DETRIMENTAL IMPACT OF TOXICITY ON QUALITY OF LIFE IN HEPATOCELLULAR CARCINOMA PATIENTS TREATED WITH LENVATINIBOR SORAFENIB
Author(s)
Hudgens S1, Misurski D2, Meier G2
1Clinical Outcomes Solutions, Tucson, AZ, USA, 2Eisai Inc., Woodcliff Lake, NJ, USA
OBJECTIVES: To determine whether adverse events (AE) were associated with statistically significant differences in overall health utility in patients with unresectable hepatocellular carcinoma (µHCC). METHODS: Data on the impact of AEs on the EQ-5D health utility index (HUI) were taken from a multicenter, randomized, open-label, non-inferiority Phase 3 study comparing lenvatinib (LEN) to sorafenib (SOR) as first-line µHCC systemic treatments. The impact of each AE event during the stable treatment period (all post baseline assessments prior to disease progression) on the HUI score was presented using least squares mean (Adj Mean) estimates as a fixed effect relative to the score estimate of patients who did not present with the particular AE event. The statistical significance of the resulting estimate was determined via ANCOVA with alpha of 0.05. RESULTS: The adjusted HUI scores for Grade 3/4 and Any Grade asthenic conditions were statistically significant (Grade 3/4 Adj Mean = -0.108,p < 0.0001 and Any Grade Adj Mean= -0.026, p = 0.0008; respectively). Similarly, decreased appetite and weight decrease were significant for both the Grade 3/4 and Any Grade estimates (decreased appetite: Grade 3/4 Adj Mean = -0.078, p = 0.0023 and Any Grade Adj Mean = -0.052, p < 0.0001, respectively; weight decrease: Grade 3/4 Adj Mean = -0.053, p=0.0070 and Any Grade Adj Mean = -0.030, p = 0.0003, respectively). For Any AE, differences were significant for Grade 3/4 and Any Grade estimates (Grade 3/4 Adj Mean = -0.031, p = 0.0006 and Any Grade Adj Mean = -0.028, p = 0.0045, respectively). No additional events were significant for the Grade 3/4 or Any Grade models (p > 0.05). CONCLUSIONS: These data illustrate that asthenic conditions, decreased appetite and weight decrease were the most common AEs that had a detrimental effect on HUI scores.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN2
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Oncology