title: Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial.
abstract: 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.
authors.affiliation: Department of Respirology, Kyoto Prefectural University of Medicine, Kyoto, Japan. takayama@koto.kpu-m.ac.jp.
authors.forename: Koichi
authors.initials: K
authors.lastname: Takayama
authors.affiliation: Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.affiliation: Department of Respiratory Medicine, Kyorin University Hospital, Mitaka, Japan.
authors.forename: Takuma
authors.initials: T
authors.lastname: Yokoyama
authors.affiliation: Department of Thoracic Oncology, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Atagi
authors.affiliation: Department of Clinical Oncology, Japan Anti-Tuberculosis Association, Fukujuji Hospital, Kiyose, Japan.
authors.forename: Kozo
authors.initials: K
authors.lastname: Yoshimori
authors.affiliation: Division of Respiratory Medicine, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kagamu
authors.affiliation: Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Aichi, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.affiliation: Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takiguchi
authors.affiliation: Department of Medical Oncology, National Hospital Organization Yamaguchi - Ube Medical Center, Ube, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Aoe
authors.affiliation: Ono Pharmaceutical Co. Ltd, Osaka, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Koyama
authors.affiliation: Ono Pharmaceutical Co. Ltd, Osaka, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Komura
authors.affiliation: Health Science on Supportive Medicine for Intractable Diseases, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Eguchi
mesh_terms: D000368:Aged; D002100:Cachexia / Q000188:drug therapy*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006834:Hydrazines / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D011379:Prognosis; D011788:Quality of Life / Q000523:psychology*
chemical_list: D006834:Hydrazines; D009842:Oligopeptides; C000593861:anamorelin
keywords: Anamorelin (ONO-7643); Cachexia; Lean body mass; Non-small cell lung cancer; Randomized controlled trial