A recent phase 3, randomized, open-label, noninferiority trial compared the efficacy and safety of LEN to SOR as first-line systemic treatment in unresectable HCC (954 patients). The study included analyses to evaluate the impact of therapy for HCC on HRQOL.
HRQOL was assessed using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30), the HCC-specific module (EORTC QLQ-HCC18), and the European Quality of Life (EQ-5D-3L) at baseline, Day 1 of each cycle, and off-treatment visit. Changes from baseline in both treatment arms were assessed using linear-mixed models with selected covariates (baseline score, geographical region, macroscopic portal vein invasion and/or extrahepatic spread, ECOG-PS, body weight). Time to worsening for each domain was represented as months to deterioration defined by a minimally important difference (MID).
A total of 954 patients (LEN treatment n = 478; SOR treatment n = 476) were randomized and included in the intent-to-treat population. Baseline HRQOL scores were similar for patients receiving LEN or SOR across all domains. Significant changes from baseline HRQOL scores were noted for Nutrition, Diarrhea, Role Function (RF), Pain, and Body Image (BI). In the QLQ-HCC18 Nutrition domain, lower adjusted mean scores in favor of LEN were reported at most time points with significant differences at Cycle 6 and Cycle 9 (p
Most domains met the noninferiority assumption between LEN and SOR. The additional evidence of significant HRQOL benefits further support LEN in terms of functional deterioration delays.
Clinical trial identification
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M. Kudo: Honoraria: Bayer, Eisai, MSD, EA Pharma. S. Hudgens: Consultant to Eisai. J-H. Yoon: Research grants from Bayer HealthCare Pharmaceuticals, Daewoong Pharmaceuticals, and Bukwang Pharmaceuticals. C. López López: Grants, personal fees, non-financial support and other from Eisai, Bayer, Lilly, Daiichi Sankyo. C. Dutcus: Employee of Eisai Inc. S. Kraljevic: Employee of Eisai Co Ltd. T. Tamai, G. Meier: Employee of Eisai Inc. V. Breder: Consulting: BMS, MSD, Bayer, Boehringer-Ingelheim. Lectures: BMS, MSD, Bayer, Boehringer-Ingelheim. All other authors have declared no conflicts of interest.