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Quality-of-life benefits for tislelizumab in uHCC

Presented by
Prof. Richard Finn, University of California Los Angeles, CA, USA
ASCO GI 2023
Phase 3, RATIONALE-301

Tislelizumab delivers improved health-related quality-of-life (HRQoL) outcomes compared with sorafenib in patients with unresectable hepatocellular carcinoma (uHCC), the latest results from the phase 3 RATIONALE-301 study show. These findings, together with the efficacy results, support the use of tislelizumab in the first-line treatment of patients with uHCC.

RATIONALE-301 (NCT03412773) randomised 674 patients with untreated uHCC 1:1 to sorafenib or tislelizumab [1]. Previous results from this trial showed that tislelizumab was non-inferior to sorafenib for overall survival [2]. Here, Prof. Richard Finn (University of California Los Angeles, CA, USA) outlined the data of HRQoL measures for the assessed agents.

The EORTC QLQ-C30 scale showed that patients in the sorafenib arm had a reduction from baseline in global health status/quality-of-life at cycles 4 (-5.1 vs -0.7; P=0.0037) and 6 (-5.9 vs -0.9; P=0.0022) of therapy, but that those in the tislelizumab arm did not show this deterioration. The corresponding results for physical functioning at cycle 4 (-7.7 versus -1.3; P<0.0001) and 6 (-7.2 vs -1.0; P<0.0001) displayed a benefit for tislelizumab as well. Moreover, patients in the sorafenib arm showed an increase in fatigue whereas those in the tislelizumab arm did not: cycle 4 (+9.1 vs +1.5; P<0.0001); cycle 6 (+9.8 vs +2.2; P<0.0001). The pain scores of the EORTC QLQ – HCC18 scale were comparable for the 2 arms, with an increase around +2.5 for both treatment arms at cycles 4 and 6.

After meeting its primary endpoint, data from RATIONALE-301 now demonstrated quality-of-life benefits for patients with newly diagnosed uHCC receiving tislelizumab compared with those receiving sorafenib.

  1. Finn RS, et al. Tislelizumab versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: Impact on health-related quality of life in RATIONALE-301 population. Abstract 495, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.
  2. Qin S, et al. Annals of Oncology. 2022;33(7):S1402–S1403.

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