title: Alizapride alone or alizapride-dexamethasone compared with metoclopramide-dexamethasone in patients at high risk of acute emesis after cisplatin. A randomized cross-over study.
abstract: Alizapride (ALZ) is a new benzamide derivative with promising antiemetic activity. In the present study, high-dose ALZ (16 mg/kg) alone or in combination with dexamethasone (DXM, 40 mg) was compared to a combination of DXM (40 mg) and metoclopramide (MCP, 4 mg/kg) in a randomized cross-over trial conducted on 21 out-patients at high emetic risk after moderate-dose cisplatin. All but 3 patients completed the planned cross-over trial for a total of 60 evaluable courses. The patients completed a self assessment questionnaire evaluating the severity and duration of both nausea and vomiting, the toxicity, as well as their subjective opinion of the antiemetic trial. At the dose and schedule employed, ALZ alone or in combination with DXM provided not only a significantly lower rate of complete protection against nausea and vomiting (0 and 4.8%) than MCP + DXM (28.6%) but was also less effective in reducing the number of vomiting episodes and the duration of the vomiting. In addition, the MCP - DXM regimen was the most frequently preferred. Except for one case of orthostatic hypotension following ALZ, benzamide-induced toxicity was mild, whereas that related to DXM was negligible. The results of this study suggest that high-dose ALZ gives no advantage compared to MCP in patients at high risk for emesis after moderate-dose cisplatin.
authors.affiliation: Division of Medical Oncology I, Regina Elena Institute for Cancer Research, Rome, Italy.
authors.forename: C F
authors.initials: CF
authors.lastname: Pollera
authors.forename: M
authors.initials: M
authors.lastname: Nardi
authors.forename: P
authors.initials: P
authors.lastname: Marolla
authors.forename: F
authors.initials: F
authors.lastname: Calabresi
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects*; D003907:Dexamethasone / Q000627:therapeutic use*; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D014839:Vomiting / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D011759:Pyrrolidines; D003907:Dexamethasone; C033968:alizapride; D002945:Cisplatin