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N. Karaseva

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    Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)

    • Event: ELCC 2018
    • Type: Poster Discussion session
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    • Presentations: 1
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      139PD - Patient-reported outcomes from FLAURA: Osimertinib versus standard of care (SoC) epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) (ID 396)

      07:45 - 09:00  |  Author(s): N. Karaseva

      • Abstract
      • Slides

      In the phase 3 FLAURA trial (N = 556), osimertinib demonstrated superior efficacy to SoC EGFR-TKI as first-line treatment of EGFR mutation-positive advanced NSCLC.[1]

      Patients in FLAURA completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (QLQ-C30) at baseline and then every 6 weeks, and Lung Cancer 13 items (QLQ-LC13) at baseline, then weekly for 6 weeks followed by every 3 weeks. Scores range from 0 to 100; higher scores represent greater symptom burden. A ≥10-point difference is considered clinically relevant. Pre-specified key symptoms were cough, dyspnoea, chest pain, appetite loss and fatigue.

      Compliance with completing the questionnaire was ≥60% at all time points in both treatment arms. Baseline mean scores were similar in the osimertinib and SoC arms for cough (32.8 vs 33.5), dyspnoea (22.5 vs 25.0), chest pain (19.5 vs 20.8), appetite loss (22.7 vs 25.6) and fatigue (32.2 vs 35.8). Key symptoms improved in both arms from baseline over the first 9 months, with no significant differences in least-squares mean changes between the osimertinib and SoC arm (Table). Improvements in cough were seen from week 1 and were maintained throughout the first 9 months in both arms. QLQ-C30 functional and global health/quality of life scores improved from baseline in both arms, with no clinically relevant differences. Additional analyses are ongoing, including statistical significance testing and time to deterioration.Table:Change from baseline over 9 months in key patient-reported symptoms

      SymptomTreatmentnAdjusted least-squares mean (95% CI)Estimated treatment difference (95% CI)
      CoughOsimertinib248–11.0 (–12.8, –9.2)0.7 (–1.9, 3.2)
      SoC252–11.7 (–13.5, –9.8)
      DyspnoeaOsimertinib248–4.0 (–5.6, –2.5)0.1 (–2.2, 2.4)
      SoC252–4.1 (–5.7, –2.5)
      Chest painOsimertinib248–6.6 (–8.2, –5.0)–0.2 (–2.5, 2.1)
      SoC252–6.4 (–8.0, –4.8)
      Appetite lossOsimertinib252–6.2 (–8.4, –3.9)–0.5 (–3.7, 2.7)
      SoC247–5.6 (–8.0, –3.3)
      FatigueOsimertinib252–5.5 (–7.5, –3.5)–0.8 (–3.6, 2.1)
      SoC247–4.7 (–6.7, –2.7)
      Adjusted mean and estimated treatment differences obtained from a mixed-effects model for repeated measures. Model included patient (as a random effect), treatment, visit (as fixed effect and repeated measure), and treatment-by-visit interaction as explanatory variables, and the baseline symptom score as a covariate along with the baseline symptom score by visit interaction. The covariance structure for repeated measurements within the same patient was specified as unstructured. CI, confidence interval.

      Key patient-reported symptoms in the FLAURA trial improved in both treatment arms from baseline over 9 months. Improvements in cough in the two arms were clinically relevant. [1]Soria JC et al. N Engl J Med doi: 10.1056/NEJMoa1713137.

      Clinical trial identification:

      Legal entity responsible for the study:


      N. Leighl: Research funding to University Health Network in 2015 - unrelated. Honoraria for unrelated CME from: BMS, AZ, Pfizer, Roche. K. Nakagawa: MSD K.K., A2 Healthcare Corp., in Ventiv Health Japan, Astellas Pharma Inc., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., AbbVie Inc., Quintiles Inc., Icon Japan K.K., Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., EP-CRSU Co., Ltd., Gritstone Oncology. Inc, Linical Co., Ltd., Eli Lilly Japan K.K., Eisai Co., Ltd., Bristol Myers Squibb Company, Taiho Pharmaceutical Co., Ltd., PAREXEL International Corp., Ono Pharmaceutical Co., Ltd. for Research Funding AstraZeneca K.K., Nichi-Iko Pharmaceutical Co., Ltd., Astellas Pharma Inc. Clinical Trial Co., Ltd, MSD K.K., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb Company, Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K., Novartis Pharma K.K., SymBio Pharmaceuticals Limited., Pfizer Japan Inc. for Honoraria Astellas Pharma Inc., Ono Pharmaceutical Co., Ltd. for Consulting or advisor role. J.E. Gray: Advisor to Astra Zeneca. T. Hovey: Working as a consultant (Phastar Statistician) for AstraZeneca. A. Walding: Employee and shareholder of AstraZeneca R&D. A. Rydén: Employee of AstraZeneca and has AstraZeneca stocks. S. Novello: Speaker bureau: Eli Lilly, AZ, BMS, MSD, Roche. All other authors have declared no conflicts of interest.

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