| Objective: Lung cancer is one of the highest incidence of malignant tumors,The incidence and mortality of lung cancer is increasing yearby year in China.NSCLC(Non Small Cell Lung Cancer,NSCLC)accounts for more than 80% of lung cancer,which taking up the largest p-roportion.Lung cancer patients with limited stages can take urgical treatment,the 5 year survival rate is 50%.But most of the patients with l-ung cancer were found to be in advanced stage and lost the chance of operation,which could not be removed by surgery.Therefore for advan-ced non small cell lung cancer,radiotherpy,chemotherapy and moleculartargeted treatment become the main way,in which platinum-based chemotherapy is currently the first-line standard scheme regimens.Although itcan prolong the survival of patients,the side effects,and the effect are still poor.The advent of EGFR-TKIs drugs provides a richer and moreeffective treatment options for clinicians,providing a theoreticalbasis for the individualized treatment of lung cancer.Human epidermal growth factor receptor(EGFR)is the receptor of the Erb B family of tyrosine kinase(TK),which is involved in tumor cell proliferation and angiogen-esis.A number of studies indicated that the advanced NSCLC patients with EGFR mutations who are treated with EGFR-TKIs in first-line,its progression free survival(PFS)was superior to chemotherapy.Some clinical studies have shown that patients who are treated with EGFR-TKIs,their smoking status,CEA levels and even whether using EGFR-TKIs in the first line are the factors influencing the prognosis.And in somestadies,the efficacy of patients with exon 19 deletion was superior to patients with exon 21 mutation(L858R).Therefore,it was proposed that theexon 19 deletion and exon 21 mutation may be analyzed separately.In the combined analysis of LUX-Lung 3 and LUX-Lung 6,the ORR,PFS and OS were significantly improved in patients with advanced NSCLC who had exon 19 deletion,but for the exon 21 mutation patients,t-he OS of the c-hemotherapy group was significantly longer than that of the Afatinib group,but no statistical significance.these two clinical stu-dies were conducted on the two generation of EGFR-TKI drug,Afatinib,but there are few clinical studies about whether exon 19 deletion or ex-on 21 mutation has effect on first generation of EGFR-TKI drugs.The main purposeof thisstudy is to investigate the effect and the influencing factors on the first line application of EGFR-TKIs in patients with ad-vanced lung adenocarcinoma,and exon 19 deletion and exon 21 mutat-ion on the efficacy of EGFR TKIs.Methods37 cases of advanced non small cell lung cancer patients were selected from the Fourth Hospital of Hebei Medical University during October 2013 to September 2015.These patients were pathologically proved to be adenocarcinoma,and the EGFR mutation(exon 19 deletion and exon 21 mutation(L858R))was detected by tissueor cytology test.All patients were treated with EGFR-TKIs.The first efficacy evaluation was 6 weeks after the start of treatment.After that,target lesions were evaluated every 8 weeks using CT scan,and the related adverse events wer-e recorded.The patient left this group until disease progression or adverse reactions can not be tolerated.The efficacy,influence factors and s-afety are compared.Results:We are evaluated according to the RECIST1.1 standard.In this study,among 37 patients,who were evaluated for CR,PR,SD and PD were 0/37(0.0%),23/37(62.2%),10/37(27%)and 4/37(10.8%)re-spectively.ORR:62.2%,DCR:89.2%,mPFS:12.2 months.Single factor analysis was performed on patients.The results showed that PFS was associated with different mutation sites in the advanced NSCLC patients with EGFR mutations,but was not related to gender,age and smoking status(P > 0.05).In the subgroup analysis,people with exon 19 deletion who were evaluated for CR,PR,SD and PD were 0/19(0.0%),14/19(73.7%),4/19(21.0%)and 1/19(5.3%),ORR 73.7%(14/19),DCR 94.7%(18/19),mPFS 15.7 months.people with exon 21 mutation who were evaluated for CR,PR,SD and PD were 0/18(0.0%),9/18(50.0%),6/18(33.3%)and 3/18(16.7%),ORR 50.0%(9/18),DCR 83.3%(15/18),mPFS 8.4 months.ORR and DCR have no significant difference(ORR:P=0.138;DCR:P=0.340).mPFS has significa-nt difference(P=0.044).Different age subgroups were analysed.Patients over 70 years of age were 11.Among these patients,0/11(0.0%),7/11(63.6%),3/11(27.3%)and 1/11(9.1%)were evaluated for CR,PR,SD and PD.ORR 63.6%(7/11),DCR 90.9%(10/11),mPFS 15 months.Patients less than or eq-ual to 70 year old were 26.Among these patients,0/26(0.0%),16/26(61.5%),7/26(27.0%)and 3/26(11.5%)were evaluated for CR,PR,SD and PD.ORR 61.5%(16/26),DCR 88.5%(23/26),mPFS 9.8 months.ORR,DCR and mPFS have no significant diffe-rence(ORR:P=1.000;DCR:P=1.000;mPFS:P=0.296).The most common adverse reactions were rash(n=10,27.0%),liver toxicity(n=7,18.9%)and diarrhea(n=7,18.9%).The most common adverse reactions in patients whose age above 70 were rash(n=3,27.3%),diarrhea(n=3,27.3%)and liver toxicity(n=2,18.2%).It has no significant difference with patients whose age less than or equal to 70(rash,P=1.000,Diarrhea,P=0.403,liver toxicity,P = 1.000).Conclusions:1 For patients with advanced NSCLC of EGFR mutation-positive,using first generation of EGFR-TKIs,ORR,DCR and mPFS were 62.2%,89.2% and 12.2 months,respectively.2 The efficacy of first generation EGFR-TKIs in non small cell lung adenocarcinoma patients has nothing to do with gender,age,smoking status and stage.3 For patients with advanced NSCLC who were positive for EGFR mutations,the objective response rate and the disease control rate in the exon 19 deletion group was no different with the exon 21 mutation group when applying first generation EGFR-TKIs for first-line treatment.The median progression free survival time(mPFS)in the exon 19 deletion group was significantly longer than that in the exon 21 mutation group.It has statistical difference.4 Age above 70 with less than or equal to 70 were compared,ORR,DCR and mPFS were no statistical difference.5 The common adverse reactions were rash,liver toxicity and diarrhea. |
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