Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy. National Cancer Institute of Canada Clinical Trials Group.
OBJECTIVE
To evaluate the roles of granisetron and dexamethasone for emesis control on days 2 through 7 after the administration of cisplatin in doses of 50 mg/m2 or greater to patients who had not previously received chemotherapy.


METHODS
Four hundred thirty-five eligible and assessable patients were randomized to one of two arms in a double-blind fashion: arm A; granisetron 3 mg intravenous (i.v.) plus dexamethasone 10 mg i.v. prechemotherapy followed by granisetron 1 mg orally at 6 and 12 hours, then granisetron 1 mg orally and dexamethasone 8 mg orally twice daily on days 2 through 7 (219 patients); arm B; as in arm A but with placebo substituted for granisetron on days 2 through 7 (216 patients). All patients completed diaries in which episodes of emesis and severity of nausea were recorded.


RESULTS
The addition of granisetron on days 2 through 7 had no discernable impact on nausea and vomiting during this period.


CONCLUSIONS
The administration of a 5-hydroxytryptamine3, receptor (5-HT3) antagonist, in this case granisetron, after 24 hours conferred no benefit. This negative result needs to be assessed in light of conflicting literature, but at present it does not appear that the routine use of these drugs in this setting is justified.
Latreille
J
J
Hôtel-Dieu de Montréal Hospital, Québec, Canada. jlatrei@cam.org
Pater
J
J
Johnston
D
D
Laberge
F
F
Stewart
D
D
Rusthoven
J
J
Hoskins
P
P
Findlay
B
B
McMurtrie
E
E
Yelle
L
L
Williams
C
C
Walde
D
D
Ernst
S
S
Dhaliwal
H
H
Warr
D
D
Shepherd
F
F
Mee
D
D
Nishimura
L
L
Osoba
D
D
Zee
B
B
D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002945:Cisplatin / Q000009:adverse effects*; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D017829:Granisetron / Q000627:therapeutic use*; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000932:Antiemetics; D000970:Antineoplastic Agents; D002945:Cisplatin; D003907:Dexamethasone; D017829:Granisetron; D012702:Serotonin Antagonists