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ASCO GI 2023: Patient-Reported Outcomes With Lenvatinib Plus Pembrolizumab in Advanced Liver Cancer

By: Vanessa A. Carter, BS
Posted: Tuesday, February 7, 2023

Josep M. Llovet, MD, PhD, of Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, and colleagues presented phase III results of their LEAP-002 study during the 2023 American Society of Clinical Oncology (ASCO) GI Cancers Symposium (Abstract 506). This trial evaluated health-related quality of life in patients with advanced hepatocellular carcinoma who were treated with lenvatinib and pembrolizumab as first-line therapy.

“Lenvatinib and pembrolizumab generally preserved health-related quality of life versus lenvatinib and placebo in first line for advanced hepatocellular carcinoma,” the investigators concluded. “Combined with efficacy and safety results from LEAP-002, these findings support continued development of lenvatinib plus pembrolizumab in hepatocellular carcinoma.”

The study authors focused on 794 patients with advanced hepatocellular carcinoma. Participants were randomly assigned to receive lenvatinib plus pembrolizumab (n = 390) or placebo (n = 389). They also completed subsequent health-related quality-of-life assessment questionnaires.

Compliance with patient-reported outcome assessments was more than 91% from baseline until week 27 in both treatment arms. Of note, least squares mean changes in physical functioning, global health status/quality of life, EuroQol-5D5L visual analogue scale scores, role functioning, and EORTC QLQ-HCC18 functional/domain scores were similar between both arms. Furthermore, treatment with lenvatinib plus pembrolizumab appeared to delay the deterioration of patient-reported quality of life when compared with lenvatinib plus placebo (11.5 vs. 4.3 months).

The least square mean difference for global health status/quality of life (0.5), physical functioning (–1.7), role functioning (–1.0), fatigue (2.0), pain (2.0), and EuroQol-5D5L visual analogue scale (0.6) demonstrated a trend favoring lenvatinib plus pembrolizumab. The median time to deterioration of physical function appeared to be shorter among those who received pembrolizumab (5.7 vs. 9.1 months). In comparison, the median time to deterioration of fatigue (hazard ratio [HR] = 0.98) and pain (HR = 0.93) was similar between treatment groups.

Disclosure: For full disclosures of the study authors, visit

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