Antiemetic efficacy of ondansetron and metoclopramide, both combined with corticosteroid, in malignant lymphoma patients receiving non-cisplatin chemotherapy.

The aim of the present study was to compare the antiemetic efficacy of ondansetron (OND) with metoclopramide (MCP), both combined with corticosteroid (CS) in patients with malignant lymphoma. A total of 109 patients with malignant lymphoma receiving their first series of non-cisplatin chemotherapy (CT) (CHOP or MOPP) were divided into prospective, randomized, open and parallel groups and analyzed at two hematological centres at university hospitals in Copenhagen, Denmark. The patients were randomized to receive one of the two following regimens; 1) OND 8 mg/methylprednisolone 80 mg i.v. before CT and OND 8 mg p.o. after 8 h and at bedtime. OND 8 mg tid days 2-3, and 8 mg tid prn days 4-5 and prednisolone 75-100 mg qds days 2-5 and 2) MCP 30 mg/metylprednisolone 80 mg i.v. before CT and MCP 20 mg p.r. after 4 and 8 h respectively. MCP 20 mg p.r. prn days 1-5 and prednisolone 75-100 mg qds days 2-5. In the acute phase OND/CS was superior to MCP/CS in the control of nausea and emesis, resulting in no emesis in 92% of the OND/CS treated group vs. 50% treated with MCP/CS (p < 0.001), and no nausea in 79% (OND/CS) vs. 42% (MCP/CS) (p < 0.001). The ultimate aim - neither nausea nor emesis - was reached in 77% (OND/CS) vs. 35% (MCP/CS) day 1 (p < 0.001). OND/CS is significantly better than MCP/CS in the control of delayed nausea, 81% (OND/CS) vs. 58% (MCP/CS) (p < 0.026). Both the OND/CS and MCP/CS regimens are highly effective in the control of delayed emesis, 94% (OND/CS) vs. 85% (MCP/CS) (p < 0.26). Adverse events were mild and experienced in 31% of the patients. In the OND/CS group 13% had constipation vs. 8% in the MCP/CS group. Nine percent treated with OND/CS had headaches compared to none treated with MCP/CS (p < 0.08). One extrapyramidal reaction was recorded in the MCP/CS group. In malignant lymphoma patients receiving moderately emetogenic CT, the combination of OND and CS was very effective and significantly better than low dose MCP and CS in the control of acute emesis, acute nausea and delayed nausea.

RCT Entities:   Population Interventions Outcomes