A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia

Satoshi Hamauchi, Junji Furuse, Toshimi Takano, Yoshinori Munemoto, Ken Furuya, Hideo Baba, Manabu Takeuchi, Yasuhiro Choda, Takashi Higashiguchi, Tateaki Naito, Kei Muro, Koichi Takayama, Shusuke Oyama, Toru Takiguchi, Naoyuki Komura, Kazuo Tamura

研究成果: Article

抄録

Background: Cancer cachexia is characterized by weight loss and is associated with increased morbidity and mortality in patients with cancer. Anamorelin (ONO-7643; ANAM) is a novel and selective ghrelin receptor agonist that improves appetite, lean body mass (LBM), body weight, and anorexia. Methods: This multicenter, open-label, single-arm study investigated the efficacy and safety of 100 mg anamorelin in 50 Japanese patients with advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer. ANAM was administered once daily over 12 weeks. The primary endpoint was the proportion of patients that maintained or gained LBM over the course of the study. Secondary endpoints included changes in LBM, body weight, quality of life (QoL), and nutritional status biomarkers. Results: The proportion of patients who responded to treatment was 63.3% (95% CI, 48.3%-76.6%), with a least square mean ± SE change in LBM and body weight from baseline of 1.89 ± 0.36 kg and 1.41 ± 0.61 kg, respectively. Appetite-related questions on the QoL questionnaire showed that ANAM improved appetite. Adverse events occurred in 79.6% of patients, and the most common treatment-related adverse events were increased γ-glutamyl transpeptidase (8.2%), diabetes mellitus (6.1%), hyperglycemia (6.1%), and prolonged QRS complex (6.1%). Conclusions: ANAM improved anorexia and patients' nutritional status, resulting in rapid increases in LBM and body weight in patients with advanced gastrointestinal cancer who had cancer cachexia. ANAM treatment was well tolerated over 12 weeks. ANAM is a potential clinically beneficial pharmacotherapeutic option for patients with advanced gastrointestinal cancer who have cancer cachexia.

元の言語English
ジャーナルCancer
DOI
出版物ステータスAccepted/In press - 01-01-2019

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Cachexia
Gastrointestinal Neoplasms
Neoplasms
Appetite
Body Weight
Anorexia
Nutritional Status
Quality of Life
Ghrelin Receptor
gamma-Glutamyltransferase
RC-1291
anamorelin
Least-Squares Analysis
Pancreatic Neoplasms
Hyperglycemia
Weight Loss
Stomach
Diabetes Mellitus
Therapeutics
Biomarkers

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

これを引用

Hamauchi, S., Furuse, J., Takano, T., Munemoto, Y., Furuya, K., Baba, H., ... Tamura, K. (受理済み/印刷中). A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia. Cancer. https://doi.org/10.1002/cncr.32406
Hamauchi, Satoshi ; Furuse, Junji ; Takano, Toshimi ; Munemoto, Yoshinori ; Furuya, Ken ; Baba, Hideo ; Takeuchi, Manabu ; Choda, Yasuhiro ; Higashiguchi, Takashi ; Naito, Tateaki ; Muro, Kei ; Takayama, Koichi ; Oyama, Shusuke ; Takiguchi, Toru ; Komura, Naoyuki ; Tamura, Kazuo. / A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia. :: Cancer. 2019.
@article{b4e0ce2fc5bf4dc2922461f61878a620,
title = "A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia",
abstract = "Background: Cancer cachexia is characterized by weight loss and is associated with increased morbidity and mortality in patients with cancer. Anamorelin (ONO-7643; ANAM) is a novel and selective ghrelin receptor agonist that improves appetite, lean body mass (LBM), body weight, and anorexia. Methods: This multicenter, open-label, single-arm study investigated the efficacy and safety of 100 mg anamorelin in 50 Japanese patients with advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer. ANAM was administered once daily over 12 weeks. The primary endpoint was the proportion of patients that maintained or gained LBM over the course of the study. Secondary endpoints included changes in LBM, body weight, quality of life (QoL), and nutritional status biomarkers. Results: The proportion of patients who responded to treatment was 63.3{\%} (95{\%} CI, 48.3{\%}-76.6{\%}), with a least square mean ± SE change in LBM and body weight from baseline of 1.89 ± 0.36 kg and 1.41 ± 0.61 kg, respectively. Appetite-related questions on the QoL questionnaire showed that ANAM improved appetite. Adverse events occurred in 79.6{\%} of patients, and the most common treatment-related adverse events were increased γ-glutamyl transpeptidase (8.2{\%}), diabetes mellitus (6.1{\%}), hyperglycemia (6.1{\%}), and prolonged QRS complex (6.1{\%}). Conclusions: ANAM improved anorexia and patients' nutritional status, resulting in rapid increases in LBM and body weight in patients with advanced gastrointestinal cancer who had cancer cachexia. ANAM treatment was well tolerated over 12 weeks. ANAM is a potential clinically beneficial pharmacotherapeutic option for patients with advanced gastrointestinal cancer who have cancer cachexia.",
author = "Satoshi Hamauchi and Junji Furuse and Toshimi Takano and Yoshinori Munemoto and Ken Furuya and Hideo Baba and Manabu Takeuchi and Yasuhiro Choda and Takashi Higashiguchi and Tateaki Naito and Kei Muro and Koichi Takayama and Shusuke Oyama and Toru Takiguchi and Naoyuki Komura and Kazuo Tamura",
year = "2019",
month = "1",
day = "1",
doi = "10.1002/cncr.32406",
language = "English",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",

