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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | gefitinib (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
09/27/2018
Excerpt:
Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with activating mutations of EGFR‑TK.
Title:
Gefitinib (Iressa ) is accepted for restricted use within NHS Scotland
Published date:
11/06/2015
Excerpt:
Gefitinib (Iressa ) is accepted for restricted use within NHS Scotland...the treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine
kinase (EGFR-TK).
Source:
Published date:
09/15/2020
Excerpt:
Erlotinib and gefitinib are category 1 (other recommended) options if an EGFR mutation is discovered before giving first-line systemic therapy (eg, pembrolizumab/chemotherapy), and they are category 2A options if an EGFR mutation is discovered during first-line systemic therapy.
Source:
Title:
Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Excerpt:
Addition of carboplatin and pemetrexed to gefitinib represents a first-line option in patients with EGFR-mutated tumors
Secondary therapy:
carboplatin + pemetrexed
Source:
Title:
447P - Quality of life in patients with EGFR-mutated lung cancer receiving gefitinib vs gefitinib plus pemetrexed and carboplatin chemotherapy
Published date:
11/27/2023
Excerpt:
This was a phase III randomized trial in treatment-naive patients with advanced NSCLC with an EGFR-sensitizing mutation...The addition of chemotherapy to Gefitinib improved survival outcomes (PFS an dOS) without a significant adverse impact on quality of life.
Source:
Title:
Gefitinib plus chemotherapy versus gefitinib alone in untreated patients with EGFR-mutated non–small cell lung cancer and brain metastases (GAP Brain): An open-label, randomized, multicenter, phase 3 study.
Published date:
05/26/2022
Excerpt:
In addition, gefitinib plus chemotherapy had better intracranial objective response rate (85.0% versus 63.0%, P = 0.002) and overall objective response rate (80.0% versus 64.2%, P = 0.035) than gefitinib alone….The 3-year OS rate was significantly higher in gefitinib plus chemotherapy group (47.4%, 95% CI 36.3-58.7) than in gefitinib group (24.9%, 95% CI 15.1-34.3, P = 0.003)....Inuntreated EGFR mutated NSCLC patients with brain metastases, gefitinib plus chemotherapy significantly improved intracranial PFS, PFS and a tendency of OS than gefitinib alone, and could be the optional first-line treatment.
Secondary therapy:
pemetrexed
DOI:
10.1200/JCO.2022.40.16_suppl.9095
Trial ID:
Source:
Title:
Gefitinib vs Vinorelbine Plus Cisplatin as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC
Published date:
12/30/2020
Excerpt:
...phase III trial compared adjuvant gefitinib versus vinorelbine plus cisplatin in 222 patients with EGFR-mutated, stage II–IIA non–small cell lung cancer (NSCLC) following resection...After a median follow-up of 80 months, median disease-free survival was longer in the gefitinib cohort (30.8 vs 19.8 months)....gefitinib in patients with early-stage EGFR-mutated NSCLC was associated with improved disease-free survival compared with standard chemotherapy.
Secondary therapy:
cisplatin
Trial ID:
Source:
Title:
Adjuvant Gefitinib Therapy for Early Stage EGFR-Mutant NSCLC
Published date:
12/30/2020
Excerpt:
The use of gefitinib in patients with early-stage EGFR-mutated NSCLC was associated with improved disease-free survival compared with standard chemotherapy...The overall survival with adjuvant gefitinib was longer than in historic cohorts.
Trial ID:
Source:
Title:
Gefitinib Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment for Stage II-IIIA (N1-N2) EGFR-Mutant NSCLC: Final Overall Survival Analysis of CTONG1104 Phase III Trial
Published date:
12/17/2020
Excerpt:
From September 2011 to April 2014, 222 patients from 27 sites were randomly assigned 1:1 to adjuvant gefitinib (n = 111) or VP (n = 111). Patients with resected stage II-IIIA (N1-N2) NSCLC and EGFR-activating mutation were enrolled, receiving gefitinib...Median OS (ITT) was 75.5 and 62.8 months with gefitinib and VP, respectively...
