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C. Bodnar
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-021 - Comparing T790M Identification across Testing Strategies in Advanced EGFR NSCLC: A Diagnostic Outcomes and Cost Analysis (ID 4752)
14:30 - 14:30 | Author(s): C. Bodnar
- Abstract
Background:
T790M is an acquired mutation in patients (pts) with advanced non-small cell lung cancer (aNSCLC) treated with an EGFR TKI. The tumours of approximately 60% pts treated with an EGFR TKI harbour the T790M mutation upon disease progression. With the launch of treatments targeting T790M in EGFR aNSCLC it is important to identify pts with T790M who will benefit from such therapy. However not all pts are able to undergo tissue biopsy for testing and the advent of ctDNA testing via plasma sample may increase the number of pts with access to a T790M test. This analysis assesses outcomes and costs of different diagnostic testing strategies for T790M in aNSCLC post-EGFR TKI.
Methods:
Estimates of T790M mutation prevalence and test performance were applied to a hypothetical cohort of 100 pts. Outcomes were number of true positive / true negative (TP / TN) samples and associated testing costs. The following testing strategies were assessed: i) tissue test only ii) plasma followed by tissue for pts who tested negative using plasma or, iii) both tissue and plasma tests concurrently. Total costs were also estimated for the sample procedure (biopsy or plasma extraction), laboratory testing, and biopsy adverse events (5% rate).
Results:
In sequence or concurrent testing (strategies ii & iii) produced the highest number of TP results (n=57) followed by tissue test alone (n=53). Tissue & plasma concurrently (iii) was associated with the highest total costs followed by tissue test only (i) and the lowest cost plasma followed by tissue for pts who tested negative (ii).
Conclusion:
To maximise identification of T790M, and hence the most pts who would benefit from targeted therapy, access to both plasma and tissue testing is advantageous. Plasma followed by tissue for pts who tested negative may also be a cost minimising option for healthcare systems compared to tissue testing alone.
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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): C. Bodnar
- 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.
