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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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Title: Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with Palonosetron
Authors: Komatsu, Yoshito Browse this author →KAKEN DB
Okita, Kenji Browse this author →KAKEN DB
Yuki, Satoshi Browse this author
Furuhata, Tomohisa Browse this author →KAKEN DB
Fukushima, Hiraku Browse this author
Masuko, Hiroyuki Browse this author
Kawamoto, Yasuyuki Browse this author
Isobe, Hiroshi Browse this author →KAKEN DB
Miyagishima, Takuto Browse this author
Sasaki, Kazuaki Browse this author
Nakamura, Michio Browse this author
Ohsaki, Yoshinobu Browse this author →KAKEN DB
Nakajima, Junta Browse this author
Tateyama, Miki Browse this author
Eto, Kazunori Browse this author
Minami, Shinya Browse this author
Yokoyama, Ryoji Browse this author
Iwanaga, Ichiro Browse this author
Shibuya, Hitoshi Browse this author
Kudo, Mineo Browse this author
Oba, Koji Browse this author →KAKEN DB
Takahashi, Yasuo Browse this author →KAKEN DB
Keywords: Chemotherapy-induced nausea and vomiting
moderately-emetogenic chemotherapy
Issue Date: Jul-2015
Publisher: Wiley-Blackwell
Journal Title: Cancer science
Volume: 106
Issue: 7
Start Page: 891
End Page: 895
Publisher DOI: 10.1111/cas.12675
Abstract: 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.
Type: article
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小松 嘉人

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