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Association details:
Biomarker:EGFR L858R
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...
Secondary therapy:
cisplatin + gemcitabine
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:
When restricted to L858R mutation, PFS, RR, and DCR for gefitinib versus erlotinib were 8.1 and 8.5 months (HR, 0.938; 95% CI, 0.675 to 1.304; P = .704), 57.5% and 46.3% (P = .174), and 81.3% and 79.1% (P = .744), 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:

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:
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:
More C2 evidence
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....
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:

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. ...
Less C2 evidence
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Gefitinib Monotherapy Afforded Long-Term Survival of an Octogenarian Patient with a Postoperative Recurrence of a Pulmonary Adenocarcinoma-A Case Report

Published date:
02/01/2023
Excerpt:
Postoperative pathological staging revealed a Stage ⅠB (pT2aN0M0)adenocarcinoma that was EGFR mutation-positive(exon 21: L858R)…gefitinib(250 mg daily) was prescribed as first-line therapy….A complete response was evident after 58 months of monotherapy….Gefitinib monotherapy afforded long-term survival of an octogenarian patient with a postoperative recurrence of a pulmonary adenocarcinoma.
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Case Report: An "Immune-Cold" EGFR Mutant NSCLC With Strong PD-L1 Expression Shows Resistance to Chemo-Immunotherapy

Published date:
02/22/2022
Excerpt:
...we report a case of a 50-year-old female patient, who was initially diagnosed as stage IIIA lung squamous cell carcinoma. Immunohistochemistry analysis showed that the patient presented with high PD-L1 expression….A re-biopsy revealed a poorly differentiated lung adenocarcinoma together with EGFR p.L858R mutation. Then the patient received gefitinib, which resulted in significant regression of primary lung lesion.
DOI:
10.3389/fonc.2022.765997
Evidence Level:
Sensitive: C4 – Case Studies
Title:

[Lung Adenocarcinomas with Pulmonary Miliary Metastases: A Case Report and Literature Review]

Published date:
12/20/2019
Excerpt:
The patient was a 52 year-old woman with a history of productive cough for 2 months, which aggraveted with shortness of breath for 1 month… Computed tomography (CT)-guided needle biopsy of the left lung revealed lung adenocarcinoma and epidermal growth factor receptor (EGFR) exon 21 L858R mutation. The patient was treated with gefitinib 250 mg per day. The chest CT was reviewed several times during this period, which shows the double lung nodules were reduced.
DOI:
10.3779/j.issn.1009-3419.2019.12.11
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

In vivo imaging xenograft models for the evaluation of anti-brain tumor efficacy of targeted drugs

Published date:
11/10/2017
Excerpt:
CONTRADICTING EVIDENCE:...Here, we present an in vivo imaging model for brain tumors using human cancer cell lines, including the EGFR-L858R/T790M-positive H1975 lung adenocarcinoma cells...KM12SM colorectal cancer cells containing the TPM3-NTRK1 gene fusion. Human lung adenocarcinoma H1975 cells, harboring an EGFR‐L858R‐sensitive mutation or an EGFR‐T790M‐resistant mutation, were resistant to the first‐generation EGFR‐TKI gefitinib, but were sensitive to the third‐generation EGFR‐TKI osimertinib.
DOI:
10.1002/cam4.1255