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Association details:
| Biomarker: | EGFR L858R |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | erlotinib (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.
Source:
Excerpt:
The NCCN NSCLC Panel recommends erlotinib and gefitinib as first-line therapy options in patients with metastatic nonsquamous NSCLC who have known active sensitizing EGFR mutation...The most commonly described mutations in EGFR (exon 19 deletions, p.L858R point mutation in exon 21) are associated with responsiveness to EGFR tyrosine kinase inhibitor (TKI) therapy...EGFR EXON 19 DELETION OR L858R MUTATIONS….Progression on erlotinib (± ramucirumab or bevacizumab), afatinib, gefitinib, or dacomitinib….SUBSEQUENT THERAPY...Continue erlotinib (± ramucirumab or bevacizumab) or afatinib or gefitinib or dacomitinib (if T790M-)
Source:
Title:
Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations
Excerpt:
Median PFS among those with exon 19 deletions and L858R EGFR mutations (n = 308) was 13.6 months for afatinib and 6.9 months for chemotherapy (HR, 0.47; 95% CI, 0.34 to 0.65; P = .001).
DOI:
10.1200/JCO.2012.44.2806
Trial ID:
Source:
Title:
Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial
Excerpt:
Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease…86 were randomly assigned to receive erlotinib...median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5–5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25–0·54; p<0·0001).
DOI:
https://doi.org/10.1016/S1470-2045(11)70393-X
Trial ID:
Source:
Title:
A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)
Excerpt:
...Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. ...
Trial ID:
Source:
Title:
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib
Excerpt:
...Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay 3....
Trial ID:
More C2 evidence
Source:
Title:
Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
Excerpt:
...- IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution;...
Trial ID:
Source:
Title:
A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR
Excerpt:
...- Presence of one of the EGFR activating mutations in the tumor (exon 19 deletion or L858R, G719X or L861Q)...
Trial ID:
Source:
Title:
Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation
Excerpt:
...EGFR exon 19 deletion or exon 21 L858R, which are positive by real-time PCR methods and negative by standard sequencing methods....
Trial ID:
Source:
Title:
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
Excerpt:
...previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial)....
Trial ID:
Source:
Title:
Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
Excerpt:
...- Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R, L861Q)...
Trial ID:
Source:
Title:
Phase I/II of Oral Vorinostat Combination With Erlotinib in NSCLC Patients With EGFR Mutations With DP After Erlotinib.
Excerpt:
...Have demonstrated mutations at epidermal growth factor receptor (EGFR) at Exon 19 or Exon 21 (Exon 19 mutations characterized by in-frame deletions (747-750), and Exon 21 mutations resulting in L858R substitutions)....
Trial ID:
Source:
Title:
A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
Excerpt:
...A patients with EGFR mutation (including exon 19 deletion, L858R) 5....
Source:
Title:
A prospective, open-labelled, randomized, multicenter phase II study to evaluate efficacy and safety of Erlotinib vs NP chemotherapy as adjuvant therapy in post radical operation IIIA NSCLC patients with EGFR 19 or 21 exon mutation
Excerpt:
...Inclusion Criteria of Target Disease: IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution; Accept study adjuvant therapy within 4 weeks post radical operation; ECOP PS 0-1; Life expectancy >=12 weeks. ...
Trial ID:
Source:
Title:
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
Excerpt:
...Progression-free Survival Per Investigator (PFS2)`Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R`Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R`Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)`Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R`Number of Participants With Adverse Events`Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)...
Trial ID:
Source:
Title:
Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation
Excerpt:
...- Confirmed with Exon 19 deletion or L858R EGFR mutation...
Trial ID:
Source:
Title:
Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
Excerpt:
...at minimum, testing for EGFR exon 19 deletion and exon 21 L858R mutations must have been included; OR...
Trial ID:
Source:
Title:
Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)
Excerpt:
...- Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria: 1....
Trial ID:
Source:
Title:
A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations
Excerpt:
...- Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)...
Trial ID:
Source:
Title:
To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Excerpt:
...The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally....
Trial ID:
Source:
Title:
INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer
Excerpt:
...- A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e. G719X, exon 19 deletion, L858R, L861Q)...
Trial ID:
Source:
Title:
A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label
Excerpt:
...- An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation....
