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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Source:
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: A2 - Guideline
New
Source:
Excerpt:
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-)
Evidence Level:
Sensitive: B - Late Trials
Title:

Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non–Small Cell Lung Cancer in Patients With Brain Metastases

Published date:
02/08/2023
Excerpt:
This was an open-label, parallel, phase 3 randomized clinical trial (GAP BRAIN) conducted in 6 centers in China. The main eligibility criteria included histologically or cytologically confirmed NSCLC with EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R mutation)...In this randomized clinical trial, gefitinib plus chemotherapy significantly improved intracranial PFS, PFS, and OS compared with gefitinib alone in patients with untreated EGFR-mutant NSCLC brain metastases...
Secondary therapy:
Chemotherapy
DOI:
10.1001/jamanetworkopen.2022.55050
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Phase III study comparing gefitinib monotherapy (G) to combination therapy with gefitinib, carboplatin, and pemetrexed (GCP) for untreated patients (pts) with advanced non-small cell lung cancer (NSCLC) with EGFR mutations (NEJ009)

Published date:
05/16/2018
Excerpt:
Pts with newly diagnosed stage III/IV/ recurrent NSCLC harboring an EGFR activating mutations (exon 19 deletion or exon 21 L858R) were randomized...GCP demonstrated significantly better PFS compared to G….Additional OS analysis (G:101 events vs GCP:83 events) revealed that median survival time of GCP was much longer than that of G (52.2 months vs 38.8 months, HR:0.695, p = 0.013).
Secondary therapy:
carboplatin + pemetrexed
DOI:
10.1200/JCO.2018.36.15_suppl.9005
Evidence Level:
Sensitive: B - Late Trials
New
Source:
Title:

Phase III study of gefitinib (G) versus gefitinib+carboplatin+pemetrexed (GCP) as first-line treatment for patients (pts) with advanced non-small cell lung cancer (NSCLC) with EGFR mutations (NEJ009)

Excerpt:
Pts with newly diagnosed stage III/IV/recurrent NSCLC harboring EGFR activating mutations (exon 19 deletion or exon 21 L858R) were randomized 1:1 to G 250 mg PO QD or GCP (G 250mg PO QD combined with carboplatin AUC 5 + pemetrexed 500mg/m2, every 3 weeks)....Although there was no difference in PFS2 between the arms, additional OS analysis (G 101 events vs GCP 83 events) revealed that median survival time of GCP was much longer than that of G (52.2 months vs 38.8 months, HR: 0.695, p = 0.013)....NEJ009 was the first phase III study which evaluated the efficacy of a combination of EGFR-TKI and platinum doublet chemotherapy in untreated advanced NSCLC pts with EGFR mutations.
Secondary therapy:
carboplatin + pemetrexed
DOI:
10.1093/annonc/mdy292.005
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Gefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR

Excerpt:
First-line gefitinib for patients with advanced non–small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival, with acceptable toxicity, as compared with standard chemotherapy.
DOI:
10.1056/NEJMoa0909530
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

the Clinical Trial of Gefitinib(Non - Small Cell Lung Cancer)

Excerpt:
...Detection of EGFR-positive exon 19 deletion or exon 21 (L858R) mutation was performed by providing a detectable specimen (tissue or cancerous pleural effusion) prior to enrollment; 5....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone

Excerpt:
...EGFR mutation assessment:...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance

Excerpt:
...- EGFR exon 19 deletion or exon 21 L858R....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Evaluation of the safety, pharmacokinetics and efficacy of domestic gefitinib tablets in the treatment of patients with advanced non-small cell lung cancer by a multicenter, randomized, positive drug gefitinib (trade name: Iressa ?) Efficacy

Excerpt:
...to provide a testable specimen (tissue or cancerous pleural effusion) before the group to carry out genotyping, test results show EGFR-positive exon 19 deletion or exon 21 (L858R) mutation; 4) major organ function within 7 days prior to treatment, meeting the following criteria: (1) blood routine examination criteria (14 days without blood transfusion): hemoglobin (HB) ≥ 90g/L; neutrophil absolute (ANC) ≥ 1.5×10^9/L; platelet (PLT) ≥80×10^9/L; (2) biochemical tests to meet the following criteria: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 ULN, Liver metastases, ALT and AST ≤ 5 ULN; serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low (50%). ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Clinical application of dynamic monitoring EGFR acquired resistance mutations in circulating tumor cells (CTCs) of patients with non-small cell lung cancer

