Oral granisetron for the prevention of acute late onset nausea and vomiting in patients treated with moderately emetogenic chemotherapy.
OBJECTIVE
To demonstrate the efficacy of oral granisetron 1 mg twice daily for the prevention of late onset nausea and vomiting after moderately emetogenic chemotherapy that includes cyclophosphamide, carboplatin, or doxorubicin.


METHODS
Prior to chemotherapy, patients were stratified by gender and randomized to receive oral granisetron (1 mg tablet twice daily) or prochlorperazine (10 mg sustained release capsule twice daily). Study agents were administered 1 h prior to and 12 h after chemotherapy. Antiemetics were administered for seven consecutive days. Efficacy variables were assessed 48 and 72 h after administration of chemotherapy, and included no emesis, no nausea, no moderate or severe nausea, and no antiemetic rescue. Safety analysis included all patients who received medication.


RESULTS
A total of 230 patients were included in the intent-to-treat analysis; 119 patients received granisetron and 111 patients received prochlorperazine. Females, and all patients combined, who received granisetron had significantly higher no-emesis rates at 48 h (p =.010 and p =.016, respectively) than patients who received prochlorperazine. No-nausea rates at 48 h were numerically higher for all patients combined and females who received granisetron rather than prochlorperazine. Response rates for no nausea or mild nausea were also numerically higher in females treated with granisetron, compared to prochlorperazine, at 48 h. Significantly more patients (p <.001) and females (p <.001) in the granisetron group than in the prochlorperazine group did not require rescue antiemetics at 48 h. At 72 h, efficacy results were comparable for granisetron and prochlorperazine.


CONCLUSIONS
Oral granisetron is well tolerated and more effective than prochlorperazine in preventing nausea and vomiting for up to 48 h following treatment with moderately emetogenic chemotherapy.
Friedman
C J
CJ
Clinical Research and Development, North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA.
Burris
H A
HA
Yocom
K
K
Blackburn
L M
LM
Gruben
D
D
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D016190:Carboplatin / Q000009:adverse effects; D003520:Cyclophosphamide / Q000009:adverse effects; D004311:Double-Blind Method; D004317:Doxorubicin / Q000009:adverse effects; D005260:Female; D017829:Granisetron / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D011346:Prochlorperazine / Q000008:administration & dosage; D012737:Sex Factors; D014840:Vomiting, Anticipatory / Q000209:etiology / Q000517:prevention & control*
D000932:Antiemetics; D000970:Antineoplastic Agents; D016190:Carboplatin; D003520:Cyclophosphamide; D004317:Doxorubicin; D017829:Granisetron; D011346:Prochlorperazine