Evaluation of quality of life from a phase II study of anamorelin HCl in NSCLC patients.

42 Background: Anamorelin HCl (ANA) is an oral ghrelin receptor agonist in development for non-small cell lung cancer (NSCLC)-associated anorexia/cachexia. Cancer cachexia is a multifactorial syndrome, characterized by decreased body weight and muscle, and worsened survival and quality of life (QoL). Here we present Phase II data, including an evaluation of QoL using the MD Anderson Symptom Inventory (MDASI) to assess severity of core symptoms in cancer patients and their impact on daily life. Methods: An international, randomized, double-blind, placebo-controlled, 12-week Phase II trial (NCT00622193) enrolled 226 Stage IIIB/IV NSCLC patients (N=76 for 50 mg ANA; N=73 for 100 mg ANA; N=77 for placebo [PL]). Co-primary endpoints were body weight and handgrip strength (HGS); safety was also assessed. QoL by MDASI was a secondary endpoint; a negative change in MDASI score represents improvement. Assessments were performed at baseline and approximately every 3 weeks over the 12-week treatment period. Results:...