ID | 13215 |
Sort Key | 2
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タイトル(別表記) | Adenoviral p53 gene therapy for lung cancer
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フルテキストURL | |
著者 |
田中 紀章
岡山大学大学院医歯薬学総合研究科 消化器・腫瘍外科学
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抄録 | To determine the feasibility, safety, humoral immune response, and biological activity of multiple intratumoral injections of Ad5CMV-p53, and to characterize the pharmacokinetics of Ad5CMV-p53 in patients with advanced non-small cell lung cancer (NSCLC). Fifteen patients with histologically confirmed NSCLC and p53 mutations were enrolled into this phase I trial. Nine patients received escalating dose levels of Ad5CMV-p53 (1 × 109 to 1 × 1011 plaque-forming units[PFU]) as monotherapy once every 4 weeks. Six patients were treated on a 28-day schedule with Ad5CMV-p53 in combination with intravenous administration of cisplatin (80 mg/m2). Patients were monitored for toxicity, vector distribution, antibody formation, and tumor response. Fifteen patients received a total of 63 intratumoral injections of Ad5CMV-p53 without dose-limiting toxicity. The most common treatment-related toxicity was a transient fever. Specific p53 transgene expression was detected using reverse-transcriptase polymerase chain reaction in biopsied tumor tissues throughout the period of treatment despite of the presence of neutralizing anti-adenovirus antibody. Distribution studies revealed that the vector was detected in the gargle and plasma, but rarely in the urine. Thirteen of 15 patients were assessable for efficacy; one patient had a partial response (squamous cell carcinoma at the carina), 10 patients had stable disease, with three lasting ≥9 months, and 2 patients had progressive disease. Multiple courses of intratumoral Ad5CMV-p53 injection alone or in combination with intravenous administration of cisplatin were feasible and well tolerated in advanced NSCLC patients, and appeared to provide clinical benefit.
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キーワード | p53 遺伝子
アデノウイルスベクター (adenovirus vector)
肺癌 (lung cancer)
臨床試験 (clinical trial)
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備考 | 平成18年度岡山医学会賞(林原賞)受賞論文
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出版物タイトル |
岡山医学会雑誌
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発行日 | 2008-01-04
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巻 | 119巻
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号 | 3号
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出版者 | 岡山医学会
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出版者(別表記) | Okayama Medical Association
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開始ページ | 229
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終了ページ | 234
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ISSN | 00301558
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NCID | AN00032489
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資料タイプ |
学術雑誌論文
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OAI-PMH Set |
岡山大学
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言語 |
日本語
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著作権者 | 岡山医学会
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論文のバージョン | publisher
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査読 |
有り
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DOI | |
NAID | |
Eprints Journal Name | joma
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