Excerpt:
...EGFR mutation, exon 19 Del or exon 21 L858R, must be confirmed before enrollment. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Clinical study of gefitinib combined with recombinant human endostatin or gefitinib in the first-line treatment of EGFR mutation positive advanced NSCLC

Excerpt:
...Patients with advanced non-small cell lung cancer (NSCLC) confirmed by histopathology or cytology, who can not be operated or have postoperative recurrence and metastasis [2009 IASLC international lung cancer staging (8th Edition) TNM stage III B-IV, see Appendix 2 of the trial protocol], according to the definition of the joint committee on cancer staging standards, they are not suitable for radical treatment; To confirm EGFR 19del or L858R mutation according to the detection method recommended by "expert consensus on detection of epidermal growth factor receptor gene mutation in Chinese patients with non-small cell lung cancer"; [Chinese Journal of Pathology, 2011,40 (10): 700-702] 2. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Multicentre, randomized, placebo-controlled, double-blind study of gefitinib plus "Fuzheng Kang'ai" decoction versus gefitinib in advanced non-small-cell lung cancer patients with EGFR mutation

Excerpt:
...Harbouring activating EGFR mutations (either exon 19 deletion or L858R in exon 21); 4. ...
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:

A exploratory Study of Apatinib and Gefitinib First-line treatment in Patients With Advanced Non-squamous Non-Small-Cell Lung Cancer Harboring EGFR Mutations

Excerpt:
...Documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and 21 L858R). ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Preoperative Gefitinib for EGFR Mutant II-IIIa NSCLC (ECTOP-1001)

Excerpt:
...Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance

Excerpt:
...EGFR mutation (exon 19 deletion or exon 21 L858R) with Bim deletion or low abundance for EGFR mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Third-line Treatment of Gefitinib in NSCLC Patients

Excerpt:
...EGFR exon 19 deletion or exon 21 L858R substitution mutation confirmed; 5....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.

Excerpt:
...Tumors with common EGFR mutations (19del or L858R) 3....
Trial ID:
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:

Comparator-Controlled Study for EGFR(+) Patients With Multiple BMs From NSCLC (BROKE) (EGFR-epidermal Growth Factor Receptor;BM-brain Metastases)

Excerpt:
...- Sequencing EGFR mutation(primary lesion or metastases,exon 19 deletions or exon 21 L858R (EGFR mutation in exon 21, L858R point mutation) mutations;...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Excerpt:
...- Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation);...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)

Excerpt:
...- History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)...
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR

Excerpt:
...- Target population is completely resected pathological stage IIIA-N2 NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC

Excerpt:
...Harboring activating mutation of EGFR,only including an exon 19 deletion or an exon 21 point mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Selumetinib in Combination With Gefitinib in NSCLC Patients

Excerpt:
...Must have discontinued any previous anti-cancer and investigational therapy (excluding EGFR TKI) for at least 28 days or radiotherapy ≥14 days before study treatment administration, and must have recovered to Grade 1 from the adverse effects of such treatment before starting study treatment....
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: C3 – Early Trials
Title:

Gefitinib Maintenance After Definitive CCRT in EGFR mutant Stage III NSCLC: Single Arm, Open Label, Multicenter Phase 2 Trial

Published date:
08/08/2023
Excerpt:
This was an open-label, single arm, multi-center phase II trial that included patients aged 19 or older with sensitizing EGFR mutations and stage III NSCLC who had received platinum-based CCRT. Participants were treated with Gefitinib (250mg daily) up to 12 months....53.5% (8/15) of the patients had L858R point mutation and 40% (6/15) of the patients had 19 deletion….Overall response rate was 66.67% (10/15) and disease control rate was 93.33% (14/15).
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Identification of TCR rearrangements specific for genetic alterations in EGFR-mutated non-small cell lung cancer: results from the ADJUVANT-CTONG1104 trial

