重组人血管内皮抑素联合化疗治疗晚期消化道恶性肿瘤的临床观察

Endostar combined with chemotherapy in 28 patients with advanced gastrointestinal system cancer

目的探讨重组人血管内皮抑素(恩度)联合化疗治疗Ⅳ期消化道恶性肿瘤的临床疗效和毒性反应。方法28例消化道恶性肿瘤均经病理组织学或细胞学检查确诊,均为Ⅳ期,其中胃癌13例,大肠癌10例,肝癌2例,胰腺癌3例,采用恩度联合化疗治疗。其中恩度15mg/次,加入生理盐水500ml中匀速缓慢静脉滴注,第1～14天,每3～4周重复使用。28例均为复治患者,恩度联合二线化疗者19例,联合三线及以上化疗者9例。按照RECIST标准评价疗效,参照Karnofsky评分(KPS)变化评价生活质量(QOL),按照NCICTC3.0评价毒性反应。用药1个周期可评价毒性,2个周期后评价疗效。结果全组28例共完成治疗周期62个,平均每例2.2个周期。获得PR4例,SD15例,PD9例,有效率(CR+PR)为14.3%(4/28),疾病控制率(DCR)为67.9%(19/28)。QOL改善率32.1%(9/28),稳定率为53.6%(15/28),下降率14.3%(4/28),QOL改善稳定率达85.7%(24/28)。与恩度相关的毒副反应主要为食欲不振、疲乏和轻度心脏毒副反应,包括胸闷、心悸、心电图T波和ST-T改变、轻度高血压,其他毒副反应与化疗药物相关。结论恩度联合化疗治疗Ⅳ期消化道恶性肿瘤具有良好疗效,可以改善或稳定患者的QOL,毒性低,安全性和耐受性好,值得临床推广应用。

Objective To observe the clinical efficacy and safety of endastar,a new molecular targeted antitumor agent, combined with the chemotherapy on stage Ⅳ gastrointestinal cancer. Methods Endostar combined with chemotherapy were administrated to 28 cases of stage Ⅳ gastrointestinal cancer confirmed by histopathology or cytopathology（ including 13 cases of gastric cancer, 10 cases of rectum cancer,2 cases of liver cancer,3 cases of pancreatic cancer）. 15mg endostar solved in 500ml of normal saline was slow intravenously dropped from day 1 to day 14. The chemotherapy agents were selected to be given simultaneously. The combined regimen was repeated every three or four weeks. All cases were re-treated（including 19 cases combined with second-line chemotherapy, another 9 cases combined with three-hne chemotherapy） ,The efficacy quality of life（QOL） and toxicity were evaluated according to RECIST criteria, Karnofsky scores and NCI CTC 3.0 version criteria respectively. The toxicity was evaluated after 1 cycle and the efficacy was evaluated after 2 cycles. Results Totally 62 cycles have be completed and average cycle number was 2. 2. Among the 28 evaluable eases, there were 4 cases achieved PR,15 cases SD, and 9 cases PD, the objective response rate（PR） was 14. 3% （4/28） and disease control rate（DCR） was 67.9% （19/28）. The quality of life（QOL） were improved on 9 cases（32. 1% ）, stabled on 15cases（53.6% ）, and decreased on 4 cases（ 14. 3% ）. The improvement and stable rate of QOL achieved to 85.7% （24/28）. The side effects were mainly loss of appetite, fatigue and mildly cardiac toxicity （including chest tightness, palpitation and ECG T wave and ST-T changes, mild hypertension）, other toxicities were mainly related with the chemotherapy agents. Conclusion There are better efficacy of endostar combined with the related chemotherapy on the gastrointestinal cancer and QOL of such patients may be improved or remained stable. The combined regimen was low toxic and tolerable. It is worthy of clinical generalization and further clinical observation.