國家衛生研究院 NHRI:Item 3990099045/15517

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Title:	Nivolumab plus ipilimumab (N plus I) for potentially resectable hepatocellular carcinoma (HCC): Efficacy and surgical outcome
Authors:	Su, YY;Lin, YJ;Hsiao, CF;Ou, DL;Chen, SC;Wang, HW;Wang, JH;Wu, YM;Lee, WC;Chou, SC;Ho, CL;Chiu, CF;Chen, LT;Shen, YS;Cheng, AL;Hsu, C
Contributors:	National Institute of Cancer Research;Institute of Population Health Sciences
Abstract:	Background: This study evaluated the efficacy, safety, and surgical outcome for HCC patients who are potentially eligible for curative surgery after neoadjuvant N+I, as defined by one of the following: (a) macrovascular invasion (AJCC T3) (b) multiple (>3) or tumors in bilateral lobes (AJCC T2) (c) AJCC T2 tumors with significant portal hypertension (d) other conditions with high risk of recurrence (NCT03510871). Methods: Eligible subjects must have histological diagnosis of HCC, measurable tumors (RECIST 1.1), ECOG 0-1, Child-Pugh A. Nivolumab 3 mg/kg + ipilimumab 1 mg/kg were given every 3 weeks. Tumor assessment was done after 2 and 4 cycles of N+I. The primary endpoint was the proportion of subjects who had >10% tumor size reduction. Subjects were considered evaluable if they received 2 cycles of N+I and the first imaging evaluation. Subjects will proceed to curative surgery if feasible; otherwise, they will receive other treatment according to guidelines. Results: From Feb. 2019 to Mar. 2022, 43 subjects were enrolled (men/women 37/6, median age 64 years, HBsAg+/anti-HCV+ 26/5, BCLC stage A/B/C 4/13/26, median tumor size 8.7 cm (range 1.8-16.3), median alpha-fetoprotein 97.1 ng/mL (range 0.9-303000). Three subjects had early progression after 1 cycle of N+I. In the 40 evaluable subjects, 16 (40%) had >10% tumor size reduction, and 3 had downstage by BCLC. Twenty-four subjects received surgery and 8 (33%) had major pathological response (>90% tumor necrosis). As of July 15, 2022, the estimated 2-year PFS and OS were 47.1% (95% CI, 28.7-65.4) and 72.0% (95% CI, 56.0-88.1). The most common all-grade adverse event (AE) is hepatitis in 22 (51%). Grade 3-4 AE occurred to 19 subjects (most commonly hepatitis in 12), 14 of which were considered immune-related AE and required steroid. Conclusion: Neoadjuvant N+I is feasible for patients with potentially resectable HCC. Long-term follow-up is needed to clarify its efficacy in terms of reducing recurrence and improving survival.
Date:	2023-11
Relation:	Annals of Oncology. 2023 Nov;34(Suppl. 3):S1390.
Link to:	http://dx.doi.org/10.1016/j.annonc.2023.09.140
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:001106690100114
Appears in Collections:	[Yung-Yeh Su] Conference Papers/Meeting Abstract [Li-Tzong Chen] Conference Papers/Meeting Abstract [Chin-Fu Hsiao] Conference Papers/Meeting Abstract

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