课件：胰腺癌的药物治疗.ppt

结果：不良反应 Toxicity in Percentage of Cycles by Gemcitabine Group and Control Group Gemcitabine （n=1116cycles） Observation （n=1092cycles） Any grade Grade 3 Grade 4 Any grade Grade 3 Grade 4 Hematologic Hemoglobin 27.9 0.6 0 3.3 0.1 0 Leukocytes 30.8 2.4 0 2.1 0.1 0 Platelets 6.4 0.5 0.3 1.0 0 0 Nonhematologic Nausea/Vomiting 21.2 1.3 0 2.8 0.2 0 Diarrhea 9.0 0.9 0 5.1 0.4 0 Edema 8.9 0.4 0,1 0.4 0.1 0 Infection 3.9 0.4 0 1.7 0.3 0 Biochemical Alanine transaminase /aspartate transaminase 20.5 0.5 0.1 12.5 0.5 0.1 Bilirubin 1.2 0.1 0 2.1 0.1 0.1 Alkaline phosphatase 11.7 0.1 0 9.8 0.5 0 结论 胰腺癌根治术后，予以健择辅助化疗，较观察组显著延长复发时间，延长生存期。 ?级的毒性反应轻微，耐受良好。 基于此项研究的结果，NCCN胰腺癌指南2007年第一版胰腺癌辅助化疗部分推荐健择作为胰腺癌切除后辅助化疗的首选。 Oettle，H.et al.JAMA 2007;297:267-277 胰腺癌一线化疗 适应症：局部进展期不能手术 方案选择： PS好： PS差： * Burris Ha 3rd, Moore MJ, Anderson J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol, 1997; 15(6):2403-13 随机III期临床研究设计 晚期PC患者 N=126 主要研究终点：CBR 次要研究终点：RR、TTP、OS * 健择组的1年生存率比5-FU组提高9倍 Burris Ha 3rd, Moore MJ, Anderson J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol, 1997; 15(6):2403-13 50% 40% 30% 20% 10% 0% 46% 31% 24% 6% 18% 2% n=30 n=19 n=14 n=4 n=9 n=2 6 months 9 months 12 months 时间 健择? n=63 生存率 5-FU n=63 * 健择?组23.8%获得临床受益反应(CBR) Burris Ha 3rd, Moore MJ, Anderson J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol, 1997; 15(6):2403-13 40% 30% 20% 10% 0% 23.8% 4.8% n=15 n=3 p=0.0022 获得CBR的病人百分率 病人数 健择? n=63 5-FU n=63 * 临床受益反应(Clinical Benefit Response,CBR)定义为： 至少下列一项指标好转(持续4周或以上)，并且无任一项指标恶化： 镇痛药用量减少≥50% + 疼痛强度减轻≥50% = 体力状况改善≥20分 体重增加≥7%无体液潴留＊ + 每日记录，每周总结 每周评估，用KPS评分 = 每日评价，用MPAC卡每周总结 ＊ 每周称