| 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 |
| dexamethasone |
| moderately-emetogenic chemotherapy |
| palonosetron |
| phaseIII |
| 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. |
| Rights: | https://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Type: | article |
| URI: | http://hdl.handle.net/2115/59800 |
| 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)
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