000121193 001__ 121193
000121193 005__ 20240319081019.0
000121193 0247_ $$2doi$$a10.1136/jitc-2022-005457
000121193 0248_ $$2sideral$$a131789
000121193 037__ $$aART-2022-131789
000121193 041__ $$aeng
000121193 100__ $$ade la Torre-Aláez, Manuel
000121193 245__ $$aNivolumab after selective internal radiation therapy for the treatment of hepatocellular carcinoma: a phase 2, single-arm study
000121193 260__ $$c2022
000121193 5060_ $$aAccess copy available to the general public$$fUnrestricted
000121193 5203_ $$aPurpose: 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.
000121193 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/
000121193 590__ $$a10.9$$b2022
000121193 592__ $$a3.403$$b2022
000121193 591__ $$aONCOLOGY$$b30 / 241 = 0.124$$c2022$$dQ1$$eT1
000121193 593__ $$aCancer Research$$c2022$$dQ1
000121193 591__ $$aIMMUNOLOGY$$b18 / 161 = 0.112$$c2022$$dQ1$$eT1
000121193 593__ $$aImmunology$$c2022$$dQ1
000121193 593__ $$aPharmacology$$c2022$$dQ1
000121193 593__ $$aMolecular Medicine$$c2022$$dQ1
000121193 593__ $$aOncology$$c2022$$dQ1
000121193 593__ $$aImmunology and Allergy$$c2022$$dQ1
000121193 594__ $$a16.8$$b2022
000121193 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000121193 700__ $$aMatilla, Ana
000121193 700__ $$aVarela, Maria
000121193 700__ $$aIñarrairaegui, Mercedes
000121193 700__ $$aReig, Maria
000121193 700__ $$aLledó, Jose Luis
000121193 700__ $$aArenas, Juan Ignacio
000121193 700__ $$0(orcid)0000-0003-4672-8083$$aLorente, Sara$$uUniversidad de Zaragoza
000121193 700__ $$aTestillano, Milagros
000121193 700__ $$aMárquez, Laura
000121193 700__ $$aDa Fonseca, Leonardo
000121193 700__ $$aArgemí, Josepmaria
000121193 700__ $$aGómez-Martin, Carlos
000121193 700__ $$aRodriguez-Fraile, Macarena
000121193 700__ $$aBilbao, Jose I
000121193 700__ $$aSangro, Bruno
000121193 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000121193 773__ $$g10, 11 (2022), e005457 [9 pp.]$$pJ. immunotherap. cancer$$tJournal for immunotherapy of cancer$$x2051-1426
000121193 8564_ $$s600003$$uhttps://zaguan.unizar.es/record/121193/files/texto_completo.pdf$$yVersión publicada
000121193 8564_ $$s3155244$$uhttps://zaguan.unizar.es/record/121193/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000121193 909CO $$ooai:zaguan.unizar.es:121193$$particulos$$pdriver
000121193 951__ $$a2024-03-18-15:59:23
000121193 980__ $$aARTICLE