Improving Anorexia-Cachexia in Non-small Cell Lung Cancer
Cachexia is a common side effect of advanced cancer
Anamorelin effectively relieves anorexia-cachexia in patients with advanced non-small cell lung cancer (NSCLC), according to a study published in Palliative Care: Research and Treatment.
Cachexia is a commonly reported syndrome in patients with advanced cancer and presents as weight loss, anorexia, muscle breakdown, and is associated with poor prognoses in patients. Previous studies have demonstrated that anamorelin, an analogue of the satiety hormone ghrelin, may improve cachexia symptoms.
In this study, data from three phase 2 studies and two phase 3 studies are presented.
In a phase 2, blinded, crossover study, 16 patients were randomly assigned to anamorelin 50 mg once daily or placebo for 3 days. After a 3 to 7 day washout period, the patients switched arms. Body weight increased by 0.77 kg in patients receiving anamorelin, whereas a 0.33-kg loss was seen in patients receiving placebo (P =.016).
In a second phase 2 study, this one a 3-day crossover design study, 82 patients with various solid tumors randomly received anamorelin or placebo. Patients in the anamorelin group and placebo group experienced a weight change of 1.89±0.53 kg and –0.20±0.52 kg, respectively (P =.0006).
In the final presented phase 2 study, researchers enrolled 226 patients to receive anamorelin 50 mg, anamorelin 100 mg, or placebo. Patients who received anamorelin 100 mg gained 0.14 kg, while weight changes in patients receiving anamorelin 50 mg or placebo were –0.3 kg and –1.32 kg, respectively. The average difference seen in patients receiving anamorelin 100 mg vs 50 mg was 1.47 kg (P =.0005).
Among the phase 3 trials, the ROMANA 1 study (ClinicalTrials.gov Identifier: NCT01387269) enrolled 484 patients with stage III/IV NSCLC presenting with cachexia and randomly assign them 2:1 to receive anamorelin 100 mg or placebo. Patients in the anamorelin groups gained an average of 1.10 kg in body mass vs a 0.44 kg loss in the placebo group. Body weight increased by 2.2 kg in the anamorelin arm vs 0.14 kg in the placebo arm. Appetite was significantly improved in all patients, but grip strength increased in male patients only.
In the second phase 3 trial, the ROMANA 2 trial (ClinicalTrials.gov Identifier: NCT01387282), 495 patients with advanced NSCLC experienced similar benefits. Patients receiving anamorelin gained an average of 0.95 kg vs an average loss of 0.57 kg in the placebo group. Again, a significant increase was noted in appetite, but not in grip strength.
Frequently occurring adverse events included hyperglycemia and nausea, but anamorelin demonstrated a consistent and favorable safety profile throughout the studies presented.
These investigators conclude that anamorelin “represents a new option for the management of cancer anorexia-cachexia.”
Prommer E. Oncology update: anamorelin [published online August 21, 2017]. Palliat Care Res Treat. doi: 10.1177/1178224217726336