重组人血管内皮抑制素联合化疗治疗晚期恶性肿瘤的临床观察

Rh-endostatin injection combined with chemotherapy on the advanced malignancies

目的:观察抗肿瘤新药重组人血管内皮抑制素注射液(恩度)联合化疗治疗晚期恶性肿瘤的有效性和安全性。方法:经病理组织学或细胞学检查确诊的Ⅳ期恶性肿瘤患者40例,其中胃肠肿瘤10例,非小细胞肺癌12例,其他肿瘤18例(头颈部肿瘤6例,胰腺癌、小细胞肺癌、胆囊癌、胆管癌各2例,骨肉瘤、子宫体癌、卵巢癌、腹腔转移性腺癌各1例)。患者接受恩度联合化疗,其中恩度15mg静脉滴注,第1～14天,同时联合一线化疗方案或既往未使用的化疗药物。21天为1个周期。按照RECIST标准评价近期疗效,参照Karnofsky评分(KPS)变化评价生活质量(QOL),按照NCI CTC 3.0标准评价毒性反应。用药1周期即可评价毒性,2周期后评价疗效。结果:全组40例患者中,有35例可以评价客观疗效,40例均可进行安全性评价。35例可评价病例中,PR 10例,SD 15例,PD 10例,即客观有效率(RR)为28.57%(10/35),疾病控制率(DCR)为71.43%(25/35);而生活质量改善者有20例(57.14%),稳定者12例(34.29%),仅3例(8.57%)下降。G3/4级毒性主要与化疗药物有关,包括3例(7.5%)白细胞下降,3例(7.5%)血小板下降,5例(12.5%)恶心呕吐以及2例(5.0%)腹泻。结论:恩度联合化疗可以改善和稳定晚期恶性肿瘤患者的生活质量,延长无疾病进展时间。与化疗药物具有一定的协同作用,其毒性低,安全性好,值得临床推广和进一步研究。

Objective：To investigate the efficacy and safety of rh-endostatin injection （endostar） combined with chemotherapy on the advanced malignancies. Methods：Endostar combined with chemotherapy were administrated to 40 malignant cases of stage Ⅳ （ including 10 cases with gastrocolorectal cancer, 12 cases non-small cell lung cancer, 18 cases with other cancers） confirmed by histopathology or cytopathology. 15mg endostar solved in 500ml of normal saline was slow intravenously dropped from day 1 to day 14. The chemotherapy agents which was fisrt line agents or not used before were selected to be given simultaneously. The regimen was repeated every 21 days. The efficacy 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 310 version criteria. Results：Thirty- five cases were evaluated for efficacy among the total 40 cases that were capable of safety evaluation. Among 35 evaluable cases, there were 10 cases achieved PR, 15 cased of SD, and l0 cases of PD. The objective response rate （RR） was 28.57% （10/35） and disease control rate（DCR） was 71.43% （25/35）. The quality of life （QOL） were improved on 20 cases（ 57. 14% ）, stabled on 12 cases （34.29%）,and decresed on 3 cases （8.57%）. The occurrence rates of G3/4 toxicities were low, including neutropenia （3/40, 7. 5% ） , thrombocytopenia （ 3/40, 7.5% ） , nausea/vomiting （5/40, 12. 5% ） and diarrhea （ 2/40, 5.0% ）. These toxicities were mainly ralated with the chemotherapy agents. Conclusion：The QOL and times of DFS of patients with advaced malignencies may be improved and prolonged by endostar combined with chemotherapy. And there have synergetic effects of endostar with cytotoxic agents. It is worthy of clinical generalization and further clinical investigation.