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ID 47069
本文ファイル
著者
Hatooka, Masahiro
Inagaki, Yuki
Morio, Kei 大学院医歯薬保健学研究科(医) 広大研究者総覧
Nakahara, Takasi 病院総合医療研究推進センター 広大研究者総覧
Tsuge, Masataka 自然科学研究支援開発センター 広大研究者総覧
Kawakami, Yoshiiku 病院総合医療研究推進センター
Awai, Kazuo 大学院医歯薬保健学研究科(医) 広大研究者総覧
Masaki, Keiichi
Waki, Koji
Kohno, Hirotaka
Kohno, Hiroshi
Moriya, Takashi
Nagaoki, Yuko
Tamura, Toru
Amano, Hajime
Katamura, Yoshio
Chayama, Kazuaki 大学院医歯薬保健学研究科(医) 広大研究者総覧
キーワード
HAIC
HCC
RECIST
Sorafenib
Tumor marker
NDC
医学
抄録(英)
[BACKGROUND]:In patients with advanced hepatocellular carcinoma (HCC), evidence is unclear as to whether hepatic arterial infusion chemotherapy (HAIC) or sorafenib is superior. We performed a prospective, open-label, non-comparative phase II study to assess survival with HAIC or HAIC converted to sorafenib.
[METHODS]:Fifty-five patients were prospectively enrolled. Patients received HAIC as a second course if they had complete response, partial response, or stable disease (SD) with an alpha fetoprotein (AFP) ratio < 1 or a des-γ-carboxy prothrombin (DCP) ratio < 1. Patients were switched to sorafenib if they had SD with an AFP ratio > 1 and a DCP ratio > 1 or disease progression. The primary endpoint was the 1-year survival rate. Secondary endpoints were the 2-year survival rate, HAIC response, survival rate among HAIC responders, progression-free survival, and adverse events.
[RESULTS]:Of the 55 patients in the intent-to-treat population, the 1-year and 2-year survival rates were 64.0 and 48.3%, respectively. After the first course of HAIC, one (1.8%) patient showed complete response, 13 (23.6%) showed partial response, 30 (54.5%) had SD, and 10 (18.1%) patients had progressive disease. Twenty-three patients (41.8%) had SD with AFP ratios < 1 or DCP ratios < 1, and 7 (12.7%) had SD with AFP ratios > 1 and DCP ratios > 1. Thirty-seven patients (68.5%) were responders and 17 (30.9%) were non-responders to HAIC. In responders, the 1-year and 2-year survival rates were 78 and 62%, respectively.
[CONCLUSION]:Given the results of this study, this protocol deserves consideration for patients with advanced HCC. This trial was registered prospectively from December 12. 2012 to September 1. 2016.
掲載誌名
BMC Cancer
18巻
開始ページ
633
出版年月日
2018-06-04
出版者
BioMed Central
ISSN
1471-2407
出版者DOI
PubMedID
言語
英語
NII資源タイプ
学術雑誌論文
広大資料タイプ
学術雑誌論文
DCMIタイプ
text
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application/pdf
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publisher
権利情報
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
関連情報URL
部局名
医歯薬学総合研究科
自然科学研究支援開発センター
病院