Trial ID:
Source:
Title:
Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)
Excerpt:
...- Metastatic NSCLC with documented EGFR exon 19 deletion or exon 21 (L858R) substitution mutation...
Trial ID:
Source:
Title:
Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
Excerpt:
...If tumor histology is adenocarcinoma, must have wild-type EGFR genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (L858R) substitution....
Trial ID:
Less C2 evidence
Source:
Title:
Treatment and Outcomes of Metastatic Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: Are They Different from Those with Common EGFR Mutations?
Published date:
10/07/2020
Excerpt:
...EGFR mutation-positive NSCLC received first-generation (1G, gefitinib or erlotinib) or 2G EGFR-TKI (afatinib) as the first-line (1L) systemic therapy....The objective response rate (ORR) for the 1L EGFR-TKI was 63.3%. The median progression-free survivals (PFSs) were 8.6 months (95% CI: 3.8-13.5), 11.7 months (95% CI: 6.6-16.7), 7.7 months (95% CI: 4.9-17.4), and 5.0 months (95% CI: 3.7-6.1) for major uncommon EGFR mutation (G719X, L861Q), compound mutation with major EGFR mutation (Del 19 or EGFR exon 21 p.L858R), other compound mutation, and other uncommon mutations, respectively.
DOI:
10.3390/biology9100326
Source:
Title:
EGF receptor gene mutations are common in lung cancers from “never smokers” and are associated with sensitivity of tumors to gefitinib and erlotinib
Excerpt:
Characteristics of patients sensitive to gefitinib (G) and erlotinib (E)….By contrast, the L858R mutant had an ≈10-fold greater sensitivity to both gefitinib (data not shown) and erlotinib…
DOI:
10.1073/pnas.0405220101
Source:
Title:
Genotypic and Histological Evolution of Lung Cancers Acquiring Resistance to EGFR Inhibitors
Excerpt:
All patients had activating EGFR mutations; 20 (54%) had an exon 19 deletion mutation and 15 (41%) had the exon 21 point mutation L858R. All patients had responded clinically to either gefitinib (n=5) or erlotinib (n=32).
DOI:
10.1126/scitranslmed.3002003
Source:
Title:
Comparison of Clinical Outcomes Following Gefitinib and Erlotinib Treatment in Non–Small-Cell Lung Cancer Patients Harboring an Epidermal Growth Factor Receptor Mutation in Either Exon 19 or 21
Excerpt:
A total of 375 patients with recurrent or metastatic stage IIIB/IV NSCLC, who had either exon 19 deletion or the L858R mutation in exon 21, and had received either gefitinib (n = 228) or erlotinib (n = 147), were included in the study...The median PFS from EGFR TKI treatment in the gefitinib and erlotinib group was 11.7 months (95% CI, 9.4–13.9) and 9.6 months (95% CI 8.1–11.1), respectively (Fig. 1)....In conclusion, the present study demonstrated that both gefitinib and erlotinib are well tolerated and have similar effectiveness in NSCLC patients harboring EGFR mutation.
DOI:
https://doi.org/10.1097/JTO.0000000000000095
Trial ID:
Source:
Title:
Leptomeningeal Metastatic L858R EGFR-mutant Lung Cancer: Prompt Response to Osimertinib in the Absence of T790M-mutation and Effective Subsequent Pulsed Erlotinib
Published date:
06/14/2022
Excerpt:
We present a 52-year-old male patient with metastatic non-small-cell lung cancer (NSCLC). The patient was found to have L858R mutation in exon 21 of the EGFR gene….osimertinib (160 mg once daily) promptly induced clinical and radiological response that continued for five months. High dose pulsed erlotinib (1500 mg weekly) improved his quality of life and extended his survival for a further four months.
DOI:
https://doi.org/10.2147/OTT.S336012
Source:
Title:
Non–Small-Cell Lung Cancer and Ba/F3 Transformed Cells Harboring the ERBB2 G776insV_G/C Mutation Are Sensitive to the Dual-Specific Epidermal Growth Factor Receptor and ERBB2 Inhibitor HKI-272
Excerpt:
Consistent with previous reports, H3255 (EGFR L858R) and HCC827 (EGFR E746_A750del) were sensitive to erlotinib treatment ( 15, 16), with IC50 values of 0.031 and 0.003 μmol/L, respectively ( Fig. 1A).
DOI:
10.1158/0008-5472.CAN-06-0971
