Treatment with anamorelin significantly increased lean body mass (LBM) and improved anorexia symptoms in patients with advanced non–small-cell lung cancer (NSCLC), according to a new study conducted in Japan.
“Cachexia is frequently observed in patients with cancer (50%–80%) and leads to approximately 20% of deaths among cancer patients,” wrote study authors led by Nobuyuki Katakami, MD, of the Institute of Biomedical Research and Innovation in Kobe, Japan. “Cancer cachexia cannot be completely reversed with conventional nutritional support, and there are limited pharmacological therapies useful for the management of cachexia.”
The researchers conducted a study of anamorelin, a selective agonist of the ghrelin receptor, in 174 stage III/IV unresectable NSCLC patients. They were randomized to either daily oral anamorelin (84 patients, two excluded from final analysis) or placebo (90 patients), administered for 12 weeks. More than half the patients (57.8% of placebo patients, 60.2% of anamorelin patients) had lost between 5% and 10% of their weight at baseline; 42.2% of placebo patients and 39.8%, respectively, had lost more than 10%. The results of the analysis were published online ahead of print in Cancer.
The anamorelin patients showed a significantly larger increase in LBM over 12 weeks, with a mean increase of 1.38 kg compared with –0.17 in the placebo group, for a difference of 1.56 kg (P < .0001). The difference in LBM gain was significant from week 3 and after.
There was also a significant difference in body weight, with a gain of 1.06 kg with anamorelin compared with a reduction of 0.50 kg with placebo (P < .0001). A measure of appetite was also increased more with the study drug than without (P = .0005). Other secondary endpoints including cancer fatigue, handgrip strength, and 6-minute walk distance were no different between the groups.
Anamorelin also yielded significantly bigger increases in biomarkers including serum insulin-like growth factor 1, insulin-like growth factor-binding protein 3, and prealbumin; these suggest improvements in skeletal muscle growth and overall nutritional status.
The frequency of adverse events was similar between the two groups, at 89.2% of anamorelin patients and 81.1% of placebo patients. There were more adverse drug reactions with anamorelin, but most were grade 3 or lower and the authors reported that the treatment was generally well tolerated. The overall survival of the two groups was similar.
“Because no effective treatment for cancer cachexia is currently available, anamorelin can be one of the beneficial treatment options,” the authors concluded.