Anamorelin, a ghrelin-receptor agonist, may significantly increase lean body mass in patients with non–small cell lung cancer (NSCLC) and cachexia, according to data published in the Lancet Oncology.1
Study author Jennifer Temel, MD, of Harvard Medical School and Massachusetts General Hospital Cancer Center in Boston, said the findings are good news, because there is little treatment available to help patients with cancer who suffer from cachexia.
“ROMANA 1 and 2 represent a significant, positive step both in bringing much needed attention to a debilitating and distressing symptom and in showing benefits in body mass, weight, and symptoms with anamorelin,” Dr Temel told Cancer Therapy Advisor.
Dr Temel and her team looked at data from 2 randomized, double-blind, phase 3 studies conducted at 93 sites in 10 countries. ROMANA 1 included 484 patients (323 received anamorelin and 161 received placebo), and ROMANA 2 included 495 patients (330 received anamorelin and 165 received placebo).
Over 12 weeks, lean body mass increased in patients assigned to anamorelin compared with those assigned to placebo. In ROMANA 1, the median increase was 0.99 kg compared with −0.47 for the placebo arm, and in ROMANA 2, the median increase was 0.65 kg compared with −0.98 kg for the placebo group.
The researchers also looked at handgrip strength but found no improvements with anamorelin compared with placebo. Preclinical and clinical studies have suggested anamorelin is associated with significant appetite-enhancing activity and resultant improvements in body weight, lean body mass, and handgrip strength compared with placebo.2
Anamorelin also was found to have minimal side effects. There were no differences in grade 3 to 4 treatment-related adverse events between the patients receiving this agent and those receiving placebo. The most common grade 3 to 4 adverse event was hyperglycemia. But there were notable grade 1 – 2 treatment-related adverse events.
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Leora Horn, MD, of the Vanderbilt-Ingram Cancer Center in Nashville, TN, said these patients often have comorbidities that must be considered.
“It is always good to have supportive care options to add to our armamentarium to improve the quality of life of our cancer patients,” Dr Horn told Cancer Therapy Advisor.