ASCO肺癌的研究热点.pptVIP

L Zhang, et al ASCO 2011. # 7511 L Zhang, et al ASCO 2011. # 7511 ITT population Gefitinib (n=148) Placebo (n=148) p HR (95% CI) PFS Median (month) 4.8 2.6 0.0001 0.42 (0.32, 0.54) 6-month ( %) 47.3 15.0 12-month ( %) 33.2 2.9 No. events, n (%) 124 (83.8) 144 (97.3) OS Median (month) 18.7 16.9 0.2109 0.83 (0.61, 1.12) 6-month ( %) 82.2 84.9 12-month ( %) 68.8 66.0 No. events, n (%) 79(53.4) 93(62.5) ORR(%) 23.6 0.7 0.0001 57.0 (7.53, 431) DCR(%) 71.6 50.7 0.0001 2.66 (1.61, 4.40) L Zhang, et al ASCO 2011. # 7511 Gefitinib Placebo HR (95% CI) EGFR mut+ n 15 15 0.17 (0.07, 0.42) Median PFS (month) 16.6 2.8 No. events, n (%) 9(60) 15(100) EGFR mut- n 25 24 0.86 (0.48, 1.51) Median PFS (month) 2.7 1.5 No. events, n (%) 25(100) 24(100) EGFR mut unknown n 108 109 0.40 (0.29, 0.54) Median PFS (month) 6.0 2.7 No. events, n (%) 90（83.3） 105（96.3） L Zhang, et al ASCO 2011. # 7511 结　论 INFORM是全球首个在亚裔病人中开展的大型随机、 对照维持治疗研究 结果显示： 靶向药物吉非替尼维持治疗能明显延长肺癌病人 的疾病缓解期 维持治疗，肿瘤持续缩小、生活质量改善 基因突变者获益更加明显 不良反应耐受良好 L Zhang, et al ASCO 2011. # 7511 PARAMOUNT（西班牙） Phase Ⅲ Stud of Maintenance Pemetrexed (Pem) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC Immediately Following Induction Treatment With Pem Plus Cisplatin for Advanced Nonsquamous Non-small Cell Lung Cancer Maintenance Pem Following Induction With Pem/Platinum Double-blind phase III trial Paz-Ares LG, et al. ASCO 2011. #7510. Paz-Ares LG, et al. ASCO 2011. #7510. Pemetrexed 500 mg/m2 + Cisplatin 75 mg/m2 21-day cycle*4 (n = 939) Previously untreated advanced-stage nonsquamous NSCLC Pemetrexed 500 mg/m2 21-day cycle+ BSC (n = 359) Placebo 21-day cycle+ BSC (n = 180) Induction phase (4 cycles) Maintenance phase (until PD) PD 培美曲塞维持化疗有益于PFS 西班牙学者Paz-Ares:安慰剂对照、随机双盲Ⅲ期临床试验（PARAMOUNT） 研究目的:晚期非鳞癌NSCLC患者培美曲塞+顺铂诱导治疗后，继续培美曲塞维持治疗能否延长PFS。 PARAMOUNT: Efficacy, Safety, and QoL 1.0 0.8 0.6 0.4 0.2 0.0 0 3 6 9 12 15 Mos Pem + BSCPlacebo + BSC HR: 0.62 (95% CI: 0.49-0.79; P = .00006)