91O - 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
Event ELCC 2014
Session Proffered Papers 1 - Advanced disease with tageted agents
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Supportive Care
Presenter Yi-Long Wu
Citation Journal of Thoracic Oncology (2014) 9 (Supplement 9): S7-S52. 10.1097/JTO.0000000000000131
Authors Y. Wu1, C. Zhou2, G. Wu3, X. Liu4, Z. Zhong5, S. Lu6, M.C.L. Fernando7, C. Liam8, M. Chen9, Y. Zuo10
  • 1Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 510080 - Guangzhou/CN
  • 2Department Of Oncology, Affiliated Shanghai Pulmonary Hospital of Tongji University, Shanghai/CN
  • 3Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan/CN
  • 4Department Of Lung Cancer, 307 Hospital of PLA, Beijing/CN
  • 5Cancer Centre, Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing/CN
  • 6Shanghai Lung Cancer Center, Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University, Shanghai/CN
  • 7Internal Medicine, Manila Doctors Hospital, Manila/PH
  • 8Department Of Medicine, University of Malaya, Kuala Lumpur/MY
  • 9Biostatistics, Roche Product Development in Asia Pacific, Shanghai/CN
  • 10Clinical Scientist, Roche Product Development in Asia Pacific, Shanghai/CN



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.