1246PQUALITY OF LIFE ANALYSIS OF ESOGIA-GFPC-GECP TRIAL- A PHASE III, RANDOMIZED, MULTICENTER STUDY COMPARING IN ELDERLY PATIENTS (≥70 YEARS) WITH STAGE IV NSCLC A TREATMENT ALLOCATION BASED ON PS AND AGE WITH AN EXPERIMENTAL STRATEGY ACCORDING TO A COMPREHENSIVE GERIATRIC ASSESSMENT (CGA)

Abstract Aim: The use of a CGA is recommended to detect a patient's vulnerability but its integration in treatment decision making has never been prospectively evaluated. Our main objective was to test if the use of CGA in the allocation of treatment could improve the management of advanced NSCLC in first line. Methods: Randomized, multicentric, prospective phase III study in patients ≥70 y, PS 0-2 with stage IV NSCLC. Arm A standard algorithm of chemotherapy allocation: carboplatin based doublet in PS ≤ 1 and age ≤75y, docetaxel in PS =2 or age >75y. Arm B treatment allocation based on CGA: carboplatin based doublet for fit patients, mono-therapy for vulnerable patients and BSC for frail patients. Four cycles were given every three weeks. Main endpoint: time to failure free survival (TFFS) Secondary endpoints: overall Response Rate (ORR), overall survival (OS), toxicity, QoL and life expectancy adjusted on QoL. QoL was assessed during treatment by EQ-5D health questionnaire at baseline, weeks 6, 12, 20, 28, and 36. A mixed-effects model was used, to compare the utility score and therefore the QOL between arms A and B. Results: 493 patients were randomized from 01/2010 to 01/2013 by 45 centers. Respectively in arms A and B, 34.4% and 47% of patients received a carboplatin-based doublet, 65.6% and 31.4% received docetaxel and in arm B 21.5% received BSC. Median TFFS was 3.2 m, 95%CI:[2.9; 4.1] for standard arm and 3.1 m, 95%CI:[2.7; 4.4] for experimental arm, p = 0.71. Compliance with QoL was 87% at baseline and respectively 66%, 65%, 54%, 60% and 57% at week 6, 12, 20, 28 and 36. The utility score at each evaluation is superior in the experimental arm than in the standard arm, but this difference is significant only at week 36 (p = 0.02). Using a linear mixed generalized model, the utility score tends to decrease over time and is not significantly different between the two arms (p = 0.85). Life expectancy adjusted on QoL was 130.1 days in standard arm and 133.3 days in experimental arm, p = 0.51. Conclusions: ESOGIA did not show a superiority of a CGA-based treatment allocation. In the experimental arm, more patients received a carboplatin-based doublet and 21% of frail patients received an exclusive BSC management. Despite a trend in favor of CGA arm, there is no significant difference in terms of QoL score and life expectancy adjusted on QoL. Further sudies are needed for GA in NSCLC elderly patients. Disclosure: C. Chouaid: advisory board LILLY; H. Lena