Patients with hepatocellular carcinoma treated with frontline tislelizumab had better health-related quality of life outcomes, particularly in terms of fatigue and physical functioning, compared with those treated with sorafenib.

Lead author Richard Finn, MD, David Geffen School of Medicine at University of California Los Angeles, CA, and coauthors wrote, the global, phase 3 RATIONALE-3 study, “comparing tislelizumab to sorafenib as [a first-line] treatment in adult patients with unresectable hepatocellular carcinoma, met its primary end point of [overall survival] non-inferiority.” The current analysis evaluated health-related quality of life outcomes for patients in both arms.

These results were presented on Thursday, January 19, 2023, at the American Society of Clinical Oncologists Gastrointestinal Cancers Symposium in San Francisco, CA, by Byung Kwan Park, MD, Chung-Ang University Hospital, Seoul, South Korea.

In the RATIONALE-3 trial, patients were randomized on a 1-to-1 basis to receive either 200 mg tislelizumab once every 3 weeks (n = 342), or 400 mg sorafenib twice daily (n = 332). Health-related quality of life outcomes were determined through 3 questionnairexs: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC QLQ Hepatocellular Carcinoma (QLQ-HCC18), 5-level EuroQol Group Five Dimensions (EQ-5D-5L). Mixed model for repeated measures using patient-reported outcome end points of global health status/quality of life, physical functioning and fatigue scores of the QLQ-C30, and -HCC18 index score, fatigue and pain scores at prespecified clinical cycles 4 and 6 were performed.

The tislelizumab group had better health-related quality of life outcomes compared to the sorafenib group at both cycles in global health status/quality of life, physical functioning, fatigue, and hepatocellular carcinoma symptom index, but not for pain. There was also a lower risk of deterioration of QLQ-C30 global health score/quality of life, physical functioning and fatigue, and in the HCC18 index and fatigue, with tislelizumab. There was a similar risk of deterioration of pain in both arms. At cycle 4 and cycle 6 EQ-5D-5L general health status scores declined for the sorafenib arm but were maintained in the tislelizumab arm.

Dr Finn, et al, concluded, “These results, along with effects in overall survival, response rate, and a favorable safety profile, support the benefit of [tislelizumab] as a potential [first-line] treatment option for [unresectable hepatocellular carcinoma].”

Source:

Finn RS, Qin S, Kudo M, et al. Tislelizumab versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: Impact on health-related quality of life in RATIONALE-301 population. Presented at 2023 ASCO Gastrointestinal Cancers Symposium; January 19-21, 2023; San Francisco, CA. Abstract 495