Radiotherapy Combined With Iressa For Patients With Locally Advanced Non-small Cell Lung Cancer Who Couldn't Receive Surgery And Concurrent Chemoradiotherapy:the Preliminary Results Of A Phase ? Clinical Trial

Purpose:To study the response rate,survival and safety of radiotherapy combined Irassa for patients with locally advanced non-small cell lung cancer(NSCLC)who couldn't receive surgery and concurrent chemoradiotherapyMaterials and Methods:The patients with the locally advanced NSCLC who couldn't receive surgery and concurrent chemoradiotherapy,received thoracic intensity modulated radiothetapy(IMRT)combined with Iressa 250mg daily in Dpartment of Radiation Onco-logy,National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences.Results:A total of 30 patients were registered between July 2014 and March 2017.Twenty-nine patients were analyzed.The response rates included partial response(PR)21(72.4%),stable disease(SD)6(20.7%),progressive disease(PD)2(6.9%).The treatment response rate(CR+PR+SD)was 93.1%.and the objective effective rate was 72.4%.And the response rate included PR 15(53.6%).SD 6(21.4%).PD 7(25%).The treatment response rate was 75%,and the objective effective rate was 53.6%three months later.The last follow-up time was May 15,2017,the median follow-up time was 18 months.Eight(27.6%)patients were dead,and twenty-one(72.4%)alive.The disease progression showed in 20(68.9%)patients.including local progression in 16(55.2%)and distant metastasis in 8(27.6%).The median survival time(MST)was not reached,the median PFS was 11 months.The one-year OS and PFS were 83.9%and 44.5%,the two-year OS and PFS were 66.7%and 21.4%.Unvariable analysis showed that disease stage.the primary tumor diameter and the volume of the PTV were influencing factors.Multivariable analysis showed that disease stage and the volume of the PTV were independent prognostic factors for PFS.Patients with stage IIIB disease had better OS and PFS than stage III A disease.No grade 4 acute adverse events were observed,and two patients developed grade 3 acute irradiation esophagitis,two patients grade 2 acute irradiation pneumonits,no grade 3 acute irradiation pneumonits.Conclusions:For patients with locally advanced NSCLC who couldn't receive surgery and concurrent chemoradiotherapy,IMRT combined with Irassa reached acceptable response rates and was well tolerated.The further effect needs observation.