title: Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with Palonosetron.
abstract: The purpose of this study is to compare the efficacy of a single administration of dexamethasone (DEX) on day 1 against DEX administration on days 1-3 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 phase III 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 (0.75 mg, i.v.) and DEX (9.9 mg, i.v.) prior to chemotherapy (study treatment group), or a group administered additional DEX (8 mg, i.v. or p.o.) on days 2-3 (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, 305 patients 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 day 1 was non-inferior to PALO plus DEX days 1-3 (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 days 2-3 may be eliminated when used in combination with PALO in patients receiving non-AC MEC.
authors: Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.
authors: Yoshito
authors: Y
authors: Komatsu
authors: Department of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo, Japan.
authors: Kenji
authors: K
authors: Okita
authors: Cancer Center, Hokkaido University Hospital, Sapporo, Japan.
authors: Satoshi
authors: S
authors: Yuki
authors: School of Health Sciences, Sapporo Medical University, Sapporo, Japan.
authors: Tomohisa
authors: T
authors: Furuhata
authors: Cancer Center, Hokkaido University Hospital, Sapporo, Japan.
authors: Hiraku
authors: H
authors: Fukushima
authors: Surgery, Sapporo-Kosei General Hospital, Sapporo, Japan.
authors: Hiroyuki
authors: H
authors: Masuko
authors: Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan.
authors: Yasuyuki
authors: Y
authors: Kawamoto
authors: Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan.
authors: Hiroshi
authors: H
authors: Isobe
authors: Department of Internal Medicine, Kushiro Rosai Hospital, Kushiro, Japan.
authors: Takuto
authors: T
authors: Miyagishima
authors: Surgery, Otaru Ekisaikai Hospital, Otaru, Japan.
authors: Kazuaki
authors: K
authors: Sasaki
authors: Gastroenterology, Sapporo City General Hospital, Sapporo, Japan.
authors: Michio
authors: M
authors: Nakamura
authors: Respiratory Center, Asahikawa Medical University, Asahikawa, Japan.
authors: Yoshinobu
authors: Y
authors: Ohsaki
authors: Department of 3rd Internal Medicine, Obihiro Kousei General Hospital, Obihiro, Japan.
authors: Junta
authors: J
authors: Nakajima
authors: Internal Medicine, Tomakomai Nisshou Hospital, Tomakomai, Japan.
authors: Miki
authors: M
authors: Tateyama
authors: Gastroenterology, Tomakomai City Hospital, Tomakomai, Japan.
authors: Kazunori
authors: K
authors: Eto
authors: Gastroenterology, Oji General Hospital, Tomakomai, Japan.
authors: Shinya
authors: S
authors: Minami
authors: Surgery, Iwamizawa Municipal General Hospital, Iwamizawa, Japan.
authors: Ryoji
authors: R
authors: Yokoyama
authors: Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, Japan.
authors: Ichiro
authors: I
authors: Iwanaga
authors: Surgery, Muroran City General Hospital, Muroran, Japan.
authors: Hitoshi
authors: H
authors: Shibuya
authors: Gastroenterology, Sapporo Hokuyu Hospital, Sapporo, Japan.
authors: Mineo
authors: M
authors: Kudo
authors: Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors: Koji
authors: K
authors: Oba
authors: Department of Gastroenterology, Hokkaido Cancer Center, Sapporo, Japan.
authors: Yasuo
authors: Y
authors: Takahashi
mesh_terms: D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D009369:Neoplasms / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D000077924:Palonosetron; D011788:Quality of Life; D011812:Quinuclidines / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D009944:Organoplatinum Compounds; D011812:Quinuclidines; D012702:Serotonin Antagonists; D000077150:Oxaliplatin; D000077924:Palonosetron; D000077146:Irinotecan; D003907:Dexamethasone; D002166:Camptothecin
keywords: Chemotherapy-induced nausea and vomiting; dexamethasone; moderately-emetogenic chemotherapy; palonosetron; phase III