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A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations
Retrospective analysis has shown that activating mutations in exons 18–21 of the epidermal growth factor receptor (EGFR) gene are a predictor of response to gefitinib. We conducted a phase II trial to evaluate the efficacy and safety of gefitinib as first-line therapy for advanced non-small cell lun...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Nature Publishing Group
2006
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360715/ https://www.ncbi.nlm.nih.gov/pubmed/17047648 http://dx.doi.org/10.1038/sj.bjc.6603393 |
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author | Asahina, H Yamazaki, K Kinoshita, I Sukoh, N Harada, M Yokouchi, H Ishida, T Ogura, S Kojima, T Okamoto, Y Fujita, Y Dosaka–akita, H Isobe, H Nishimura, M |
author_facet | Asahina, H Yamazaki, K Kinoshita, I Sukoh, N Harada, M Yokouchi, H Ishida, T Ogura, S Kojima, T Okamoto, Y Fujita, Y Dosaka–akita, H Isobe, H Nishimura, M |
author_sort | Asahina, H |
collection | PubMed |
description | Retrospective analysis has shown that activating mutations in exons 18–21 of the epidermal growth factor receptor (EGFR) gene are a predictor of response to gefitinib. We conducted a phase II trial to evaluate the efficacy and safety of gefitinib as first-line therapy for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Patients with stage IIIB or IV chemotherapy-naïve NSCLC with EGFR mutation were treated with 250 mg gefitinib daily. For mutational analysis, DNA was extracted from paraffin-embedded tissues and EGFR mutations were analysed by direct sequence of PCR products. Twenty (24%) of the 82 patients analysed had EGFR mutations (deletions in or near E746-A750, n=16; L858R, n=4). Sixteen patients were enrolled and treated with gefitinib. Twelve patients had objective response and response rate was 75% (95% CI, 48–93%). After a median follow-up of 12.7 months (range, 3.1–16.8 months), 10 patients demonstrated disease progression, with median progression-free survival of 8.9 months (95% CI, 6.7–11.1 months). The median overall survival time has not yet been reached. Most of the toxicities were mild. This study showed that gefitinib is very active and well tolerated as first-line therapy for advanced NSCLC with EGFR mutations. |
format | Text |
id | pubmed-2360715 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2006 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-23607152009-09-10 A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations Asahina, H Yamazaki, K Kinoshita, I Sukoh, N Harada, M Yokouchi, H Ishida, T Ogura, S Kojima, T Okamoto, Y Fujita, Y Dosaka–akita, H Isobe, H Nishimura, M Br J Cancer Clinical Study Retrospective analysis has shown that activating mutations in exons 18–21 of the epidermal growth factor receptor (EGFR) gene are a predictor of response to gefitinib. We conducted a phase II trial to evaluate the efficacy and safety of gefitinib as first-line therapy for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Patients with stage IIIB or IV chemotherapy-naïve NSCLC with EGFR mutation were treated with 250 mg gefitinib daily. For mutational analysis, DNA was extracted from paraffin-embedded tissues and EGFR mutations were analysed by direct sequence of PCR products. Twenty (24%) of the 82 patients analysed had EGFR mutations (deletions in or near E746-A750, n=16; L858R, n=4). Sixteen patients were enrolled and treated with gefitinib. Twelve patients had objective response and response rate was 75% (95% CI, 48–93%). After a median follow-up of 12.7 months (range, 3.1–16.8 months), 10 patients demonstrated disease progression, with median progression-free survival of 8.9 months (95% CI, 6.7–11.1 months). The median overall survival time has not yet been reached. Most of the toxicities were mild. This study showed that gefitinib is very active and well tolerated as first-line therapy for advanced NSCLC with EGFR mutations. Nature Publishing Group 2006-10-23 2006-10-17 /pmc/articles/PMC2360715/ /pubmed/17047648 http://dx.doi.org/10.1038/sj.bjc.6603393 Text en Copyright © 2006 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Clinical Study Asahina, H Yamazaki, K Kinoshita, I Sukoh, N Harada, M Yokouchi, H Ishida, T Ogura, S Kojima, T Okamoto, Y Fujita, Y Dosaka–akita, H Isobe, H Nishimura, M A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations |
title | A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations |
title_full | A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations |
title_fullStr | A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations |
title_full_unstemmed | A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations |
title_short | A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations |
title_sort | phase ii trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations |
topic | Clinical Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360715/ https://www.ncbi.nlm.nih.gov/pubmed/17047648 http://dx.doi.org/10.1038/sj.bjc.6603393 |
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