DOI:
10.1200/JCO.20.01820
Trial ID:
Source:
Title:
The role of adjuvant targeted therapy for postoperative EGFR mutant non-small cell lung cancer: A network meta-analysis
Published date:
11/17/2020
Excerpt:
Osimertinib showed the most favorable DFS, with significant superiority versus erlotinib (HR 0.4, 95% CI 0.24-0.66), gefitinib (0.42, 0.26-0.67), chemotherapy (0.23, 0.15-0.33) and placebo (0.17, 0.12- 0.24), but with no significant improvement versus CT +TKI (0.86, 0.42-1.74)....EGFR-TKIs monotherapy provided more survival improvement for patients with exon 19 deletion than with L858R mutation (HR, 0.31 [0.13, 0.75] for exon 19 deletion, and 0.48 [0.35, 0.65] for L858R mutation, respectively).
Source:
Title:
Adding Pemetrexed and Carboplatin to Gefitinib Doubled PFS in EGFR-Mutant NSCLC
Published date:
04/08/2020
Excerpt:
The addition of pemetrexed and carboplatin chemotherapy to gefitinib (Iressa) doubled progression-free survival (PFS) and significantly improved overall survival (OS) in patients with non–small cell lung cancer (NSCLC) harboring an EGFR mutation compared with gefitinib alone, according to results from a randomized phase III clinical trial.
Secondary therapy:
carboplatin + pemetrexed
Source:
Title:
Molecular Predictors of Outcome With Gefitinib and Docetaxel in Previously Treated Non–Small-Cell Lung Cancer: Data From the Randomized Phase III INTEREST Trial
Excerpt:
For all biomarker subgroups analyzed, survival was similar for gefitinib and docetaxel... EGFR mutation–positive patients had longer progression-free survival (PFS; hazard ratio [HR], 0.16; 95% CI, 0.05 to 0.49; P = .001) and higher objective response rate (ORR; 42.1% v 21.1%; P = .04)...
Secondary therapy:
docetaxel
DOI:
10.1200/JCO.2009.24.3030
Trial ID:
Source:
Title:
Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy in EGFR-Mutated Lung Cancer
Excerpt:
This was a phase III randomized trial in patients with advanced NSCLC harboring an EGFR-sensitizing mutation and a performance status of 0 to 2 who were planned to receive first-line palliative therapy….Adding pemetrexed and carboplatin chemotherapy to gefitinib significantly prolonged PFS and OS...
Secondary therapy:
carboplatin + pemetrexed
DOI:
10.1200/JCO.19.01154
Source:
Title:
Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer
Excerpt:
The phase III Iressa Survival Evaluation in Lung Cancer (ISEL) trial compared gefitinib with placebo in 1,692 patients with refractory advanced non-small-cell lung cancer. We analyzed ISEL tumor biopsy samples to examine relationships between biomarkers and clinical outcome after gefitinib treatment in a placebo-controlled setting....Patients with EGFR mutations had higher response rates than patients without EGFR mutations (37.5% v 2.6%);...
DOI:
10.1200/JCO.2006.06.3958
Source:
Title:
A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer
Excerpt:
...- Available tumor tissue for determination of EGFR mutational status and immunohistochemistry analysis...
Trial ID:
Source:
Title:
Induction Therapy With Intercalated Tyrosine Kinase Inhibitor (TKI) and Chemotherapy in NSCLC With Activating Epidermal Growth Factor Receptor (EGFR) Mutation in Stages II-IIIB
Excerpt:
...Patients with histologically or cytologically confirmed non-squamous non-small-cell lung cancer (NSCLC) stage II, IIIA and IIIB detected preoperatively by adequate methods and activating EGFR mutation in exons 18-21 and deemed to be able to undergo curative surgery after induction therapy....
Trial ID:
More C2 evidence
Source:
Title:
GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial
Excerpt:
...- Evidence of activating mutations of EGFR...
Trial ID:
Source:
Title:
Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis
Excerpt:
...- Activating mutation of EGFR...
Trial ID:
Source:
Title:
Gefitinib Usage and Outcomes in Routine Treatment
Excerpt:
...- Locally advanced or metastatic EGFR mutation positive NSCLC...
Trial ID:
Source:
Title:
First Line Gefitinib by FDG-PET Metabolic Response
Excerpt:
...- Patients with tissue for the detection of EGFR mutation...
Trial ID:
Source:
Title:
Management of Advanced Non-Small Cell Lung Cancer (NSCLC) and Clinical Outcomes in Patients Who Received Gefitinib in Thailand
Excerpt:
...Time to maximum response`Overall survival`Prevalence of EGFR & KRAS mutation from laboratory result...
Trial ID:
Source:
Title:
Phase I/II Trails of NKT Cell in Combination With Gefitinib For Non Small Cell Lung Cancer
Excerpt:
...Evidence of activating mutations of EGFR and can be treated with gefitinib; 5. ...
