Anamorelin (ONO-7643) for the treatment of patients with non–small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04)

Nobuyuki Katakami, Junji Uchino, Takuma Yokoyama, Tateaki Naito, Masashi Kondo, Kouzo Yamada, Hiromoto Kitajima, Kozo Yoshimori, Kazuhiro Sato, Hiroshi Saito, Keisuke Aoe, Tetsuya Tsuji, Yuichi Takiguchi, Koichi Takayama, Naoyuki Komura, Toru Takiguchi, Kenji Eguchi

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia. METHODS: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non–small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results. RESULTS: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and −0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P <.0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients. CONCLUSIONS: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16.

Original languageEnglish
Pages (from-to)606-616
Number of pages11
JournalCancer
Volume124
Issue number3
DOIs
Publication statusPublished - 01-02-2018

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Cachexia
Non-Small Cell Lung Carcinoma
Multicenter Studies
Placebos
Anorexia
Therapeutics
Neoplasms
Body Weight
Ghrelin Receptor
Prealbumin
Appetite
RC-1291
anamorelin
Least-Squares Analysis
Weight Loss
Japan
Quality of Life
X-Rays
Clinical Trials
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Katakami, Nobuyuki ; Uchino, Junji ; Yokoyama, Takuma ; Naito, Tateaki ; Kondo, Masashi ; Yamada, Kouzo ; Kitajima, Hiromoto ; Yoshimori, Kozo ; Sato, Kazuhiro ; Saito, Hiroshi ; Aoe, Keisuke ; Tsuji, Tetsuya ; Takiguchi, Yuichi ; Takayama, Koichi ; Komura, Naoyuki ; Takiguchi, Toru ; Eguchi, Kenji. / Anamorelin (ONO-7643) for the treatment of patients with non–small cell lung cancer and cachexia : Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04). In: Cancer. 2018 ; Vol. 124, No. 3. pp. 606-616.
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title = "Anamorelin (ONO-7643) for the treatment of patients with non–small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04)",
abstract = "BACKGROUND: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia. METHODS: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non–small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results. RESULTS: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and −0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P <.0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients. CONCLUSIONS: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16.",
author = "Nobuyuki Katakami and Junji Uchino and Takuma Yokoyama and Tateaki Naito and Masashi Kondo and Kouzo Yamada and Hiromoto Kitajima and Kozo Yoshimori and Kazuhiro Sato and Hiroshi Saito and Keisuke Aoe and Tetsuya Tsuji and Yuichi Takiguchi and Koichi Takayama and Naoyuki Komura and Toru Takiguchi and Kenji Eguchi",
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Katakami, N, Uchino, J, Yokoyama, T, Naito, T, Kondo, M, Yamada, K, Kitajima, H, Yoshimori, K, Sato, K, Saito, H, Aoe, K, Tsuji, T, Takiguchi, Y, Takayama, K, Komura, N, Takiguchi, T & Eguchi, K 2018, 'Anamorelin (ONO-7643) for the treatment of patients with non–small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04)' Cancer, vol. 124, no. 3, pp. 606-616. https://doi.org/10.1002/cncr.31128

Anamorelin (ONO-7643) for the treatment of patients with non–small cell lung cancer and cachexia : Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04). / Katakami, Nobuyuki; Uchino, Junji; Yokoyama, Takuma; Naito, Tateaki; Kondo, Masashi; Yamada, Kouzo; Kitajima, Hiromoto; Yoshimori, Kozo; Sato, Kazuhiro; Saito, Hiroshi; Aoe, Keisuke; Tsuji, Tetsuya; Takiguchi, Yuichi; Takayama, Koichi; Komura, Naoyuki; Takiguchi, Toru; Eguchi, Kenji.

In: Cancer, Vol. 124, No. 3, 01.02.2018, p. 606-616.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Anamorelin (ONO-7643) for the treatment of patients with non–small cell lung cancer and cachexia

T2 - Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04)

AU - Katakami, Nobuyuki

AU - Uchino, Junji

AU - Yokoyama, Takuma

AU - Naito, Tateaki

AU - Kondo, Masashi

AU - Yamada, Kouzo

AU - Kitajima, Hiromoto

AU - Yoshimori, Kozo

AU - Sato, Kazuhiro

AU - Saito, Hiroshi

AU - Aoe, Keisuke

AU - Tsuji, Tetsuya

AU - Takiguchi, Yuichi

AU - Takayama, Koichi

AU - Komura, Naoyuki

AU - Takiguchi, Toru

AU - Eguchi, Kenji

PY - 2018/2/1

Y1 - 2018/2/1

N2 - BACKGROUND: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia. METHODS: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non–small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results. RESULTS: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and −0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P <.0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients. CONCLUSIONS: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16.

AB - BACKGROUND: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia. METHODS: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non–small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results. RESULTS: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and −0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P <.0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients. CONCLUSIONS: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16.

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DO - 10.1002/cncr.31128

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