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Impact of Tislelizumab Versus Sorafenib on Quality of Life in Hepatocellular Carcinoma

By: Celeste L. Dixon
Posted: Tuesday, September 5, 2023

More evidence has emerged—this time, regarding better health-related quality-of-life outcomes—that first-line treatment with the anti–PD-1 monoclonal antibody tislelizumab may be a viable option for patients with unresectable hepatocellular carcinoma. This health-related quality-of-life analysis of the global, phase III RATIONALE-301 study followed the trial meeting its primary endpoint: Overall survival with first-line tislelizumab was not inferior to overall survival with first-line sorafenib. Better health-related quality of life was particularly notable in terms of fatigue and physical functioning, said Richard S. Finn, MD, of the University of California, Los Angeles, and colleagues in their work, presented during the 2023 American Society of Clinical Oncology (ASCO) Breakthrough meeting (Abstract 43).

Almost 700 adults who had not received previous systemic therapy for unresectable hepatocellular carcinoma were randomly assigned on a 1:1 basis to receive tislelizumab (n = 342) or sorafenib (n = 332). The team assessed health-related quality of life using the European Organisation for the Research and Treatment of Cancer Quality-of-Life Questionnaires (EORTC QLQ)-C30 and -HCC18 and the five-level European Quality-of-Life five-dimension version (EQ-5D-5L).

At two prespecified clinical cycles—4 and 6—tislelizumab had better health-related quality-of-life outcomes than did sorafenib, noted Dr. Finn and co-investigators, as indicated by least-squares mean differences. Specifically, with tislelizumab, there was a lower risk for deterioration of QLQ-C30 global health status/quality of life (hazard ratio [HR] = 0.68) and of physical functioning (HR = 0.53), and for fatigue (HR = 0.48), as well as for deterioration in the HCC18 index (HR = 0.53) and fatigue (HR = 0.60). “Both arms had a similar risk for deterioration in pain (HR = 0.78),” the researchers noted. However, “tislelizumab maintained while sorafenib declined EQ-5D-5L [general health status] scores at cycle 4 (mean change from baseline, –0.4 vs. –4.3) and cycle 6 (–0.2 vs. –5.4).”

Disclosure: The study authors’ disclosure information can be found at

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