贝伐单抗治疗卵巢癌III期临床实验.ppt

贝伐单抗治疗卵巢癌III期临床实验 R.A. Burger,1 M.F. Brady,2 M.A. Bookman,3R.A. Burger,1 M.F. Brady,2 M.A. Bookman,3J.L. Walker,4 H.D. Homesley,5 J. Fowler,6 B.J. Monk,7 B.E. Greer,8 M. Boente,9 S.X. Liang10 1Fox Chase Cancer Center, Philadelphia, PA; 2Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; 3University of Arizona Cancer Center, Tucson, AZ; 4University of Oklahoma Health Sciences Center, Oklahoma City, OK; 5Brody School of Medicine, Greenville, NC; 6James Cancer Hospital at the Ohio State University, Hilliard, OH; 7University of California, Irvine Medical Center, Orange, CA; 8Seattle Cancer Care Alliance, Seattle, WA; 9Minnesota Oncology and Hematology, Minneapolis, MN; 10State University of New York at Stony Brook, Stony Brook, NY, USA 贝伐单抗为人源化单克隆IgG1抗体 主要作用靶点为抑制VEGF活性 2004年FDA批准上市用于结直肠癌 2007年Burger et al和Cannistra et al.在J Clin Oncol上分别报道贝伐单抗单抗治疗复发卵巢癌II期临床实验取得较好效果 2009年NCCN把贝伐单抗列为卵巢上皮性癌二线治疗內容 研究的目的：贝伐单抗联合－线化疗方案做为初始治疗方案治疗卵巢上皮癌,腹膜癌和输卵管是否能可行？ 主要观察点 研究与对照组： PFS Overall survival (OS) safety quality of life correlative laboratory studies 入组条件 Histologic diagnosis of epithelial OV, PP, or FT cancer Following maximal debulking surgery: stage III optimal (macroscopic residual disease ?1 cm) or suboptimal (1 cm), or stage IV No prior chemotherapy 1–12 weeks after initial surgery GOG PS 0–2 No history of significant vascular events No evidence of intestinal obstruction requiring parenteral support Written informed consent 入选病人情况 入选病人情况 GOG-0218:结论 CP + BEV ? BEV维护方案在PFS优于CP和CP + BEV BEV联合－线化疗方案做为初始治疗方案治疗卵巢上皮癌,腹膜癌和输卵管癌患者时病人可以耐受，副反应与BEV单药使用相似 CP + BEV ? BEV维护方案可考虑用于卵巢上皮癌,腹膜癌和输卵管癌一线治疗 血管生成素抑制剂AMG 386联合紫杉醇周疗方案治疗复发卵巢上皮癌的II期临床研究 Beth Y. Karlan,1 Amit M. Oza,2 Vincent L. Hansen,3 Gary E. Richardson,4 Diane Provencher,5 Prafull Ghatage,6 Marjan Tassoudji,7 Daniel E. Stepan,7 David M. Weinreich,7 Ignace B. Vergote8 80%就诊时为晚期卵巢癌的患者将会复发并最终死亡 复发后经治疗，铂类敏感患者平均PFS 9.4-11.3 months，铂类耐药为3.7