國家衛生研究院 NHRI:Item 3990099045/13588
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    题名: Nivolumab plus ipilimumab as neoadjuvant therapy for potentially resectable hepatocellular carcinoma
    作者: Su, Y;Lin, Y;Hsiao, C;Ou, D;Chen, S;Wu, Y;Lee, W;Lin, J;Hsu, C;Ho, M;Lu, L;Wu, T;Lai, S;Chao, Y;Chou, T;Yen, C;Chen, L;Shan, Y;Cheng, A;Hsu, C
    贡献者: National Institute of Cancer Research
    摘要: Background: Nivolumab plus ipilimumab (N+I) therapy has shown promising antitumor efficacy and safety for advanced hepatocellular carcinoma (HCC) patients after sorafenib therapy. This study aimed to explore whether N+I may improve the treatment efficacy of HCC patients who are potentially eligible for curative surgery (NCT03510871). Methods: Eligible subjects must have had a histological diagnosis of HCC, measurable tumors (by RECIST 1.1), ECOG score 0 or 1, Child-Pugh class A, and fulfilling one of the following criteria of ‘potentially eligible for curative surgery’: (a) AJCC T3 tumor(s) (tumor with macrovascular invasion); (b) AJCC T2 tumors with multiple (>3) tumors or tumors in bilateral lobes; (c) AJCC T2 tumors with significant portal hypertension (splenomegaly, esophageal varices or platelet 10% tumor size reduction as per RECIST 1.1 after N+I treatment. Subjects who were considered eligible for curative surgery received surgery, while those considered not eligible for surgery received other anti-cancer therapy according to current practice guidelines. Results: From February 2019 to January 2021, 29 subjects were enrolled (men/women 23/6, median age 62 years, HBsAg+/ anti-HCV+ 12/3, BCLC stage A/B/C 2/8/19, liver tumor single/multiple 3/26, median tumor size 11.1 cm (range 1.8 – 16.2), median alpha-fetoprotein 64.9 ng/mL (range 2-71560)). In the 28 subjects evaluable for response, 11 (39.3%) had > 10% tumor size reduction; 7 (25%) partial responses, 10 (35.7%) stable diseases, and 11 (39.3%) progressive diseases were documented. Fifteen subjects received surgery, and 5 (33.3%) had major pathological response (>90% of tumor necrosis). The most common all-grade adverse event (AE) was hepatitis (48.3%). Grade 3-4 AE occurred in 12 subjects (hepatitis 5, infection 2, lipase increase 2, pruritus/ leukocyte decrease/ pneumonitis (one for each)), 7 of which were considered immune-related AE and required steroid treatment. RNA-Seq analysis of the pre-treatment biopsy indicated that high expression of type I interferon response genes was associated with longer progression-free survival. As of February 2021, the progression-free survival was 13.4 months (95% CI, 1.4-not reached) and 3 subjects died, all due to tumor progression. Conclusions: N+I neoadjuvant therapy is feasible for patients with potentially resectable HCC. Long-term follow-up is needed to clarify its efficacy in terms of increasing resectability and reducing recurrence after surgery.
    日期: 2021-07
    關聯: Annals of Oncology. 2021 Jul;32(Suppl. 3):S141-S141.
    Link to: http://dx.doi.org/10.1016/j.annonc.2021.05.179
    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:000670004200123
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