F. Roila et al., DEXAMETHASONE, GRANISETRON, OR BOTH FOR THE PREVENTION OF NAUSEA AND VOMITING DURING CHEMOTHERAPY FOR CANCER, The New England journal of medicine, 332(1), 1995, pp. 1-5
Background. Serotonin-receptor antagonists seem to be as effective as
corticosteroids in preventing emesis induced by moderately emetogenic
antineoplastic agents. We compared the antiemetic effect of a combinat
ion of granisetron and dexamethasone with that of granisetron or dexam
ethasone administered alone. Methods. From December 1992 to January 19
94, 428 consecutive patients who were to receive moderately emetogenic
chemotherapy for the first time (600 to 1000 mg of cyclophosphamide p
er square meter of body-surface area, greater than or equal to 50 mg o
f doxorubicin per square meter, greater than or equal to 75 mg of epir
ubicin per square meter, or greater than or equal to 300 mg of carbopl
atin per square meter, alone or in some combination) were enrolled in
a double-blind, randomized, multicenter study evaluating the efficacy
and toxicity of three antiemetic regimens. The following antiemetic re
gimens were used: 8 mg of dexamethasone given intravenously before che
motherapy plus 4 mg given orally immediately before chemotherapy and t
hen every six hours for a total of four doses, 3 mg of granisetron giv
en intravenously be fore chemotherapy, or a combination of granisetron
and dexamethasone given in the doses used for the single-drug regimen
s. Results. We evaluated 408 patients (136 receiving dexamethasone, 13
7 receiving granisetron, and 135 receiving both drugs), In the first 2
4 hours after chemotherapy, complete protection from vomiting and comp
lete protection from nausea were achieved in 70.6 and 55.1 percent, re
spectively, of the patients receiving dexamethasone, in 72.3 and 48.2
percent of those receiving granisetron, and in 92.6 and 71.9 percent o
f those receiving granisetron combined with dexamethasone (P<0.001 for
all comparisons). Patients who received granisetron alone had less pr
otection from delayed vomiting and nausea than those who received dexa
methasone alone or the two drugs combined. All the regimens were equal
ly well tolerated. Conclusion. Granisetron combined with dexamethasone
was the most effective regimen for the prevention of emesis induced b
y moderately emetogenic chemotherapy.