恩度联合化疗治疗晚期恶性肿瘤的临床观察

目的观察重组人血管内皮抑制素注射液（Endostar,YH-16,恩度）联合化疗治疗晚期恶性肿瘤的有效性和安全性。方法经病理组织学和/或细胞学检查,确诊为Ⅲ-Ⅵ期恶性肿瘤患者21例,包括消化道肿瘤,泌尿生殖系统肿瘤,软组织肉瘤等均接受恩度联合化疗的方案治疗。其中恩度15mg,加入生理盐水250ml中匀速缓慢静脉滴注,第1-14天连续给药,间歇7d重复;同时联合继往未使用或无交叉耐药的化疗药物,每21d为1周期。2周期后评价疗效和不良反应。结果21例患者中CR 2例,PR 3例,SD 12例,PD 4例。客观有效率RR23.8%,疾病控制率DCR为80.9%。其中一二线联合恩度治疗的有效率和疾病控制率较三线高,有统计学意义（P〈0.05）。生活质量改善6例,11例稳定,4例下降。QOL改善稳定率达到28.6%。可观察到的TTP8位患者5-12个月,1年生存率85.7%。无G4级毒性,G3级的毒性仅有4.76%（9/189）,包括血小板下降,白细胞下降和恶心、呕吐,贫血,主要和联合的化疗药物有关。结论恩度与化疗联合治疗晚期恶性肿瘤近期客观疗效较好,生活质量得到改善,毒性低,安全性高值得做进一步临床观察研究。

Endostar combined with chemotherapy on the multiple kinds of advanced malignancies.

Objective To obseve the efficacy and safety of rh-endostatin injection （YH-16, Endostar）, combined with chemotherapy on the multiple kinds of advanced malignancies. Methods Endostar combined with chemotherapy were administrated to 21 malignant cases of stage Ⅲ-Ⅳ confirmed by histopathology or cytopathology. 15mg Endostar solved in 250ml of normal saline was slow intravenously dropped from day 1 to day 14, repeated after 7 day later. The chemotherapy agents which was not used before or not cross-resistant to pre-chemtherapeutic agents were selected to be given simultaneously. The regimen was repeated every 21 days. The effcacy was evaluated strictly after 2 cycles according to RECIST criteria, and quality of life （QOL）was evaluated according to Karnofsky scores. Otherwise safety was evaluated after 1 cycle according to NCI CTC 3. 0version criteria. Results Among 21 cases, there were 2 cases of CR,3 cases of PR and 12 cases of SD,4 eases of PD. The objective response rate （RR） was 23.8% and disease control rate（DCR） was 80.9%. the efficacy of Endostar combined with chemotherapy was higber The quality of life（QOL） were improved on 6 cases,stabled on 11 cases, and decreased on 4 cases. The occurrence rates of G3 toxicities were low 4.76% （ 9/189 ）, including thrombocytopenia （ 4/21 ）, neutropenia （ 2/2 1 ）, nausea/vomiting （ 2/21 ） and anaemia（ 1/21 ）. These toxicities were mainly related with the chemotherapy agents. Conclusion The objective response and QOL of patients with advanced malignancies may be improved by endostar combined with chemotherapy. It is worghy of further clinical, observation.