title: A phase II, randomized study of aprepitant in the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in colorectal cancer patients.
abstract: The present study aimed to study the efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) for colorectal cancer (CRC), and comprised a multicenter, phase II, open-label, randomized, parallel comparative study conducted as part of the Kagoshima aprepitant study for colon cancer in Japan. Patients with advanced or recurrent CRC were treated with standard MEC regimens (FOLFOX, XELOX or FOLFIRI) and received either standard chemotherapy [5-hydroxytryptamine-3 receptor antagonist (5-HT3RA) + dexamethasone] or aprepitant regimen chemotherapy (5-HT3RA + reduced-dose dexamethasone + aprepitant). The primary endpoint of the present study was the proportion of patients who achieved a complete response (CR) during the overall, acute, and delayed phases of the first planned chemotherapy cycle. Secondary endpoints were complete protection, the proportions of patients without emetic episodes or nausea, patients with no more than moderate nausea during the overall, acute and delayed phases, and the time to treatment failure. The CR rates in the overall, acute and delayed phases were similar in the aprepitant and the standard-regimen groups. Additionally, there were no significant differences in secondary endpoints between the two groups. In summary, aprepitant in combination with 5-HT3RA and reduced-dose corticosteroids was well tolerated and effective in preventing CINV associated with moderately emetogenic antitumor agents in Japanese patients with CRC.
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Sakuragaoka, Kagoshima 890-8520, Japan; Department of Surgery, Saiseikai Sendai Hospital, Satsumasendai, Kagoshima 895-0074, Japan.
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Aridome
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Sakuragaoka, Kagoshima 890-8520, Japan.
authors.forename: Shin-Ichirou
authors.initials: SI
authors.lastname: Mori
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Sakuragaoka, Kagoshima 890-8520, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Baba
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Sakuragaoka, Kagoshima 890-8520, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Yanagi
authors.affiliation: Department of Surgery, Imakiire General Hospital, Kagoshima 892-8502, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hamanoue
authors.affiliation: Department of Surgery, Kagoshima Prefectural Satsunan Hospital, Minamisatsuma, Kagoshima 897-1123, Japan.
authors.forename: Futoshi
authors.initials: F
authors.lastname: Miyazono
authors.affiliation: Department of Digestive Surgery, Kobayashi City Hospital, Kobayashi, Miyazaki 886-0004, Japan.
authors.forename: Kouki
authors.initials: K
authors.lastname: Tokuda
authors.affiliation: Department of Surgery, Izumi Regional Medical Center, Akune, Kagoshima 899-1611, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.affiliation: Department of Surgery, Kagoshima Kouseiren Hospital, Kagoshima 890-0061, Japan.
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Ogura
authors.affiliation: Department of Surgery, Kaneko Hospital, Ichikikushikino, Kagoshima 896-0055, Japan.
authors.forename: Kouichi
authors.initials: K
authors.lastname: Kaneko
authors.affiliation: Department of Surgery, Saiseikai Sendai Hospital, Satsumasendai, Kagoshima 895-0074, Japan.
authors.forename: Fumio
authors.initials: F
authors.lastname: Kijima
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Sakuragaoka, Kagoshima 890-8520, Japan.
authors.forename: Kousei
authors.initials: K
authors.lastname: Maemura
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Sakuragaoka, Kagoshima 890-8520, Japan.
authors.forename: Sumiya
authors.initials: S
authors.lastname: Ishigami
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medicine, Kagoshima University, Sakuragaoka, Kagoshima 890-8520, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Natsugoe
keywords: aprepitant; chemotherapy-induced nausea and vomiting; colorectal cancer; dexamethasone; moderately emetogenic chemotherapy