Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial
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...
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SpringerOpen
2025-04-01
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| Series: | Journal of Patient-Reported Outcomes |
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| Online Access: | https://doi.org/10.1186/s41687-025-00873-6 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Manuel De la Torre-Aláez |
| collection | DOAJ |
| 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 . |
| format | Article |
| id | doaj-art-6d14bb7b161740068ccd9ae9575e10cf |
| institution | OA Journals |
| issn | 2509-8020 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj-art-6d14bb7b161740068ccd9ae9575e10cf2025-08-20T02:17:13ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202025-04-019111210.1186/s41687-025-00873-6Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trialManuel De la Torre-Aláez0Ana Matilla1María Varela2Mercedes Iñarrairaegui3María Reig4José Luis Lledó5Juan Ignacio Arenas6Sara Lorente7Milagros Testillano8Laura Márquez9Gemma Iserte10Josepmaria Argemí11Carlos Gómez-Martin12Macarena Rodríguez-Fraile13José I. Bilbao14Richard F. Pollock15Johannes Pöhlmann16Ion Agirrezabal17Bruno Sangro18Liver Unit and HPB Oncology Area, Clínica Universidad de NavarraCentro de Investigación Biomédica en Red de Efermedades Hepáticas y Digestivas (CIBEREHD)Liver Unit, Hospital Universitario Central de Asturias, IUOPA, ISPA, Universidad de OviedoCentro de Investigación Biomédica en Red de Efermedades Hepáticas y Digestivas (CIBEREHD)Centro de Investigación Biomédica en Red de Efermedades Hepáticas y Digestivas (CIBEREHD)Centro de Investigación Biomédica en Red de Efermedades Hepáticas y Digestivas (CIBEREHD)Digestive Diseases, Hospital Universitario DonostiaLiver Unit, Hospital Clínico Lozano BlesaDigestive Diseases, Hospital Universitario de CrucesDigestive Diseases Service, Hospital General Universitario Gregorio MarañónCentro de Investigación Biomédica en Red de Efermedades Hepáticas y Digestivas (CIBEREHD)Centro de Investigación Biomédica en Red de Efermedades Hepáticas y Digestivas (CIBEREHD)Medical Oncology, Hospital UniversitarioNuclear Medicine, Clínica Universidad de NavarraInterventional Radiology, Clínica Universidad de NavarraCovalence Research LtdCovalence Research LtdSirtex Medical Europe GmbHLiver Unit and HPB Oncology Area, Clínica Universidad de NavarraAbstract 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 .https://doi.org/10.1186/s41687-025-00873-6Hepatocellular carcinomaQuality of lifeSelective internal radiation therapySIR-SpheresNivolumabImmunotherapy |
| spellingShingle | 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 Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial Journal of Patient-Reported Outcomes Hepatocellular carcinoma Quality of life Selective internal radiation therapy SIR-Spheres Nivolumab Immunotherapy |
| 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 |
| title_full | Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial |
| title_fullStr | Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial |
| title_full_unstemmed | Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial |
| title_short | Health-related quality of life in patients with unresectable hepatocellular carcinoma treated with SIRT and nivolumab: a sub-analysis of the NASIR-HCC trial |
| title_sort | health related quality of life in patients with unresectable hepatocellular carcinoma treated with sirt and nivolumab a sub analysis of the nasir hcc trial |
| topic | Hepatocellular carcinoma Quality of life Selective internal radiation therapy SIR-Spheres Nivolumab Immunotherapy |
| url | https://doi.org/10.1186/s41687-025-00873-6 |
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