A randomized trial comparing alizapride alone or with dexamethasone vs a metoclopramide-dexamethasone combination for emesis induced by moderate-dose cisplatin

Summary

To evaluate the antiemetic effectiveness and toxicity of a novel congener of metoclopramide (MCP), alizapride (AZP), 29 patients receiving cisplatin (50 mg/m²) alone or with adriamycin (40 mg/m²) were entered into a randomized cross-over trial comparing moderate-dose AZP (2 mg/kg for 4 doses) administered alone or with dexamethasone (DXM) (8 mg for five doses) vs a standard combination of MCP (1 mg/kg for four doses) and DXM (as above). With the dosage and schedule used, AZP provided only limited antiemetic protection, with less than 10% of the patients free of emesis. The AZP-DXM combination was significantly more effective than AZP alone in reducing the intensity of the emesis (P<0.03). The incidence, however, was statistically unaffected. The additional toxicity of DXM was negligible. Except for the patients' preference for MCP-DXM (P<0.01), no differences could be found between the DXM-based regimens, although a trend towards a better antiemetic effect with the MCP combination was evident. The benzamide-related dystonic reactions were equally distributed. Among the 11 patients affected there were 6 who required specific treatments. Unfavourable prognostic factors in the patient population could provide a reasonable explanation for the disappointing antiemetic protection obtained with all the regimens evaluated in this study.