Use of a Comprehensive Geriatric Assessment for the Management of Elderly Patients With Advanced Non Small Cell Lung Cancer: The Phase III Randomized ESOGIA GFPC GECP 08 02 Study.
PURPOSE Comprehensive geriatric assessment (CGA) is recommended to assess the vulnerability of elderly patients, but its integration in cancer treatment decision making has never been prospectively evaluated. Here, in elderly patients with advanced non small cell lung cancer (NSCLC) we compared a standard strategy of chemotherapy allocation on the basis of performance status (PS) and age with an experimental strategy on the basis of CGA. PATIENTS AND METHODS In a multicenter, open label, phase III trial, elderly patients 70 years old with a PS of 0 to 2 and stage IV NSCLC were randomly assigned between chemotherapy allocation on the basis of PS and age (standard arm: carboplatin based doublet if PS 1 and age 75 years; docetaxel if PS 2 or age 75 years) and treatment allocation on the basis of CGA (CGA arm: carboplatin based doublet for fit patients, docetaxel for vulnerable patients, and best supportive care for frail patients) The primary end point was treatment failure free survival (TFFS) Secondary end points were overall survival (OS) progression free survival, tolerability, and quality of life. RESULTS Four hundred ninety four patients were randomly assigned (standard arm, n 251; CGA arm, n 243) Median age was 77 years. In the standard and CGA arms, 35.1% and 45.7% of patients received a carboplatin based doublet, 64.9% and 31.3% received docetaxel, and 0% and 23.0% received best supportive care, respectively. In the standard and CGA arms, median TFFS times were 3.2 and 3.1 months, respectively (hazard ratio, 0.91; 95% CI, 0.76 to 1.1) and median OS times were 6.4 and 6.1 months, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.1) Patients in the CGA arm, compared with standard arm patients, experienced significantly less all grade toxicity (85.6% v 93.4% respectively P .015) and fewer treatment failures as a result of toxicity (4.8% v 11.8% respectively; P .007) CONCLUSION In elderly patients with advanced NSCLC, treatment allocation on the basis of CGA failed to improve the TFFS or OS but slightly reduced treatment toxicity.
Journal of clinical oncology official journal of the American Society of Clinical Oncology