A direct comparison of HRQoL in patients who are considered progression-free with those patients who experience tumour growth is often limited. Several investigators have assessed the relationship between HRQoL and tumour response in patients with breast, mTOR activity colorectal and renal cell cancer,7–10 and suggest that patients who remain on treatment and who experience delayed progression have a stable HRQoL or experience a less rapid decline
in HRQoL than patients whose tumours are progressing. To the best of our knowledge, no data have been reported in non-small cell lung cancer (NSCLC). Two RCTs investigated the role of afatinib, an irreversible ErbB Family Blocker, in NSCLC and included assessment of patient-reported symptoms and HRQoL in addition to tumour progression: LUX-Lung 1 (NCT00656136)11 12 and LUX-Lung 3 (NCT00949650).13 14 The analyses reported here use data collected in these trials to investigate HRQoL in patients before and after progression, and to explore the relationship between tumour progression and HRQoL. Two different statistical analysis methods were used in order to assess the strength of the findings. Patients and methods Study design This analysis used data from two RCTs.12 14 Key details of the methodology and findings of these trials are summarised in table 1. Table 1 Summary of trial
design and results of LUX-Lung 111 12 and LUX-Lung 313 14 Health-related quality of life assessment HRQoL was assessed using the self-administered cancer-specific European Organization for Research and Treatment of Cancer (EORTC) multidimensional core questionnaire QLQ-C30.15 QLQ-C30 comprises of 30 questions of multi-item and single-item measures. Individual
items are scored on a four-point scale, while Global health status (question 29) and quality of life (QoL, question 30) are scored on a seven-point scale. For the purpose of this analysis, the QLQ-C30 Global health status/QoL (composite of QLQ-C30 questions 29 and 30) score was used to evaluate patients’ overall self-reported HRQoL. The EuroQol disease-generic questionnaire, comprising the EQ-5D overall utility and EQ-visual analogue scale (VAS),16 Cilengitide was used to assess health status. The EQ-5D measures five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Utility scores range from 0 to 1 and were calculated from the five EQ-5D item scores using the UK valuation algorithm.17 The EQ VAS records the patient’s self-rated health status on a vertical graduated (0–100) VAS. In LUX-Lung 1, HRQoL questionnaires were scheduled at randomisation, two weekly during the first 2 months of treatment and then every 4 weeks. In LUX-Lung 3, HRQoL was assessed at randomisation and every 21 days. For chemotherapy patients, this was on day 1 of each cycle and was delayed if the chemotherapy was delayed.