovarian Neoplasms
/ drug therapy
Pancreatic Neoplasms
/ drug therapy
Phenylurea Compounds
/ administration & dosage
Progression-Free Survival
Pyridines
/ administration & dosage
Response Evaluation Criteria in Solid Tumors
Sarcoma
/ drug therapy
Thymoma
/ drug therapy
Treatment Outcome
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
26 Jun 2020
26 Jun 2020
Historique:
entrez:
27
6
2020
pubmed:
27
6
2020
medline:
9
7
2020
Statut:
ppublish
Résumé
Regorafenib, a multitargeted tyrosine kinase inhibitor, proved to be active in patients with soft tissue sarcomas (STS). We conducted an open-label, non-randomized, single-center phase II study in advanced pretreated STS patients. Patients received regorafenib 160 mg daily on days 1 enrule 21 of a 28-day cycle. The primary endpoint was the progression-free survival (PFS) at 8 weeks. Toxicity was registered. Between April 2015 and November 2016, 21 patients were enrolled in the trial. A total of 13 out of 21 evaluable patients (61.9%) were progression-free at 8 weeks. Median PFS was 3.8 months (95% CI: 2.1-9.4). Median overall survival was 14.8 months (95% CI: 7.7-27.8). In the intention-to-treat population, we reported a PFS of 66.7% at 3 months (95% CI: 40.4-83.4) and 16.7% at 12 months (95% CI: 4.1-36.5). As per the RECIST criteria, the response rate was 4.7% (1 partial response out of 21 evaluable patients) with a clinical benefit rate of 61.9%; no complete response was observed. Treatment was well tolerated. Regorafenib shows signs of clinical activity in patients with advanced STS. ClinicalTrials.gov NCT02307500.
Sections du résumé
BACKGROUND
BACKGROUND
Regorafenib, a multitargeted tyrosine kinase inhibitor, proved to be active in patients with soft tissue sarcomas (STS).
METHODS
METHODS
We conducted an open-label, non-randomized, single-center phase II study in advanced pretreated STS patients. Patients received regorafenib 160 mg daily on days 1 enrule 21 of a 28-day cycle. The primary endpoint was the progression-free survival (PFS) at 8 weeks. Toxicity was registered.
RESULTS
RESULTS
Between April 2015 and November 2016, 21 patients were enrolled in the trial. A total of 13 out of 21 evaluable patients (61.9%) were progression-free at 8 weeks. Median PFS was 3.8 months (95% CI: 2.1-9.4). Median overall survival was 14.8 months (95% CI: 7.7-27.8). In the intention-to-treat population, we reported a PFS of 66.7% at 3 months (95% CI: 40.4-83.4) and 16.7% at 12 months (95% CI: 4.1-36.5). As per the RECIST criteria, the response rate was 4.7% (1 partial response out of 21 evaluable patients) with a clinical benefit rate of 61.9%; no complete response was observed. Treatment was well tolerated.
CONCLUSION
CONCLUSIONS
Regorafenib shows signs of clinical activity in patients with advanced STS.
CLINICAL TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02307500.
Identifiants
pubmed: 32590747
doi: 10.1097/MD.0000000000020719
pii: 00005792-202006260-00022
pmc: PMC7328961
doi:
Substances chimiques
Antineoplastic Agents
0
Enzyme Inhibitors
0
Phenylurea Compounds
0
Pyridines
0
regorafenib
24T2A1DOYB
Banques de données
ClinicalTrials.gov
['NCT02307500']
Types de publication
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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