(QoL, quality of life) n, number of patients with progression by

(QoL, quality of life). n, number of patients with progression by independent review/ investigator assessment. Patients … Baseline HRQoL questionnaires were completed by 94% of patients in LUX-Lung 1 and 97% of patients in LUX-Lung 3.12 13 In both studies, compliance with questionnaire completion remained high (92–99%) at or after progression, in both treatment groups. c-Kit expression The mean number of assessments at or after progression in patients with at least one baseline assessment was 2.5 by independent review and 1.4 by investigator assessment. Results of ANCOVA The progression effects (PEs) over the treatment period

in LUX-Lung 1 (12 weeks) and LUX-Lung 3 (36 weeks), in terms of adjusted mean changes from baseline in EORTC Global Health/QoL, EQ-5D UK Utility and EQ VAS scores in patients with and without progression for independent review, are shown in figure 2. Figure 2 Progression effect and adjusted mean change from baseline for Global health status/QoL, EQ-5D utility and EQ VAS scores, by progression status in LUX-Lung 1 and LUX-Lung 3, independent review (QoL, quality of life; VAS, visual analogue scale). Progression … In LUX-Lung 1, patients with progression by independent review consistently experienced numerically poorer HRQoL at the time of progression than

patients without progression over the first 12 weeks of treatment. Mean scores differed significantly between patients with and without progression at week 4 for Global Health/QoL (PE: −8.5),

EQ-5D UK Utility (PE: −0.1) and EQ VAS scores (PE: −7.3; all p<0.05). Differences in mean change from baseline in VAS scores were also statistically significant (p<0.05) between patients who experienced progression by independent review and those who did not at week 8 (PE: −5.4). Results were similar for investigator assessment of progression (see online supplementary figure 1). In LUX-Lung 3, patients with progression by independent review consistently experienced poorer HRQoL progression than patients without progression. Differences in mean change from baseline in EORTC Global Health/QoL, EQ-5D UK Utility and EQ VAS scores were statistically significant between patients who experienced progression and those who did not at multiple time points in all assessments (figure 2). Results were similar for investigator assessment Entinostat of progression (see online supplementary figure 1). Interaction tests investigating the PE with each of baseline HRQoL and randomised treatment as well as with gender and ECOG score in LUX-Lung 1, and EGFR status and race in LUX-Lung 3 did not show any consistent trend. This indicates that these factors do not have a significant impact on the analyses and therefore supports the conclusion that the effects of progression on HRQoL that were identified by the ANCOVA models are consistent throughout the patient population.

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