奈达铂联合吉西他滨对比顺铂联合吉西他滨一线治疗晚期肺鳞癌随机对照临床研究  

Randomized controlled clinical study of nedaplatin combined with gemcitabine compared with cisplatin with gemcitabine in the firstline treatment of advanced lung squamous cell carcinoma

作　　者：陈胜佳[1] 朱凯[1] 林金兰[1] 张晶[1] 徐振武[1] 庄武[1] 徐海鹏[1] CHEN Shengjia;ZHU Kai;LIN Jinlan;ZHANG Jing;XU Zhenwu;ZHUANG Wu;XU Haipeng(Department of Thoracic Oncology,Fujian Cancer Hospital,Fujian Medical University Hospital,Fujian,Fuzhou 350014,China)

机构地区：[1]福建省肿瘤医院福建医科大学附属肿瘤医院胸部肿瘤内科,福建福州350014

出　　处：《中国医药科学》2021年第4期5-8,46,共5页China Medicine And Pharmacy

基　　金：福建省自然科学基金(2018J01276)。

摘　　要：目的通过与一线标准方案顺铂联合吉西他滨(DDP+GEM,GP)治疗晚期肺鳞癌随机对照研究,评价奈达铂联合吉西他滨(NDP+GEM,GNP)在晚期肺鳞癌一线治疗中的疗效与不良反应。方法本研究为多中心、开放性、前瞻性、随机对照临床研究,依照入选标准,福建省肿瘤医院胸部肿瘤内科2012年9月至2013年12月入组101例晚期肺鳞癌初治患者,随机分组,69例接受GNP治疗(试验组),32例接受GP(对照组)治疗。评价两组患者的总生存率(OS)、无进展生存时间(PFS)、客观有效率(RR)及疾病控制率(DCR)和不良反应。结果实验组与对照组一线化疗晚期肺鳞癌的近期有效率分别为26.1%和18.7%,疾病控制率分别为75.36%和71.88%,差异无统计学意义(P>0.05)。试验组与对照组中位OS分别为10.10个月与8.05个月,试验组中位OS延长了2.05个月,但差异无统计学意义(P>0.05)。试验组与对照组中位PFS分别为4.0个月与4.0个月,差异无统计学意义(P>0.05)。不良反应主要为骨髓抑制,差异无统计学意义(P>0.05),试验组恶心呕吐发生率低于对照组,差异有统计学意义(P<0.05)。结论奈达铂联合吉西他滨方案治疗晚期肺鳞癌有效率和传统方案相近,耐受性要好于传统方案,可考虑其选择作为肺鳞癌一线治疗的选择之一。Objective To evaluate the efficacy and adverse reactions of nedaplatin combined with gemcitabine(NDP+GEM)in the first-line treatment of advanced lung squamous cell carcinoma(LSCC)through a randomized controlled study with the first-line regimen of cisplatin combined with gemcitabine(DDP+GEM).Methods This study was a multicenter,open,prospective,randomized controlled clinical study.According to the inclusion criteria,101 initially treated patients with advanced LSCC enrolled Department of Thoracic Oncology,Fujian Provincial Cancer Hospital from September 2012 to December 2013 were randomly divided into the study group(n=69,GNP)and the control group(n=32,GP).The overall survival rate(OS),progression-free survival time(PFS),objective response(RR),disease control rate(DCR)and adverse reactions(ARs)were evaluated in both groups.Results The short-term RR of first-line chemotherapy for advanced LSCC in the study group and the control group were 26.1%and 18.7%,respectively,and the DCR in the study group and the control group were 75.36%and 71.88%,respectively,with no statistically significant difference(P>0.05).The median OS of the study group and the control group were 10.1 months and 8.05 months,respectively,and the median OS of the study group was prolonged by 2.05 months,with no statistically significant difference(P>0.05).The median PFS of the study group and control group were 4.0 months and 4.0 months,respectively,with no statistical difference(P>0.05).The main adverse reaction was myelosuppression,and there was no significant difference between the two groups.The incidences of study group and vomiting in the study group were lower than that in the control group,with statistically significant difference(P<0.05).Conclusion Nedaplatin combined with gemcitabine is similar in efficiency and better in tolerance as compared with traditional regimen in the treatment of advanced LSCC,so it can be considered as one of the first-l ine therapy for LSCC.

关 键 词：奈达铂 吉西他滨 顺铂 晚期肺鳞癌 不良反应 

分 类 号：R734.2[医药卫生—肿瘤]