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K. Rüdell
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-080 - Analysis of Patient-Reported Symptom Response with Osimertinib (AZD9291) Treatment for Advanced Non-Small-Cell Lung Cancer (ID 4592)
14:30 - 14:30 | Author(s): K. Rüdell
- Abstract
Background:
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 tumour response status (OTRS).
Methods:
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.
Results:
Tables show the change in some symptoms overall/by OTRS. Table 1. Symptom change overall/by OTRS (AURA extension).
NR, non-responder; R, responder; w, weeks Table 2. Symptom change overall/by OTRS (AURA2).Least squares mean symptom scores (95% CI) 6w 12w 18w 24w Cough Total -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) Dyspnoea Total -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 pain Total -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, weeksLeast squares mean symptom scores (95% CI) 6w 12w 18w 24w Cough Total -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) R 13.61 (-17.13,-10.08) -12.98 (-16.58,-9.39) -14.97 (-18.61,-11.32) -12.78 (-16.51,-9.05) Dyspnoea Total -3.99 (-6.18,-1.80) -5.31 (-7.55,-3.07) -4.73 (-7.03,-2.44) -4.23 (-6.60,-1.87) NR 1.35 (-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 pain Total -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) R 9.68 (-12.59,-6.78) -9.91 (-12.87,-6.95) -8.29 (-11.29,-5.30) -7.55 (-10.60,-4.49)
Conclusion:
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.
