Evaluation of Association of Progression-Free Survival (Pfs) with Health-Related Quality of Life (Hrqol) in Lung Cancer Patients (Pts)

Abstract

ABSTRACT Aim: PFS is a common primary endpoint in oncology trials. However, there is limited evidence supporting a positive association between PFS extension and HRQoL improvement and whether PFS improvement translates into pt-relevant benefits. Methods: LUX-Lung 6 trial data comparing afatinib with cisplatin/gemcitabine in EGFR mutation-positive NSCLC pts were analysed to determine whether tumour progression is accompanied by worsening of HRQoL (prior to providing new tumour information to the pt). HRQoL was assessed by using the cancer-specific European Organization for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 (global health status [GHS]/QoL), the EuroQol EQ-5D UK utility and EuroQol EQ visual analogue scale (VAS). The relationship between tumour progression by investigator assessment (irrespective of treatment arm) and HRQoL was evaluated using analysis of covariance and a longitudinal model. Results: HRQoL questionnaire completion on study treatment was high (>85%). HRQoL was considerably poorer for pts with progression versus pts without progression at the same timepoint. Differences in mean scores from baseline to progression were shown independent of time of progression, but more pronounced for pts progressing more rapidly (Table). For all three HRQoL measures, results from the longitudinal analysis consistently showed that progression had a significant negative impact on HRQoL: for GHS/QoL (EORTC QLQ-C30) the effect of progression was –7.69 (95% CI –9.22, –6.17; p Effect of progression on HRQoL for GHS/QoL (EORTC QLQ-C30) Week Effect of progression (SE) p-value 6 –8.78 (4.41) 0.047 12 –11.84 (6.54) 0.071 18 –11.65 (4.24) 0.007 24 –12.02 (3.28) 30 –4.51 (3.98) 0.259 36 –3.31 (4.80) 0.491 42 0.18 (4.38) 0.968 48 –3.18 (4.70) 0.499 Conclusions: Tumour progression in EGFR mutation-positive NSCLC is associated with a statistically significant, clinically meaningful worsening in HRQoL at time of progression. These findings confirm those from previous analyses of afatinib and underline the value of PFS as a pt-relevant endpoint. Disclosure: M. Palmer: Stock ownership with AstraZeneca Corporate sponsored research for Boehringer Ingelheim, payment for statistical analyses; I. Griebsch: Other substantive relationships Employee of Boehringer Ingelheim GmbH; J. Lungershausen: Other substantive relationships Employee of Boehringer Ingelheim GmbH. All other authors have declared no conflicts of interest.