特罗凯发展历程资料.ppt

EGFR野生型患者 Gefitinib Carboplatin / Paclitaxel EGFR M+ odds ratio (95% CI) = 2.75(1.65, 4.60), p=0.0001 EGFR M- odds ratio (95% CI) = 0.04(0.01, 0.27), p=0.0013 (n=132) (n=129) (n=91) (n=85) Odds ratio 1 提示gefitinib疗效更好 71.2% 47.3% 1.1% 23.5% Mok et al ESMO LBA 2, 2008 IPASS：RR EGFR wild-type HR=0.74 (0.52–1.05) p=0.0924 Exon 19 or 21 mutations 100 80 60 40 20 0 Survival (%) Time (months) 0 6 12 18 24 Zhu, et al. JCO 2008 Improved survival with erlotinib in patients with EGFR mutations (small patient numbers) Clear trend towards improved survival with erlotinib in patients with wild-type EGFR 而特罗凯…… Median (months) Erlotinib (n=115) 7.9 Placebo (n=55) 3.3 Median (months) Erlotinib (n=15) 10.9 Placebo (n=19) 8.3 HR=0.55 (0.25–1.19) p=0.1217 100 80 60 40 20 0 Survival (%) Time (months) 0 6 12 18 24 Interaction p=0.45 II期临床研究：厄洛替尼在经治的EGFR野生型晚期非小细胞肺癌中的疗效 Okayama Lung Cancer Study Group Trial 0705 (OLCSG 0705) Yoshioka H, Hotta K, Kiura K, et al. J Thorac Oncol 2010;5:99–104 A phase II trial of erlotinib monotherapy in pretreated patients With Advanced non-small-cell lung cancer who do not possess active EGFR mutations 试验背景：TALENT研究 Gatzemeier, U et al. J Clin Oncol 2007;25:1545–1552. 0 10 20 30 40 50 60 (周) 1.0 0.8 0.6 0.4 0.2 0 生存概率 (%) 化疗阶段 Log-rank p=0.0453 特罗凯+化疗 安慰剂+化疗 SATURN: a double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinum-based chemotherapy in patients with advanced NSCLC Federico Cappuzzo1, Tudor Ciuleanu2, Lilia Stelmah3, Saulius Cicenas4, Aleksandra Szczesna5, Erzsebet Juhasz6, Emilio Esteban Gonzalez7, Olivier Molinier8, Gaelle Klingelschmitt9, Giuseppe Giaccone10, on behalf of the SATURN investigators F. Cappuzzo. et al, J Clin Oncol 27:7s, 2009 (suppl; abstr 8001) SATURN: 厄洛替尼作为NSCLC一线含铂双药化疗后未进展患者维持治疗的随机双盲III期临床研究 PFS* in all patients (ITT) 1.0 0.8 0.6 0.4 0.2 0 0 8 16 24 32 40 48 56 64 72 80 88 96 Time (weeks) HR=0.71 (0.62–0.82) Log-rank p0.0001 Erlo