EGFR-TKI 標靶治療藥品用於晚期及轉移性非小細胞肺癌 －療 …

1 EGFR-TKI .. 1, 2.. 2015 2 101 . 2010 . [1] . (small cell lung cancer) (non-small cell lung cancer, NSCLC) . 13% 87% . Stage IIIb . (advanced NSCLC) 40% Stage IV (metastatic NSCLC) [2-6] .. III IIIb . IV .. (performace status, PS) .. [2, 6] .. cisplatin carboplatin . 1.. 2.. RegMed 2015 Vol. 61 20. etoposide mitomycin ifosfamide topotecan irinotecan paclitaxel . docetaxel vinblastine vinorelbine gemcitabine pemetrexed . (platinum-based doublets) carboplatin/paclitaxel, cisplatin/docetaxel, cisplatin/paclitaxel, cisplatin/gemcitabine, cisplatin/vinorelbine, cisplatin/irinotecan [6] .. egfr KRAS ALK PIK3CA . BRAF HER2 p161NK4a p53 (molecular-targeted therapy) (monoclonal antibodies) . (small molecule inhibitors) tyrosine kinase inhibitors, TKIs [3, 6-7] .. (1) VEGF bevacizumab (2) ALK ALK . [ 1] ALK-TKI crizotinib ceritinib (3). egfr EGFR-TKI [ 2] gefitinib, erlotinib afatinib . cetuximab cetuximab . egfr (overexpression) 40-80% [4, 6-10] . EGFR-TKI .

2 3],[6] 4],[11] 5], NCCN[ ASCO[ ESMO[ [12-13]. egfr erlotinib, egfr erlotinib, afatinib, gefitinib afatinib - . erlotinib erlotinib erlotinib, afatinib erlotinib, gefitinib erlotinib egfr erlotinib egfr egfr . gefitinib, erlotinib, gefitinib PS 0-3 PS 0-3: . afatinib erlotinib EGFR-TKI .. 1 ALK EGFR-TKI . 2 25% KRAS KRAS KRAS . /vinorelbin EGFR-TKI egfr , ALK, KRAS . 3 National Comprehensive Cancer Network . 4 American Society of Clinical Oncology . 5 European Society for Medical Oncology . RegMed 2015 Vol. 61 21. EGFR-TKI egfr . 50% . [6] . EGFR-TKI 2003 . gefitinib erlotinib 2006 afatinib . EGFR-TKI . HTA TKIs . PICOS Pubmed/Cochrane .. EGFR-TKI afatinib, erlotinib, gefitinib .. 4 II III EGFR-TKI . Kim et al. [14] LUX-lung [15] . LUX-lung 7 [16] NCT01955421 [17] .. LUX-lung 7 IIb afatinib 316. [ 6],[14]. egfr . gefitinib LUX-lung 8 III afatinib 795. 2015 [15] ( egfr . erlotinib ) . Kim et al. II gefitinib 96. 2012 [16] ( egfr . erlotinib ) . NCT01955421 II gefitinib 224.

3 [ 7], [17]. egfr . erlotinib .. 6 2016/12. 7 2016/06. RegMed 2015 Vol. 61 22. LUX-lung 8 Kim et al.. EGFR-TKI egfr [ 8] . LUX-lung 8 afatinib erlotinib . Kim et al.. gefitinib erlotinib . Kim et al. gefitinib erlotinib . ( vs. , p= ) ( vs. , p= ) .. 96 (gefitinib erlotinib 48 ) gefitinib erlotinib . LUX-lung 8 afatinib erlotinib . ( vs. ) ( vs. ) 6 . 12 18 afatinib erlotinib . afatinib . erlotinib . afatinib erlotinib . 1 .. LUX-lung 7 egfr . EGFR-TKI . afatinib gefitinib .. 316 .. NCT01955421 224 . Kim et al gefitinib erlotinib .. egfr [ 9] . 89 Kim et al egfr egfr ( ). egfr . RegMed 2015 Vol. 61 23.. gefitinib erlotinib . afatinib erltoinib . afatinib gefitinib . LUX-lung 7 .. 1. 101 .. 101 ..pdf. Published 2015. Accessed August 31, 2015. 2. [ ] ..pdf. Published 2013. Accessed August 31, 2015. 3.. , 2010; 3(1): 332-350. 4. Wahbah M, Boroumand N, et trends in the distribution of the histologic types of lung cancer: a review of 4,439 cases. Annals of diagnostic pathology 2007.

4 11(2): 89-96. 5. Goldstraw P, Crowley J, Chansky K, et al. The IASLC Lung Cancer Staging Project: Proposals for the revision of the TNM stage groups in the forthcoming (seventh) edition of the TNM classification of malignant tumours. J Thorac Oncol 2007; 2:706. 6. Non-Small Cell Lung Cancer 2015. National Comprehensive Cancer Network. Published 2015. Accessed September 1, 2015. 7. Finberg KE, Sequist LV, et al. Mucinous differentiation correlates with absence of egfr . mutation and presence of KRAS mutation in lung adenocarcinomas with bronchioloalveolar features. The Journal of Molecular Diagnostics 2007; 9(3): 320-326. 8. -104 . RegMed 2015 Vol. 61 24. -104 . ( ).pdf Published 2015. Accessed September 2, 2015. 9. Pallis AG, Syrigos KN. Epidermal growth factor receptor tyrosine kinase inhibitors in the treatment of NSCLC. Lung Cancer 2013; 80(2): 120-130. 10. , , . (ALK) .. 2011; 27(4): 143-156. 11. Gregory AM, Sarah T, et al. Systemic Therapy for Stage IV Non Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update.

5 J. Clin Oncol 2015; 33: [Epub ahead of print]. 12. D'addario G, Fr h M, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 2010; 21: v116-v119. 13. Besse B, Adjei A, et al. 2nd ESMO Consensus Conference on Lung Cancer: non-small-cell lung cancer first-line/second and further lines of treatment in advanced disease. Annals of Oncology 2014; 25(8): 1475-1484. 14. Kim ST, et al. Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous Cancer 2012; 75(1): 82-88. 15. Soria JC, Felip E, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. The Lancet Oncology 2015; 16(8): 897-907. 16. LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line egfr Mutation Positive Adenocarcinoma of the Lung.

6 Accessed September 7, 2015. 17. Erlotinib 100mg qd Versus Gefitinib 250mg qd for egfr Mutant NSCLC (NSCLC. egfr TKI. Accessed September 7, 2015. RegMed 2015 Vol. 61 25.)