肺癌治疗的现状与展望PPT幻灯片.pptVIP

* * * * * * * * * * * * 12/22/99 11:59 AM 3 Patients in the trial were stratified based on their ECOG performance status of 0/1 vs. 2 and on whether, while on platinum-based therapy, they had demonstrated progressive disease or complete response, partial response or stable disease. Patients were randomized to receive either Taxotere 100 mg/m2 given as a 1 hr. infusion every 3 weeks or best supportive care. This methodology of comparing against BSC is the most pure and rigorous way to assess the efficacy of new agents. Routine monitoring of safety data revealed 5 (10%) early toxic deaths in the chemotherapy arm. Therefore, after discussion with the principal investigators and the FDA, the Taxotere dose was reduced to 75mg/m2 in the second half of the study. The sample size was maintained at 200 patients as originally planned due to difficulty in accruing patients to this study because of the control arm being BSC. Premedication with dexamethasone, for the first 100 patients, was given at a dose of 8 mg bid for 10 doses; but for the second 104 patients only five doses were given. The first dose of dexamethasone began the night before the first Taxotere infusion. Treatment was administered every 3 weeks until disease progression or unacceptable toxicity. * * * * trials served as the stimulus to investigate the safety and utility of preoperative chemoradiotherapy delivered sequentially (12, 13) or concurrently (14) for N2-positve patients * I、II期有生存区别，III期没有生存区别 * * * * * * * 早中期非小细胞肺癌术后辅助长春瑞滨＋顺铂（NP）联合重组人血管内皮抑素对比单纯NP方案的III期临床研究 方案编号：2006 BAI 02A02[1]-01 术后辅助化疗子课题 * 研究设计 长春瑞滨顺铂重组人血管内皮抑素 长春瑞滨 25mg/m2 IV d1.8 顺 铂 75 mg/m2 IV d1 重组人血管内皮抑素7.5mg/m2 IV d1-14 21天为一周期，用4周期 非小细胞肺癌 NSCLC IB-IIIA术后 随 机 长春瑞滨顺铂 长春瑞滨 25mg/m2 IV d1.8 顺 铂 75 mg/m2 IV d1 21天为一周期，用4周期 多中心、开放、随机、双组的III期临床试验， 将入组完全切除的早、中期非小细胞肺癌 N=1107 * 研究目的 主要目的 比较长春瑞滨＋顺铂