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Abstract Details
Quality of life assessment of cabozantinib in patients with advanced hepatocellular carcinoma in the CELESTIAL trial
1University College London, London, UK. Electronic address: nicholas.freemantle@ucl.ac.uk.
2Ipsen Pharma SAS, Boulogne-Billancourt, France.
3University College London, London, UK.
4National Taiwan University Hospital and National Taiwan University Cancer Center, Taiwan, Republic of China.
5Norris Comprehensive Cancer Center, Keck School of Medicine of USC, Los Angeles, CA, USA.
6UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
7California Pacific Medical Center, San Francisco, CA, USA.
8Ipsen Bioscience, Cambridge, MA, USA.
9Exelixis, Inc., South San Francisco, CA, USA.
10Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Medical College at Cornell University, New York, NY, USA.
Abstract
Background: The CELESTIAL trial (NCT01908426) demonstrated overall survival benefit for cabozantinib versus placebo in patients with advanced hepatocellular carcinoma (aHCC) who had received prior sorafenib treatment. This analysis of CELESTIAL compared the impact of cabozantinib versus placebo on health-related quality of life (HRQoL).
Materials and methods: Health status was assessed using the EuroQol five-dimension five-level (EQ-5D-5L) questionnaire over the 800-day follow-up period. EQ-5D-5L health states were mapped to health utility scores using reference values for the UK population. Quality-adjusted life years (QALYs) were calculated for each treatment group as the area under the curve for the plot of health utility score over time. The between-treatment group difference in restricted mean QALYs was calculated by generalized linear models and adjusted for baseline differences. A difference of 0.08 in health utility score (or in QALY) was deemed a minimally important difference and to be clinically significant.
Results: At week 5, the difference in mean health utility score between cabozantinib and placebo was -0.097 (95% confidence interval [95% CI]: -0.126, -0.067; p ≤ 0.001). Between-group differences in health utility scores diminished over time and were generally non-significant. The cabozantinib group accrued more QALYs than the placebo group over follow-up. Differences in mean QALYs (cabozantinib minus placebo) were statistically and clinically significant, ranging from +0.092 (95% CI: 0.016, 0.169) to +0.185 (95% CI: 0.126, 0.243) in favour of cabozantinib, depending on the reference value set used.
Conclusions: These HRQoL findings support a positive benefit-risk profile for cabozantinib in previously treated patients with aHCC.