重组人血管内皮抑素联合化疗治疗多种晚期恶性肿瘤的临床观察

目的观察重组人血管内皮抑素注射液(YH-16,恩度)联合常规化疗方案治疗多种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晚期恶性肿瘤患者15例接受恩度联合化疗的方案治疗,其中非小细胞肺癌(NSCLC)12例,小细胞肺癌(SCLC)1例,大肠癌2例。恩度15 mg加入生理盐水500 mL中输液泵泵入4 h,第1~14天连续给药,间歇7天重复;同时联合既往未使用的或与既往治疗无交叉耐药的化疗药物。每21天为1个周期。按照WHO疗效标准评价近期疗效,参照Karnofsky评分(KPS)变化评价生活质量(QOL),按照NCICTC 3.0版标准评价毒副反应。用药1周期即可评价毒性,2周期后评价疗效。结果全组15例患者中,有12例可以评价客观疗效,15例均可进行安全性评价。总共完成的周期数为51个,平均3.4周期/例。12例可评价病例中,获得PR 3例,SD 8例,PD 1例,客观有效率(RR)为25%(3/12),疾病控制率(DCR)为91.7%(11/12);QOL改善者5例(41.7%),稳定6例(50%),仅1例下降(8.3%)。血液学毒性主要与化疗有关,包括白细胞下降,血小板下降;心电图改变和血栓性事件考虑可能与恩度有关,具体机制尚待进一步研究。结论恩度与化疗药物联合使用可以改善和稳定多种晚期恶性肿瘤患者的生活质量,与部分化疗药物具有协同作用,其毒性低,安全性好,值得临床上推广应用和进一步深入观察。

Clinical observation of endostar combined with chemotherapy on the multiple kinds of malignancies

Objective To observe prospectively and systematically the efficacy and safety of rh-endostatin injection (YH-16,Endostar) combined with the chemotherapy on the multiple kind of advanced malignancies.Methods Endostar combined with chemotherapy were administrated to 15 cases of advanced malignancies (including 12 cases with non-small cell lung cancer,1 case with small cell lung cancer and 2 cases with colorectal carcinoma) confirmed by histopathology or cytology.15 mg endostar dissolvedin 500 mL of normal saline was intravenously dropped from day 1 to day 14,repeated after 7 days.The chemotherapy agents which were not used before or not cross-resistant to pre-chemotherapeutic agents were selected to be given simultaneously.The regimen was repeated every 21 days.The efficacy was evaluatedstrictly after 2 cycles according to WHO criteria,and quality of life (QOL) was evaluated according to Karnofsky.Safety was evaluated after 1 cycle according to NCICTC 3.0 version criteria.Results 12 cases were evaluable for efficacy among the total 15 casesthat were capable of safety evaluation.Totally 51 cycles were completed and mean cycle was 3.4.Among 12 evaluable cases,there were 3 cases of PR,8 cases of SD,and 1 case of PD.Theobjectiveresponserate(RR) was2 5 %(3 / 1 2) and disease control rate (DCR) was 91.7 %(1 1 / 1 2).The quality of life (QOL) was improvedin 5 cases (4 1.7 %),stabledin 6 cases (50 %),and decreasedin 1 case (8.3 %).The hematology toxicities were mainly related with the chemotherapy agents,including Neutrogena and thrombocytopenia.The change of electrocardiogram and thrombus events maybe relate to endostar,but the mechanism is worthy of further research.Conclusion The QOL of patients with multiple kinds of advanced malignancies may be improved by endostar combined with the related chemotherapy.Maybe endostar has synergetic effects with some cytotoxic agents.It is worthy of clinical generalization and further clinical observation.