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Association details:
Biomarker:EGFR exon 19 deletion
Cancer:Lung Adenocarcinoma
Drug:gefitinib (EGFR inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

First-SIGNAL: First-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung

Excerpt:
Of 313 patients enrolled, 96 patients (31%) were assessable for EGFR mutations, and 42 patients (44%) had EGFR mutation–positive tumors. Deletional mutations in exon 19 and the L858R mutation in exon 21 of EGFR were detected in 27 patients (64%) and 15 patients (36%), respectively, and those mutations were mutually exclusive....In the EGFR mutation–positive subgroup, the gefitinib arm, compared with the GP arm, showed a higher ORR (84.6% [22 of 26 patients] v 37.5% [six of 16 patients], respectively; P = .002) and a trend toward longer PFS (HR, 0.544; 95% CI, 0.269 to 1.100; P = .086...
DOI:
10.1200/JCO.2011.36.8456
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Randomized Phase III Study Comparing Gefitinib With Erlotinib in Patients With Previously Treated Advanced Lung Adenocarcinoma: WJOG 5108L

Excerpt:
Exploratory subset analysis of EGFR mutation restricted to Ex19del indicated that, for gefitinib versus erlotinib, the PFS, RR, and DCR were 11.1 and 11.5 months (HR, 1.120; 95% CI, 0.813 to 1.544; P = .487), 65.4% and 65.1% (P = .965), and 83.3% and 91.6% (P = .113), respectively.
DOI:
10.1200/JCO.2015.63.4154
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
Excerpt:
IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Clinical Study of YYJD Decoction Combined With Gefitinib in Advanced Pulmonary Adenocarcinoma

Excerpt:
...- With activating EGFR mutation (either exon19del or exon21L858R) and one month of gefitinib as first-line or second-line therapy without disease progression (PD);...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

Excerpt:
...- Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Evaluation of efficacy of gefitinib drug in patients with non-small cell tumors with EGFR and TP53 gene mutation Valutazione di efficacia del farmaco gefitinib in pazienti affetti da tumore non a piccole cellule con mutazione del gene EGFR e TP53

Excerpt:
...Locally identified EGFR exon 19 deletion or exon 21 p.L858R. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

Excerpt:
...Sensitive EGFR mutations (19del, 21L858R); 5....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

Excerpt:
...EGFR exon 19 deletion (19del) or exon 21 mutation (L858R) has been confirmed....
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Characterization of patients with lung adenocarcinoma treated at a reference oncology center in northeastern Brazil and submitted to EGFR gene mutation research.

Published date:
05/26/2022
Excerpt:
However, when stratifying analyzes according to mutation type, it was observed that patients with exon 19 deletion treated with gefitinib had greater median overall survival (32, 95%CI = 27-37 months) than patients with this mutation not treated with gefitinib (median = 15, 95%CI = 2-25 months) (p < 0.001)....In the population studied, the exon 19 deletion was the most frequent and the only one associated with a substantial benefit from using gefitinib.
DOI:
10.1200/JCO.2022.40.16_suppl.e20548