Cited by 509Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchLung Cancer Diagnosis and Treatment

Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations

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Inoue, Akira, Suzuki, Takuji, Fukuhara, Tatsuro, Maemondo, Makoto, Kimura, Yuichiro, Morikawa, Naoto, Watanabe, Hiroshi, Saijo, Yasuo +1 more·2006·Journal of Clinical Oncology

Abstract

PURPOSE: This study was undertaken to investigate the efficacy and the feasibility of gefitinib for chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. PATIENTS AND METHODS: The EGFR gene status in various tumor samples obtained from chemotherapy-naïve advanced NSCLC patients was examined by DNA sequencing of EGFR exons 18 to 23. Patients harboring EGFR mutations received gefitinib (250 mg/d) alone. The response rate, progression-free survival (PFS), and toxicity profile were assessed prospectively. RESULTS: Between June 2004 and October 2005, 75 patients were examined for the EGFR status, and 25 patients (33%) harbored EGFR mutations. EGFR mutations were significantly frequent in females (P < .01) and never or light smokers (P < .001). Sixteen patients with EGFR mutations were enrolled onto the study. The overall response rate in these patients was 75% (95% CI, 54% to 96%), and the disease control rate was 88% (95% CI, 71% to 100%). The median PFS time of these patients was 9.7 months (95% CI, 7.4 to 9.9 months). No life-threatening toxicity was observed. CONCLUSION: Treatment with gefitinib alone for chemotherapy-naïve NSCLC patients with EGFR mutations could achieve a high efficacy with acceptable toxicity. To assess the proper timing of gefitinib in such patients, a subsequent randomized trial comparing gefitinib with standard chemotherapy is warranted.

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Crossref · 10.1200/jco.2005.05.4692

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  • The discovery of EGFR mutations and the dramatic responses observed with EGFR TKIs in retrospective and small phase II studies paved the way to a paradigm shift in clinical trial design, favoring development of clinically and then molecularly selected studies in NSCLC.

    “The discovery of EGFR mutations and the dramatic responses observed with EGFR TKIs in retrospective and small phase II studies [20, 61, 62] paved the way to a paradigm shift in the clinical trial design, favoring the development of clinically and then molecularly selected studies in NSCLC.”

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Authors
Inoue, A., Suzuki, T., Fukuhara, T., Maemondo, M., Kimura, Y., Morikawa, N., Watanabe, H., Saijo, Y., & Nukiwa, T.
Affiliations
Tohoku University (JP)
Venue
Journal of Clinical Oncology
Published
2006-07-20
Volume
24
Issue
21
Pages
3340-3346
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2093922887
Cited by
509
References
39
Citations by year
2026: 4 · 2025: 3 · 2024: 2 · 2023: 9 · 2022: 4 · 2021: 5 · 2020: 3 · 2019: 4 · 2018: 13 · 2017: 9 · 2016: 13 · 2015: 29 · 2014: 29 · 2013: 39 · 2012: 42
FWCI
58.65
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
  • Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords
gefitinib, non-small cell lung cancer, EGFR mutation, EGFR tyrosine kinase inhibitors, chemotherapy-naive patients, advanced non-small cell lung cancer, progression-free survival, response rate, toxicity, smoking status, sex differences
MeSH terms
Gefitinib, Adult, Aged, Aged, 80 and over, Alanine, Antineoplastic Agents, Arginine, Carcinoma, Non-Small-Cell Lung, Feasibility Studies, Female, Humans, Leucine, Lung Neoplasms, Male, Middle Aged, Mutation, Neoplasm Staging, Prospective Studies, Quinazolines, Treatment Outcome, Disease-Free Survival, Glutamic Acid, Positron-Emission Tomography, ErbB Receptors

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