A randomized cross-over study of high-dose metoclopramide plus dexamethasone versus granisetron plus dexamethasone in patients receiving chemotherapy with high-dose cisplatin.
We carried out a randomized, single-blind, cross-over trial to compare the antiemetic effect, for both acute and delayed emesis, of granisetron plus dexamethasone (GRN+Dx) with that of high-dose metoclopramide plus dexamethasone (HDMP+Dx). Fifty-four patients with primary or metastatic lung cancer, given single-dose cisplatin (> 80 mg/m2) chemotherapy more than twice, were enrolled in this study. They were treated with both HDMP+Dx and GRN+Dx in two consecutive chemotherapy courses. On day 1, patients experienced a mean of 2.5 (SD = 4.3) and 0.1 (SD = 0.4) episodes of vomiting in the HDMP+Dx and the GRN+Dx groups, respectively (P = 0.0008). Complete response rate on day 1 was 45 and 90% in the HDMP+Dx and the GRN+Dx groups, respectively (P = 0.0001). Patients treated with GRN+Dx had a tendency to suffer more episodes of vomiting than the HDMP+Dx group on days 2-5, but it was not statistically significant. Twenty-four patients (57%) preferred the GRN+Dx treatment and 14 patients (33%), HDMP+Dx. In the HDMP+Dx group, nine patients (21%) had an extrapyramidal reaction, and 5 patients (12%) had constipation that lasted for at least two days. In contrast, no patients had extrapyramidal reactions, and 18 patients (43%) had constipation in the GRN+Dx group (P < 0.01). GRN+Dx was more effective than HDMP+Dx only in preventing the acute emesis induced by cisplatin. An effective treatment for delayed emesis is still needed.
Ohmatsu
H
H
Department of Internal Medicine and Thoracic Oncology, National Cancer Center Central Hospital, Tokyo.
Eguchi
K
K
Shinkai
T
T
Tamura
T
T
Ohe
Y
Y
Nisio
M
M
Kunikane
H
H
Arioka
H
H
Karato
A
A
Nakashima
H
H
D000328:Adult; D000368:Aged; D002945:Cisplatin / Q000009:adverse effects*; 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; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D015999:Multivariate Analysis; D009325:Nausea / Q000517:prevention & control*; D016037:Single-Blind Method; D014839:Vomiting / Q000517:prevention & control*
D002945:Cisplatin; D003907:Dexamethasone; D017829:Granisetron; D008787:Metoclopramide