| アイテムタイプ |
学術雑誌論文 / Journal Article(1) |
| 公開日 |
2025-04-17 |
| タイトル |
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タイトル |
A Phase Ib Study of Durvalumab (MEDI4736) in Combination with Carbon-Ion Radiotherapy and Weekly Cisplatin for Patients with Locally Advanced Cervical Cancer (DECISION Study): The Early Safety and Efficacy Results. |
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言語 |
en |
| 言語 |
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言語 |
eng |
| 資源タイプ |
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資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
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資源タイプ |
journal article |
| 著者 |
Noriyuki Okonogi
Kazutoshi Murata
Shigeru Yamada
Yuji Habu
Makoto Hori
Tomoya Kurokawa
Yosuke Inaba
Tadami Fujiwara
Yasuhisa Fujii
Michiko Hanawa
Yohei Kawasaki
Yoko Hattori
Kazuko Suzuki
Kyoko Tsuyuki
Masaru Wakatsuki
Masashi Koto
Sumitaka Hasegawa
Hitoshi Ishikawa
Hideki Hanaoka
Makio Shozu
Hiroshi Tsuji
Hirokazu Usui
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| 抄録 |
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内容記述タイプ |
Abstract |
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内容記述 |
We conducted a phase Ib study to examine the safety of a combination of carbon-ion RT (CIRT) with durvalumab (MEDI4736; AstraZeneca) in patients with locally advanced cervical cancer. This was an open-label, single-arm study with a modified 3 + 3 design. Patients with newly diagnosed histologically proven locally advanced cervical cancer were enrolled. All patients received 74.4 Gy of CIRT in 20 fractions and concurrent weekly cisplatin (chemo-CIRT) at a dose of 40 mg/m. Durvalumab was administered (1500 mg/body) at weeks two and six. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs), including dose-limiting toxicity (DLT). All three enrolled patients completed the treatment without interruption. One patient developed hypothyroidism after treatment and was determined to be an SAE. No other SAEs were observed. The patient recovered after levothyroxine sodium hydrate treatment. None of the AEs, including hypothyroidism, were associated with DLT in the present study. All three patients achieved complete responses within the CIRT region concerning treatment efficacy. This phase 1b trial demonstrates the safety of combining chemo-CIRT and durvalumab for locally advanced cervical cancer in the early phase. Further research is required as only three patients were included in this study. |
| 書誌情報 |
International journal of molecular sciences
巻 24,
号 13,
p. 10565,
発行日 2023-06
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| 出版者 |
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出版者 |
MDPI |
| ISSN |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
1422-0067 |
| PubMed番号 |
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識別子タイプ |
PMID |
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関連識別子 |
37445743 |
| DOI |
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識別子タイプ |
DOI |
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関連識別子 |
10.3390/ijms241310565 |
