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F. Felizzi

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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-052 - Patient-Reported Outcomes (PROs) in OAK: A Phase III Study of Atezolizumab vs Docetaxel in Non-Small-Cell Lung Cancer (NSCLC) (ID 9903)

      09:30 - 16:00  |  Author(s): F. Felizzi

      • Abstract
      • Slides

      The phase III OAK study in NSCLC (NCT02008227) demonstrated prolonged overall survival with atezolizumab (an anti-programmed death-ligand 1 antibody) versus docetaxel (median 13.8 vs 9.6 months; HR:0.73, 95% CI 0.62–0.87; p=0.0003). PROs were collected to support documentation of clinical benefit. We report data regarding symptom burden, functioning, and health-related quality of life (HRQoL).

      Patients (n=850) with squamous/non-squamous, previously treated NSCLC, ≥18 years, with measurable disease (RECIST), and ECOG PS 0–1 were randomized to receive atezolizumab 1200mg or docetaxel 75mg/m[2] q3w. PROs were collected using two questionnaires: EORTC QLQ-C30 and its lung module, QLQ-LC13. Analyses included time-to-confirmed-deterioration (TTD) in lung cancer symptoms, physical and role function, HRQoL, longitudinal analyses of mean scores change from baseline to Cycles 5 and 6, proportion of patients with clinically meaningful worsening (≥10-point change from baseline) by Cycles 5 and 6.

      High completion rates were observed throughout treatment (>80% for most cycles). Atezolizumab delayed TTD in physical (HR:0.75, 95% CI 0.58–0.98) and role function (HR:0.79, 95% CI 0.62–1.00). Prolonged TTD in chest pain (HR:0.71, 95% CI 0.49–1.05) was observed with atezolizumab; no differences in TTD were seen for other lung cancer symptoms and HRQoL. Longitudinal analyses demonstrated average changes from baseline in favor of atezolizumab for lung cancer symptoms (Cycle 6: dyspnea, fatigue), domains of functioning (Cycle 6: physical function, social function), HRQoL (Cycle 5); see Table. Fewer atezolizumab-treated patients experienced clinically meaningful worsening in possible treatment-related symptoms during treatment (Cycle 6: diarrhea [OR:0.51, p<0.0001], sore mouth [OR:0.40, p<0.0001], dysphagia [OR:0.61; p=0.0052], peripheral neuropathy [OR:0.50, p<0.0001], alopecia [OR:0.02; p<0.0001]).

      In OAK, atezolizumab delayed the time until NSCLC patients experience limitations in physical and role functioning versus docetaxel. Patient-reported data indicate atezolizumab maintained/improved lung cancer symptom burden and HRQoL compared with baseline, while demonstrating improved tolerability, versus docetaxel.

      By Cycle 5 By Cycle 6
      LS means difference between treatment arms (average change from baseline) P value LS means difference between treatment arms (average change from baseline) P value
      EORTC QLQ-C30 Global Health Status and Function Scales (positive values indicate greater improvement with atezolizumab over docetaxel)
      Global Health Status 4.32* p=0.0151 3.08 p=0.1257
      Physical Function 3.33* p=0.0290 6.64* p<0.0001
      Role Function 2.93 p=0.1959 4.72 p=0.0542
      Emotional Function 2.66 p=0.1110 1.92 p=0.2868
      Cognitive Function -0.67 p=0.6790 -1.08 p=0.5309
      Social Function 3.25 p=0.1159 4.68* p=0.0319
      EORTC QLQ-C30 Symptom Scales (negative values indicate greater improvement with atezolizumab over docetaxel)
      Fatigue -6.27* p=0.0015 -7.66* p=0.0003
      Nausea/Vomiting -0.37 p=0.7824 -0.18 p=0.9040
      Pain 1.44 p=0.5132 -1.67 p=0.4727
      Dyspnea -4.70* p=0.0317 -5.92* p=0.0138
      Insomnia 3.50 p=0.1675 0.83 p=0.7564
      Appetite Loss -2.94 p=0.1994 -4.49 p=0.0586
      Constipation -0.31 p=0.8772 -0.33 p=0.8816
      Diarrhea -3.14* p=0.0482 -2.05 p=0.1748
      EORTC QLQ-LC13 Symptom Scales (negative values indicate greater improvement with atezolizumab over docetaxel)
      Dyspnea -1.66 p=0.3146 -4.80* p=0.0140
      Coughing -2.60 p=0.2572 -1.38 p=0.5772
      Sore Mouth -7.29* p<0.0001 -9.23* p<0.0001
      Dysphagia -0.08 p=0.9595 -2.01 p=0.1575
      Peripheral Neuropathy -12.98* p<0.0001 -15.71* p<0.0001
      Hemoptysis -0.24 p=0.7365 -0.91 p=0.2080
      Alopecia -50.59* p<0.0001 -47.04* p<0.0001
      Chest Pain -0.91 p=0.6064 -0.58 p=0.7779
      Arm/Shoulder Pain -2.27 p=0.3177 -0.58 p=0.8109
      Pain in Other Parts 0.94 p=0.7197 -1.05 p=0.7034
      *Values that are significantly in favor of atezolizumab versus docetaxel

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