The Potential Role of Anamorelin

The Oncology Nurse–APN/PA conducted an interview with Jennifer Temel, MD. The written interview is based on a presentation at the 2015 Annual Meeting of the American Society of Clinical Oncology, Phase III Trials for Anamorelin in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Cachexia (ROMANA 1 and 2).

How does unintended weight loss due to anorexia/cachexia affect patients with late-stage cancers?
Cancer anorexia/cachexia is characterized by decreased appetite, low food intake, and unintended weight loss. The symptoms significantly impact patients’ physical functioning as they feel more weak and tired. Importantly, these symptoms also negatively affect patients’ cancer outcomes, as patients with anorexia/cachexia do not tolerate chemotherapy as well as patients without these symptoms.

How is unintended weight loss currently being treated in patients with advanced cancer? Is it effective?
Unfortunately, treatment options are quite limited at this time. There are medications that increase appetite and food intake, which is half the battle. However, these medications do not significantly impact loss of weight through decreased muscle mass, which is a key part of the morbidity of cancer anorexia/cachexia. Additionally, these medications currently being used have potentially serious side effects, including thromboembolic events and adrenal insufficiency.

What have researchers and oncologists done to confront this unmet medical need?
Overall, research on treatments for cancer anorexia/cachexia has been limited. For example, there has been significantly more attention and research on treatments for symptoms such as pain and nausea/vomiting. This is quite unfortunate as cancer anorexia/cachexia are devastating symptoms and a large source of morbidity and mortality in patients with advanced cancer.

What were the purposes of the ROMANA 1 and 2 trials and how were they conducted?
The purposes of ROMANA 1 and 2 were to evaluate the effect of anamorelin on lean body mass, handgrip strength, body weight, and symptom burden in patients with advanced non–small cell lung cancer and unintended weight loss.

What do the results suggest about the potential role of anamorelin in supportive care?
ROMANA 1 and 2 demonstrated that patients assigned to anamorelin experienced increases in lean body mass and body weight and decreases in their symptom burden. These are incredibly exciting results and a much needed breakthrough in the management of these troubling symptoms. Patients assigned to anamorelin did not experience improvements in their handgrip strength, which was a disappointing result. However, other studies of medications to treat cancer anorexia/cachexia have had similar results, suggesting that handgrip strength may not be a sound measure in patients with advanced cancer. Importantly, anamorelin was well tolerated and patients did not experience significant side effects while taking it.

What are the next steps for the use of anamorelin?
I very much hope that the US and European regulatory agencies are considering approval for anamorelin. Both the oncology community and our patients are desperate to have a treatment option for this common and devastating condition.