Annotation Detail

Information
Associated Genes
EGFR
Associated Variants
EGFR EXON 19 DELETION ( ENST00000275493.7 )
EGFR EXON 19 DELETION ( ENST00000275493.7 )
Associated Disease
lung adenocarcinoma
Source Database
CIViC Evidence
Description
A Japanese Phase III clinical study assessed the noninferiority of gefitinib in comparison to erlotinib in 561 patients with postoperative or recurrent stage IIIB/IV lung adenocarcinoma. Patients were pretreated with at least one chemotherapy regimen, but no tyrosine kinase inhibitors. In the subgroup of 156 patients with exon 19 deletions as their sole EGFR mutation, 83 and 78 were treated with erlotinib and gefitinib, respectively. Objective response (defined as complete + partial response) was approximately 65 percent for both erlotinib gefitinib and non significantly different (p= .965). Disease control rate (defined as complete response + partial response + stable disease) was 91.6 and 83.3 percent for erlotinib and gefitinib, respectively (p=.113). The study was unable to demonstrate statistical noninferiority via the planned end point; however, the lack of statistically significant differences between erlotinib and gefitinib responses, and the milder adverse effects experienced by gefitinib treated patients, led the authors to conclude that gefitinib is a feasible alternative to erlotinib in treating patients with ex19del EGFR positive, advanced lung adenocarcinoma.
Variant Origin
somatic
Variant Origin
Somatic
Evidence URL
https://civic.genome.wustl.edu/links/evidence_items/6184
Gene URL
https://civic.genome.wustl.edu/links/genes/19
Variant URL
https://civic.genome.wustl.edu/links/variants/133
Rating
3
Evidence Type
Predictive
Disease
Lung Adenocarcinoma
Evidence Direction
Does Not Support
Drug
Gefitinib
Evidence Level
B
Clinical Significance
Reduced Sensitivity
Pubmed
27022112
Drugs
Drug NameSensitivitySupported
GefitinibN/Afalse