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ePoster Display

1674P - Does body mass index (BMI) affect the type of response to anamorelin (ANAM) over time? Focus on body composition and anorexia symptoms and concerns

Date

16 Sep 2021

Session

ePoster Display

Presenters

David Currow

Citation

Annals of Oncology (2021) 32 (suppl_5): S1175-S1198. 10.1016/annonc/annonc714

Authors

D. Currow1, G. Ballinari2, R.J.E. Skipworth3

Author affiliations

  • 1 Faculty Of Health, University of Technology Sydney, IMPACCT – Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, 2007 - Sydney/AU
  • 2 Medical Affairs, Helsinn Healthcare SA, 6912 - Pazzallo/CH
  • 3 Clinical Surgery, University of Edinburgh, EH16 4SA - Edinburgh/GB
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Abstract 1674P

Background

Weight loss (WL) and anorexia are clinical hallmarks of cancer cachexia, a multifactorial condition that may be present at the time of cancer diagnosis and can impair treatment response. Early detection and treatment of cancer-associated WL and anorexia are key, especially in patients (pts) with low BMI and reduced food intake. ANAM is an investigational orally active selective ghrelin receptor agonist. Herein, we report the effect of ANAM on anorexia symptoms and concerns and body composition of pts with advanced non-small cell lung cancer (NSCLC) and cachexia.

Methods

In ROMANA 1 and 2 (NCT01387269, NCT01387282) pts with advanced NSCLC and BMI <20 kg/m2 or WL ≥5% in the past 6 months received ANAM or placebo (PBO) for 12 weeks. Body weight (BW), lean mass (LM), and fat mass (FM) were recorded. Pt-reported anorexia symptoms and concerns were assessed using the 12-item Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT A/CS) and analyzed by the 5-item Anorexia Symptom Scale (5-IASS) and 4-item Anorexia Concerns Subscale (4-IACS), derived from FAACT A/CS; higher scores denote improvement. This posthoc exploratory analysis includes data collected at baseline, week 6 and 12; changes from baseline were assessed by BMI (<20 vs ≥20 kg/m2).

Results

Anorexia symptoms and concerns and body composition improved in ANAM-treated pts, in both BMI groups. Improvements in 5-IASS, 4-IACS, and 12-FAACT A/CS were higher in pts with BMI <20 kg/m2. Pts with BMI <20 kg/m2 experienced a higher increase in BW, FM, and LM. For PBO-treated pts, while anorexia symptoms and concerns improved slightly, body composition worsened. Table: 1674P

BMI, kg/m2 Wk <20 Wk 6 <20 Wk 12 ≥20 Wk 6 ≥20 Wk 12
ANAM Mean ± SD N 156 156 497 497
5-IASS 2.29 ± 4.64 2.43 ± 5.57 1.54 ± 4.33 1.25 ± 4.82
4-IACS 2.51 ± 3.51 3.21 ± 4.04 1.47 ± 3.31 1.47 ± 3.51
12-FAACT A/CS 5.45 ± 8.42 6.35 ± 10.26 3.65 ± 7.87 3.23 ± 8.80
BW, % 3.7 ± 6.4 6.5 ± 9.0 1.9 ± 4.5 2.9 ± 6.1
LM, kg 1.30 ± 2.67 1.40 ± 2.75 1.23 ± 2.51 1.30 ± 2.67
FM, kg 0.63 ± 2.09 1.69 ± 3.03 0.33 ± 1.94 0.70 ± 2.87
PBO Mean ± SD N 85 85 241 241
5-IASS 0.00 ± 4.88 0.69 ± 5.03 0.78 ± 4.44 1.16 ± 4.81
4-IACS 0.78 ± 3.30 1.16 ± 3.78 0.33 ± 3.56 0.41 ± 3.57
12-FAACT A/CS 1.05 ± 8.59 1.85 ± 9.70 1.59 ± 8.31 2.02 ± 8.94
BW, % -0.2 ± 4.7 -0.3 ± 6.3 -0.3 ± 4.2 -0.3 ± 5.9
LM, kg -0.24 ± 2.70 -0.26 ± 1.97 -0.14 ± 2.39 -0.30 ± 2.61
FM, kg -0.43 ± 1.49 -0.12 ± 1.56 -0.25 ± 2.08 -0.21 ± 2.93

Conclusions

ANAM treatment improved anorexia symptoms and concerns and body composition in pts with NSCLC. While improvements in LM were similar independently of BMI, pts with BMI <20 kg/m2 showed a higher increase in BW, FM, and LM and better improvements in anorexia symptoms and concerns.

Clinical trial identification

Editorial acknowledgement

Editorial and medical writing assistance was provided by Iratxe Abarrategui, PhD, CMPP, from Aptitude Health, The Hague, the Netherlands, and funded by Helsinn Healthcare SA, Lugano, Switzerland.

Legal entity responsible for the study

Helsinn Healthcare SA.

Funding

Helsinn Healthcare SA.

Disclosure

D. Currow: Non-Financial Interests, Personal, Advisory Board: Helsinn Healthcare SA; Financial Interests, Personal, Advisory Role: Mayne Pharma; Financial Interests, Personal, Licensing Fees, payment for intellectual property: Mayne Pharma; Financial Interests, Personal, Advisory Role: Specialised Therapeutics Australia Pty. Ltd. G. Ballinari: Financial Interests, Personal, Full or part-time Employment, Full-time employment: Helsinn Healthcare SA. R.J.E. Skipworth: Financial Interests, Personal, Funding, Clinician post: NHS Research Scotland; Financial Interests, Personal, Advisory Board, Previous member: Helsinn Healthcare SA; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Advisory Role, Helsinn Healthcare SA: Avidity Biosciences; Financial Interests, Personal, Invited Speaker: Helsinn Healthcare SA; Financial Interests, Personal, Writing Engagements: Helsinn Healthcare SA.

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