CAJ | 학술논문

目的观察分子靶标指导下个体化治疗与长春瑞滨治疗表皮生长因子受体(EGFR)野生型的老年晚期非小细胞肺癌(NSCLC)的疗效及不良反应.方法 2010年6月至2012年10月福建省肿瘤医院经病理确诊且为EGFR野生型的86例老年晚期NSCLC患者,其中男69例,女17例,年龄70 ～ 83岁.通过SPSS 16.0软件随机程序按照1:1的比例随机分为两组,分子靶标指导下个体化治疗43例(研究组),根据肿瘤组织核苷酸切除修复交叉互补基因1(ERCC1)、核苷酸还原酶调节因子1(RRM1)、Ⅲ型β-微管蛋白及胸苷酸合成酶(TS)的表达情况给予顺铂、吉西他滨、紫杉醇、培美曲塞单药方案化疗.对照组43例,给予长春瑞滨25 mg/m2第1天、第8天,每21天为1个周期单药方案化疗.结果研究组和对照组的无进展生存期分别为4.O个月(95％ CI为3.1 ～4.9)和3.0个月(95％ CI为2.4～3.6),两组比较差异有统计学意义(x2=4.750,P=0.029).客观有效率分别为23％(10/43)和19％(8/43),差异无统计学意义(x2 =0.281,P=0.596),疾病控制率分别为79％(34/43)和77％(33/43),差异无统计学意义(x2=0.068,P=0.795),两组的中位生存期分别为8.3和7.5个月,差异无统计学意义(x2=0.756,P =0.385).研究组和对照组不良反应相似,主要为血液学毒性、恶心、呕吐、脱发、关节肌肉酸痛及乏力等,多为Ⅰ、Ⅱ级不良反应,两组均无药物治疗相关死亡病例.结论分子靶标指导下个体化治疗EGFR野生型的老年晚期NSCLC患者与对照组相比,无进展生存期延长,客观有效率、疾病控制率和生存期未明显提高,值得临床进一步研究.
목적 관찰분자파표지도하개체화치료여장춘서빈치료표피생장인자수체(EGFR)야생형적노년만기비소세포폐암(NSCLC)적료효급불량반응.방법 2010년6월지2012년10월복건성종류의원경병리학진차위EGFR야생형적86례노년만기NSCLC환자,기중남69례,녀17례,년령70 ～ 83세.통과SPSS 16.0연건수궤정서안조1:1적비례수궤분위량조,분자파표지도하개체화치료43례(연구조),근거종류조직핵감산절제수복교차호보기인1(ERCC1)、핵감산환원매조절인자1(RRM1)、Ⅲ형β-미관단백급흉감산합성매(TS)적표체정황급여순박、길서타빈、자삼순、배미곡새단약방안화료.대조조43례,급여장춘서빈25 mg/m2제1천、제8천,매21천위1개주기단약방안화료.결과 연구조화대조조적무진전생존기분별위4.O개월(95％ CI위3.1 ～4.9)화3.0개월(95％ CI위2.4～3.6),량조비교차이유통계학의의(x2=4.750,P=0.029).객관유효솔분별위23％(10/43)화19％(8/43),차이무통계학의의(x2 =0.281,P=0.596),질병공제솔분별위79％(34/43)화77％(33/43),차이무통계학의의(x2=0.068,P=0.795),량조적중위생존기분별위8.3화7.5개월,차이무통계학의의(x2=0.756,P =0.385).연구조화대조조불량반응상사,주요위혈액학독성、악심、구토、탈발、관절기육산통급핍력등,다위Ⅰ、Ⅱ급불량반응,량조균무약물치료상관사망병례.결론 분자파표지도하개체화치료EGFR야생형적노년만기NSCLC환자여대조조상비,무진전생존기연장,객관유효솔、질병공제솔화생존기미명현제고,치득림상진일보연구.
Objective To compare the efficacy and toxicity of chemotherapy under the guidance of molecular markers and with vinorelbine in elderly patients with epidermal growth factor receptor (EGFR) wild-type advanced non-small cell lung cancer (NSCLC).Methods A total of 86 elderly patients with pathologically-confirmed advanced NSCLC with EGFR wild-type were recruited between June 2010 to October 2012.There were 69 males and 17 females,aging from 70 to 83 years.They were divided randomly into 2 groups according to the proportion of 1:1 by SPSS 16.0 software.The study group received chemotherapy (cisplatin,gemcitabine,paclitaxel,and pemetrexed) under the guidance of molecular markers (excision repair cross-complementing 1 ERCC1,ribonucleotide reductase M1 RRM1,Class Ⅲ beta-tubulin,thymidylatesynthetase TS).The control group received vinorelbine 25 mg/m2 days 1 and 8 with 21 days as a cycle.Results The progression-free survival (PFS) of the study group and the control group was 4.0 months (95％ CI:3.1-4.9) and 3.0 months (95％ CI:2.4-3.6) respectively,the difference being statistically significant (x2 =4.750,P =0.029).The objective response rate (ORR) was 23 ％ (10/43)and 19％ (8/43) (x2 =0.281,P =0.596),the disease control rate (DCR) was 79％ (34/43) and 77％(33/43) (x2 =0.068,P =0.795),and the median overall survival (OS) was 8.3 months and 7.5 months (x2 =0.756,P =0.385),respectively; the differences being not significant.Adverse effects were similar between the study group and the control group.The most commonly seen adverse events were hematological toxicity,nausea,vomiting,fatigue,alopecia,joint and muscle pain.Most of the toxicity was of grade Ⅰ and grade Ⅱ.There was no treatment-related death.Conclusions The PFS was prolonged in elderly patients with EGFR wild-type advanced NSCLC under the guidance of molecular markers,but there was no improvement in ORR,DCR and OS.Further studies are needed to evaluate the clinical significance of this treatment modality.