Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers

Costa, Daniel B.; Kobayashi, Susumu; Tenen, Daniel G.; Huberman, Mark S.

doi:10.1016/j.lungcan.2007.05.017

Cited by 160Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentHER2/EGFR in Cancer Research

Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers

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Costa, Daniel B., Kobayashi, Susumu, Tenen, Daniel G., Huberman, Mark S.·2007·Lung Cancer

DOI 10.1016/j.lungcan.2007.05.017PMC PMC2551312

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Abstract

Purpose Epidermal growth factor receptor (EGFR) mutations have been found in the majority of gefitinib-responsive non-small cell lung cancer (NSCLC) patients from retrospective studies. We sought to compile the available phase II and prospective trials of this EGFR tyrosine kinase inhibitor (TKI) to better understand the efficacy and safety of selecting patients to receive gefitinib based on their genotype.Design We searched published trials involving EGFR-mutant patients and gefitinib. Five reports were identified (published between June 2006 and April 2007) in which gefitinib was given in a prospective manner to EGFR mutation positive patients at a dose of 250mg/day. Responses were determined by RECIST and toxicities by NCI-CTC.Results A total of 101 patients were pooled from these studies. Fifty-nine received gefitinib as their first line of therapy and 42 after having received chemotherapy. The combined rate of complete and partial response (CR+PR) in the 99 measured patients was 80.8% (80/99) and only 7.1% (7/99) had progressive disease as best response. The response rate (CR+PR) for exon 19 deletion and L858R patients were 80.3% (53/66) and 81.8% (27/33), respectively. The median progression-free survival ranged from 7.7 to 12.9 months. Overall survival had not been reached in 4/5 reports and was 15.4 months in one of them. Gefitinib administration was safe (<50% of patients developed grades 1-2 skin rash or diarrhea) and interstitial lung disease was only reported in two patients (2%), without deaths.Conclusions Gefitinib monotherapy leads to objective responses in most patients with EGFR mutations. Both L858R and deletion 19 mutations derived similar clinical benefits. Small molecule TKIs are the new treatment paradigm for EGFR-mutant NSCLC.

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Most patients with exon 19 deletions or L858R have radiographic responses to gefitinib, erlotinib, and afatinib.
“Most patients whose tumors harbor exon 19 deletions or L858R EGFR activating mutations have radiographic responses to monotherapy with the reversible adenosine triphosphate (ATP)-competitive EGFR tyrosine kinase inhibitors (TKIs) gefitinib and erlotinib 17–23 and the irreversible EGFR TKI afatinib 24.”
From Structural, Biochemical, and Clinical Characterization of Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations in Lung Cancer (2013) · cites this paper as [18]

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Alteration in Mir-21/PTEN Expression Modulates Gefitinib Resistance in Non-Small Cell Lung Cancer
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A Sensitive Method for Detecting EGFR Mutations in Non-small Cell Lung Cancer Samples with Few Tumor Cells
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Uncommon Epidermal Growth Factor Receptor mutations in non-small cell lung cancer and their mechanisms of EGFR tyrosine kinase inhibitors sensitivity and resistance
Massarelli, E., Johnson, F. M., Erickson, H. S., Wistuba, I. I., & Papadimitrakopoulou, V. (2013) · Lung Cancer · doi:10.1016/j.lungcan.2013.01.018 · Cited by 110 · see citing works
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Azzoli, C. G., Giaccone, G., & Temin, S. (2010) · Journal of Oncology Practice · doi:10.1200/jop.091065 · Cited by 96 · see citing works
Complex Mutations in the Epidermal Growth Factor Receptor Gene in Non-small Cell Lung Cancer
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Chinese Herbal Medicine for Advanced Non-Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis
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Erlotinib at a Dose of 25 mg Daily for Non-small Cell Lung Cancers with EGFR Mutations
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Mechanisms of Resistance to Epidermal Growth Factor Receptor Inhibitors and Novel Therapeutic Strategies to Overcome Resistance in NSCLC Patients
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Using Whole Genome Amplification (WGA) of Low-Volume Biopsies to Assess the Prognostic Role of EGFR, KRAS, p53, and CMET Mutations in Advanced-Stage Non-small Cell Lung Cancer (NSCLC)
Lim, E. H., Zhang, S.-L., Li, J., Yap, W. S., Howe, T.-C., Tan, B. P., Lee, Y.-S., Wong, D., Khoo, K., Seto, K., et al. (2009) · Journal of Thoracic Oncology · doi:10.1097/jto.0b013e3181913e28 · Cited by 77 · see citing works
Blockade of Hedgehog Signaling Synergistically Increases Sensitivity to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Non-Small-Cell Lung Cancer Cell Lines
Bai, X., Zhang, X., Yang, S., An, S., Chen, Z., Su, J., Xie, Z., Gou, L.-Y., & Wu, Y.-L. L. C. (2016) · PLoS ONE · doi:10.1371/journal.pone.0149370 · Cited by 73 · see citing works
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Oct4 plays a crucial role in the maintenance of gefitinib-resistant lung cancer stem cells
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First- or Second-line Therapy with Gefitinib Produces Equal Survival in Non–Small Cell Lung Cancer
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Hypoxia induces gefitinib resistance in non‐small‐cell lung cancer with both mutant and wild‐type epidermal growth factor receptors
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Anexelekto (AXL) Increases Resistance to EGFR-TKI and Activation of AKT and ERK1/2 in Non-Small Cell Lung Cancer Cells
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Primary and Acquired Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Non-small Cell Lung Cancer: An Update
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Authors: Costa, D. B., Kobayashi, S., Tenen, D. G., & Huberman, M. S.
Affiliations: Beth Israel Deaconess Medical Center (US)
Corresponding author: Costa, Daniel B.
ORCID: Costa, Daniel B.
Kobayashi, Susumu
Tenen, Daniel G.
Venue: Lung Cancer
Publisher: Elsevier BV
Published: 2007-10
Volume: 58
Issue: 1
Pages: 95-103
ISSN: 0169-5002 (ISSN-L)
DOI: 10.1016/j.lungcan.2007.05.017
PMC: PMC2551312
OpenAlex: W2048538776
Cited by: 160
References: 66
Citations by year: 2026: 2 · 2025: 3 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 7 · 2018: 7 · 2017: 10 · 2016: 9 · 2015: 21 · 2014: 12 · 2013: 12 · 2012: 15
FWCI: 12.96
Type: journal article
Language: en
Open access: green
europepmc.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Lung Cancer (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (CA090578, P50CA090578, P20CA090578)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Keywords: gefitinib, EGFR mutation, non-small cell lung cancer, EGFR tyrosine kinase inhibitors, monotherapy, exon 19 deletion, L858R mutation, first-line therapy, progression-free survival, interstitial lung disease, rash, diarrhea
MeSH terms: Gefitinib, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Mutation, Neoplasm Staging, Prospective Studies, Quinazolines, Chemotherapy, Adjuvant, Clinical Trials, Phase II as Topic, Disease-Free Survival, Protein Kinase Inhibitors, Kaplan-Meier Estimate, ErbB Receptors

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Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers

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