Trial ID:
Source:
Title:
Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Excerpt:
...NSCLC with an activating sensitizing EGFR mutation...
Trial ID:
Source:
Title:
Gefitinib Long-term Survivor Study
Excerpt:
...EGFR mutation positive 4....
Trial ID:
Source:
Title:
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Excerpt:
...- Documented EGFR mutation...
Trial ID:
Source:
Title:
Phase I of Vorinostat-Iressa Combined Therapy on Resistance by BIM Polymorphysim in EGFR Mutant Lung Cancer
Excerpt:
...- EGFR mutations (deletion of exon 19 and L858R mutation of exon 21) for which the clinical benefits of an EGFR-TKI (gefitinib or erlotinib) are recognized by testing methods that are listed by the national health insurance...
Source:
Title:
Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations
Excerpt:
...- Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically....
Trial ID:
Source:
Title:
Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer
Excerpt:
...- EGFR mutation status unknown....
Trial ID:
Source:
Title:
Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Excerpt:
...- Locally advanced or metastatic non-small cell lung cancer (i.e. cancer that has spread from where it started) which is EGFR mutation positive...
Trial ID:
Source:
Title:
Epidermal Growth Factor Receptor (EGFR) Status Based Gefitinib Neoadjuvant Therapy in Non Small Cell Lung Cancer (NSCLC)
Excerpt:
...- Patients pathological diagnosed with NSCLC,with EGFR sensitive mutation;...
Trial ID:
Source:
Title:
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
Excerpt:
...To evaluate the disease free survival of gefitinib combined with radiotherapy as adjuvant therapy in completely resected patients with Pathological stage IIIA-pN2 NSCLC harbouring sensitive mutations of EGFR.Disease free survival (DFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.`...
Trial ID:
Source:
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:
Source:
Title:
Bone Metastasis on the Survival of Gefitinib Effective Patients
Excerpt:
...whether patient was detected for EGFR gene mutation was...
Trial ID:
Source:
Title:
Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone
Excerpt:
...EGFR mutation assessment:...
Trial ID:
Source:
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:
Source:
Title:
Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients
Excerpt:
...- Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)...
Trial ID:
Source:
Title:
Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance
Excerpt:
...- Bim deletion by realtime PCR, or low abundance for EGFR mutation, for 19Del less than 4.9%, for L858R less than 9.5%....
Trial ID:
Source:
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:
Source:
Title:
Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Excerpt:
...- Must have activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene...
Trial ID:
Source:
Title:
SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
Excerpt:
...- Patient who can provide sample for EGFR mutation test...
Trial ID:
Source:
Title:
Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
Excerpt:
...The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC....
Trial ID:
Source:
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:
Source:
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). ...
Trial ID:
Source:
Title:
Clinical study of combined action of gefitinib and brain radiotherapy on EGFR-mutated non-small-cell lung cancer patients with brain metastasis
Excerpt:
...1) patient confirmed NSCLS; 2) MRI indicated that the measurable brain metastasis lesion; 3) patient with EGFR mutations; 4) age 18 ~ 75 years old;ECOG PS 0 ~ 2 points;Life expectancy > 3 months; 5) all subjects or their guardians must sign the subject informed consent before entering the test....
Trial ID:
Source:
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. ...
Trial ID:
Source:
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....
Trial ID:
Source:
Title:
A Single-arm Study to Evaluate the Efficacy of Intercalated Combination of Chemotherapy and Gefitinib as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
Excerpt:
...EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 5. ...
Trial ID:
Source:
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. ...
Trial ID:
Source:
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. ...
Trial ID:
Source:
Title:
Gefitinib for EGFR Sensitive Mutation Postoperative Stage Ib NSCLC Patients
Excerpt:
...Patients with deletion of exon 19 or mutation of L858R at exon 21 in EGFR gene 4....
Trial ID:
Source:
Title:
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
Excerpt:
...- EGFR mutations (in exon 18, 19, or 21)*...
Trial ID:
Source:
Title:
Clinical study of gefitinib combined with recombinant human endostatin or single-agent gefitinib in the treatment of EGFR mutation-positive advanced NSCLC
Excerpt:
...According to the US Joint Committee on Cancer Staging Standards, it is not suitable for radical treatment; according to the Chinese non-small cell lung expert consensus on detection of epidermal growth factor receptor gene mutation in cancer patients, recommended detection means to confirm EGFR sensitive base positive for mutation. ...
