Effect of anamorelin on body weight in patients with gastric cancer-associated cachexia: an observational study.

[BACKGROUND] In 2021, anamorelin, a ghrelin receptor agonist, was approved in Japan for cancer cachexia in select cancers, including gastric cancer. However, evidence regarding its efficacy and predictive factors in patients with gastric cancer remains lacking.

[METHODS] This prospective observational study encompassed 229 patients with unresectable, advanced, or recurrent gastric cancer and cancer cachexia who received anamorelin from 2021 to 2023 at 25 institutions affiliated with Osaka University. Body weight change at 12 weeks was the primary endpoint. Appetite, food intake, treatment compliance, and adverse events comprised the secondary endpoints. Multivariable logistic regression analyses were employed for identifying weight gain predictors.

[RESULTS] Of the 229 patients (median age, 73 years), 126 completed the 12-week follow-up. The median anamorelin administration duration was 62 days. The mean weight significantly increased from baseline to 4, 8, and 12 weeks (up to + 0.88 kg, p < 0.001). Moreover, appetite and food intake improved. Multivariable analysis identified baseline body mass index (BMI) < 20 kg/m and neutrophil-to-lymphocyte ratio (NLR) < 4.0 as independent predictors of significant weight gain at 12 weeks. Treatment was generally well tolerated, with a 41% completion rate; 59% of the participants discontinued mainly owing to disease progression.

[CONCLUSION] In patients with gastric cancer-related cachexia, anamorelin was associated with significant increases in body weight and improvements in appetite. Lower BMI and lower systemic inflammation (NLR < 4.0) were predictive of better response.