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

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

106 ( 7 )  , pp.891 - 895 , 2015-07 , Wiley-Blackwell
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.

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