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Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with Palonosetron


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タイトル: Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with Palonosetron
著者: Komatsu, Yoshito 著作を一覧する
Okita, Kenji 著作を一覧する
Yuki, Satoshi 著作を一覧する
Furuhata, Tomohisa 著作を一覧する
Fukushima, Hiraku 著作を一覧する
Masuko, Hiroyuki 著作を一覧する
Kawamoto, Yasuyuki 著作を一覧する
Isobe, Hiroshi 著作を一覧する
Miyagishima, Takuto 著作を一覧する
Sasaki, Kazuaki 著作を一覧する
Nakamura, Michio 著作を一覧する
Ohsaki, Yoshinobu 著作を一覧する
Nakajima, Junta 著作を一覧する
Tateyama, Miki 著作を一覧する
Eto, Kazunori 著作を一覧する
Minami, Shinya 著作を一覧する
Yokoyama, Ryoji 著作を一覧する
Iwanaga, Ichiro 著作を一覧する
Shibuya, Hitoshi 著作を一覧する
Kudo, Mineo 著作を一覧する
Oba, Koji 著作を一覧する
Takahashi, Yasuo 著作を一覧する
キーワード: Chemotherapy-induced nausea and vomiting
moderately-emetogenic chemotherapy
発行日: 2015年 7月
出版者: Wiley-Blackwell
誌名: Cancer science
巻: 106
号: 7
開始ページ: 891
終了ページ: 895
出版社 DOI: 10.1111/cas.12675
抄録: The purpose of this study is to compare the efficacy of a single administration of dexamethasone (DEX) on day1 against DEX administration on days1-3 in combination with palonosetron (PALO), a second-generation 5-HT3 receptor antagonist, for chemotherapy-induced nausea and vomiting (CINV) in non-anthracycline and cyclophosphamide (AC) moderately-emetogenic chemotherapy (MEC). This phaseIII trial was conducted with a multi-center, randomized, open-label, non-inferiority design. Patients who received non-AC MEC as an initial chemotherapy were randomly assigned to either a group administered PALO (0.75mg, i.v.) and DEX (9.9mg, i.v.) prior to chemotherapy (study treatment group), or a group administered additional DEX (8mg, i.v. or p.o.) on days2-3 (control group). The primary endpoint was complete response (CR) rate. The CR rate difference was estimated by logistic regression with allocation factors as covariates. The non-inferiority margin was set at -15% (study treatment group - control group). From April 2011 to March 2013, 305patients who received non-AC MEC were randomly allocated to one of two study groups. Overall, the CR rate was 66.2% in the study treatment group (N=151) and 63.6% in the control group (N=154). PALO plus DEX day1 was non-inferior to PALO plus DEX days1-3 (difference, 2.5%; 95% confidence interval [CI]: -7.8%-12.8%; P-value for non-inferiority test=0.0004). There were no differences between the two groups in terms of complete control rate (64.9 vs 61.7%) and total control rate (49.7% vs 47.4%). Anti-emetic DEX administration on days2-3 may be eliminated when used in combination with PALO in patients receiving non-AC MEC.
資料タイプ: article
出現コレクション:雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

提供者: 小松 嘉人


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