Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial.
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Biomarkers, Tumor
Carcinoma, Non-Small-Cell Lung
/ diagnosis
ErbB Receptors
/ antagonists & inhibitors
Estrogen Receptor Modulators
/ administration & dosage
Female
Humans
Lung Neoplasms
/ diagnosis
Middle Aged
Mutation
Neoplasm Staging
Prognosis
Protein Kinase Inhibitors
/ administration & dosage
Treatment Outcome
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
01 07 2020
01 07 2020
Historique:
received:
21
10
2019
revised:
16
12
2019
accepted:
02
03
2020
pubmed:
8
3
2020
medline:
15
9
2021
entrez:
8
3
2020
Statut:
ppublish
Résumé
The incidence of lung cancer has dramatically increased in women. Preclinical data have suggested that combining EGFR-tyrosine kinase inhibitor (TKI) with an antiestrogen may overcome resistance to EGFR-TKI. The IFCT-1003 LADIE trial was a 2 × 2 arms parallel open-label randomized phase II trial. EGFR-TKI-naïve postmenopausal women with advanced lung cancer were treated with gefitinib (G) versus gefitinib + fulvestrant (G+F) in the EGFR-mutated group (EGFR Overall, 204 patients (gefitinib 104 and G+F 100) and 175 patients (erlotinib 87 and E+F 88) were enrolled in the EGFR Adding fulvestrant to EGFR-TKI is feasible, but not associated with prolonged PFS regardless of EGFR status. The lack of benefits while combining fulvestrant to EGFR-TKI does not support its future development in an unselected population.
Identifiants
pubmed: 32144133
pii: 1078-0432.CCR-19-3056
doi: 10.1158/1078-0432.CCR-19-3056
doi:
Substances chimiques
Biomarkers, Tumor
0
Estrogen Receptor Modulators
0
Protein Kinase Inhibitors
0
EGFR protein, human
EC 2.7.10.1
ErbB Receptors
EC 2.7.10.1
Banques de données
ClinicalTrials.gov
['NCT01556191']
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3172-3181Informations de copyright
©2020 American Association for Cancer Research.