A randomized double-blind trial to compare the clinical efficacy of granisetron with metoclopramide, both combined with dexamethasone in the prophylaxis of chemotherapy-induced delayed emesis.
BACKGROUND
The prophylactic use of 5-HT(3) receptor antagonists (setrons), after the first 24 h (acute phase) of exposure to emetic chemotherapy, to decrease the incidence of 'delayed phase' emesis increases costs. We designed a study to evaluate the efficacy of a setron (granisetron) in the delayed phase, compared with metoclopramide, each combined with a corticosteroid.


METHODS
Patients on their first course of single-day emetic chemotherapy (cisplatin, carboplatin, doxorubicin, cyclophosphamide and others) received granisetron 2 mg p.o. and dexamethasone 8 mg p.o. on day 1, followed for 5 days by dexamethasone 4 mg p.o. od combined with either metoclopramide 20 mg p.o. tds or granisetron 1 mg bd in a double-blinded double-dummy protocol. Patients evaluated the results using a diary card. Randomization was stratified by institution, sex, emetic chemotherapy naïve versus previous, alcohol consumption and platinum versus non-platinum regimen.


RESULTS
131 evaluable patients received granisetron in the delayed phase, and 127 received metoclopramide. Control of acute emesis in both arms was similar (86% granisetron; 85% metoclopramide). The 35 patients experiencing acute emesis had poor control in the delayed phase, with only four granisetron and three metoclopramide patients having no or mild nausea and no vomiting.


CONCLUSIONS
In daily practice, a combination of oral dexamethasone and oral granisetron achieves an extremely high control of acute emesis (86% protection). Our data suggest that routine prescription of setrons for delayed phase control is not advisable as it increases costs without any benefit for the majority of patients. Delayed emesis in the rare patients with acute phase emesis remains an unsolved problem.
Aapro
M S
MS
Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Vaud, Switzerland. aapro@cdg.ch
Thuerlimann
B
B
Sessa
C
C
De Pree
C
C
Bernhard
J
J
Maibach
R
R
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000009:adverse effects* / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000494:pharmacology*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D017829:Granisetron; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage / Q000494:pharmacology*; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control*
D000932:Antiemetics; D003907:Dexamethasone; D017829:Granisetron; D008787:Metoclopramide