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Hamauchi, S, Furuse, J, Takano, T, Munemoto, Y, Furuya, K, Baba, H, Takeuchi, M, Choda, Y, Higashiguchi, T, Naito, T, Muro, K, Takayama, K, Oyama, S, Takiguchi, T, Komura, N & Tamura, K 2019, 'A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia', Cancer. https://doi.org/10.1002/cncr.32406

A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia. / Hamauchi, Satoshi; Furuse, Junji; Takano, Toshimi; Munemoto, Yoshinori; Furuya, Ken; Baba, Hideo; Takeuchi, Manabu; Choda, Yasuhiro; Higashiguchi, Takashi; Naito, Tateaki; Muro, Kei; Takayama, Koichi; Oyama, Shusuke; Takiguchi, Toru; Komura, Naoyuki; Tamura, Kazuo.

:: Cancer, 01.01.2019.

研究成果: Article

TY - JOUR

T1 - A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia

AU - Hamauchi, Satoshi

AU - Furuse, Junji

AU - Takano, Toshimi

AU - Munemoto, Yoshinori

AU - Furuya, Ken

AU - Baba, Hideo

AU - Takeuchi, Manabu

AU - Choda, Yasuhiro

AU - Higashiguchi, Takashi

AU - Naito, Tateaki

AU - Muro, Kei

AU - Takayama, Koichi

AU - Oyama, Shusuke

AU - Takiguchi, Toru

AU - Komura, Naoyuki

AU - Tamura, Kazuo

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Cancer cachexia is characterized by weight loss and is associated with increased morbidity and mortality in patients with cancer. Anamorelin (ONO-7643; ANAM) is a novel and selective ghrelin receptor agonist that improves appetite, lean body mass (LBM), body weight, and anorexia. Methods: This multicenter, open-label, single-arm study investigated the efficacy and safety of 100 mg anamorelin in 50 Japanese patients with advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer. ANAM was administered once daily over 12 weeks. The primary endpoint was the proportion of patients that maintained or gained LBM over the course of the study. Secondary endpoints included changes in LBM, body weight, quality of life (QoL), and nutritional status biomarkers. Results: The proportion of patients who responded to treatment was 63.3% (95% CI, 48.3%-76.6%), with a least square mean ± SE change in LBM and body weight from baseline of 1.89 ± 0.36 kg and 1.41 ± 0.61 kg, respectively. Appetite-related questions on the QoL questionnaire showed that ANAM improved appetite. Adverse events occurred in 79.6% of patients, and the most common treatment-related adverse events were increased γ-glutamyl transpeptidase (8.2%), diabetes mellitus (6.1%), hyperglycemia (6.1%), and prolonged QRS complex (6.1%). Conclusions: ANAM improved anorexia and patients' nutritional status, resulting in rapid increases in LBM and body weight in patients with advanced gastrointestinal cancer who had cancer cachexia. ANAM treatment was well tolerated over 12 weeks. ANAM is a potential clinically beneficial pharmacotherapeutic option for patients with advanced gastrointestinal cancer who have cancer cachexia.

AB - Background: Cancer cachexia is characterized by weight loss and is associated with increased morbidity and mortality in patients with cancer. Anamorelin (ONO-7643; ANAM) is a novel and selective ghrelin receptor agonist that improves appetite, lean body mass (LBM), body weight, and anorexia. Methods: This multicenter, open-label, single-arm study investigated the efficacy and safety of 100 mg anamorelin in 50 Japanese patients with advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer. ANAM was administered once daily over 12 weeks. The primary endpoint was the proportion of patients that maintained or gained LBM over the course of the study. Secondary endpoints included changes in LBM, body weight, quality of life (QoL), and nutritional status biomarkers. Results: The proportion of patients who responded to treatment was 63.3% (95% CI, 48.3%-76.6%), with a least square mean ± SE change in LBM and body weight from baseline of 1.89 ± 0.36 kg and 1.41 ± 0.61 kg, respectively. Appetite-related questions on the QoL questionnaire showed that ANAM improved appetite. Adverse events occurred in 79.6% of patients, and the most common treatment-related adverse events were increased γ-glutamyl transpeptidase (8.2%), diabetes mellitus (6.1%), hyperglycemia (6.1%), and prolonged QRS complex (6.1%). Conclusions: ANAM improved anorexia and patients' nutritional status, resulting in rapid increases in LBM and body weight in patients with advanced gastrointestinal cancer who had cancer cachexia. ANAM treatment was well tolerated over 12 weeks. ANAM is a potential clinically beneficial pharmacotherapeutic option for patients with advanced gastrointestinal cancer who have cancer cachexia.

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U2 - 10.1002/cncr.32406

DO - 10.1002/cncr.32406

M3 - Article

AN - SCOPUS:85070750682

JO - Cancer

JF - Cancer

SN - 0008-543X

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