Published date:
11/24/2022
Excerpt:
In this study, tumor tissues were collected from 101 patients with stage II/III resectable NSCLC with an EGFR mutation (57 patients were treated with gefitinib and 44 were treated with chemotherapy) in the ADJUVANT-CTONG1104 trial…use of Vβ20-1Jβ2-3 specifically for EGFR exon 19 del or Vβ9Jβ2-1 specifically for EGFR exon 21 mutation (L858R), and these were significantly associated with favorable overall survival (OS) for NSCLC patients harboring EGFR exon 19 del or exon 21 L858R, particularly in the adjuvant gefitinib setting...high abundance Vβ20-1Jβ2-3 or Vβ9Jβ2-1 may be an immune biomarker for guiding adjuvant gefitinib decisions for NSCLC patients harboring EGFR exon 19 del or EGFR exon 21 L858R.
DOI:
10.1007/s00262-022-03330-1
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and Failure Patterns of Early SBRT to the Primary Tumor in Advanced EGFR-Mutation-Positive Lung Cancer with EFGR-TKI Treatment: A Prospective, Single Arm, Phase II Study

Published date:
11/22/2022
Excerpt:
All patients were administered a first-generation EGFR-TKI (icotinib 125 mg tid or gefitinib 250 mg qd, orally)....The PFS of subgroups in number of metastases >5 vs. <5 and EGFR mutation L858R vs. 19-del were 11.13 months vs. 16.33 months (HR 0.45, 95% CI (0.23–0.91), p = 0.016) and 13.43 months vs. 26.69 months (HR 0.23, 95% CI (0.12–0.46), p = 0.0017), respectively (Figure 3)....early-phase SBRT for the primary lung tumor combined with EGFR-TKI followed by RT may be an alternative choice for advanced NSCLC harboring the EGFR mutation.
DOI:
https://doi.org/10.3390/life12121954
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy of epidermal growth factor receptor tyrosine kinase inhibitors in patients with recurrent non-small cell lung cancer after definitive concurrent chemoradiation or radiotherapy

Published date:
09/05/2022
Excerpt:
Among the 60 patients, 52 patients (86.7%) had exon 19 deletion or L858R mutation, with 49 patients (81.7%) receiving gefitinib as the first-line EGFR TKI. The median PFS and OS from the initiation of EGFR TKI were 10.4 months (95% confidence interval [CI], 7.4–13.2) and 21.3 months (95% CI, 13.4–28.8), respectively.
DOI:
https://doi.org/10.1007/s00432-022-04287-5
Evidence Level:
Sensitive: C3 – Early Trials
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).
Evidence Level:
Sensitive: C3 – Early Trials
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
Evidence Level:
Sensitive: C3 – Early Trials
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.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Gefitinib as neoadjuvant therapy for resectable stage II-IIIA non-small cell lung cancer: A phase II study

Published date:
04/29/2020
Excerpt:
...patients with operable stage II-IIIA NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation were enrolled.... ORR, the primary endpoint, was 54.5% (95% confidence interval [CI], 37.7-70.7), and the rate of MPR was 24.2% (95% CI, 11.9-40.4)....Neoadjuvant therapy with gefitinib in patients with stage II-IIIA NSCLC is safe and may be a viable treatment for patients whose tumors have EGFR mutations.
DOI:
10.1016/j.jtcvs.2020.02.131
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

A phase II randomized trial evaluating gefitinib intercalated with pemetrexed/platinum chemotherapy or pemetrexed/platinum chemotherapy alone in unselected patients with advanced non-squamous non-small cell lung cancer

Excerpt:
Predefined subgroup analysis showed that PC-G produced favorable HR (0.20, 95% CI 0.05–0.75; P = 0.017) for patients with EGFR mutations (exons 19/21) compared with PC with regard to PFS...In patients with EGFR mutations (exons 19/21), the ORR was 76.9% for the PC-G arm and 50% for the PC arm (P = 0.13).
Secondary therapy:
pemetrexed
DOI:
10.4161/cbt.28874
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
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
Evidence Level:
Sensitive: C3 – Early Trials
New
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
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Long-term progression-free survival in a patient with advanced non-small-cell lung cancer treated with low-dose gefitinib and traditional herbal medicine: A case report

Published date:
02/05/2021
Excerpt:
The patient was diagnosed with stage IV NSCLC (T2aN3M1)...An EGFR deletion was detected in exon 19….The patient was treated with gefitinib (250 mg/d) and traditional herbal medicine, modified Bojungikki-tang (BJIKT)….A partial response was achieved, but after 3 months severe papulopustular skin rashes developed and became aggravated with time. Thus, the gefitinib dose was reduced. However, the PFS has been maintained for approximately 78 months.
DOI:
10.1097/MD.0000000000024292