CAJ | 학술논문

目的评价尼妥珠单抗联合紫杉醇脂质体和卡铂(LP)方案治疗晚期非小细胞肺癌(NSCLC)的近期疗效和毒副反应.方法 41例晚期NSCLC患者随机分为联合组(21例)和对照组(20例),联合组采用尼妥珠单抗联合LP方案治疗,对照组采用LP方案化疗.治疗前后每周检测患者外周血中癌胚抗原(CEA)、细胞角蛋白19片段(CYFR21-1)和神经元特异性烯醇化酶(NSE)的变化.结果联合组完全缓解(CR)2例,部分缓解(PR)7例,稳定缓解(SD)9例,进展缓解(PD)3例,有效率为42.9％,中位肿瘤进展时间(TTP)为6.9个月.对照组CR 1例,PR 6例,SD 8例,PD 5例,有效率为35.0％,TTP为5.7个月.两组患者的有效率差异无统计学意义(P=0.751),TTP差异有统计学意义(P =0.027).联合组和对照组患者外周血NSE下降,差异有统计学意义(P=0.039).联合组患者治疗后CEA和NSE下降明显,差异有统计学意义(P值分别为0.010和0.002).除联合组有3例患者发生Ⅰ～Ⅱ级皮肤反应(以颜面为主)外,其他无差异.结论尼妥珠单抗联合LP方案化疗有一定的协同作用,能提高疗效,延长患者TTP,且毒副反应较轻,患者一般可以耐受.
목적 평개니타주단항연합자삼순지질체화잡박(LP)방안치료만기비소세포폐암(NSCLC)적근기료효화독부반응.방법 41례만기NSCLC환자수궤분위연합조(21례)화대조조(20례),연합조채용니타주단항연합LP방안치료,대조조채용LP방안화료.치료전후매주검측환자외주혈중암배항원(CEA)、세포각단백19편단(CYFR21-1)화신경원특이성희순화매(NSE)적변화.결과 연합조완전완해(CR)2례,부분완해(PR)7례,은정완해(SD)9례,진전완해(PD)3례,유효솔위42.9％,중위종류진전시간(TTP)위6.9개월.대조조CR 1례,PR 6례,SD 8례,PD 5례,유효솔위35.0％,TTP위5.7개월.량조환자적유효솔차이무통계학의의(P=0.751),TTP차이유통계학의의(P =0.027).연합조화대조조환자외주혈NSE하강,차이유통계학의의(P=0.039).연합조환자치료후CEA화NSE하강명현,차이유통계학의의(P치분별위0.010화0.002).제연합조유3례환자발생Ⅰ～Ⅱ급피부반응(이안면위주)외,기타무차이.결론 니타주단항연합LP방안화료유일정적협동작용,능제고료효,연장환자TTP,차독부반응교경,환자일반가이내수.
Objective To evaluate the efficacy of nimotuzumab combined with palitaxel liposome and carboplatin (LP) regimen for treatment of advanced non-small cell lung cancer (NSCLC),and to observe the changes of tumor markers and toxicities in the treatment.Methods Forty-one patients with advanced NSCLC were randomly divided into 2 groups:21 patients in the observation group were treated with nimotuzumab (200 mg per week for 6 weeks),palitaxel liposome 160 mg/m2 and carboplatin (AUC =6).20 patients in the control group were given LP regimen.Each group completed two cycles of chemotherapy.The level of tumor markers (CEA,CYFR21-1 and NSE) and toxicities were checked at one week before and after the treatment.Thoracic CT examinations were taken before treatment and at the fourth week and eighth week after treatment.Results In the observation group,there were 2 cases of CR,7 cases of PR,9 cases of SD and 3 cases of PD.The objective response rate (RR) was 42.9％ in the observation group.In the control group,there were 1 case of CR,6 cases of PR,8 cases of SD and 5 cases of PD,with a RR of 35.0％ in this group.There was no significant difference in the RR between the two groups (P =0.751 ).The time to progression (TTP) was 6.9 months in the observation group and 5.7 months in the control group,with a significant difference ( P =0.027 ).The levels of NSE decreased significantly in both groups and showed a significant difference (P =0.039).The levels of CEA and CYFRA21 in both groups were decreased after treatment,but did not show a significant difference before and after treatment,respectively.Except 3 cases had Ⅰ ～ Ⅱ skin toxicities on the faces in the observation group,there was no significant difference in toxicities between the two groups.Conclusion Nimotuzmab combined with LP regimen shows a synergistic effect,can increase the efficacy and prolong TTP in advanced NSCLC patients.The toxicities are mild and tolerable.