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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Lung Adenocarcinoma |
| Drug: | gefitinib (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Excerpt:
The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib.
Secondary therapy:
paclitaxel + carboplatin
DOI:
10.1056/NEJMoa0810699
Trial ID:
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.
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:
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
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:
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:
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:
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:
Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis
Excerpt:
...- Activating mutation of EGFR...
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:
First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Excerpt:
...- Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis...
Trial ID:
Less C2 evidence
Source:
Title:
361P - 8-year long term survival status in a phase III randomized study in EGFR mutated advanced lung cancer patients in the first-line
Published date:
11/28/2022
Excerpt:
This was an open-labelled, randomized, parallel group study comparing gefitinib (250 mg orally daily) with pemetrexed (500 mg/m2) and carboplatin (area under the curve 5) doublet intravenous induction chemotherapy regimen followed by maintenance pemetrexed (500 mg/m2) in patients with EGFR-activating mutation-positive stage IIIB or stage IV adenocarcinoma lung in the first-line setting....The updated median PFS was 8.4 months with gefitinib against 6.2 months with pemetrexed/carboplatin with HR= 1.287 (95% CI, 1.019-1.625), p= 0.034....This study established the advantage of using the oral TKI, gefitinib, in the first line setting over chemotherapy in terms of PFS advantage and safety profile. Because of crossover post progression it has failed to show an advantage in terms of OS.
Source:
Title:
Treatment pattern and outcomes in patients with uncommon or compound EGFR mutations in India: CRSF 2020-03 study.
Published date:
05/26/2022
Excerpt:
CONTRADICTING EVIDENCE: Total 99 patients with uncommon or compound mutations were included in the study….Thirty-two patients (32%) received first-generation TKI, 30 patients (30%) received palliative chemotherapy and 11 patients (11 %) received Osimertinib. Gefitinib with chemotherapy was used in 2 patients and combination of Gefitinib with Afatinib was used in one patient. Overall response rate and clinical benefit rate with first line treatment was 23% and 35% respectively....Outcomes of patients with these rare mutations are dismal in the real world setting with the available treatment options.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2022.40.16_suppl.e21034
Source:
Title:
Proton pump inhibitors reduce the survival of advanced lung cancer patients with therapy of gefitinib or erlotinib
Published date:
04/29/2022
Excerpt:
CONTRADICTING EVIDENCE: PPI group had the shortest median OS and TTNT compared to the H2RA and non-user groups (in gefitinib cohort: OS: 14.35 vs. 17.67 vs. 21.87 months; P < 0.0001, TTNT: 8.47 vs. 10.78 vs. 10.33 months; P < 0.0001); (in erlotinib cohort: OS: 16.97 vs. 20.07 vs. 23.92 months; P < 0.0001...Concurrent use of PPIs with first-line gefitinib or erlotinib therapy was associated with a worse OS and TTNT in patients with lung adenocarcinoma harboring EGFR mutations.
Secondary therapy:
Proton pump inhibitor
DOI:
https://doi.org/10.1038/s41598-022-10938-x
Source:
Title:
Treatment Effectiveness and Tolerability of Long-term Adjuvant First- and Second-Generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor at Different Doses in Patients With Stage IIA–IIIB Epidermal Growth Factor Receptor-Mutated Lung Adenocarcinoma: A Retrospective Study
Published date:
03/11/2022
Excerpt:
...patients with stage II–III EGFR-mutated adenocarcinoma who underwent cancer resection surgery at a single center were enrolled....The initial EGFR TKIs were mostly gefitinib (n = 25, 83%), and others were erlotinib (n = 3, 10%) and afatinib (n = 2, 6%). The mean disease-free survival (DFS) was 53.3 months. The 2- and 5-year DFS rate was 90.0 and 73.3%, respectively….To our knowledge, this study provides the longest experience of TKI in patients with resected EGFR mutations...
