TIME TO CLINICALLY MEANINGFUL WORSENING IN HEPATOCELLULAR CARCINOMA PATIENTS TREATED WITH LENVATINIB OR SORAFENIB
Author(s)
Hudgens S1, Misurski D2, Meier G2
1Clinical Outcomes Solutions, Tucson, AZ, USA, 2Eisai Inc., Woodcliff Lake, NJ, USA
OBJECTIVES: To compare time to clinically meaningful worsening (TSW) in patients with unresectable hepatocellular carcinoma (µHCC) treated with lenvatinib (LEN) or sorafenib (SOR) using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and HCC-specific EORTC QLQ-HCC18 questionnaires. METHODS: This was a multicenter, randomized, open-label, non-inferiority Phase 3 study comparing lenvatinib (LEN) to sorafenib (SOR) as first-line µHCC systemic treatments. Analyses on TSW, which is a within-subject analysis of meaningful change in terms of patient-reported deterioration, were conducted for these patient-reported measures including their domains and summary scores using published meaningful change thresholds which ranged from 6 to 12 points. Kaplan Meier curves were generated to characterize the diversion of the first TSW event occurring over time for each patient; median time and its 95% confidence interval (CI) was calculated with a prespecified significance level of 0.05. Unadjusted proportional hazard models were conducted to estimate the hazard ratio and its 95% CI. RESULTS: TSW was statistically significant favoring LEN for the QLQ-C30 domains of Role Functioning (2.0 versus 1.9 months in the LEN and SOR arms, respectively; p = 0.0098), Pain (2.0 versus 1.8 months, respectively; p = 0.0060), and Diarrhea (4.6 versus 2.7 months, respectively; p < 0.0001). In the QLQ‑HCC18 results favored LEN for the domains of Body Image (2.8 versus 1.9 months, respectively; p = 0.0041) and Nutrition (4.1 versus 2.8 months, respectively; p = 0.0060). The p-values were calculated without multiplicity adjustment CONCLUSIONS: Patients on SOR experienced a more rapid clinically meaningful deterioration in terms of Role Functioning, Nutrition (perhaps due to an increased severity of diarrhea), Pain (specifically affecting their daily lives) and Body Image.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN27
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology