Abstract 1829P
Background
WL and anorexia are major clinical manifestations of cancer cachexia, a multifactorial and debilitating condition that causes morbidity, and additional distress for patients (pts) and caregivers. Other symptoms include appetite loss, early satiety, and decline in fitness status, highlighting the need for a multimodal management approach. This exploratory post-hoc analysis evaluates anorexia symptoms and concerns reported by pts with advanced non-small cell lung cancer (NSCLC) and cachexia on the basis of their BMI and WL degree.
Methods
ROMANA 1 and 2 (NCT01387269 and NCT01387282) enrolled adults with advanced NSCLC and BMI <20 kg/m2 or WL ≥5% in the past 6 months. Pt-reported data (12-item Functional Assessment of Anorexia/Cachexia Therapy [FAACT] anorexia/cachexia scale) at study entry were included in this analysis. Anorexia symptoms and concerns were evaluated by the newly identified 5-item anorexia symptoms subscale (5-IASS) and the 4-item anorexia concerns subscale (4-IACS), both derived from FAACT. Lower scores for each domain denoted a higher degree of symptoms and concerns. Scores were analyzed on the basis of pts’ BMI and WL, and variation among groups was computed using SAS 9.4.
Results
Mean BMI of the analyzed population (N=829) was 23.0 ± 3.6 kg/m2 and mean overall 5-IASS and 4-IACS scores were 12.4 ± 4.5 and 9.2 ± 3.7, respectively. Scores for the groups of pts categorized according to BMI and WL are shown in the Table. 5-IASS and 4-IACS scores were statistically lower for pts with BMI <20 vs BMI ≥20, and lower among pts with WL >10% vs WL ≤10%. The combination of BMI <20 and WL >10% conferred the lowest scores.
Conclusions
Pts with BMI <20 and WL >10% report the highest degree of both symptoms and concerns, reaffirming the need for early diagnosis and intervention to prevent WL progression. Anorexia symptoms and concerns subscales represent potential outcome measures for intervention trials in cancer cachexia. Table: 1829P
| N Mean ± SD | 5-IASS | 4-IACS |
| By BMI | ||
| BMI <20 kg/m2 | 18011.5 ± 5.0* | 1806.8 ± 3.5** |
| BMI ≥20 kg/m2 | 64712.6 ± 4.4* | 6469.8 ± 3.5** |
| By WL | ||
| WL ≤10% | 48413.1 ± 4.1+ | 48410.2 ± 3.3++ |
| WL >10% | 34311.4 ± 4.9+ | 3427.7 ± 3.8++ |
| By BMI and WL | ||
| BMI <20 kg/m2 and WL ≤10% | 6212.6 ± 4.4AB | 628.2 ± 3.5B |
| BMI <20 kg/m2 and WL >10% | 11810.9 ± 5.2C | 1186.1 ± 3.4C |
| BMI ≥20 kg/m2 and WL ≤10% | 42213.2 ± 4.0A | 42210.5 ± 3.1A |
| BMI ≥20 kg/m2 and WL >10% | 22511.6 ± 4.8BC | 2248.5 ± 3.8B |
SD: standard deviation.*p=0.0032, **p<0.0001 ANOVA comparison.+p<0.0001,++p<0.0001 ANOVA comparison.ABCScheffe test of mean comparison; the means with same letter are not statistically different at alpha=0.05. Tests of 5-IASS and 4-IACS were performed separately.
Clinical trial identification
NCT01387269 and NCT01387282.
Editorial acknowledgement
Editorial and medical writing assistance was provided by Sandra Mendes, PhD, CMPP, and Judith Land, PhD, from Aptitude Health, The Hague, the Netherlands, and funded by Helsinn Healthcare SA, Lugano, Switzerland. The authors are fully responsible for all content and editorial decisions for this abstract.
Legal entity responsible for the study
Helsinn.
Funding
Helsinn.
Disclosure
S. Kaasa: Honoraria (institution): Fresenius Kabi; Honoraria (institution), Research grant/Funding (institution): Nutricia; Shareholder/Stockholder/Stock options: Eir Solution. D. Currow: Advisory/Consultancy: Specialised Therapeutics Australia Pty. Ltd; Advisory/Consultancy, Licensing/Royalties: Mayne Pharma ; Advisory/Consultancy, un-paid advisory board member: Helsinn Pharmaceuticals. R.J.E. Skipworth: Advisory/Consultancy: Avidity Biosciences; Advisory/Consultancy: Helsinn; Research grant/Funding (self): NHS Research Scotland; Research grant/Funding (institution): Novartis.