Hartung G, Hofheinz R-D, Dencausse Y, Sturm J, Kopp-Schneider A, Dietrich G, Fackler-Schwalbe I, Bornbusch D, Gonnermann M, Wojatschek C, Lindemann W, Eschenburg H, Jost K, Edler L, Hochhaus A, Queisser W
Abteilung Hämatologie und Onkologie, Universität Rostock, Germany.
Onkologie. 2005 Jun;28(6-7):347-50. doi: 10.1159/000084595. Epub 2005 Jun 2.
In a phase III study recruiting patients with stage II colon cancer the effect of adjuvant therapy with edrecolomab, a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, was compared to observation alone.
From January 1997 until July 2000 a total of 377 patients were postoperatively stratified according to tumor stage (T3 vs. T4) and center, and randomly allocated to either treatment with edrecolomab (cohort A, n = 183) or observation (cohort B, n = 194). Patients in cohort A received a total of 900 mg edrecolomab. The study was terminated prematurely because of discontinuation of drug supply in Germany.
305 patients were eligible for the primary endpoint of overall survival and 282 patients for disease-free survival. After a median follow-up of 42 months overall survival and disease-free survival were not significantly different. Toxicity was mild.
In the present study, postoperative adjuvant treatment with edrecolomab in patients with resected stage II colon cancer did not improve overall or disease-free survival.
在一项招募II期结肠癌患者的III期研究中，将抗细胞表面糖蛋白17-1A的鼠单克隆抗体爱地西单抗辅助治疗的效果与单纯观察进行了比较。
从1997年1月至2000年7月，共有377例患者术后根据肿瘤分期（T3与T4）和中心进行分层，并随机分配至爱地西单抗治疗组（A组，n = 183）或观察组（B组，n = 194）。A组患者共接受900 mg爱地西单抗治疗。由于德国停止供应药物，该研究提前终止。
305例患者符合总生存主要终点标准，282例患者符合无病生存标准。中位随访42个月后，总生存和无病生存无显著差异。毒性轻微。
在本研究中，爱地西单抗对II期结肠癌切除术后患者进行辅助治疗并不能改善总生存或无病生存。
