A multicenter, open‐label, single‐arm study of anamorelin (ONO‐7643) in patients with cancer cachexia and low body mass index

作者：Tateaki Naito, Junji Uchino, Toru Kojima, Yutaka Matano, Koichi Minato, Kentaro Tanaka, Takuro Mizukami, Shinji Atagi, Takashi Higashiguchi, Kei Muro, Koichi Takayama, Junji Furuse, Eiichiro Morishima, Toru Takiguchi, Kazuo Tamura · 发表于：Cancer · 年份：2022 · DOI：10.1002/cncr.34154 · 被引用次数：46 · 研究领域：Nutrition and Health in Aging、Regulation of Appetite and Obesity、Muscle Physiology and Disorders

BACKGROUND: Cancer cachexia is a syndrome characterized by anorexia and decreased body weight. This study evaluated the efficacy and safety of anamorelin, an orally active, selective ghrelin receptor agonist, in patients with cancer cachexia and a low body mass index (BMI). METHODS: , involuntary weight loss > 2% in the last 6 months, and anorexia). Patients were administered 100 mg of anamorelin once daily for up to 24 weeks. The primary end point was a composite clinical response (CCR) at 9 weeks, which was defined as an increase in body weight of ≥5% from the baseline, an increase of ≥2 points in the score of the 5-item Anorexia Symptom Scale of the Functional Assessment of Anorexia/Cachexia Therapy, and being alive. RESULTS: , respectively. The CCR rate at 9 weeks was 25.9% (95% confidence interval [CI], 18.3%-35.3%), which met the primary end point with a lower 95% CI exceeding the prespecified minimum of 8%. Improvements in body weight and anorexia were durable and were accompanied by improvements in patients' global impression of change for appetite/eating-related symptoms and overall condition. Adverse drug reactions occurred in 37 of 101 treated patients (36.6%), with the most common being glycosylated hemoglobin increases, constipation, and peripheral edema. CONCLUSIONS: Anamorelin improved body weight and anorexia-related symptoms in patients with cancer cachexia and a low BMI with durable efficacy and favorable safety and tolerability. LAY SUMMARY: Anamorelin is a...