title: Antiemetic effects of granisetron and dexamethasone combination therapy during cisplatin-containing chemotherapy for head and neck cancer: dexamethasone dosage verification trial.
abstract: BACKGROUND
  Chemotherapy-induced nausea and vomiting (CINV) remains a significant problem for patients and is associated with a substantial deterioration in quality of life; appropriate use of antiemetic drugs is crucial in maintaining the quality of life in patients undergoing chemotherapy.
  
  
  METHODS
  This randomized, crossover trial evaluated the antiemetic efficacy and safety of 8 mg per day (low-dose) and 16 mg per day (standard-dose) dexamethasone, in combination with the 5-HT(3) receptor antagonist granisetron, in 36 patients receiving cisplatin (CDDP)-containing chemotherapy for head and neck cancer. Following chemotherapy, the antinausea/vomiting inhibition rate for each dexamethasone dose was measured.
  
  
  RESULTS
  During the 24-h period following administration of chemotherapy (acute phase), the antinausea/vomiting inhibition rates (no nausea and no episodes of vomiting) for 8 mg and 16 mg dexamethasone were comparably high (58.3% and 63.8%, respectively; P = 0.8092). Similar results were seen on days 2-5 following chemotherapy. Efficacy during the acute phase, based on the number of instances of vomiting and degree of nausea, was also comparably high for the two dexamethasone doses (overall efficacy rates were 94.4% and 88.8%, respectively, for 8 mg and 16 mg dexamethasone; P = 0.7637). Both doses maintained an 80% or higher response rate until day 3, and neither dose produced severe side effects.
  
  
  CONCLUSIONS
  The results suggest that granisetron and dexamethasone combination therapy is useful in controlling acute and delayed nausea and vomiting induced by CDDP-containing chemotherapy for head and neck cancer. Furthermore, 8 mg and 16 mg dexamethasone have equivalent antiemetic efficacy.
authors.affiliation: Department of Otolaryngology, and Head and Neck Surgery, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan. mtsukuda@med.yokohama-cu.ac.jp
authors.forename: Mamoru
authors.initials: M
authors.lastname: Tsukuda
authors.forename: Junichi
authors.initials: J
authors.lastname: Ishitoya
authors.forename: Yasukazu
authors.initials: Y
authors.lastname: Mikami
authors.forename: Hideki
authors.initials: H
authors.lastname: Matsuda
authors.forename: Hideaki
authors.initials: H
authors.lastname: Katori
authors.forename: Choichi
authors.initials: C
authors.lastname: Horiuchi
authors.forename: Machiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Takahide
authors.initials: T
authors.lastname: Taguchi
authors.forename: Takafumi
authors.initials: T
authors.lastname: Yoshida
authors.forename: Junichi
authors.initials: J
authors.lastname: Nagao
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Sakuma
authors.forename: Gabor
authors.initials: G
authors.lastname: Toth
mesh_terms: D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001066:Appetite / Q000187:drug effects; D002945:Cisplatin; D018592:Cross-Over Studies; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D017829:Granisetron / Q000008:administration & dosage* / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009367:Neoplasm Staging; D058831:Serotonin 5-HT3 Receptor Antagonists; D012702:Serotonin Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D002945:Cisplatin; D003907:Dexamethasone; D017829:Granisetron; D058831:Serotonin 5-HT3 Receptor Antagonists; D012702:Serotonin Antagonists
references.citation: Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):13-47
references.pmid: 10758303
references.citation: Gan To Kagaku Ryoho. 2000 Sep;27(10):1557-63
references.pmid: 11016001
references.citation: Support Care Cancer. 2002 Oct;10(7):519-22
references.pmid: 12324805
references.citation: Oncologist. 2004;9(6):673-86
references.pmid: 15561811
references.citation: Jpn J Clin Oncol. 1996 Jun;26(3):164-8
references.pmid: 8656557
references.citation: Br J Cancer. 2006 Apr 10;94(7):1011-5
references.pmid: 16552437
references.citation: J Clin Oncol. 2000 Oct 1;18(19):3409-22
references.pmid: 11013282
references.citation: Ann Oncol. 1996 Feb;7(2):189-95
references.pmid: 8777177
references.citation: Eur J Cancer Clin Oncol. 1983 Feb;19(2):203-8
references.pmid: 6681766
references.citation: Anticancer Drugs. 1998 Jun;9(5):381-5
references.pmid: 9660533
references.citation: Cancer. 2005 Aug 15;104(4):864-8
references.pmid: 15973669
references.citation: Chemotherapy. 2005 Aug;51(5):280-5
references.pmid: 16103667
references.citation: Endocr J. 2001 Dec;48(6):723-6
references.pmid: 11873873
references.citation: BMJ. 1999 Nov 20;319(7221):1337-8
references.pmid: 10567137
references.citation: Gan To Kagaku Ryoho. 1992 Sep;19(11):1891-903
references.pmid: 1387775
references.citation: Eur J Cancer Care (Engl). 2005 Dec;14(5):435-9
references.pmid: 16274464
references.citation: Recent Prog Horm Res. 2004;59:333-57
references.pmid: 14749509
references.citation: J Bone Miner Metab. 2003;21(1):34-42
references.pmid: 12491092