title: Aprepitant, granisetron, and dexamethasone versus palonosetron and dexamethasone for prophylaxis of cisplatin-induced nausea and vomiting in patients with upper gastrointestinal cancer: a randomized crossover phase II trial (KDOG 1002).
abstract: We conducted a randomized trial to compare the safety and effectiveness of aprepitant, granisetron, and dexamethasone (AGD) with those of palonosetron and dexamethasone (PD) in patients who received highly emetogenic chemotherapy (HEC). Patients with esophageal or gastric cancer who were scheduled to receive HEC including at least 60 mg/m of cisplatin as the first-line treatment were randomly assigned to receive AGD (oral aprepitant 125 mg on day 1 and 80 mg on days 2-3; intravenous granisetron 3 mg on day 1; intravenous dexamethasone 6.6 mg on day 1 and oral dexamethasone 4 mg on days 2-3) or PD (intravenous palonosetron 0.75 mg on day 1; intravenous dexamethasone 13.2 mg on day 1 and oral dexamethasone 8 mg on days 2-3). The primary endpoint was a complete response during the overall study period (0-120 h after the start of chemotherapy) in the first cycle. Eighty-five patients were enrolled, and 84 were eligible. The complete response rate did not differ between the treatment groups, but the proportion of patients with no vomiting was significantly higher in the AGD group than in the PD group (81.4 vs. 58.5%; P=0.031). The results of a quality-of-life survey indicated that the proportion of patients with no or minimal impact on daily life in the vomiting domain was significantly higher in the AGD group (79.1 vs. 53.7%; P=0.020). The primary endpoint of complete response was not achieved, but AGD seems to be more effective than PD for the prevention of HEC-induced vomiting.
authors.affiliation: aDepartment of Gastroenterology, Kitasato University School of Medicine bSchool of Medicine, Research and Development Center for New Frontier, Kitasato University, Sagamihara, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishido
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Higuchi
authors.forename: Mizutomo
authors.initials: M
authors.lastname: Azuma
authors.forename: Tohru
authors.initials: T
authors.lastname: Sasaki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.forename: Chikatoshi
authors.initials: C
authors.lastname: Katada
authors.forename: Takafumi
authors.initials: T
authors.lastname: Yano
authors.forename: Takuya
authors.initials: T
authors.lastname: Wada
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D000077608:Aprepitant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018592:Cross-Over Studies; D003907:Dexamethasone / Q000627:therapeutic use; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005260:Female; D017829:Granisetron / Q000627:therapeutic use; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D000077924:Palonosetron; D011812:Quinuclidines / Q000627:therapeutic use; D012702:Serotonin Antagonists / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000077608:Aprepitant; D002945:Cisplatin; D003907:Dexamethasone; D017829:Granisetron; D007546:Isoquinolines; D009025:Morpholines; D000077924:Palonosetron; D011812:Quinuclidines; D012702:Serotonin Antagonists