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Carbon Ion Radiotherapy for Hepatocellular Carcinoma: Phase I/II and Phase II Clinical Trials

https://repo.qst.go.jp/records/61073
https://repo.qst.go.jp/records/61073
62b27c0d-6508-43c9-bd3e-b8d52cf8149f
Item type 会議発表用資料 / Presentation(1)
公開日 2005-09-09
タイトル
タイトル Carbon Ion Radiotherapy for Hepatocellular Carcinoma: Phase I/II and Phase II Clinical Trials
言語
言語 eng
資源タイプ
資源タイプ識別子 http://purl.org/coar/resource_type/c_c94f
資源タイプ conference object
アクセス権
アクセス権 metadata only access
アクセス権URI http://purl.org/coar/access_right/c_14cb
著者 Katou, Hirotoshi

× Katou, Hirotoshi

WEKO 605118

Katou, Hirotoshi

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Yamada, Shigeru

× Yamada, Shigeru

WEKO 605119

Yamada, Shigeru

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Yasuda, Shigeo

× Yasuda, Shigeo

WEKO 605120

Yasuda, Shigeo

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Maeda, Yukiteru

× Maeda, Yukiteru

WEKO 605121

Maeda, Yukiteru

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Kamada, Tadashi

× Kamada, Tadashi

WEKO 605122

Kamada, Tadashi

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Mizoe, Junetsu

× Mizoe, Junetsu

WEKO 605123

Mizoe, Junetsu

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Ootou, Masao

× Ootou, Masao

WEKO 605124

Ootou, Masao

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Tsujii, Hirohiko

× Tsujii, Hirohiko

WEKO 605125

Tsujii, Hirohiko

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加藤 博敏

× 加藤 博敏

WEKO 605126

en 加藤 博敏

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山田 滋

× 山田 滋

WEKO 605127

en 山田 滋

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安田 茂雄

× 安田 茂雄

WEKO 605128

en 安田 茂雄

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前田 幸輝

× 前田 幸輝

WEKO 605129

en 前田 幸輝

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鎌田 正

× 鎌田 正

WEKO 605130

en 鎌田 正

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溝江 純悦

× 溝江 純悦

WEKO 605131

en 溝江 純悦

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大藤 正雄

× 大藤 正雄

WEKO 605132

en 大藤 正雄

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辻井 博彦

× 辻井 博彦

WEKO 605133

en 辻井 博彦

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抄録
内容記述タイプ Abstract
内容記述 Purpose:
To evaluate the safety and efficacy of carbon ion radiotherapy (CIRT) for hepatocellular carcinoma (HCC)
Patients and Methods:
Eligibility criteria for this study were as follows: biopsy-proven HCC; recurrent or residual tumor after other ineffective treatments or no indication for any other treatment; no tumor thrombosis of the portal main branch; no other viable lesion outside the planning target volume; no prior radiotherapy for target tumors; hepatic disorder of Child-Pugh grade A or B; Karnofsky performance status of 60-100; no other active cancer; and digestive tract not in contact with clinical target volume. CIRT was administered in 15 fractions for 5 weeks for 24 patients, 12 fractions for 3 weeks for 34 patients, 8 fractions for 2 weeks for 24 patients, 4 fractions for 1 week for 75 patients, or 2 fractions for 2 days for 32 patients within Phase I/II or Phase II clinical trials. Total dose ranged from 49.5 cobalt gray equivalent (GyE) in 15 fractions to 38.8 GyE in 2 fractions.
Results:
Between April 1995 and February 2005, 189 patients were totally enrolled. The subjects of this report were 181 patients with follow-up period of over 6 months, 13 of whom were twice treated with CIRT in this study. Therefore, the number of subjects for local control and survival analysis was 181 and 168, respectively. The survival period was calculated from the day of commencement of the first CIRT. The median age at therapy was 68 years (range, 37-84 years). All the patients had chronic liver diseases of Child-Pugh grade A in 145, B in 33, and inevaluable in 3. Ninety-six patients (53%) had intrahepatic recurrent lesions. The median tumor size was 4.0 cm in diameter (range, 1.2-12.0 cm).
During a median follow-up of 58 months (range, 8-118 months), no hepatic failure resulting from the therapy and no treatment-related death occurred. Incidence of grade 3 early hepatic toxicity according to NCI-CTC was 13%, 1%, 2%, 8%, and 0% in the serum-GPT, ALB, T.BIL, prothrombin activity (PT%) and ALP, essential valuables concerning hepatic function, respectively. No grade 4 toxicity occurred with exception of 1 patient in T.BIL. No other grade 3 or worse adverse effect occurred. In 92% and 81% of the evaluable patients, the Child-Pugh score did not increase by more than 1 point in the early and late phase, respectively.
Local control rate was 94%, 88%, and 88% at 1, 3, and 5 years, respectively. Overall survival rate was 93%, 54%, and 29% at 1, 3, and 5 years, respectively. The rate in the 27 patients initially treated with CIRT of 52.8GyE/4-fraction in the phase II study was 96% and 71% at 1 and 3 years, respectively, that was comparable with that in the hepatic resection in Japan.
Conclusion:
Carbon ion radiotherapy for hepatocellular carcinoma, especially short-course carbon ion radiotherapy of 52.8GyE/4-fraction, seems to be safe and effective, and to have a promising potential as a new, radical, and minimally invasive therapeutic option for Hepatocellular Carcinoma.
会議概要(会議名, 開催地, 会期, 主催者等)
内容記述タイプ Other
内容記述 第42回 Particle Therapy Co-operative Group Meeting
発表年月日
日付 2005-06-10
日付タイプ Issued
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