Trial ID:
Source:
Title:
PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery
Excerpt:
...- EGFR mutation positive Non-Small Cell lung cancer (NSCLC) (regardless of smoking status), or control group may encompass other molecular subtypes of lung cancer e.g....
Trial ID:
Source:
Title:
NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.
Excerpt:
...- Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR activating mutation in exon 19 or 21...
Trial ID:
Source:
Title:
Re-administration of Iressa to EGFR-mutated NSCLC patients who were eralier treated succesfully with an EGFR-TKI and a subsequent treatment Het opnieuw geven van Iressa aan niet-kleincellig longkanker patienten met een EGFR-mutatie, die eerder al met goed resultaat behandeld zijn met een tyrosine kinase inhibitor en een volgende behandeling
Excerpt:
...Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK mutation as determined before starting the first EGFR-TKI treatment by using a well-validated and robust methodology 2. ...
Trial ID:
Source:
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:
Source:
Title:
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
Excerpt:
...- Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally...
Trial ID:
Source:
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:
Source:
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:
Source:
Title:
To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma
Excerpt:
...The gene detects EGFR mutations is positive; 3....
Trial ID:
Source:
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:
Source:
Title:
High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
Excerpt:
...- High likelihood of gefitinib sensitivity, as evidenced by one or more of the following: previous complete or partial response to treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor, erlotinib, or gefitinib; known somatic mutation of the EGFR tyrosine kinase...
Trial ID:
Source:
Title:
The Continuation of Gefitinib Treatment Beyond Progression in Non-small Cell Lung Cancer Patients With EGFR Mutation
Excerpt:
...- Histologically confirmed stage IIIB/IV or recurrent NSCLC with activating EGFR mutation in exon 18 through exon 21 except T790M...
Trial ID:
Less C2 evidence
Source:
Title:
Patterns of Systemic Anti-Cancer Therapy & Overall Survival of Stage IV NSCLC at Tertiary General Hospital
Published date:
08/08/2023
Excerpt:
This retrospective study included 97 patients with metastatic NSCLC...The patterns of available systemic treatment, the most common first-line chemotherapy regimen in patients with metastatic NSCLC without driver mutation was platinum + taxanes (46%) while the most common first-line targeted therapy in patients with metastatic NSCLC with EGFR mutant was Gefitinib (89%). The median survival of patients in the non-treated group versus treated group was 1 and 12 months (p<0.05) while the median survival of the chemotherapy group versus targeted therapy group was 11 and 16 months (p<0.05)....
Source:
Title:
Effect of Gefitinib Combined with Chemotherapy in Patients with Advanced NSCLC: A Retrospective Cohort Study
Published date:
01/15/2022
Excerpt:
A retrospective analysis was performed on 120 NSCLC patients with advanced EGFRm+ ...and they were divided into the control group (CG, received chemotherapy alone) or the observation group (OG, received chemotherapy and gefitinib) according to the treatment methods (Figure 1)....The chemotherapy and gefitinib treatment improved the DCR better than chemotherapy alone, as evidenced by data in Table 3....The chemotherapy and gefitinib treatment greatly improved the medians of PFS and OS than chemotherapy alone (Figures 2, 3 and Table 4).
Secondary therapy:
Chemotherapy
DOI:
https://doi.org/10.2147/IJGM.S342917
Source:
Title:
Real-World Pattern of Treatment and Clinical Outcomes of EGFR-Mutant Non-Small Cell Lung Cancer in a Single Academic Centre in Quebec
Published date:
12/07/2021
Excerpt:
All 170 patients received EGFR-TKI treatment for metastatic EGFRm NSCLC….Of the 170 patients, 110 (65%) patients received gefitinib, 56 (33%) received erlotinib and 4 (2%) received afatinib (Table 2)….There were 170 patients available for analysis of the best response to treatment. The objective response rate of first-line EGFR-TKI therapy was 74.7%: 83/170 (49%) had CR/PR, 44/170 (26%) had SD....When compared to type of TKI used in the first-line setting, gefitinib provided a significantly higher response rate (55%) and lower progression rate (19.0%) p = 0.005 compared to erlotinib (Table 4).
DOI:
https://doi.org/10.3390/curroncol28060434
Source:
Title:
Radiomic Signature to Predict Outcomes in EGFR-Mutant Non-Small Cell Lung Cancer
Published date:
08/18/2021
Excerpt:
A total of 44 patients with EGFR variant–positive NSCLC receiving EGFR-TKI therapy were included...25 (66%) presented PFS of more than 12 months (age at treatment start: 74 (9) years; 76% females; 16 on erlotinib, 4 on afatinib, 4 on osimertinib, 1 on gefitinib).
