P3.02b-080 Analysis of Patient-Reported Symptom Response with Osimertinib (AZD9291) Treatment for Advanced Non-Small-Cell Lung Cancer: Topic: EGFR Clinical

Abstract

We evaluated whether self-reported symptoms significantly improved in advanced non-small-cell lung cancer patients receiving osimertinib 80mg once-daily and the effect of adjusting by objective tumor response status (OTRS). In phase II trials (AURA extension, N=201, NCT01802632 and AURA2, N=210, NCT02094261) patients completed the European Organisation for Research and Treatment of Cancer QLQ-LC13. In AURA extension paper-based questionnaires were used every 6 weeks until treatment discontinuation; in AURA2 data were collected electronically weekly for 6 weeks, then every 3 weeks until death. Statistical analyses determined the change from baseline in selected symptoms overall/by OTRS. Least squares means (95% CIs) were calculated using linear mixed models for repeated measures. Tables show the change in some symptoms overall/by OTRS.Table 1Symptom change overall/by OTRS (AURA extension)Least squares mean symptom scores (95% CI)Cough6w12w18w24wTotal-13.76 (-16.27,-11.26)-11.56 (-14.46,-8.67)-12.12 (-15.12,-9.12)-8.65 (-11.88,-5.42)NR-12.74 (-16.97,-8.51)-8.24 (-13.22,-3.27)-8.06 (-13.58,-2.54)-10.47 (-16.91,-4.04)R-13.73 (-16.84,-10.62)-12.63 (-16.19,-9.08)-13.65 (-17.27,-10.02)-7.81 (-11.59,-4.04)DyspnoeaTotal-8.14 (-10.08,-6.21)-8.87 (-10.75,-7.00)-8.40 (-10.25,-6.56)-5.95 (-8.06,-3.83)NR-7.33 (-10.63,-4.03)-6.10 (-9.32,-2.88)-7.06 (-10.47,-3.64)-3.39 (-7.58,0.80)R-8.58 (-10.99,-6.16)-10.27 (-12.56,-7.98)-8.89 (-11.10,-6.67)-6.91 (-9.40,-4.42)Chest painTotal-10.36 (-12.63,-8.09)-8.56 (-11.17,-5.95)-9.76 (-11.99,-7.53)-9.21(-11.79,-6.63)NR-10.45 (-14.33,-6.57)-7.12 (-11.65,-2.58)-7.81 (-12.02,-3.61)-3.81 (-9.02,1.39)R-10.56 (-13.41,-7.71)-9.46 (-12.70,-6.22)-10.76 (-13.46,-8.06)-11.15 (-14.16,-8.13)NR, non-responder; R, responder; w, weeks. Open table in a new tab Table 2Symptom change overall/by OTRS (AURA2)Least squares mean symptom scores (95% CI)Cough6w12w18w24wTotal-11.52 (-14.51,-8.53)-10.55 (-13.63,-7.48)-12.06 (-15.22,-8.89)-10.91 (-14.19,-7.63)NR-7.33 (-13.25,-1.42)-3.89 (-10.22,2.45)-1.36 (-8.21,5.50)-1.39 (-9.03,6.26)R13.61 (-17.13,-10.08)-12.98 (-16.58,-9.39)-14.97 (-18.61,-11.32)-12.78 (-16.51,-9.05)DyspnoeaTotal-3.99 (-6.18,-1.80)-5.31 (-7.55,-3.07)-4.73 (-7.03,-2.44)-4.23 (-6.60,-1.87)NR1.35 (-2.94,5.65)2.55 (-1.99,7.10)-0.37 (-5.23,4.49)-2.29 (-7.65,3.08)R-5.56 (-8.14,-2.98)-7.52 (-10.14,-4.90)-5.85 (-8.50,-3.20)-4.89 (-7.59,-2.18)Chest painTotal-8.12 (-10.64,-5.60)-7.55 (-10.13,-4.98)-5.97 (-8.61,-3.34)-4.82 (-7.55,-2.10)NR-3.27 (-8.12,1.59)0.09 (-5.06,5.23)4.13 (-1.39,9.65)5.29 (-0.84,11.42)R9.68 (-12.59,-6.78)-9.91 (-12.87,-6.95)-8.29 (-11.29,-5.30)-7.55 (-10.60,-4.49)NR, non-responder; R, responder; w, weeks. Open table in a new tab NR, non-responder; R, responder; w, weeks. NR, non-responder; R, responder; w, weeks. Overall, a significant reduction in symptoms was observed for 6 months with osimertinib treatment, with improvement observed as early as 6 weeks. Patients with OTRS had greater symptom improvement, although this was more apparent in AURA2 than in AURA extension over time. This difference may be explained by symptom collection post-progression in the later trial, AURA2.