title: Efficacy of palonosetron and 1-day dexamethasone in moderately emetogenic chemotherapy compared with fosaprepitant, granisetron, and dexamethasone: a prospective randomized crossover study.
abstract: BACKGROUND
  Although palonosetron (PALO) and NK1 receptor antagonist both reduce chemotherapy-induced nausea and vomiting, no comparison trial in moderately emetogenic chemotherapy (MEC) had been reported. The purpose of this study was to find out which drug combinations are preferable for patients receiving MEC.
  
  
  METHODS
  Chemotherapy-naive patients receiving MEC were randomized to two groups; group A first received PALO therapy [PALO plus 1-day dexamethasone (DEX)], and group B first received fosaprepitant (FAPR) therapy [FAPR, granisetron (GRAN), and DEX]. Patients were re-allocated to the other therapy, respectively, for the second cycle of chemotherapy. We administered intravenous PALO (0.75 mg) and DEX (9.9 mg) to the PALO therapy group, and FAPR (150 mg), DEX (4.95 mg), and GRAN (3 mg) to the FAPR therapy group, on Day 1. Complete response (CR) was the primary endpoint; complete control (CC), total control (CT), and the therapy chosen by the patients for their third and following cycles of antiemetic therapy were the secondary endpoints. We evaluated CR, CC, and TC in the acute phase, in the delayed phase, and over the whole period.
  
  
  RESULTS
  A total of 35 patients and 70 cycles of therapy was evaluable for analysis. No significant difference was found at all evaluation points. Overall CR rates for PALO and FAPR therapy were 74 vs 69 % (P = 0.567), CC rates 66 vs 69 % (P = 0.521), and TC rates 46 vs 60 % (P = 0.235), respectively. Patients also showed no clear preference for their third and following cycles of chemotherapy, choosing both regimens almost equally often (PALO 10 vs FAPR 13).
  
  
  CONCLUSIONS
  PALO and 1-day DEX is almost equivalent to FAPR, GRAN, and DEX for MEC.
authors.affiliation: Department of Medical Oncology, Tonan Hospital, Kita 1 Jo Nishi 6 Chome, Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan. m02032hk@jichi.ac.jp.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kitayama
authors.affiliation: Department of Medical Oncology, Tonan Hospital, Kita 1 Jo Nishi 6 Chome, Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Tsuji
authors.affiliation: Department of Medical Oncology, Tonan Hospital, Kita 1 Jo Nishi 6 Chome, Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan.
authors.forename: Junko
authors.initials: J
authors.lastname: Sugiyama
authors.affiliation: Department of Medical Oncology, Tonan Hospital, Kita 1 Jo Nishi 6 Chome, Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan.
authors.forename: Ayako
authors.initials: A
authors.lastname: Doi
authors.affiliation: Department of Medical Oncology, Tonan Hospital, Kita 1 Jo Nishi 6 Chome, Chuo-ku, Sapporo, Hokkaido, 060-0001, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kondo
authors.affiliation: Department of Gastroenterological Medicine, Tonan Hospital, Hokkaido, Japan.
authors.forename: Michiaki
authors.initials: M
authors.lastname: Hirayama
mesh_terms: D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects; D018592:Cross-Over Studies; D003907:Dexamethasone / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; 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; D057240:Patient Preference; D011446:Prospective Studies; D011812:Quinuclidines / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D003907:Dexamethasone; D017829:Granisetron; D007546:Isoquinolines; D009025:Morpholines; D000077924:Palonosetron; D011812:Quinuclidines; C579707:fosaprepitant
keywords: 1-Day dexamethasone; Chemotherapy-induced nausea and vomiting; Fosaprepitant; Granisetron; Moderately emetogenic chemotherapy; Palonosetron
references.citation: Ann Oncol. 2006 Jan;17(1):20-8
references.pmid: 16314401
references.citation: J Pain Symptom Manage. 2007 Aug;34(2):148-59
references.pmid: 17509816
references.citation: Ann Oncol. 2010 May;21(5):1083-8
references.pmid: 20080830
references.citation: J Pharmacol Exp Ther. 2010 Nov;335(2):362-8
references.pmid: 20724484
references.citation: J Clin Oncol. 2011 Nov 1;29(31):4189-98
references.pmid: 21947834
references.citation: Support Care Cancer. 2010 Sep;18(9):1171-7
references.pmid: 19756774
references.citation: Support Care Cancer. 2010 Apr;18(4):423-31
references.pmid: 19568773
references.citation: Ann Oncol. 2006 Sep;17(9):1441-9
references.pmid: 16766588
references.citation: Support Care Cancer. 2011 Aug;19(8):1217-25
references.pmid: 20574663
references.citation: J Natl Cancer Inst. 2012 Sep 5;104(17):1280-92
references.pmid: 22911671
references.citation: J Clin Oncol. 2011 Apr 10;29(11):1495-501
references.pmid: 21383291
references.citation: N Engl J Med. 2008 Jun 5;358(23):2482-94
references.pmid: 18525044
references.citation: Support Care Cancer. 2005 Apr;13(4):219-27
references.pmid: 15538640
references.citation: Anesth Analg. 2008 Aug;107(2):469-78
references.pmid: 18633025
references.citation: Nat Clin Pract Oncol. 2005 Apr;2(4):196-201
references.pmid: 16264934
references.citation: Cancer Chemother Pharmacol. 2011 Sep;68(3):653-9
references.pmid: 21125277