摘要
目的 评价多西他赛联合重组人血管内皮抑素治疗初治后进展或毒性反应不可耐受的非小细胞肺癌（NSCLC）患者的疗效和安全性。方法采用随机、双盲、多中心前瞻性临床对照研究，以多西他赛联合重组人血管内皮抑素（联合组）和单药多西他赛（化疗组）在一线化疗后继续治疗嗍NSCLC，观察客观缓解率（ORR）、临床受益率（CBR）、疾病进展时间（TTP）和不良反应。结果联合组和化疗组的ORR均为0，CBR分别为62．5％和53．3％，差异无统计学意义（P〉0．05）。联合组和化疗组患者的TTP分别为2．63和2．07个月，差异无统计学意义（P=0．079）。因一线化疗后PD人组的患者中，联合组和化疗组的TTP分别为1．33和1．67个月，差异无统计学意义（P=0．946）；因一线化疗出现不可耐受毒性人组的患者中，联合组和化疗组的TTP分别为4．70和3．17个月，差异无统计学意义（P=0．070）。入组治疗2个周期后获疾病稳定（SD）的29例患者中，联合组和化疗组的中位TTP分别为6．23和3．27个月（P=0．040）。联合组和化疗组的不良反应差异无统计学意义（均P〉0．05）。结论重组人血管内皮抑素可能在不增加毒副作用的情况下延长多西他赛化疗获益患者的TTP。
Objective To analyze the efficacy and safety of combination of rh-endostatin （Endostar） with docetaxel treatment on patients of non-small cell lung cancer （NSCLC） who presented PD or intolerable toxicity in/after first-line chemotherapy. Methods A randomized, double-blind, placebocontrolled and multi-center clinical trial was conducted. Patients with stage ⅢB/IV of NSCLC experienced previous chemotherapy of one-regimen were screened for this trial. A total of 68 cases were included in this study. Single docetaxel and that combined with endostar were conducted in two arms. The response, time to progression （TIP） and adverse effects were observed in both arms. Results The objective response rate （ORR） and clinical benefit rate （CBR） were 0 and 62.5% in the combined arm, along with 0 and 53.3% in the single docetaxel arm, with a non-significant difference between the two groups （all P 〉 0. 05 ）, respectively. The median TIPs in the combined and single docetaxel arms were 2.63 and 2.07 months, respectively （ P = 0. 079 ）. The median TTPs of the participants with progressive disease （ PD ） after first-line chemotherapy were 1.33 and 1.67 months in the combined and single docetaxel arms, respectively （ P = 0. 946）. The median TFPs of the participants with intolerant adverse effects in first-line chemotherapy were 4.70 months and 3.17 months in the combined and single docetaxel arms, respectively （ P = 0. 070）. The median TTPs of the patients with SD after 2 therapeutic cycles in the combined and single docetaxel arms were 6.23 months and 3.27 months, respectively （P = 0. 040）. The differences between two arms were nonsignificant in adverse, serious adverse and cardiovascular adverse effects （ all P 〉 0.05）. Conclusions Endostar may prolong TTP in patients with advanced NSCLC benefited from docetaxel treatment without increased toxicities.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
2013年第8期618-622,共5页
Chinese Journal of Oncology
基金
天津市科委科研项目（12ZCDSY15600、09ZCZDSF04400）
CSCO基金（Y-X2011-001）
关键词
肺肿瘤
多西他赛
重组人血管内皮抑素
治疗结果
Carcinoma, non-small-cell lung
Docetaxel
rh-endostatin
Treatment outcome
