Academic Journal
An open label phase II study evaluating first-line EGFR tyrosine kinase inhibitor erlotinib in non-small cell lung cancer patients with tumors showing high EGFR gene copy number
| العنوان: | An open label phase II study evaluating first-line EGFR tyrosine kinase inhibitor erlotinib in non-small cell lung cancer patients with tumors showing high EGFR gene copy number |
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| المؤلفون: | Szutowicz-Zielinska, Ewa, Konopa, Krzysztof, Kowalczyk, Anna, Suszko-Kazarnowicz, Malgorzata, Duchnowska, Renata, Szczesna, Aleksandra, Ratajska, Magdalena, Sowa, Aleksander, Limon, Janusz, Biernat, Wojciech, Burzykowski, Tomasz, Jassem, Jacek, Dziadziuszko, Rafal |
| بيانات النشر: | IMPACT JOURNALS LLC |
| سنة النشر: | 2017 |
| المجموعة: | Document Server@UHasselt (Universiteit Hasselt) |
| مصطلحات موضوعية: | non-small cell lung cancer, epidermal growth factor receptor, gene copy number, erlotinib |
| الوصف: | Background: First-line treatment with epidermal growth factor receptor (EGFR) inhibitors in NSCLC is effective in patients with activating EGFR mutations. The activity of erlotinib in patients harboring high EGFR gene copy number has been considered debatable. Patients and Methods: A multicenter, open-label, single-arm phase II clinical trial was performed to test the efficacy of erlotinib in the first-line treatment of NSCLC patients harboring high EGFR gene copy number defined as >= 4 copies in >= 40% of cells. Findings: Between December 2007 and April 2011, tumor samples from 149 subjects were screened for EGFR gene copy number by fluorescence in-situ hybridization (FISH), Out of 49 patients with positive EGFR FISH test, 45 were treated with erlotinib. Median PFS in the intent-to-treat population was 3.3 months (95% CI: 1.8-3.9 months), and median overall survival was 7.9 months (95% CI: 5.1-12.6 months). Toxicity profile of erlotinib was consistent with its known safety profile. The trial was stopped prematurely at 63% of originally planned sample size due to accumulating evidence that EGFR gene copy number should not be used to select NSCLC patients to first-line therapy with EGFR TKI. Data on erlotinib efficacy according to EGFR, KRAS and BRAF mutations are additionally presented. Interpretation: This trial argues against using high gene copy number for selection of NSCLC patients to first-line therapy with EGFR TKIs. The study adds to the discussion on efficacy of other targeted agents in patients with target gene amplified tumors. ; The study was sponsored by Central and East European Oncology Group (CEEOG), which was responsible for writing the trial protocol, submission of regulatory documents to competent authorities, conducting monitoring visits, final data analysis and interpretation, and other sponsor duties. This investigator initiated trial received scientific support from the Gdansk Branch of the Polish Oncological Society, and was financed by an unrestricted grant from Roche Poland with ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1949-2553 |
| Relation: | ONCOTARGET, 8(10), p. 17270-17278; http://hdl.handle.net/1942/24021; 17278; 10; 17270; 000396024600094 |
| DOI: | 10.18632/oncotarget.13793 |
| الاتاحة: | http://hdl.handle.net/1942/24021 https://doi.org/10.18632/oncotarget.13793 |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.B1675CEA |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 19492553 |
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| DOI: | 10.18632/oncotarget.13793 |