Survival Analysis Of Ectinib Hydrochloride In Patients With Advanced Lung Squamous Cell Carcinoma

Background and purposeTyrosine kinase inhibitors(TKIs)targeting the epidermal growth factor receptor(EGFR)are well established in treating metastatic pulmonary adenocarcinoma(ADC),especially patients with activating EGFR mutations.There are conflicting data support-ing the efficacy of EGFR-TKIs in advanced lung squamous cell carcinoma(SCC).The first part of this study will retrospectively analyze the impact of EGFR-TKI icotinib on progression free survival(PFS)and overall survival(OS)in unselected patients with advanced lung SCC.The rate of EGFR mutation in lung SCC was much lower than that in ADC,the efficiency of EGFR-TKI treatment in SCC patients with EGFR mutant is more contro-versial than that in ADC,many researchers thought TKI in SCC patients is less effective.The second part of this study will compare the treatment efficacy of icotinib in EGFR mutant SCC and ADC patients.MethodsRetrospectively analyze lung SCC patients taking icotinib between 2013.06 and 2016.06 who meet all the following inclusion criterias:age?18y;signed the informed consent;pathologically confirmed lung squamous cell carcinoma;clinical stage IIIB/IV;KPS?60;appropriate bone marrow?liver and kidney function;accept the treatment of icotinib into the charity range.Exclusion criterias are icotinib combined with chemoth-erapy;sever cardiopulmonary disease;habitual diarrhea or constipation which affects the absorption of drugs;pregnancy or breastfeeding.Patients need to have regular physical examination?imaging and routine laboratory tests.Telephone follow-up patients survival time,the deadline was 2017.04.The primary endpoint was PFS,the secondary endpoints included OS?objective response rate(ORR)?disease control rate(DCR).Kaplain-Meier method was used to estimate PFS and OS with two sided 95%confidence intervals(CIs),log-rank test was used to analyze single survival factor,Cox proportional hazards model was used to identify independent factors of PFS and OS,the difference between groups and ORR used ?2 test.Statistical significance was defined as P<0.05(P<0.1 in Cox pro-portional hazards model).Retrospectively analyze lung ADC patients taking icotinib between 2013.06 and 2016.06 who meet all the following inclusion criterias:pathologically confirmed lung adenocarcinoma;EGFR testing are mutant;others same as SCC.Exclusion criterias are same as SCC.The follow-up deadline was 2017.04.Choose appropriate ADC to have 1:1 ratio of propensity score matching with SCC patients who are EGFR mutant,match-ing factors are age?sex?clinical stage?KPS?smoking status?EGFR mutantion type?treatment lines,clipper was 0.03.Comparing the survival time between two group pati-ents.The endpoints and statistic methods are same as SCC.Statistical signifycance was defined as P<0.05.ResultsA total of 487 advanced SCC patients were enrolled.The median PFS was 13.0 months(95%Cl 12.2-13.8),the median OS was 16.0 months(95%CI 14.7-17.3),the rate of 1-year survival was 55.4%,the rate of 2-year survival was 22.8%,ORR was 41.3%,DCR was 99.8%.Based on the Cox proportional hazards model,considering the effects of KPS(?80 vs 60-80)and therapeutic effect(ORR vs Non-ORR)on PFS have a statistically significant difference(P=0.063,P=0.001),and also the effects on OS have a statistically significant difference(P=0.018,P=0.003).The most common adverse events were rash?diarrhoea and elevated tran saminase.A total of 156 advanced SCC and ADC with mutant EGFR were enrolled,78 SCC and 78 ADC.The median PFS for the SCC and ADC was 12.7 months(95%CI 10.4-15.0)and 15.8 months(95%CI 12.4-19.2)respectively.The median OS for the SCC and ADC was 18.5 months(95%CI 14.4-22.6)and 24.2 months(95%Cl undefined)respectively.The rate of 1-year survival was 53.8%and 61.5%respectively(P=0.297),the rate of 2-year survival was 26.7%and 30.9%respectively(P=0.191),ORR was 48.7%and 59.0%respectively(P=0.199).Subgroup analysis treatment line has an impact on PFS and OS statistically significant(P=0.024,P=0.018).ConclusionIcotinib could be a good treatment option for advanced lung SCC patients,which can prolong patients survival time.The objective response rate of icotinib in EGFR mutant advanced SCC and ADC patients has no statistically significant difference.