ゲフィチニブ使用に関するガイドライン 2005. 3. 15 …

1 2005. 3. 15 2005. 7. 25 46 1 EGFR II IDEAL-1 1 2002 2003 FDA 36 / 2004 12 28 1473 588 2002 10 15 / 2002 12 25 1

2 26 2003 2003 26 2 2004 250 3 2003 12 3322 193 /3322 75 /3322 PS>2 PS>2 43 2003 10 4 2004 EGFR 5 6 EGFR 2 7 2004 12 17 1692 ISEL 2005 96 AACR 8 p= Cox p= MST 27 21 342 MST 375 MST FDA FDA 2005 Oncologic Drugs Advisory

3 Committee ODAC ISEL EMEA 2005 20 10 17 24 ISEL 9 1 ISEL 2 EGFR 3 3 9 3 2005 15 10 2005 11 2005 2005 17 2003 10 3 / 2005 15 10 2005 41 ASCO III III 11 4 1.

4 2. 1. 2. II 12-14 30 MST 11 10 10 3. III III 11 4. EGFR 1 I 15 31 PR IDEAL-1 16 MST 414 309 MST 406 275 17-19 2 EGFR 5 6 20 5 EGFR EGFR EGFR-TK

5 EGFR 21 22 EGFR EGFR 23 EGFR EGFR 24-28 EGFR 5. III INTACT 29 30 31 32 6. II 1 1 7.

6 PS2 17 8. 6 9. ISEL / 10. 1. SpO2 2. 3.

7 4. 17 5. CT HRCT AaDO2 DLco 6. 7 1. 2. 500 1000 mg 3.

8 ILD 1 ZD1839(IRESSATM) 250mg/ 500mg/ II 1. III IV NSCLC NSCLC 2. 3. 4. WHO Performance Status (PS) 5. 12 6. 18 7. 1. 2. 21 83. CTC 4. 14 5.

9 6. 7. 8. 9. PS 10. 11. 1500/mm3 7 5 /mm3 12. 13. ALT AST 14. 15. HIV B 16. 9 1. Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of Gefitinib for previously treated patients with advanced non-small-cell lung cancer.

10 J Clin Oncol 2003; 21: 2237-2246 2. R 250 ILD 2003 3. R 250 2004 4.. 2003 43 780-784 5. Paez JG, Janne PA, Lee JC, et al. EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497-1500 6. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 2129-2139 7. Pao W, Zakowski M, Cordon-Cardo C, et al. Molecular characteristics of non-small cell lung cancer (NSCLC) patients sensitive to gefitinib. Proc Am Soc Clin Oncol 2004; 23: 623s (abstract) 8.