Nivolumab after selective internal radiation therapy for the treatment of hepatocellular carcinoma: a phase 2, single-arm study
de la Torre-Aláez, Manuel ; Matilla, Ana ; Varela, Maria ; Iñarrairaegui, Mercedes ; Reig, Maria ; Lledó, Jose Luis ; Arenas, Juan Ignacio ; Lorente, Sara (Universidad de Zaragoza) ; Testillano, Milagros ; Márquez, Laura ; Da Fonseca, Leonardo ; Argemí, Josepmaria ; Gómez-Martin, Carlos ; Rodriguez-Fraile, Macarena ; Bilbao, Jose I ; Sangro, Bruno
Resumen: Purpose: To evaluate the safety and efficacy of selective internal radiation therapy (SIRT) in combination with a PD-1 inhibitor in patients with unresectable hepatocellular carcinoma (uHCC) and liver-only disease ineligible for chemoembolization.
Patients and methods: NASIR-HCC is a single-arm, multicenter, open-label, phase 2 trial that recruited from 2017 to 2019 patients who were naïve to immunotherapy and had tumors in the BCLC B2 substage (single or multiple tumors beyond the up-to-7 rule), or unilobar tumors with segmental or lobar portal vein invasion (PVI); no extrahepatic spread; and preserved liver function. Patients received SIRT followed 3 weeks later by nivolumab (240 mg every 2 weeks) for up to 24 doses or until disease progression or unacceptable toxicity. Safety was the primary endpoint. Secondary objectives included objective response rate (ORR), time to progression (TTP), and overall survival (OS).
Results: 42 patients received SIRT (31 BCLC-B2, 11 with PVI) and were followed for a median of 22.2 months. 27 patients discontinued and 1 never received Nivolumab. 41 patients had any-grade adverse events (AE) and 21 had serious AEs (SAE). Treatment-related AEs and SAEs grade 3-4 occurred in 8 and 5 patients, respectively. Using RECIST 1.1 criteria, ORR reported by investigators was 41.5% (95% CI 26.3% to 57.9%). Four patients were downstaged to partial hepatectomy. Median TTP was 8.8 months (95% CI 7.0 to 10.5) and median OS was 20.9 months (95% CI 17.7 to 24.1).
Conclusions: The combination of SIRT and nivolumab has shown an acceptable safety profile and signs of antitumor activity in the treatment of patients with uHCC that were fit for SIRT.
Idioma: Inglés
DOI: 10.1136/jitc-2022-005457
Año: 2022
Publicado en: Journal for immunotherapy of cancer 10, 11 (2022), e005457 [9 pp.]
ISSN: 2051-1426
Factor impacto JCR: 10.9 (2022)
Categ. JCR: ONCOLOGY rank: 30 / 241 = 0.124 (2022) - Q1 - T1
Categ. JCR: IMMUNOLOGY rank: 18 / 161 = 0.112 (2022) - Q1 - T1
Factor impacto CITESCORE: 16.8 - Biochemistry, Genetics and Molecular Biology (Q1) - Immunology and Microbiology (Q1) - Pharmacology, Toxicology and Pharmaceutics (Q1) - Medicine (Q1)
Factor impacto SCIMAGO: 3.403 - Cancer Research (Q1) - Immunology (Q1) - Pharmacology (Q1) - Molecular Medicine (Q1) - Oncology (Q1) - Immunology and Allergy (Q1)
Tipo y forma: Artículo (Versión definitiva)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
Debe reconocer adecuadamente la autoría, proporcionar un enlace a la licencia e indicar si se han realizado cambios. Puede hacerlo de cualquier manera razonable, pero no de una manera que sugiera que tiene el apoyo del licenciador o lo recibe por el uso que hace. No puede utilizar el material para una finalidad comercial.
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Patients and methods: NASIR-HCC is a single-arm, multicenter, open-label, phase 2 trial that recruited from 2017 to 2019 patients who were naïve to immunotherapy and had tumors in the BCLC B2 substage (single or multiple tumors beyond the up-to-7 rule), or unilobar tumors with segmental or lobar portal vein invasion (PVI); no extrahepatic spread; and preserved liver function. Patients received SIRT followed 3 weeks later by nivolumab (240 mg every 2 weeks) for up to 24 doses or until disease progression or unacceptable toxicity. Safety was the primary endpoint. Secondary objectives included objective response rate (ORR), time to progression (TTP), and overall survival (OS).
Results: 42 patients received SIRT (31 BCLC-B2, 11 with PVI) and were followed for a median of 22.2 months. 27 patients discontinued and 1 never received Nivolumab. 41 patients had any-grade adverse events (AE) and 21 had serious AEs (SAE). Treatment-related AEs and SAEs grade 3-4 occurred in 8 and 5 patients, respectively. Using RECIST 1.1 criteria, ORR reported by investigators was 41.5% (95% CI 26.3% to 57.9%). Four patients were downstaged to partial hepatectomy. Median TTP was 8.8 months (95% CI 7.0 to 10.5) and median OS was 20.9 months (95% CI 17.7 to 24.1).
Conclusions: The combination of SIRT and nivolumab has shown an acceptable safety profile and signs of antitumor activity in the treatment of patients with uHCC that were fit for SIRT.
Idioma: Inglés
DOI: 10.1136/jitc-2022-005457
Año: 2022
Publicado en: Journal for immunotherapy of cancer 10, 11 (2022), e005457 [9 pp.]
ISSN: 2051-1426
Factor impacto JCR: 10.9 (2022)
Categ. JCR: ONCOLOGY rank: 30 / 241 = 0.124 (2022) - Q1 - T1
Categ. JCR: IMMUNOLOGY rank: 18 / 161 = 0.112 (2022) - Q1 - T1
Factor impacto CITESCORE: 16.8 - Biochemistry, Genetics and Molecular Biology (Q1) - Immunology and Microbiology (Q1) - Pharmacology, Toxicology and Pharmaceutics (Q1) - Medicine (Q1)
Factor impacto SCIMAGO: 3.403 - Cancer Research (Q1) - Immunology (Q1) - Pharmacology (Q1) - Molecular Medicine (Q1) - Oncology (Q1) - Immunology and Allergy (Q1)
Tipo y forma: Artículo (Versión definitiva)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
Debe reconocer adecuadamente la autoría, proporcionar un enlace a la licencia e indicar si se han realizado cambios. Puede hacerlo de cualquier manera razonable, pero no de una manera que sugiera que tiene el apoyo del licenciador o lo recibe por el uso que hace. No puede utilizar el material para una finalidad comercial.Exportado de SIDERAL (2024-03-18-15:59:23)
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Registro creado el 2023-01-11, última modificación el 2024-03-19