Usefulness of the collage gel droplet embedded culture drug sensitivity test (CD-DST) in post-operative adjuvant chemotherapy

（一）临床前研究（体外）临床研究前，研究化疗敏感性试验中抗癌药物的浓度和共培养时间。采用小鼠肿瘤细胞系、人肿瘤细胞系和胃癌患者或结直肠癌患者的人癌细胞对CPT-11、紫杉醇、奥沙利铂和TS-1进行评价。（二）临床研究为探讨化疗敏感性试验在术后辅助化疗中的作用，经大阪大学医学院伦理委员会批准，开展临床研究。所有患者随机分为两组：胃癌A组：化疗敏感（+）□标准化疗联合5-富化疗敏感（-）□紫杉醇二线化疗B组：化疗敏感(+)/(-)□标准化疗联合5-富化疗敏感（-）□无化疗A组：化疗敏感（+）□标准化疗联合5-富化疗敏感（-）□标准化疗联合5-富化疗敏感（+）□标准化疗联合5-富主要终点：无病生存次要终点：总生存在初步临床研究中，所有患者均使用5-FU进行单一方案的术后辅助化疗，结果显示化疗敏感（+）组的无病生存期更长，总生存期更长。化疗敏感性试验有望预测术后辅助化疗的有效性。

(I) Preclinical Study (in vitro)Before the clinical study, the concentration and the co-culture time of anticancer drugs in the chemo-sensitivity test were investigated. CPT-11,Paclitaxel, Oxaliplatin and TS-1 were evaluated using murine tumor cell lines, human tumor cell lines and human cancer cells from gastric cancer patients or colorectal cancer patients.(II) Clinical studyTo investigate the usefulness of chemo-sensitivity test in post-operative adjuvant chemotherapy, the clinical study was started after the approval by the ethic committee of Osaka University School of Medicine.All patients were randomized to the following 2 groupsGastric cancerGroup A :Chemo-sensitivity (+) □ Standard chemotherapy with 5-FUChemo-sensitivity (-) □ Second line chemotherapy with PaclitaxelGroup B :Chemo-sensitivity (+)/(-) □ Standard chemotherapy with 5-FUColorectal cancerGroup A :Chemo-sensitivity (+) □ Standard chemotherapy with 5-FUChemo-sensitivity (-) □ No chemotherapyGroup B :Chemo-sensitivity (+)/(-) □ Standard chemotherapy with 5-FUPrimary end-point : Disease-free survival Secondary end-point : Overall survivalThe preliminary clinical study, in which all patients were performed single protocol postoperative adjuvant chemotherapy using 5-FU, showed the longer disease-free survival and the longer overall survival in the chemo-sensitivity (+) group.The chemo-sensitivity test is expected to predict the effectiveness of post-operative adjuvant chemotherapy.