The protocol for both studies required that patients completed HR

The protocol for both studies required that patients completed HRQoL questionnaires in the

clinic using an electronic portable data capture tool before they were provided with any test results by their treating physicians or any other health professional. Assessment of tumour progression Hesperidin ic50 Tumour assessments were performed by CT or MRI. In LUX-Lung 1, tumour assessments were undertaken at baseline and every 4 weeks until week 12, and then every 8 weeks until disease progression by independent review. In LUX-Lung 3, tumour assessments were undertaken at baseline and every 6 weeks for the first 48 weeks and then every 12 weeks thereafter until disease progression by independent review or start of new anticancer therapy. RECIST criteria were used for independent review, which was conducted by a central imaging group that included radiologist and oncologist reviewers blinded to treatment assignments; investigators also assessed tumour progression based on radiological

and clinical assessment in both studies. In LUX-Lung 3, the primary end point was based on independent review. Independent review is regarded as the most conservative approach and is recommended in RECIST guidelines.18 19 Statistical analyses The statistical methods used in this analysis were prespecified. For the main analyses, randomised treatment

groups were combined in order to increase the numbers of patients available. Additional subgroup analyses were conducted to assess consistency of results between groups. To be included in analysis, patients had to have completed a baseline assessment and at least one measurement at the time of tumour progression or follow-up assessment. A HRQoL assessment was considered valid for inclusion in the statistical analysis if it occurred within ±7 days of the date of tumour assessment. In the event there was more than one HRQoL assessment, the one nearest the actual tumour assessment date was used. For patients who progressed, only the first HRQoL assessment was used; after that they were censored for future time points. In the longitudinal analysis, all HRQoL assessments at, or after progression, were used but were censored at the start of any new anticancer Brefeldin_A therapy. Assessments that were carried out after the start of other subsequent cancer treatment following progression were excluded. All analyses were conducted using data from independent review and investigator assessment of tumour progression. Statistical programming was carried out using S-Plus. Analysis of covariance The hypothesis for this analysis was that patients with and without progression at any time would have different average levels of QoL.

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