EGFR突变阴性肺腺癌寡转移培美曲塞联合顺铂同步化放疗序贯培美曲塞维持治疗临床观察  

Efficacy of pemetrexed and cisplatin plus concurrent radiation therapy followed by maintenance pemetrexed in patients with oligometastatic lung adenocarcinoma of EGFR gene wild

作　　者：王建芳[1] 刘建江[1] 孙彩萍[1] 陈遐林[1] WANG Jian-fang;LIU Jian-jiang;SUN Cai-ping;CHEN Xia-lin(Department of Radiation Oncology,Shaoxing People's Hospital,Shaoxing 312000,P.R.China)

机构地区：[1]绍兴市人民医院放疗科,浙江绍兴312000

出　　处：《中华肿瘤防治杂志》2018年第22期1588-1592,共5页Chinese Journal of Cancer Prevention and Treatment

基　　金：绍兴市公益性技术应用研究计划(2017B70027);浙江省医学会临床科研基金肿瘤科研项目(正大青春宝专项2016ZYC-A81);浙江省公益技术研究社会发展项目(2016C33224)

摘　　要：目的现阶段国内外对于EGFR突变阴性的寡转移肺腺癌根治性同步放化疗后继续培美曲塞(PEM)维持治疗的研究较少,本研究旨在探讨PEM联合顺铂方案同步化放疗+PEM维持化疗治疗EGFR突变阴性的寡转移肺腺癌患者的疗效及安全性。方法收集2014-05-01-2016-06-01绍兴市人民医院治疗的41例患者入组,根据病情急重选择放疗部位,胸部原发肿瘤调强放疗30min或寡转移肿瘤根治剂量放疗,同步培美曲塞联合顺铂化疗,培美曲塞500mg/m^2,2h内静脉滴入;d1+顺铂75mg/m^2,静脉滴入,d1,3周为1个周期。同步放化疗完成后予培美曲塞500mg/m^2,30min内静脉滴入,d1,4周为1个周期维持治疗,直至疾病进展或出现不可耐受的毒副作用。研究的主要终点为中位无进展生存时间(median progression free survival,mPFS)和1年无进展生存时间(progression-free survival,PFS)率,次要终点为中位总生存时间(median overall survival,mOS)、客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)及不良反应。结果中位随访22个月,mPFS为9.4个月(95%CI为6.6～12.3个月),1年PFS率为41.9%,mOS为19.5个月(95%CI为14.3～26.3个月),ORR为58.5%,DCR为82.9%。不良反应方面:胸部原发灶放化疗期间,4例患者出现3～4度白细胞减少,3～4度放射性食管炎、吞咽困难、恶心呕吐各2例;寡转移灶治疗期间,2例患者在脑转移灶治疗中出现3～4度恶心呕吐;PEM维持治疗期间无3～4度不良反应;以上不良反应经对症治疗后均可缓解。结论 PP方案同步放化疗+培美曲塞维持化疗可延长EGFR突变阴性的寡转移肺腺癌患者的PFS及总生存时间,提高DCR,患者的不良反应耐受性良好。OBJECTIVE At present,there are few studies on the maintenance of pemetrexed after radical chemoradiotherapy in patients with oligometastatic lung adenocarcinoma with negative EGFR mutation at home and abroad,this study aimed to explore the efficacy and safety of pemetrexed and cisplatin plus concurrent radiation therapy followed by maintenance pemetrexed in these patients.METHODS From May 2014 to June 2016,a total of 41 patients from Shaoxing People’s Hospital who met the above standards were enrolled.According to the patient’s condition,patients received radiation therapy of appropriate tumor locations concurrent with pemetrexed(500 mg/m^2 on first day)and cisplatin(75mg/m^2 on first day)every 3weeks,followed by maintenance pemetrexed(500mg/m^2 on first day)every 4weeks until disease progression or unacceptable toxicity.The first end point was median PFS and 12 months PFS rate.The secondary end points included median OS objective response rate(ORR),disease control rate(DCR)and adverse events.RESULTS With a median follow-up of 22 months,median PFS was 9.4months(95%CI:6.6-12.3),PFS rate of 12 months was 41.9%,median OS was 19.5months(95%CI:14.3-26.3),the ORR and DCR were 58.5and 82.9%respectively.During thoracic chemoradiotherapy,4patients suffered grade 3/4leukopenia,2patients suffered grade 3/4esophagitis,2patients suffered grade 3/4vomiting and 2patients suffered grade 3/4dysphagia.During the treatment of oligometastatic disease,2patients with brain metastases suffered grade 3/4vomiting.No grade 3/4adverse events occurred during maintenance therapy.All of the above adverse reactions can be relieved after symptomatic treatment.CONCLUSION Pemetrexed and cisplatin plus concurrent radiation therapy followed by maintenance pemetrexed demonstrates an improvement in PFS,DCR and OS with well-tolerated adverse events.

关 键 词：肺腺癌 寡转移 表皮生长因子受体 培美曲塞 同步放化疗 维持治疗 

分 类 号：R734.2[医药卫生—肿瘤]