Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial.
In: Supportive Care in Cancer, Jg. 24 (2016-08-01), Heft 8, S. 3495-3505
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Purpose: 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. Methods: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]
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Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial.
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Autor/in / Beteiligte Person: | Takayama, Koichi ; Katakami, Nobuyuki ; Yokoyama, Takuma ; Atagi, Shinji ; Yoshimori, Kozo ; Kagamu, Hiroshi ; Saito, Hiroshi ; Takiguchi, Yuichi ; Aoe, Keisuke ; Koyama, Akira ; Komura, Naoyuki ; Eguchi, Kenji |
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Zeitschrift: | Supportive Care in Cancer, Jg. 24 (2016-08-01), Heft 8, S. 3495-3505 |
Veröffentlichung: | 2016 |
Medientyp: | academicJournal |
ISSN: | 0941-4355 (print) |
DOI: | 10.1007/s00520-016-3144-z |
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