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Poster display session

3441 - Efficacy of anamorelin in advanced non-small cell lung cancer (NSCLC) patients with anorexia/cachexia and modified Glasgow Prognostic Score (mGPS) of 2: pooled analysis of two phase 3 trials

Date

10 Sep 2017

Session

Poster display session

Presenters

Stein Kaasa

Citation

Annals of Oncology (2017) 28 (suppl_5): v497-v501. 10.1093/annonc/mdx382

Authors

S. Kaasa1, B. Laird2, M. Fallon2, D. McMillan3, R. Skipworth4, D. Currow5, R. Giorgino6

Author affiliations

  • 1 Department Of Oncology, Oslo University Hospital and University of Oslo, 0450 - Oslo/NO
  • 2 Institute Of Genetics And Molecular Medicine, University of Edinburgh, Edinburgh/GB
  • 3 Academic Unit Of Surgery, New Lister Building, Glasgow Royal Infirmary, University of Glasgow, Glasgow/GB
  • 4 Clinical Surgery, University of Edinburgh, Edinburgh/GB
  • 5 Impacct – Improving Palliative Aged And Chronic Care Through Clinical Research And Translation, Faculty Of Health, University of Technology Sydney, 2007 - Sydney/AU
  • 6 Research And Development Innovation And Strategy Department, Helsinn Healthcare, Lugano/CH
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Resources

Abstract 3441

Background

Anorexia/cachexia occurs in patients with advanced NSCLC. In 2 randomized, double-blind, placebo-controlled phase 3 trials in cachectic NSCLC patients, the ghrelin receptor agonist anamorelin was well tolerated and significantly improved body composition parameters and anorexia/cachexia symptoms over 12 weeks (Temel JS et al, Lancet Oncol 2016). The mGPS (0–2) has independent prognostic value; patients with mGPS 2 have worse prognosis. This analysis determined anamorelin’s efficacy in cachectic NSCLC patients with mGPS 2 (C-reactive protein levels >10mg/L and albumin levels

Methods

Stage III/IV NSCLC patients with cachexia (BMI

Results

Anamorelin treatment effect was statistically significantly better, compared with placebo, for all body composition parameters in all mGPS subgroups. This effect was numerically larger in patients with mGPS 2 and statistically significant, compared with placebo, for all analyzed parameters, except fatigue subscale score (Table). In patients with mGPS 2, the placebo-adjusted mean increase in body weight exceeded the 5% weight loss cutoff used as an official criterion for cancer cachexia diagnosis.Table:

1390P

Treatment Effect of Anamorelin in patients with mGPS 2 (n = 123)
Mean95% CIP value, compared with placebo
Body weight, kg3.071.47–4.68

Conclusions

In cachectic NSCLC patients with mGPS 2, anamorelin leads to significant improvements in body composition parameters and symptom burden. The extent of weight improvement in this population suggests that treatment with anamorelin may on average reverse pathologic weight loss.

Clinical trial identification

ROMANA 1: NCT01387269 ROMANA 2: NCT01387282

Legal entity responsible for the study

Helsinn

Funding

Helsinn

Disclosure

S. Kaasa: Stock ownership: Eir solutions AS. B. Laird: Advisory board membership: Chugai Pharma. R. Skipworth: Corporate-sponsored research: Research grant/agreement with Novartis. D. Currow: Unpaid advisory board member for Helsinn. Paid consultant and receive payment for intellectual property with Mayne Pharma and consultant with Specialist Therapeutics Australia Pty. Ltd. R. Giorgino: Helsin Healthcare employee. All other authors have declared no conflicts of interest.

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