Gefitinib for non-small-cell lung cancer patients with epidermal growth factor receptor gene mutations screened by peptide nucleic acid-locked nucleic acid PCR clamp
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This study was prospectively designed to evaluate a phase II study of gefitinib for non-small-cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. Clinical samples were tested for EGFR mutations by peptide nucleic acid-locked nucleic acid PCR clamp, and patients having EGFR mutations were given gefitinib 250 mg daily as the second treatment after chemotherapy. Poor PS patients omitted chemotherapy. Of 107 consecutive patients enrolled, samples from 100 patients were informative, and EGFR mutations were observed in 38 patients. Gefitinib was given to 27 patients with EGFR mutations, and the response rate was 78% (one complete response and 20 partial responses; 95% confidence interval: 58-93%). Median time to progression and median survival time (MST) from gefitinib treatment were 9.4 and 15.4 months, respectively. Grade 3 hepatic toxicity and skin toxicity were observed in one patient each. There were significant differences between EGFR mutations and wild-type patients in response rates (78 vs 14%, P = 0.0017), and MST (15.4 vs 11.1 months, P = 0.0135). A Cox proportional hazards model indicated that negative EGFR mutation was a secondary prognostic factor (hazards ratio: 2.259, P = 0.036). This research showed the need for screening for EGFR mutations in NSCLC patients.
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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.”
From A decade of EGFR inhibition in EGFR-mutated non small cell lung cancer (NSCLC): Old successes and future perspectives (2015) · cites this paper as [62]
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- Authors
- Sutani, A., Nagai, Y., Udagawa, K., Uchida, Y., Koyama, N., Murayama, Y., Tanaka, T., Miyazawa, H., Nagata, M., Kanazawa, M., Hagiwara, K., & Kobayashi, K.
- Affiliations
- Saitama Medical University (JP)
- Corresponding author
- Kobayashi, K
- Venue
- British Journal of Cancer
- Published
- 2006-11-14
- Volume
- 95
- Issue
- 11
- Pages
- 1483-1489
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC2360739
- OpenAlex
- W2069312070
- Cited by
- 167
- References
- 20
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 1 · 2019: 2 · 2018: 5 · 2017: 5 · 2016: 1 · 2015: 7 · 2014: 11 · 2013: 16 · 2012: 15
- FWCI
- 14.78
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-sa
- www.springer.com/tdm (unspecified)
- Locations
- British Journal of Cancer (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- American Society of Clinical Oncology
- Ministry of Education, Culture, Sports, Science and Technology
- 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, targeted therapy, second-line chemotherapy, response rate, survival, prognostic factors, hepatotoxicity, skin toxicity
- MeSH terms
- Gefitinib, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, DNA Mutational Analysis, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Prognosis, Quinazolines, Survival Analysis, Polymerase Chain Reaction, Genes, erbB-1, Drug Resistance, Neoplasm, Peptide Nucleic Acids
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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