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Background: Survival in patients who relapse after first-line chemotherapy(CT)for advanced esophago-gastric adenocarcinoma(EGC)is poor though recently randomised trials(RCT)have suggested a small benefit for second line chemotherapy with taxanes or irinotecan.There is very little data on health related quality of life(HRQL)or overall survival(OS),particularly in patients who progress shortly after first-line therapy.Methods: COUGAR-02 was a multicentre open-label,phase Ⅲ RCT for patients with locally advanced or metastatic EGC of performance status(PS)0-2 who had progressed within 6 months of previous platinum/fluoropyrimidine CT.Patients were randomised(1:1)to receive either docetaxel 75mg/m2every 3 weeks for up to 6 cycles or active symptom control(ASC).The primary endpoint was OS.The secondary endpoint of HRQL,assessed using EORTC QLQ-C30 and QLQ-ST022,was analysed using standardised area under a curve and compared using Wilcoxon rank sum test.Sensitivity analysis adjusting for dropouts due to death were performed using quality adjusted survival.Results: 168 patients(84 patients in each arm)were recruited between April 2008 and April 2012.Median age was 65 years(range 28-84); 81%were males.PS at randomisation was 0 for 27%,1 for 57%and 2 for 15%.86%had metastatic disease.43%progressed during previous CT,28%progressed within 3 months of end of previous CT and 29%progressed between 3 and 6 months.Median number of cycles of docetaxel was 3.23%completed 6 cycles.Docetaxel was well tolerated and resulted in a significantly improved OS over ASC alone(HR=0.67(95%CI 0.49-0.92); p=0.01).Objective response rate was 7%.For QLQ-C30,patients on docetaxel arm reported significantly less pain(p=0.0008)and trend for less nausea and vomiting(p=0.02)and constipation(p=0.02)than those on ASC arm.Similar global HRQL seen(p=0.53).For QLQ-ST022,trend seen for less dysphagia(p=0.02)and pain symptoms(p=0.01)for patients on docetaxel arm than ASC Conclusions: Docetaxel provided a significant OS benefit over ASC with improvements in symptom scores and no loss in overall HRQL.Docetaxel can be considered a standard of care in this setting.