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目的观察重组人血管内皮抑制素(恩度)与化疗联合治疗晚期结直肠癌的有效性和安全性。方法自2006年8月至2009年5月,5例初治转移性结直肠癌患者和18例复治转移性结直肠癌患者接受恩度联合细胞毒药物治疗。恩度15mg/d,加入生理盐水500m l静脉滴注,连用14天。同时8例患者采用FOLFIR I方案化疗,2例患者采用CAPIR I方案化疗,9例患者采用GLF方案化疗,4例患者采用FOLFOX 4或XELOX方案化疗。分别按照REC IST 1.0和NC I-CTC 3.0评价疗效和毒性。结果 23例可评价毒性,21例可评价疗效。在4例初治患者中,2例SD,2例PD。在17例复治患者中,8例SD,9例PD,疾病控制率(DCR)为47.1%。全组中位肿瘤进展时间(mTTP)为5个月(95%C I:2.2~7.8个月),中位总生存时间(mOS)为12个月(95%C I:10.5~13.5个月)。复治患者的mTTP和mOS分别为4个月(95%C I:1.7~6.3个月)和11.5个月(95%C I:8.5~14.5个月)。主要不良反应为血液学毒性、恶心呕吐,考虑主要与化疗相关。轻度心血管系统毒性考虑与恩度相关。结论恩度联合细胞毒药物治疗转移性结直肠癌安全性好,恩度未增加化疗药物的毒性。对复治患者有延长疾病控制时间的趋势,值得进一步研究。
Objective To observe the efficacy and safety of recombinant human endostatin (Endo) combined with chemotherapy in the treatment of advanced colorectal cancer. Methods From August 2006 to May 2009, 5 patients with primary metastatic colorectal cancer and 18 patients with recurrent metastatic colorectal cancer received endocytosis combined with cytotoxic drugs. Endo 15mg/d, add normal saline 500m l intravenous infusion for 14 days. At the same time, 8 patients received FOLFIR I chemotherapy, 2 patients received CAPIR I chemotherapy, 9 patients received GLF chemotherapy, and 4 patients received FOLFOX 4 or XELOX chemotherapy. Efficacy and toxicity were evaluated according to REC IST 1.0 and NC I-CTC 3.0, respectively. Results Twenty-three patients were evaluated for toxicity and 21 patients were evaluated for efficacy. Among 4 untreated patients, 2 had SD and 2 had PD. Of the 17 retreatment patients, 8 had SD and 9 had PD, and the disease control rate (DCR) was 47.1%. The median tumor progression time (mTTP) for the whole group was 5 months (95% C I: 2.2-7.8 months), and the median overall survival time (mOS) was 12 months (95% C I: 10.5-13.5 months). Retreatment of patients with mTTP and mOS was 4 months (95% C I: 1.7 to 6.3 months) and 11.5 months (95% C I: 8.5 to 14.5 months). The main adverse reactions were hematologic toxicity, nausea and vomiting, which were mainly related to chemotherapy. Mild cardiovascular toxicity considerations are related to degree of patience. Conclusion Endotherapy combined with cytotoxic drugs has good safety in the treatment of metastatic colorectal cancer, and Endo does not increase the toxicity of chemotherapy drugs. The trend of prolonged disease control time for retreatment patients deserves further study.