Anorexia/cachexia occurs in patients with advanced NSCLC. In 2 randomized, double-blind, placebo-controlled phase 3 trials in cachectic NSCLC patients, the ghrelin receptor agonist anamorelin was well tolerated and significantly improved body composition parameters and anorexia/cachexia symptoms over 12 weeks (Temel JS et al, Lancet Oncol 2016). The mGPS (0–2) has independent prognostic value; patients with mGPS 2 have worse prognosis. This analysis determined anamorelin’s efficacy in cachectic NSCLC patients with mGPS 2 (C-reactive protein levels >10mg/L and albumin levels
Stage III/IV NSCLC patients with cachexia (BMI
Anamorelin treatment effect was statistically significantly better, compared with placebo, for all body composition parameters in all mGPS subgroups. This effect was numerically larger in patients with mGPS 2 and statistically significant, compared with placebo, for all analyzed parameters, except fatigue subscale score (Table). In patients with mGPS 2, the placebo-adjusted mean increase in body weight exceeded the 5% weight loss cutoff used as an official criterion for cancer cachexia diagnosis.Table:
|Treatment Effect of Anamorelin in patients with mGPS 2 (n = 123)|
|Mean||95% CI||P value, compared with placebo|
|Body weight, kg||3.07||1.47–4.68|
In cachectic NSCLC patients with mGPS 2, anamorelin leads to significant improvements in body composition parameters and symptom burden. The extent of weight improvement in this population suggests that treatment with anamorelin may on average reverse pathologic weight loss.
Clinical trial identification
ROMANA 1: NCT01387269 ROMANA 2: NCT01387282
Legal entity responsible for the study
S. Kaasa: Stock ownership: Eir solutions AS. B. Laird: Advisory board membership: Chugai Pharma. R. Skipworth: Corporate-sponsored research: Research grant/agreement with Novartis. D. Currow: Unpaid advisory board member for Helsinn. Paid consultant and receive payment for intellectual property with Mayne Pharma and consultant with Specialist Therapeutics Australia Pty. Ltd. R. Giorgino: Helsin Healthcare employee. All other authors have declared no conflicts of interest.