1268P - Evaluation of association of progression-free survival (PFS) with health-related quality of life (HRQoL) in lung cancer patients (pts)

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Supportive Care
Non-Small-Cell Lung Cancer, Metastatic
Presenter Yi-Long Wu
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors Y. Wu1, M. Palmer2, S. Ellis3, I. Griebsch4, J. Lungershausen5
  • 1Medical Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 510080 - Guangzhou/CN
  • 2Medical Oncology, Keele University, Keele/GB
  • 3Statistics, Independent Statistical Consultant, Cheadle Hulme/GB
  • 4Medical Oncology, Boehringer Ingelheim GmbH, Ingelheim/DE
  • 5Health Economics, Boehringer Ingelheim GmbH, Ingelheim/DE

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 < 0.0001); for EQ-5D UK utility –0.11 (95% CI –0.13, –0.09; p < 0.0001); and for EQ VAS –5.66 (95% CI –6.70, –4.63; p < 0.0001).

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) <0.001
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.