title: Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy.
abstract: OBJECTIVE
  This study aimed to determine the antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor (TGCT) receiving 5-day cisplatin-based combination chemotherapy.
  
  
  METHODS
  An open-label, single-arm, multicenter study was performed in patients with TGCT who were scheduled to receive 5-day cisplatin-based combination chemotherapy. The antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2 to 5, and dexamethasone 9.9 mg on day 1 and 6.6 mg on days 2 to 8. The primary endpoint was complete response (CR) rate, which was defined as no vomiting and no rescue medication, in the overall period (0 to 216 h) in the first chemotherapy course. Incidence and severity of nausea were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) and a subjective rating scale completed by patients.
  
  
  RESULTS
  Thirty patients were included in the analysis. CR was achieved in 90.0% of the patients in the first chemotherapy course, and high CR rates were also observed in the second and third courses (82.1 and 78.3%, respectively). The incidence of nausea peaked on days 4 to 6 in about 50% of the patients. The reported adverse drug reactions were hiccups (13.3%), anorexia (3.3%), and stomach pain (3.3%). None of these were unexpected and none were grade 3 or 4.
  
  
  CONCLUSIONS
  The combination antiemetic therapy examined in this study was highly effective and well-tolerated in patients with TGCT receiving 5-day cisplatin-based combination chemotherapy.
authors.affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoecho, Sakyo-ku, Kyoto, 606-8501, Japan.
authors.forename: Shota
authors.initials: S
authors.lastname: Hamada
authors.forename: Shiro
authors.initials: S
authors.lastname: Hinotsu
authors.forename: Koji
authors.initials: K
authors.lastname: Kawai
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Yamada
authors.forename: Shintaro
authors.initials: S
authors.lastname: Narita
authors.forename: Tomomi
authors.initials: T
authors.lastname: Kamba
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nishiyama
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Arai
authors.forename: Tomonori
authors.initials: T
authors.lastname: Habuchi
authors.forename: Osamu
authors.initials: O
authors.lastname: Ogawa
authors.forename: Koji
authors.initials: K
authors.lastname: Kawakami
mesh_terms: D000328:Adult; D000932:Antiemetics / Q000009:adverse effects* / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000077608:Aprepitant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy; D000077924:Palonosetron; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use; D013736:Testicular Neoplasms / Q000188:drug therapy; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D009025:Morpholines; D011812:Quinuclidines; D000077608:Aprepitant; D000077924:Palonosetron; D003907:Dexamethasone; D002945:Cisplatin