Efficacy and Safety of Rociletinib Versus Chemotherapy in Patients With
EGFR tyrosine kinase inhibitor
Epidermal growth factor receptor mutations
Non–small cell lung cancer
Phase III randomized clinical trial
Rociletinib
Journal
JTO clinical and research reports
ISSN: 2666-3643
Titre abrégé: JTO Clin Res Rep
Pays: United States
ID NLM: 101769967
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
05
10
2020
accepted:
16
10
2020
entrez:
30
9
2021
pubmed:
1
10
2021
medline:
1
10
2021
Statut:
epublish
Résumé
The TIGER-3 (NCT02322281) study was initiated to compare the efficacy and safety of rociletinib, a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets Patients with advanced or metastatic Enrollment was halted when rociletinib development was discontinued in 2016. Of 149 enrolled patients, 75 were randomized to rociletinib (n = 53: 500 mg twice daily; n = 22: 625 mg twice daily) and 74 to chemotherapy. The median investigator-assessed progression-free survival (PFS) was 4.1 months (95% confidence interval [CI]: 2.6-5.4) in the rociletinib 500-mg group and 5.5 months (95% CI: 1.8-8.1) in the 625-mg group versus 2.5 months (95% CI: 1.4-2.9) in the chemotherapy group. An improved PFS was observed in patients with T790M-positive NSCLC treated with rociletinib (n = 25; 500 mg and 625 mg twice daily) versus chemotherapy (n = 20; 6.8 versus 2.7 mo; hazard ratio = 0.55, 95% CI: 0.28-1.07, Rociletinib had a more favorable median PFS versus chemotherapy but had higher rates of hyperglycemia and corrected QT prolongation in patients with advanced
Identifiants
pubmed: 34589984
doi: 10.1016/j.jtocrr.2020.100114
pii: S2666-3643(20)30160-0
pmc: PMC8474221
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100114Informations de copyright
© 2020 The Authors.
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