重组人血管内皮抑制素联合化疗治疗晚期消化道肿瘤的疗效观察

Clinical study of Endostar combined with chemotherapy in advanced gastrointestinal cancer

目的探讨重组人血管内皮抑制素联合化疗治疗晚期消化道肿瘤的疗效和安全性。方法经病理组织学或细胞学检查确诊的Ⅳ期患者65例,其中胃癌15例、结肠癌21例、直肠癌19例、食管癌10例。15例为初治,37例为二线治疗,13例为三线及三线以上治疗。治疗方案为:重组人血管内皮抑制素15 mg加生理盐水500 ml匀速缓慢滴注1～14天,间歇7天后重复给药;胃癌患者联合FOLFOX4方案,结直肠癌患者联合FOLFIRI方案,食管癌患者联合紫杉醇脂质体(135～175 mg/m^2)+顺铂(75 mg/m^2)方案。按照RECIST标准评价疗效,参照Karnofsky评分(KPS)标准评价生活质量(QOL),按照NCICTC3.0标准评价毒性反应。结果全组65例患者共完成治疗周期160个,平均每例2.46个周期。用药1个周期后评价毒性,两周期后评价疗效。获得CR 1例,PR 20例,SD 18例,PD 26例,有效率(RR)为32.3%(21/65),疾病控制率(DCR)为60%(39/65)。QOL改善率26.1%(17/65),稳定率为63.0%(41/65),下降率10.7%(7/65)。与重组人血管内皮抑制素相关的毒副反应主要为乏力、食欲减退、轻度心脏毒副反应,主要表现为胸闷、心悸,其他毒副反应与化疗药物相关。结论重组人血管内皮抑制素联合化疗治疗晚期消化道恶性肿瘤疗效较佳,且毒性低、安全性高、耐受性好,可以改善或稳定患者的QOL,特别对于老年患者也具有较好的安全性,具有进一步研究和应用的价值。

Objective To investigate the efficacy and safety of rh-endostatin injection （Endostar） combined with chemotherapy in advanced gastrointestinal cancer. Methods Endostar combined with chemotherapy were administrated to 55 cases of gastrointestinal cancer of stage IV confirmed by histopathology or cytopathology, including 7 cases of gastric cancer, 27 cases of colon cancer, 12 cases of colorectal cancer, 3 cases of esophageal cancer. And 4 patients were newly diagnosed, 37 patients were on second-line therapy, and 14 patients were on third or fourth line therapy. 15 mg Endostar solved in 500 ml of normal saline was intravenously dripped from day 1 to day 14, then the administration was repeated 7 days later. The treatment therapies for gastric, eolorectal, and esophageal cancer patients were Endostar combined with FOLFOX4, with FOLFIRI and with paclitaxel liposome （175 mg/m2） ＋ cisplatinum （75 mg/m2）, respectively. The efficacy, quality of life （QOL） and toxicity were evaluated according to RECIST criteria, Karnofsky scores and NCICTC 3.0 version criteria, respectively. Results Totally 160 cycles of therapy were completed and the average cycle number was 2.46. Among the 65 evaluable cases, there was one patient achieving CR, 20 cases achieved PR, 18 cases were in SD, and 26 cases in PD. The objective response rate was 32. 3% （21/65）, and disease control rate （DCR） was 60% （39/ 65）. The QOL was improved in 17 cases （26. 1%）, stabled in 41 cases （63.0%）, and decreased in 7 cases （ 10. 7% ）. Endostar-associated toxicities were mainly loss of appetite, fatigue, and mild cardiac toxicity, including chest tightness, heart tiredness. The other toxicities were associated with chemotherapy. Conclusion The combination of En- dostar with chemotherapy in curing advanced gastrointestinal cancer demonstrates favorable efficacy, and can improve or stabilize the patient＇s QOL. It had low toxicity, good safety and tolerability, especially for the aged. This regimen is wor- thy of further study and clinical application.