CAJ | 학술논문

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晚期NSCLC,观察客观缓解率(ORR)、临床受益率(CBR)、疾病进展时间(TrP)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入组的患者中,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入组的患者中,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.
목적 평개다서타새연합중조인혈관내피억소치료초치후진전혹독성반응불가내수적비소세포폐암(NSCLC)환자적료효화안전성.방법 채용수궤、쌍맹、다중심전첨성림상대조연구,이다서타새연합중조인혈관내피억소(연합조)화단약다서타새(화료조)재일선화료후계속치료만기NSCLC,관찰객관완해솔(ORR)、림상수익솔(CBR)、질병진전시간(TrP)화불량반응.결과 연합조화화료조적ORR균위0,CBR분별위62.5％화53.3％,차이무통계학의의(P＞0.05).연합조화화료조환자적TTP분별위2.63화2.07개월,차이무통계학의의(P=0.079).인일선화료후PD입조적환자중,연합조화화료조적TTP분별위1.33화1.67개월,차이무통계학의의(P =0.946)；인일선화료출현불가내수독성입조적환자중,연합조화화료조적TTP분별위4.70화3.17개월,차이무통계학의의(P =0.070).입조치료2개주기후획질병은정(SD)적29례환자중,연합조화화료조적중위TTP분별위6.23화3.27개월(P =0.040).연합조화화료조적불량반응차이무통계학의의(균P＞0.05).결론 중조인혈관내피억소가능재불증가독부작용적정황하연장다서타새화료획익환자적TTP.
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 Ⅲ B/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 (TTP) 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 TTPs 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 TTPs 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.