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Association details:
| Biomarker: | EGFR exon 19 deletion |
|---|---|
| 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:
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
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 (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed)....At data cutoff (Jan 26, 2011), 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 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 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:
More C2 evidence
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:
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:
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 mutation:...
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:
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:
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 Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.
Excerpt:
...histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study...
Trial ID:
Source:
Title:
A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors
Excerpt:
...- Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests...
Trial ID:
Source:
Title:
Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib
Excerpt:
...Prior sensitivity to erlotinib or gefitinib or other EGFR TKI....
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:
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:
...- Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows:...
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:
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 Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene
Excerpt:
...- Exon 19 deletion or exon 21 activating mutation in EGFR...
Trial ID:
Source:
Title:
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
Excerpt:
...- Sufficient tumor tissue available for EGFR mutation analysis...
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:
...- Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)...
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 outcomes of EGFR-TKI with or without locoregional brain therapy in advanced EGFR-mutant non-small cell lung cancer patients with brain metastases
Published date:
10/05/2023
Excerpt:
Patients were divided into 2 groups: EGFR-TKI (erlotinib) monotherapy and EGFR-TKI combined with locoregional therapy (γ knife surgery - GKS or whole-brain radiation therapy)....Exon 19 deletion patients in both groups had longer median OS (26 months) than those with L858R exon 21 (15 months) (p = 0.023).
DOI:
10.5114/wo.2023.129366
Source:
Title:
Do patient characteristics affect EGFR tyrosine kinase inhibitor treatment outcomes? A network meta-analysis of real-world survival outcomes of East Asian patients with advanced non-small cell lung cancer treated with first-line EGFR-TKIs
Published date:
09/22/2023
Excerpt:
Similarly, in patients with the EGFR Del19 mutation, afatinib and erlotinib resulted in significantly longer PFS than gefitinib (HR: 0.48 with 95% CI: 0.33-0.71 and HR: 0.54 with 95% CI: 0.36-0.80, respectively).
DOI:
https://doi.org/10.1111/1759-7714.15111
Source:
Title:
P59.10 - A Sneak Peak in the Future World of EGFR Mutations: ML Based PFS Differences Between Del 19 and L858R
Published date:
08/18/2021
Excerpt:
413 patients of stage IV EGFR mutant NSCLC were analysed...Median PFS for each drug according to mutation is depicted in Table 1....Del19 and L858R mutations differ with respect to prognosis and therapeutics. In our population, del19 cases were more commonly male, and depicted a better PFS on 1st line TKI when compared to L858R positive cases (commonly female).
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:
1395P - Who will maintain as long-term responders more than 3 years with first- or second-generation EGFR TKI among EGFR mutant NSCLC?
Published date:
09/14/2020
Excerpt:
We analyzed EGFR-mutant advanced NSCLC patients treated with first-line gefitinib, erlotinib or afatinib from Jan 2013 to Dec 2016….Of the 931 patients treated with first-line EGFR-TKI other than osimertinib, 140 (15.0%) patients were LTRs; gefitinib (n=85, 60.7%), erlotinib (n=22, 15.7 %), and afatinib (n=33, 23.6%), respectively...Patients with recurrent disease (OR 0.40, p<0.001), Exon 19 deletion (OR 0.58, p=0.007) and without wet pleura (OR 3.11, p<0.001), bone (OR 1.93, p=0.003), CNS (OR 1.69, p=0.018) or other extrathoracic organ (OR 7.09, p=0.001) metastases were associated with LTRs.
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:
Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib or erlotinib
Excerpt:
Patients with NSCLC and EGFR exon 19 deletions have a longer survival following treatment with gefitinib or erlotinib compared with those with the L858R mutation.
DOI:
10.1158/1078-0432.CCR-06-0462
Source:
Title:
Transformation of NSCLC to SCLC after 1st- and 3rd-generation EGFR-TKI resistance and response to EP regimen and erlotinib
Published date:
03/12/2021
Excerpt:
The postoperative pathology showed lung adenocarcinoma (pT2aN1M0, stage IIA)...with EGFR exon 19 deletion….In November 2017, the patients underwent stereotactic body radiation therapy (SBRT) for metastasis of spinal cord and 6 cycles of EP (etoposide, 100 mg/m2 plus cisplatin 75 mg/m2) therapy and sequential 2 cycles of oral etoposide mono-therapy (100 mg/m2, day1–5, 21 days per cycle), in combination with erlotinib (150 mg per day). The clinical outcome is partial response...
Secondary therapy:
EP + etoposide IV
DOI:
10.1097/MD.0000000000025046