Source:
Title:
Gefitinib induction followed by chemoradiotherapy in EGFR-mutant, locally advanced non-small-cell lung cancer: LOGIK0902/OLCSG0905 phase II study
Published date:
06/18/2021
Excerpt:
Patients with unresectable, EGFR-mutant, stage III NSCLC were administered gefitinib monotherapy...The 2-year OS rate was 90% (90% confidence interval: 71.4% to 96.8%), indicating that this trial met the primary objective. The overall response rate and 1- and 2-year progression-free survival rates were 85.0%, 58.1%, and 36.9%, respectively.
DOI:
10.1016/j.esmoop.2021.100191
Source:
Title:
Gefitinib With Concurrent Thoracic Radiotherapy in Unresectable Locally Advanced NSCLC With EGFR Mutation; West Japan Oncology Group 6911L
Published date:
06/09/2021
Excerpt:
The PFS rate at 2 years by independent review was 29.6% (one-sided 95% confidence interval [CI]: 17.6%-). The overall response rate was 81.5% (95% CI: 63.3%-91.3%), median PFS was 18.6 months (95% CI: 12.0-24.5 mo), and median overall survival was 61.1 months...This prospective study revealed the tolerability and the possible efficacy of gefitinib plus concurrent thoracic radiotherapy in patients with LA-NSCLC having EGFR mutation.
DOI:
10.1016/j.jtho.2021.05.019
Source:
Title:
68P - Comparison of first-generation EGFR-TKIs (gefitinib, erlotinib, and icotinib) as adjuvant therapy in resected NSCLC patients with sensitive EGFR mutations
Published date:
03/17/2021
Excerpt:
The median DFS of stage II/III patients in the gefitinib, erlotinib and icotinib group were 36.1 months (95% CI, 23.9–49.4), 42.8 months (95% CI, 29.6–97.8), and 32.5 months (95% CI, 23.9–49.4), respectively...This first and largest real-world study showed that gefitinib, erlotinib, and icotinib demonstrated comparable clinical effectiveness as adjuvant therapy in completely resected patients with EGFR mutated NSCLC.
Source:
Title:
Survival outcomes and symptomatic central nervous system (CNS) metastasis in EGFR-mutant advanced non-small cell lung cancer without baseline CNS metastasis: Osimertinib vs. first-generation EGFR tyrosine kinase inhibitors
Published date:
11/05/2020
Excerpt:
There were 813 patients enrolled, with 562, 106, and 32 received first-line gefitinib, erlotinib, and osimertinib, respectively, while 113 received second-line osimertinib. At a median follow-up of 18.1 months, the median OS was 45.5 months.
DOI:
10.1016/j.lungcan.2020.10.018
Source:
Title:
Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL)
Published date:
10/03/2020
Excerpt:
GOAL was a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease....91 received gefitinib and 91 received gefitinib plus olaparib....The gefitinib plus olaparib combination did not provide significant benefit over gefitinib alone.
DOI:
https://doi.org/10.1016/j.lungcan.2020.09.018
Source:
Title:
1236MO - A single-arm phase II study of gefitinib with concurrent thoracic radiotherapy in unresectable locally-advanced non-small cell lung cancer patients with EGFR mutation (West Japan Oncology Group 6911L)
Published date:
09/18/2020
Excerpt:
CONTRADICTING EVIDENCE: Among unresectable locally-advanced NSCLC patients with EGFR mutation, gefitinib with concurrent thoracic radiotherapy did not improve PFS rate at 2 years.
Source:
Title:
Overall survival of super-elderly (85 years or older) advanced non-small cell lung cancer patients with active epidermal growth factor receptor mutations receiving first-line gefitinib therapy: a single-institute retrospective study
Published date:
08/06/2020
Excerpt:
15 of 17 EGFR-mutant patients received EGFR-TKI therapy with gefitinib (n = 13) or osimertinib (n = 2). The OS tended to be longer in the TKI group than in the CT or BSC group (16.9 months vs. 7.2 months or 9.8 months, p = 0.059). Among the 34 super-elderly NSCLC patients with a PS score of 3-4, 7 with EGFR-mutant received gefitinib therapy and the remaining 27 received BSC alone. The OS tended to be longer in the TKI group than in the BSC group (4.6 months vs. 2.3 months, p = 0.060).
