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

Komatsu, Yoshito; Okita, Kenji; Yuki, Satoshi et al.

Cancer science, 2015, 106(7), 891-895

Permalink : https://hdl.handle.net/2115/59800

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アクセス権
open access
URI
https://hdl.handle.net/2115/59800
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 ; Okita, Kenji ; Yuki, Satoshi ; Furuhata, Tomohisa ; Fukushima, Hiraku ; Masuko, Hiroyuki ; Kawamoto, Yasuyuki ; Isobe, Hiroshi ; Miyagishima, Takuto ; Sasaki, Kazuaki ; Nakamura, Michio ; Ohsaki, Yoshinobu ; Nakajima, Junta ; Tateyama, Miki ; Eto, Kazunori ; Minami, Shinya ; Yokoyama, Ryoji ; Iwanaga, Ichiro ; Shibuya, Hitoshi ; Kudo, Mineo ; Oba, Koji ; Takahashi, Yasuo
e-Rad_Researcher
60333598
著者名
Komatsu, Yoshito
e-Rad_Researcher
70517911
著者名
Okita, Kenji
著者名
Yuki, Satoshi
e-Rad_Researcher
80359992
著者名
Furuhata, Tomohisa
著者名
Fukushima, Hiraku
著者名
Masuko, Hiroyuki
著者名
Kawamoto, Yasuyuki
e-Rad_Researcher
90241322
著者名
Isobe, Hiroshi
著者名
Miyagishima, Takuto
著者名
Sasaki, Kazuaki
著者名
Nakamura, Michio
e-Rad_Researcher
30191935
著者名
Ohsaki, Yoshinobu
著者名
Nakajima, Junta
著者名
Tateyama, Miki
著者名
Eto, Kazunori
著者名
Minami, Shinya
著者名
Yokoyama, Ryoji
著者名
Iwanaga, Ichiro
著者名
Shibuya, Hitoshi
著者名
Kudo, Mineo
e-Rad_Researcher
30422926
著者名
Oba, Koji
e-Rad_Researcher
90374610
著者名
Takahashi, Yasuo
言語
英語
キーワード
Chemotherapy-induced nausea and vomiting
dexamethasone
moderately-emetogenic chemotherapy
palonosetron
phaseIII
発行日
2015-07
出版者
Wiley-Blackwell
収録物名
Cancer science
巻(号)
106(7)
ページ
891-895
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.
資源タイプ
学術雑誌論文
出版タイプ
Version of Record
権利情報
Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
PISSN
1347-9032
関連情報 (isIdenticalTo)
出版社版DOI
https://doi.org/10.1111/cas.12675