CONTROL OF EMESIS BY INTRAVENOUS GRANISETRON IN BREAST-CANCER PATIENTS TREATED WITH 5-FU, EPIRUBICIN AND CYCLOPHOSPHAMIDE

Granisetron, a potent and selective 5-hydroxytryptamine receptor (5-HT 3) antagonist was reported to be an effective antiemetic agent both in animal studies and in patients given highly emetogenic chemotherapy. A sample of 43 patients with breast cancer was accrued from September to November 1992 in a phase II study to assess the efficacy of granise tron in patients receiving FEC (5-FU, epirubicin, cyclophosphamide). E ach patient received 3 mg intravenous granisetron as a single dose jus t prior to chemotherapy. Oral metoclopromide was prescribed to each pa tient as a rescue anti-emetic. The emetic episodes and degree of nause a were evaluated on a daily basis. Good control of emesis (0-2 episode s of vomiting) and nausea (mild or no nausea) was in the range 77%-98% and 77%-93% respectively. There was a complete response (no emetic ep isodes throughout the 6-day period) in 16 patients (37.2%). Onset of e mesis tends to occur on day 1 and tend to subside after day 3; 85% of patients had onset of emesis in the first 2 days after chemotherapy. C ontrol of emesis and nausea tends to improve after day 3, which could be the result of the reduced emetogenicity of the combination FEC with time. Altogether, 77% had good control of acute emesis; control of de layed emesis was better with 84% achieving a major response on day 2 a fter chemotherapy, which improved to more than 90% after day 4. Granis etron was generally tolerated with headache being the most common side -effect followed by constipation and flushing. This study suggests tha t granisetron is an effective and well-tolerated anti-emetic agent, wh ich deserves randomised trials to elucidate its efficacy further.