KMID : 1143920210250020206
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Annals of Hepato-Biliary-Pancreatic Surgery 2021 Volume.25 No. 2 p.206 ~ p.214
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Adjuvant therapy using ex vivo-expanded allogenic natural killer cells in hepatectomy patients with hepatitis B virus related solitary hepatocellular carcinoma: MG4101 study
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Kim Jong-Man
Cho Sung-Yoo Rhu Jin-Soo Jung Mi-Young Her Jung-Hyun Lim Ok-Jae Choi Gyu-Seong Shin Eui-Cheol Hwang Yu-Kyeong Joh Jae-Won
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Abstract
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Backgrounds/Aims: Fewer reports have been published regarding hepatectomy patients with solitary hepatocellular carcinoma (HCC) who received immunotherapeutic agents as adjuvant therapy. We evaluated the safety and efficacy of ex vivo-expanded allogenic natural killer (NK) cells in those patients with modified International Union Against Cancer (UICC) stage T3.
Methods: From August 2014 to October 2015, five patients who underwent hepatic resection received ex vivo-expanded allogenic NK cells. Patients received five rounds of NK cells (2-3¡¿107 cells/kg) at postoperative 4, 6, 8, 12, and 16 weeks. This study is registered with ClinicalTrials.gov, number NCT02008929.
Results: The median age of the five patients (three men and two women) was 44.8 years (range, 36-54 years). All had hepatitis B virus-related HCC, and the median tumor size was 2.2 cm (range, 2.1-8.2 cm). None of the patients had any adverse events. HCC recurrence developed in two patients at one year after hepatic resection, but four patients were alive at 3 years. The two recurrence-free patients showed a higher ratio of CD8+ T lymphocyte populations before and after administration of ex vivo-expanded allogenic NK cells compared with the three patients who experienced recurrence.
Conclusions: Immunotherapy using ex vivo-expanded allogenic NK cells in hepatectomy patients can be used safely. Further studies should be investigated for efficacy.
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KEYWORD
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Hepatocellular carcinoma, Natural killer cells, Immunotherapy, Safety, Efficacy
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