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ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia

Currow, D.; Temel, J. S.; Abernethy, A.; Milanowski, J.; Friend, J.; Fearon, K. C.

Authors

D. Currow

J. S. Temel

A. Abernethy

J. Milanowski

J. Friend

K. C. Fearon



Abstract

Background
Cancer anorexia–cachexia is a debilitating condition frequently observed in NSCLC patients, characterized by decreased body weight, reduced food intake, and impaired quality of life. Anamorelin, a novel selective ghrelin receptor agonist, has anabolic and appetite-enhancing activities.

Patients and methods
ROMANA 3 was a safety extension study of two phase 3, double-blind studies that assessed safety and efficacy of anamorelin in advanced NSCLC patients with cachexia. Patients with preserved Eastern Cooperative Oncology Group ≤2 after completing 12 weeks (w) on the ROMANA 1 or ROMANA 2 trials (0–12 weeks) could enroll in ROMANA 3 and continue to receive anamorelin 100 mg or placebo once daily for an additional 12w (12–24 weeks). The primary endpoint of ROMANA 3 was anamorelin safety/tolerability (12–24 weeks). Secondary endpoints included changes in body weight, handgrip strength (HGS), and symptom burden (0–24 weeks).

Results
Of the 703 patients who completed ROMANA 1 and ROMANA 2, 513 patients entered ROMANA 3 (anamorelin, N = 345, mean age 62.0 years; placebo, N = 168; mean age 62.2 years). During ROMANA 3, anamorelin and placebo groups had similar incidences of treatment–emergent adverse events (TEAEs; 52.2% versus 55.7%), grade ≥3 TEAEs (22.4% versus 21.6%), and serious TEAEs (12.8% versus 12.6%). There were 36 (10.5%) and 23 (13.8%) deaths in the anamorelin and placebo groups, respectively; none were drug-related. Improvements in body weight and anorexia–cachexia symptoms observed in the original trials were consistently maintained over 12–24 weeks. Anamorelin, versus placebo, significantly increased body weight from baseline of original trials at all time points (P 

Journal Article Type Article
Publication Date Aug 1, 2017
Journal Annals of Oncology
Print ISSN 0923-7534
Electronic ISSN 1569-8041
Publisher Oxford University Press (OUP)
Peer Reviewed Peer Reviewed
Volume 28
Issue 8
Pages 1949-1956
APA6 Citation Currow, D., Temel, J. S., Abernethy, A., Milanowski, J., Friend, J., & Fearon, K. C. (2017). ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, 28(8), 1949-1956. https://doi.org/10.1093/annonc/mdx192
DOI https://doi.org/10.1093/annonc/mdx192
Keywords ROMANA 3; Anamorelin; Non-small-cell lung cancer; Body weight; Anorexia–cachexia symptoms; ROMANA 1 and ROMANA 2
Publisher URL https://academic.oup.com/annonc/article/28/8/1949/3796493

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Copyright Statement
© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com





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