ESMO 2014: Novel Oral Agent Treats Cancer-Related Cachexia in Non–Small Cell Lung Cancer
For the first time, studies show that a drug is effective in treating cancer-related cachexia. Oral anamorelin hydrochloride increased lean body mass, achieved weight gain, and improved quality of life in patients with cancer-related cachexia in two pivotal phase III studies presented at the ESMO 2014 Congress in Madrid, Spain (Abstract 1483O_PR).
“Cachexia is one of the most troubling symptoms of cancer for patients and their families. This is a very exciting study. For the first time in more than a decade, a drug is effective in treating cachexia. This will significantly change how we think about cancer-related cachexia and how we treat patients with cancer,” said study coauthor David Currow, MD, of Flinders University, Adelaide, Australia.
Anamorelin is a first-in-class oral agonist at the ghrelin receptor agonist. Release of ghrelin stimulates multiple pathways that regulate body weight, lean body mass, appetite, and metabolism.
Patients with cancer-related cachexia keep losing weight and have no appetite. They are often too sick to get the cancer treatment that they need. A drug such as anamorelin may allow patients to be well enough to continue with their cancer treatment.
Phase III Studies
Dr. Currow presented results of ROMANA 1 and 2 at a press conference. These were identically-designed phase III studies that randomly assigned 495 patients with stage III and IV non–small lung cancer (NSCLC) and cachexia to receive either anamorelin or placebo in a 2:1 ratio. Cachexia was defined as 5% or greater weight loss within the past 6 months or body mass index < 20.
Both studies found that patients randomly assigned to placebo continued to lose weight and lean body mass over the 12-week study period, while those randomly assigned to anamorelin gained weight. The difference between the two groups was highly significant at weeks 3, 6, 9, and 12 (P < .0001 for all comparisons).
Further, quality of life as assessed by the FAACT Anorexia-Cachexia Domain, also showed a significant difference between the two treatment arms at all time points favoring anamorelin treatment over placebo.
“These are incredibly exciting results. The benefits are consistent. Up until now you couldn’t change lean body mass in patients with cancer-related cachexia. This therapy has the potential to affect cancer therapy across all treatment centers,” Dr. Currow said.
For full disclosures of the study authors, view the study abstract at www.esmo.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