DOI:
10.1007/s00432-020-03344-1
Source:
Title:
A meta-analysis of the safety and effectiveness of pemetrexed compared with gefitinib for pre-treated advanced or metastatic NSCLC
Published date:
07/17/2020
Excerpt:
Pemetrexed was not associated with survival benefit than gefitinib therapy among pre-treated NSCLC patients. While, gefitinib showed superior PFS efficacy than pemetrexed for patients with EGFR mutation-type.
DOI:
10.1097/MD.0000000000021170
Source:
Title:
Gefitinib Alone Versus Gefitinib Plus Chemotherapy for Non-Small-Cell Lung Cancer With Mutated Epidermal Growth Factor Receptor: NEJ009 Study
Excerpt:
Compared with gefitinib alone, gefitinib combined with carboplatin plus pemetrexed improved PFS in patients with untreated advanced NSCLC with EGFR mutations with an acceptable toxicity profile, although its OS benefit requires further validation.
Secondary therapy:
carboplatin + pemetrexed
DOI:
10.1200/JCO.19.01488
Source:
Title:
Impact of Epidermal Growth Factor Receptor and KRAS Mutations on Clinical Outcomes in Previously Untreated Non–Small Cell Lung Cancer Patients: Results of an Online Tumor Registry of Clinical Trials
Excerpt:
Of the 84 patients harboring a sensitizing EGFR mutation who were treated with either erlotinib or gefitinib, 56 patients (67%) achieved an objective response (1 complete response, 55 partial response).
DOI:
10.1158/1078-0432.CCR-09-0888
Source:
Title:
Continued gefitinib retreatment beyond progression in patients with advanced non-small cell lung cancer harboring sensitive EGFR mutations
Excerpt:
Patients with sensitive EGFR mutations received first-line treatment with gefitinib followed by retreatment with gefitinib after disease progression….The median PFS-1 and PFS-2 were 10.0 months and 14.0 months, respectively. The median overall survival (OS) was 36.0 months.
DOI:
10.1177/0300060520955030
Source:
Title:
Epidermal growth factor receptor mutations in needle biopsy/aspiration samples predict response to gefitinib therapy and survival of patients with advanced nonsmall cell lung cancer
Excerpt:
EGFR mutation was assessed from DNA of 63 paraffin-embedded small needle biopsy/aspiration specimens from 62 patients with NSCLC treated with gefitinib….Patients with EGFR mutations had a significantly better response rate compared to that of the nonmutation group (p < 0.001).
DOI:
10.1002/ijc.21458
Source:
Title:
First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations
Excerpt:
First-line therapy with gefitinib administered in a genotype-directed fashion to patients with advanced NSCLC harboring EGFR mutations results in very favorable clinical outcomes with good tolerance.
DOI:
10.1200/JCO.2007.14.8494
Source:
Title:
A Randomized Phase 2 Study of Gefitinib With or Without Pemetrexed as First-line Treatment in Nonsquamous NSCLC With EGFR Mutation: Final Overall Survival and Biomarker Analysis
Excerpt:
This was a phase 2, multicenter, randomized study conducted in East Asian patients with advanced nonsquamous NSCLC with EGFR mutations. Patients were randomized (2:1) to receive P+G (500 mg/m2 intravenously 3-weekly + 250 mg/day orally) or gefitinib...Median OS was 43.4 months in P+G versus 36.8 months in gefitinib arm; adjusted HR 0.77 (95% CI, 0.5-1.2); one-sided P=0.105. Median PFS was significantly longer in the P+G (16.2 months) versus gefitinib arm (11.1 months); adjusted HR 0.67 (95% CI, 0.5-0.9); one-sided P=0.009. In the P+G and gefitinib arms, median PFS was 22.6 and 11.0 months, respectively, in patients with low thymidylate synthase (TS) expression, and 12.6 and 9.9 months, respectively, in patients with high TS expression.
Secondary therapy:
pemetrexed
DOI:
10.1016/j.jtho.2019.09.008
Source:
Title:
Insight into binding mechanisms of EGFR allosteric inhibitors using molecular dynamics simulations and free energy calculations
Excerpt:
... epidermal growth factor receptor (EGFR) kinase domain mutations are a common cause of non-small-cell lung cancer (NSCLC), a major subtype of lung cancers. Patients harboring most of these mutations respond well to the EGFR inhibitors Gefitinib and Erlotinib initially, but soon develop resistance to them due to the emergence of the gatekeeper mutation T790M.
DOI:
10.1080/07391102.2018.1552197
