Takayama Koichi, Katakami Nobuyuki, Yokoyama Takuma, Atagi Shinji, Yoshimori Kozo, Kagamu Hiroshi, Saito Hiroshi, Takiguchi Yuichi, Aoe Keisuke, Koyama Akira, Komura Naoyuki, Eguchi Kenji
Department of Respirology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Japan.
Support Care Cancer. 2016 Aug;24(8):3495-505. doi: 10.1007/s00520-016-3144-z. Epub 2016 Mar 23.
Cancer cachexia is characterized by decreased body weight (mainly lean body mass [LBM]) and negatively impacts quality of life (QOL) and prognosis. Anamorelin (ONO-7643) is a novel selective ghrelin receptor agonist under development for treating cancer cachexia.
In this double-blind, exploratory phase 2 trial, we examined the efficacy and safety of anamorelin in Japanese patients (n = 181) with non-small cell lung cancer (NSCLC) and cancer cachexia (≥5 % weight loss within the previous 6 months). The participants were randomized into three groups and were administered 50 or 100 mg anamorelin, or placebo, orally every day for 12 weeks. The co-primary endpoints were the changes from baseline over 12 weeks in LBM and handgrip strength (HGS). Secondary endpoints included body weight, QOL, Karnofsky Performance Scale (KPS), and serum biomarkers.
The change in LBM over 12 weeks was 0.55 and 1.15 kg in the placebo and 100-mg anamorelin groups, respectively, but the efficacy of anamorelin in HGS was not detected. The changes in body weight were -0.93, 0.54, and 1.77 kg in the placebo, 50-mg anamorelin, and 100-mg anamorelin groups, respectively. Anamorelin (100 mg) significantly improved KPS and QOL-ACD compared with placebo. Administration of anamorelin for 12 weeks was well tolerated.
This phase 2 study showed that 100 mg anamorelin has promising results in improving lean body mass, performance status, and especially, QOL in patients with cancer cachexia.
癌症恶病质的特征是体重下降（主要是瘦体重[LBM]），对生活质量（QOL）和预后产生负面影响。阿那莫林（ONO-7643）是一种正在开发用于治疗癌症恶病质的新型选择性胃饥饿素受体激动剂。
在这项双盲、探索性2期试验中，我们研究了阿那莫林对日本非小细胞肺癌（NSCLC）合并癌症恶病质（在过去6个月内体重减轻≥5%）患者（n = 181）的疗效和安全性。参与者被随机分为三组，每天口服50或100 mg阿那莫林或安慰剂，持续12周。共同主要终点是12周内LBM和握力（HGS）相对于基线的变化。次要终点包括体重、QOL、卡氏功能状态评分（KPS）和血清生物标志物。
安慰剂组和100 mg阿那莫林组12周内LBM的变化分别为0.55 kg和1.15 kg，但未检测到阿那莫林对HGS的疗效。安慰剂组、50 mg阿那莫林组和100 mg阿那莫林组的体重变化分别为-0.93 kg、0.54 kg和1.77 kg。与安慰剂相比，阿那莫林（100 mg）显著改善了KPS和QOL-ACD。服用阿那莫林12周耐受性良好。
这项2期研究表明，100 mg阿那莫林在改善癌症恶病质患者的瘦体重、身体功能状态，尤其是QOL方面有令人鼓舞的结果。
