Background: The health-related quality of life (HRQoL) impact of therapies for hepatocellular carcinoma (HCC) influences decision-making and treatment outcomes. The present study reports HRQoL results from NASIR-HCC, a single-arm study of selective internal radiation therapy (SIRT) with Y90 resin microspheres followed by nivolumab for unresectable HCC.
Methodology: Participants completed the EQ-5D-3 L, EQ-VAS, and FACT-Hep at baseline and on the first day of each nivolumab cycle. Linear mixed-effect models were used to calculate changes in outcomes in participants with the baseline and ≥ 1 follow-up measurement. Changes were assessed for clinical meaningfulness versus published minimally important differences.
Results: Thirty-two patients from NASIR-HCC were included. Completion rates exceeded 70% at 62% of time points. Across EQ-5D-3 L domains, minimal changes were reported. Most patients had no problems at almost all time points. Mean index values were 0.864 at baseline and 0.763 in cycle 8, but this difference was not clinically meaningful. The small EQ-VAS increase, from 74.8 at baseline to 75.9 in cycle 8, was also not clinically meaningful. The various FACT scales remained stable, although transient but not clinically meaningful declines occurred for some scales. The median time to deterioration was 5.5 months for the FACT-Hep score.
Conclusions: Combining SIRT with nivolumab did not compromise HRQoL in patients with unresectable HCC. Study results were limited by the small number of patients but, combined with the previously reported clinical outcomes, suggested that the treatment combination deserves further consideration in this difficult-to-treat population.
Trial registration number/date of registration: NCT03380130. First submitted on 2017-10-20; https://clinicaltrials.gov/study/NCT03380130 .
Keywords: Hepatocellular carcinoma; Immunotherapy; Nivolumab; Quality of life; SIR-Spheres; Selective internal radiation therapy.
Patients with hepatocellular carcinoma often have poor health-related quality of life. Any treatment for hepatocellular carcinoma should aim to, at best, improve health-related quality of life, and, at the very least, prevent further declines. For the novel treatment combination of selective internal radiation therapy with Y90 resin microspheres and the immunotherapeutic drug nivolumab, clinical but no health-related quality of life data have been published before. The present study is the first to provide such data, based on the NASIR-HCC study, in which participants with unresectable hepatocellular carcinoma completed multiple instruments to measure health-related quality of life, including the EQ-5D-3 L and the FACT-Hep questionnaire. For all measurements, scores remained broadly stable over time and where changes were observed, in either a positive or a negative direction, these were transient and not clinically meaningful. These findings imply that selective internal radiation therapy followed by eight cycles of nivolumab does not reduce health-related quality of life in unresectable hepatocellular carcinoma. This treatment combination therefore should be evaluated further for this patient population, in particular as its clinical data have also been promising.
© 2025. The Author(s).