A multicenter, open‐label, single‐arm study of anamorelin (ONO‐7643) in advanced gastrointestinal cancer patients with cancer cachexia

Abstract

Background Cancer cachexia is characterized by weight loss and is associated with increased morbidity and mortality in patients with cancer. Anamorelin (ONO‐7643; ANAM) is a novel and selective ghrelin receptor agonist that improves appetite, lean body mass (LBM), body weight, and anorexia. Methods This multicenter, open‐label, single‐arm study investigated the efficacy and safety of 100 mg anamorelin in 50 Japanese patients with advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer. ANAM was administered once daily over 12 weeks. The primary endpoint was the proportion of patients that maintained or gained LBM over the course of the study. Secondary endpoints included changes in LBM, body weight, quality of life (QoL), and nutritional status biomarkers. Results The proportion of patients who responded to treatment was 63.3% (95% CI, 48.3%‐76.6%), with a least square mean ± SE change in LBM and body weight from baseline of 1.89 ± 0.36 kg and 1.41 ± 0.61 kg, respectively. Appetite‐related questions on the QoL questionnaire showed that ANAM improved appetite. Adverse events occurred in 79.6% of patients, and the most common treatment‐related adverse events were increased γ‐glutamyl transpeptidase (8.2%), diabetes mellitus (6.1%), hyperglycemia (6.1%), and prolonged QRS complex (6.1%). Conclusions ANAM improved anorexia and patients' nutritional status, resulting in rapid increases in LBM and body weight in patients with advanced gastrointestinal cancer who had cancer cachexia. ANAM treatment was well tolerated over 12 weeks. ANAM is a potential clinically beneficial pharmacotherapeutic option for patients with advanced gastrointestinal cancer who have cancer cachexia.

<p>Emerging Treatment Options For Cancer-Associated Cachexia: A Literature Review</p>

“…Moreover, the alleviating effect of anamorelin on cachexia-related anorexia was maintained throughout the treatment period. Recently, anamorelin was further evaluated in patients with advanced gastrointestinal cancer and cachexia in a non-randomized single-arm study 51. This study also showed a positive effect of anamorelin on LBM, body weight, and anorexia that was comparable to the aforementioned data in patients with lung cancer.…”

“…HGS, 6MWD, FatigueAtrioventricular block, rashHamauchi et al, Cancer. 20195150Advanced gastrointestinal cancer in Japanese (Cachexia)Not specified or combinedAnamorelin (12 weeks)Single-arm study with pre-post comparison1. LBM, BW, Appetite2.…”

Achieving sequential therapy in advanced gastric cancer: the importance of appropriate patient management for the elderly and/or those with ascites

“…1b). To this end, the ghrelin receptor agonist anamorelin has been investigated in Japanese patients with advanced gastrointestinal cancer with cachexia, resulting in gains in lean body mass and body weight [78].…”

A Retrospective Cohort Study to Investigate the Incidence of Cachexia During Chemotherapy in Patients with Colorectal Cancer

“…In advanced colorectal cancer, on the other hand, few reports have investigated the prevalence and onset of cancer cachexia based on EPCRC criteria in patients after starting chemotherapy, whereas incidences of cancer cachexia before chemotherapy or during palliative care, and the correlations between cancer cachexia before chemotherapy and prognosis, toxicity, and QOL have been reported previously [13][14][15][16][17][18][19].…”