View in EDS

Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial

Saved in:
Bibliographic Details
Title: Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial
Authors: Manuel De la Torre-Aláez, Ana Matilla, María Varela, Mercedes Iñarrairaegui, María Reig, José Luis Lledó, Juan Ignacio Arenas, Sara Lorente, Milagros Testillano, Laura Márquez, Gemma Iserte, Josepmaria Argemí, Carlos Gómez-Martin, Macarena Rodríguez-Fraile, José I. Bilbao, Richard F. Pollock, Johannes Pöhlmann, Ion Agirrezabal, Bruno Sangro
Source: Journal of Patient-Reported Outcomes, Vol 9, Iss 1, Pp 1-12 (2025)
Publisher Information: SpringerOpen, 2025.
Publication Year: 2025
Collection: LCC:Public aspects of medicine
Subject Terms: Hepatocellular carcinoma, Quality of life, Selective internal radiation therapy, SIR-Spheres, Nivolumab, Immunotherapy, Public aspects of medicine, RA1-1270
Description: Abstract 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 .
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2509-8020
Relation: https://doaj.org/toc/2509-8020
DOI: 10.1186/s41687-025-00873-6
Access URL: https://doaj.org/article/6d14bb7b161740068ccd9ae9575e10cf
Accession Number: edsdoj.6d14bb7b161740068ccd9ae9575e10cf
Database: Directory of Open Access Journals
Description
Abstract:Abstract 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 .
ISSN:25098020
DOI:10.1186/s41687-025-00873-6