DOI:
https://doi.org/10.3389/fsurg.2022.816018
Source:
Title:
Efficacy and Safety of Gefitinib Plus Pemetrexed/Platinum in Advanced EGFR-Mutated Lung Adenocarcinoma Patients: A Real-World Observational Study
Published date:
01/13/2022
Excerpt:
Fifty-one advanced lung adenocarcinoma patients with EGFR mutation who received gefitinib plus pemetrexed/platinum (GPP) were enrolled as GPP group, meanwhile 30 patients who only received gefitinib were retrospectively recruited as control group....PFS was prolonged in GPP group compared to control group (P=0.013) (median PFS: 23.0 vs 14.0 months, 1-year PFS rate: 78.4% vs 60.0%, 3-year PFS rate: 19.6% vs 5.3%). Furthermore, OS was longer in GPP group compared to control group (P=0.023) (median PFS: 42.0 vs 28.0 months, 1-year PFS rate: 94.1% vs 86.7%, 3-year PFS rate: 56.9% vs 32.7%). After adjustment by multivariate Cox proportional hazard regression, GPP group vs control group was independent predictive factor of prolonged PFS (P=0.004, hazard ratio (HR)=0.450) and OS (P=0.031, HR=0.462).
Secondary therapy:
Chemotherapy + pemetrexed
DOI:
https://doi.org/10.2147/OTT.S332998
Source:
Title:
Comparison of epidermal growth factor receptor tyrosine kinase inhibitors for patients with lung adenocarcinoma harboring different epidermal growth factor receptor mutation types
Published date:
01/11/2021
Excerpt:
...we investigated 363 patients with advanced lung adenocarcinoma harboring EGFR mutations who received EGFR TKIs....Gefitinib showed significantly inferior PFS (4.6 ± 1.1 in gefitinib vs. 11.6 ± 2.7 in afatinib vs. 10.6 ± 2.7 in erlotinib; p = 0.049) in patients with uncommon mutations.
DOI:
10.1186/s12885-020-07765-6
Source:
Title:
First-iGAP: A Randomized Placebo-Controlled Phase II Study of First-line Intercalated Gefitinib and Pemetrexed-Cisplatin Chemotherapy for Never-Smoker Lung Adenocarcinoma Patients
Published date:
05/12/2020
Excerpt:
The PFS benefit of intercalated use of gefitinib over placebo was more apparent for patients with EGFR-mutant tumors (13.3 vs. 7.8 months, P = .025) than those with EGFR-wild-type tumors (8.2 vs. 6.6 months, P = .063).
Secondary therapy:
cisplatin + pemetrexed
DOI:
10.1016/j.cllc.2020.05.003
Source:
Title:
Efficacy of gefitinib at reduced dose in EGFR mutant non-small cell lung carcinoma
Excerpt:
...159 Chinese patients with advanced adenocarcinoma of lung that carried sensitizing EGFR mutations and had received gefitinib as first-line treatment...Patients on reduced dose and standard dose of gefitinib have comparable median progression-free survival.
DOI:
10.1097/CAD.0000000000000849
Source:
Title:
Clinical Implications of KRAS Mutations in Lung Cancer Patients Treated with Tyrosine Kinase Inhibitors: An Important Role for Mutations in Minor Clones1
Excerpt:
Eighty-three patients with lung adenocarcinoma treated with erlotinib or gefitinib were included in this study. Multivariate analysis using stepwise Cox regression confirmed that EGFR and KRAS mutations detected by ME-sequencing were the only two independent predictors of both PFS and OS.
DOI:
10.1593/neo.09814
Source:
Title:
Detection of EGFR mutations in plasma circulating tumour DNA as a selection criterion for first-line gefitinib treatment in patients with advanced lung adenocarcinoma (BENEFIT): a phase 2, single-arm, multicentre clinical trial
Excerpt:
426 patients were screened for the trial, of whom 188 with EGFR mutations in ctDNA were enrolled and received gefitinib...Median progression-free survival was 9·5 months (95% CI 9·07–11·04)...Detection of EGFR mutations in ctDNA is an effective method to identify patients who might benefit from first-line gefitinib treatment.
DOI:
10.1016/S2213-2600(18)30264-9
Trial ID:
Test:
