Quality of life (QoL) analysis from ENSURE, a phase 3, open-label study of first-line erlotinib versus gemcitabine/cisplatin (gp) in Asian patients...
|Date||27 March 2014|
|Session||Proffered Papers 1 - Advanced disease with tageted agents|
|Topics|| Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
|Citation||Journal of Thoracic Oncology (2014) 9 (Supplement 9): S7-S52. 10.1097/JTO.0000000000000131|
Y. Wu1, C. Zhou2, G. Wu3, X. Liu4, Z. Zhong5, S. Lu6, M.C.L. Fernando7, C. Liam8, M. Chen9, Y. Zuo10
ENSURE, a randomised, phase 3 study, met its primary endpoint of improved progression-free survival (PFS) with erlotinib vs GP in Asian patients with EGFR mut+ NSCLC: interim analysis median PFS 11.0 vs 5.5 months (HR 0.34, 95% CI 0.22–0.51; p<0.0001); updated analysis median PFS 11.0 vs 5.5 months (HR 0.33, 95% CI 0.23–0.47). QoL is important in assessing treatment benefit, as it examines the balance between efficacy and tolerability. Here we present QoL data from ENSURE (updated data cut-off).
Patients ≥18 years with histologically confirmed stage IIIB/IV EGFR mut+ NSCLC were randomised 1:1 to erlotinib (oral; 150mg qd until progression/unacceptable toxicity) or GP (G 1250mg/m2 iv d1 & 8 q3w; P 75mg/m2 iv d1 q3w; ≤4 cycles). QoL was assessed every 6 weeks until week 25, then every 12 weeks until progression. The Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire was used, comprising subscales on physical, emotional, social and functional well-being, as well as the lung cancer subscale (LCS). These were used to calculate time to symptomatic progression (≥3-point decline in LCS score from baseline), time to deterioration in Trial Outcome Index (TOI; ≥6-point decline in LCS score plus physical and functional scores from baseline) and time to deterioration in QoL (≥6-point decline in TOI score plus social and emotional scores from baseline). Data cut-off was 19 November 2012.
FACT-L completion rates were 99% for erlotinib and 98% for GP at baseline, and 100% and 78%, respectively, at week 48. QoL results are shown in the Table.
Erlotinib was associated with improved QoL (FACT-L) compared with GP across all assessments, providing further support for the use of first-line erlotinib for Asian patients with EGFR mut+ NSCLC.
Y. Wu: Speaker fee from Roche, AstraZeneca, Eli Lilly, Sonofi, Pfizer M. Chen: M. Chen is an employee of Roche Product Development in Asia Pacific, China. Y. Zuo: Y. Zuo is an employee of Roche Product Development in Asia Pacific, China. All other authors have declared no conflicts of interest.